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Item 1. Business

2023-08-16 compared with 2022-09-27 · 681 added, 588 removed, 12 unchanged (99% of the section changed)

is a clinical-stage company developing innovative drug therapies

to overcome unmet medical needs in chronic debilitating conditions.

In liver disease , our Orphan Drug candidate BIV201 (continuous

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

complications of advanced liver cirrhosis caused by NASH, hepatitis, and alcoholism.

The initial target for BIV201 therapy is refractory

These patients suffer from frequent life-threatening complications, generate

more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months.

The US Food and Drug Administration

(FDA) has not approved any drug to treat refractory ascites.

A Phase 2a clinical trial of BIV201 was completed in 2019, and a multi-center,

randomized 30-patient Phase 2b trial is currently underway.

As of June 30, 2022, eleven US study centers had been activated and are actively

screening and enrolling patients in the study.

Top-line results from this trial are expected in mid calendar year 2023.

The BIV201 development program was initiated by LAT Pharma LLC.

11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program.

The Company currently owns all development

and marketing rights to its drug candidate.

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

In neurodegenerative disease, BioVie acquired the biopharmaceutical

assets of NeurMedix, Inc., a related party privately held clinical-stage pharmaceutical company and related party affiliate, in June 2021.

The acquired assets include NE3107, a potentially selective inhibitor of inflammatory ERK signaling that, based on animal studies, is

believed to reduce neuroinflammation.

NE3107is a novel orally administered small molecule that is thought to inhibit inflammation-driven

insulin resistance and major pathological inflammatory cascades with a novel mechanism of action.

There is emerging scientific consensus

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

Disease, and NE3107 could, if approved, represent an entirely new medical approach to treating these devastating conditions affecting

an estimated 6 million Americans suffering from Alzheimer’s and 1 million from Parkinson’s.

The FDA has authorized a potentially

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

mild to moderate Alzheimer’s disease (NCT04669028).

We initiated this trial on August 5, 2021 and are targeting primary completion

in mid calendar year 2023.

On January 20, 2022, the Company initiated a study by treating the first patient, in its Phase 2 study assessing

NE3107’s safety and tolerability and potential pro-motoric impact in Parkinson’s disease patients.

The NM201 study (NCT05083260)

is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinson’s Disease (PD).

will be treated with carbidopa/levodopa and NE3107 or placebo.

Forty patients with a defined PD medication “off state” will

be randomized 1:1 placebo to active NE3107 20 mg twice daily for 28 days.

Safety assessments will look at standard measures of patient

health and potential for drug-drug interactions affecting L-dopa pharmacokinetics and activity.

Exploratory efficacy assessments will

use the Motor Disease Society Unified Parkinson’s Disease Rating (MDS-UPDRS) parts 1-3, ON/OFF Diary, and Non-Motor Symptom Scale.

Topline results are expected for the NM201 study by the end of the calendar year 2022.

Investigator-Initiated Trial in MCI and Mild Alzheimer’s Disease,

The Company provided the financial support and the use of our NE3107

formulated drug product to The Regenesis Project of Dr Sheldon Jordan in an open-label phase 2 study in Dr.

Sheldon’s patients

with Alzheimer’s disease related dementias.

The study received FDA authorization on December 12, 2021and was designed to measure

NE3107’s effect on cognition, cerebral spinal fluid (“CSF”) and blood biomarkers, and neuro-imagining endpoints.

study seeks to measure changes in cognition through verbal and visual test procedures and changes in biomarkers of Alzheimer's disease

and inflammatory and metabolic parameters that can be measured in the central nervous system with advanced neuroimaging techniques in

patients before and after treatment with 20 mg of NE3107 twice daily for 3 months following three months of treatment.

Data analysis for the study is expected to be in completed in second half

of the calendar year 2022.

Inflammation-driven insulin resistance is believed to be implicated

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

(the Company or we or our) is a clinical-stage company developing innovative drug therapies

for the treatment of neurological and neurodegenerative disorders and advanced liver disease.

Neurodegenerative

Disease Program

In neurodegenerative disease, the Company’s

drug candidate NE3107 inhibits inflammatory activation of extracellular single-regulated kinase (“ERK”) and Nuclear factor kappa-light-chain-enhancer

of activated B cells (“NFkB”) (e.g., tumor necrosis factor (“TNF”) signaling) that leads to neuroinflammation

and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival).

Both inflammation

and insulin resistance are drivers of Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”).

Company is conducting a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to

evaluate NE3107 in patients who have mild to moderate Alzheimer’s disease (NCT04669028).

The Company is targeting primary completion

of this study in the fourth quarter of calendar year 2023.

December 2022, topline results were released from the Company’s Phase 2 study assessing NE3107’s safety and tolerability

and potential pro-motoric impact in PD patients.

The NM201 study (NCT05083260) was a double-blind, placebo-controlled, safety, tolerability,

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

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

state” were randomized 1:1 to placebo:NE3107 20 mg twice daily for 28 days.

The trial was launched with two design objectives:

1) the primary objective was safety and a drug-drug interaction study (as requested by the U.S.

Food and Drug Administration (“FDA”)) to demonstrate the absence of adverse interactions of NE3107 with levodopa;

and 2) the secondary objective was to determine

if preclinical indications of promotoric activity and apparent enhancement of levodopa activity observed in a Parkinson’s disease

model in monkeys can be seen in humans.

Both objectives of the study were met.

Patients treated with NE3107 experienced greater motor

Company provided the financial support and the use of our NE3107 formulated drug product for an open-label phase 2, Investigator-Initiated

Trial in mild cognitive impairment (“MCI”) and Mild AD, NCT05227820, conducted by (“The Regenesis Project”)

Sheldon Jordan.

The study received FDA authorization on December 12, 2021 and was designed to measure NE3107’s effect on cognition,

cerebral spinal fluid (“CSF”) and blood biomarkers, and neuro-imagining endpoints.

Topline results were released September

7, 2022, and additional data was presented at the Clinical Trial in Alzheimer’s Disease (“CTAD”) annual conference in

December 2022.

The data showed that three months of treatment with NE3107 in patients with MCI and mild AD enhanced cognition compared

to baseline, as measured using multiple rating scales, had improvement in daily function and improvements in inflammation correlated with

improved cognition.

No drug-related adverse events were observed.

Company acquired the biopharmaceutical assets of NeurMedix, Inc.

(“NeurMedix”), from a related party privately held clinical-stage

pharmaceutical company, in June 2021.

The acquired assets included NE3107, a potentially selective inhibitor of inflammatory ERK signaling that, based on animal studies and Dr.

Jordan’s study, is believed to reduce

neuroinflammation.

NE3107 is a novel orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance

and major pathological inflammatory cascades with a novel mechanism of action.

There is emerging scientific consensus that both inflammation

and insulin resistance may play fundamental roles in the development of AD and PD, and NE3107 could, if approved by the FDA represent

a new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD and 1 million

Americans suffering from PD.

Inflammation-driven

insulin resistance is believed to be implicated in a broad range of serious diseases, and we plan to begin exploring these opportunities

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

NE3107 is patented in the United States

Australia, Canada, Europe and South Korea.

Liver Cirrhosis Program

BioVie’s orphan drug candidate BIV201 (continuous infusion terlipressin)

represents a novel approach to the treatment of ascites due to chronic liver cirrhosis.

BIV201 is based on a drug that is approved in

about 40 countries to treat related complications of liver cirrhosis (part of the same disease pathway as ascites), but not yet available

in the United States.

The active agent in BIV201, terlipressin, is a potent vasoconstrictor and is marketed in multiple foreign countries.

The goal of BIV201 therapy is to interrupt the ascites disease pathway, thereby halting the cycle of accelerated fluid generation in ascites

In 2017, we began administering BIV201 to patients at the McGuire Research

Institute Inc.

in Richmond, VA.

In April 2019, we announced top-line results for our Phase 2a clinical trial of BIV201 (continuous infusion

terlipressin) in six patients with refractory ascites due to advanced liver cirrhosis.

The following results were observed:

Continuous infusion of terlipressin via portable infusion pump was maintained for 28 days in three patients with refractory ascites, and all patients remained hemodynamically stable during treatment.

The steady state plasma concentration data characterized terlipressin pharmacokinetics (PK) within the predicted PK model concentrations.

Four of the six patients treated with BIV201 experienced an increase in the number of days between paracenteses ranging from 71% to 414% compared to prior to initiating therapy.

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

Meeting to plan our next clinical study in ascites.

We discussed our clinical development program with the FDA and proposed safety and

efficacy endpoints required for future marketing approval.

In September 2019, the FDA granted our Type B meeting request and committed

to providing feedback in early 2020 for our proposed clinical trial design.

In April 2020, we received the FDA’s written response

to our Type B meeting questions which required changes to our clinical trial design.

Subsequently we received further guidance from the

Based on this guidance, the Company finalized the clinical trial protocol and prepared for a randomized 30-patient Phase 2b study.

The IND for this study was submitted and has become effective.

The Phase 2b study was initiated in June 2021.

As of July 2022, eleven

planned US study centers have been activated.

We plan to follow this study with a larger potentially pivotal Phase 3 clinical trial expected

to begin in 2023.

The FDA communicated that pending positive Phase 2 study results, a sufficiently large and well-controlled Phase 3 trial,

with supportive trend data from the Phase 2b (statistical significance not required), could potentially yield the clinical data needed

to apply for BIV201 marketing approval.

The Phase 2b clinical trial protocol is summarized on www.clinicaltrials.gov, trial identifier

We have invented a proprietary novel liquid formulation of terlipressin

which is currently being studied in the above clinical studies intended to improve convenience for outpatient administration and avoid

potential formulation errors when pharmacists reconstitute the powder version.

In May 2020, we received CMC division clearance to use

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

testing which has been successfully completed.

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.

Room temperature storage presents a key product differentiation

versus terlipressin products in countries where the drug is approved.

To the best of the Company’s knowledge, all other terlipressin

products sold globally must be stored under refrigeration and there is no prefilled syringe format of terlipressin available for treating

patients in these countries.

BioVie has also filed a Patent Cooperation Treaty (“PCT”) application covering our novel liquid

formulations of terlipressin (international patent application PCT/US2020/034269, published as WO2020/237170) and we plan to seek patent

protection in at least the United States, Europe, China and Japan.

BIV201 (continuous infusion terlipressin) has the potential to improve

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

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

a significant unmet medical need.

Patients with cirrhosis and ascites account for an estimated 116,000 U.S.

hospital discharges annually,

with frequent early readmissions.

Those requiring paracentesis (removal of ascites fluid) experience an average hospital stay lasting

8 days incurring over $86,000 in medical costs (HCUP Nationwide Readmissions Database 2016).

This translates into a total addressable

ascites market size for BIV201 therapy exceeding $650 million based on Company estimates.

The FDA has never approved any drug specifically

for treating ascites.

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

has also received Orphan Drug designation for hepatorenal syndrome (“HRS”).

Patients with refractory ascites often progress

to HRS which is the onset of kidney failure and requires emergency hospitalization.

About one-half of these patients typically succumb

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

The BIV201 development program began at LAT Pharma LLC.

On April 11, 2016,

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

the product candidate.

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

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

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

net license revenues.

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

program and simultaneously paid the remaining balance due on a related debt.

PharmaIN’s rights to our program remain unchanged.

Our pending U.S patent (a continuation application related to the ’945 Patent) for the use of BIV201 as a monotherapy for the treatment

of patients diagnosed with ascites due to liver cirrhosis in the outpatient setting using ambulatory pump infusion, issued on June 21,

2022 (U.S 11,364,277).

Corresponding patent applications are pending in Japan, Europe, China and Hong Kong.

About Ascites and Liver Cirrhosis

Cirrhosis is a leading cause of death in the US.

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.

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 Mechanism of Action

BIV201 is being developed with the goal of alleviating the portal hypertension

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

retain excess salt and water.

If successful, BIV201 could halt the cycle of accelerating fluid generation in ascites patients and reduce

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

Future Possible BIV201 Indications

Based on international investigative studies of the active agent in BIV201,

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

as those listed below.

Securing marketing approvals for any of these new uses will require well-controlled clinical trials to satisfy

the FDA and/or other countries’ regulatory requirements, none of which have commenced at this time.

The Company may be unable to,

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

Bleeding Esophageal Varices (BEV):

The bursting of blood vessels lining the esophagus due to high blood pressure (“portal hypertension”) in the vein which supplies blood to the liver resulting as a result of advanced liver cirrhosis.

This situation requires emergency treatment to avoid blood loss and death.

Hepatorenal Syndrome-Acute Kidney Injury (HR/S-AKI):

As liver cirrhosis and ascites progress, the patients’ kidneys may begin to fail, and this deadly condition may set in.

It often occurs once a patient no longer responds to (off-label) drugs used to control ascites.

Treatment of HRS-AKI requires hospitalization as multiple organ failure and death may occur, typically within 2-4 weeks absent liver transplant.

We obtained Orphan Drug designation for BIV201 in the U.S.

for the treatment of HRS on November 21, 2018.

In May 2021, BioVie submitted a Type B Meeting Package to the FDA seeking to conduct a single pivotal US Phase 3 clinical trial in the treatment of HRS-AKI.

In June 2021, we received FDA feedback on the proposed trial design.

Agreement was reached on the key elements of a Phase 3 trial in the Preliminary Meeting Comments received from the FDA on April 15, 2022 in response to a subsequent Type C meeting request.

Neurodegenerative Disease Program

BioVie acquired the biopharmaceutical assets of NeurMedix, Inc., a privately

held clinical-stage pharmaceutical company and related party affiliate, in June 2021.

The acquired assets include NE3107, a potentially

selective inhibitor of inflammatory ERK signaling that, based on animal studies, is believed to reduce neuroinflammation.

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 and Parkinson’s Disease, and NE3107 could, if approved, represent an entirely

new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from Alzheimer’s

and 1 million from Parkinson’s.

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

parallel group, multicenter study to evaluate NE3107 in subjects who have mild to moderate Alzheimer’s disease (NCT04669028).

initiated this trial on August 5, 2021 and are targeting primary completion in mid calendar year of 2023.

Alzheimer’s Disease

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

is a neuroinflammatory and neurodegenerative condition characterized by progressive deterioration of cognitive function and loss of short-term

memory and executive function.

Cognitive tests quantifying AD severity have been exhaustively developed.

Formal diagnosis of AD has historically

been dependent on the presence of extraneuronal amyloid beta (A β ) 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 A β in peripheral blood and correlate well with

imaging results.

A β plaques can also be found in people without apparent

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

of disease pathology.

Scientific investigations in the past twenty years have provided strong

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

The link between

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

A large body of evidence supports inflammation as a primary driver of pathology

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

signaling in AD pathology.

NE3107 is believed to inhibit extracellular signal regulated kinase (ERK)/NFkB activation and TNF production

stimulated by inflammatory mediators, such as lipopolysaccharide.

Inhibition of NFkB activation and TNF production from this type of stimulation

has broad potential implications for reduction of pathological peripheral and central nervous system (CNS) inflammatory signaling in AD,

which include reduction of inflammation-driven insulin resistance, decreased inflammatory cell infiltration into the CNS, and decreased

microglia activation.

Reduction of systemic inflammation and inflammation driven insulin resistance are also predicted to have beneficial

effects on hypothalamus-pituitary-adrenal (HPA) axis dysregulation and hippocampal dysregulation of cortisol secretion that are consequences

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

Inflammation, insulin resistance, and associated metabolic

dysregulation in the brain contribute to A β oligomerization and aggregation,

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

causing neuronal dysfunction (cognitive impairment) and neurodegeneration.

NE3107’s combination of anti-inflammatory and insulin

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

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

insulin resistance and T2D are closely linked to AD pathology.

Insulin signaling is involved in synaptic plasticity, learning, and memory.

(“U.S.”), Australia, Canada, Europe and South Korea.

Disease Program

In liver disease, our Orphan Drug candidate BIV201

(continuous infusion terlipressin), with FDA Fast Track status, has been evaluated in a U.S.

Phase 2b study (NCT04112199) for the treatment

of refractory ascites due to liver cirrhosis.

BIV201 is administered as a patent-pending liquid formulation.

The study was closed before

full enrollment, without clinically meaningful adverse effects associated with BIV201 treatment and data that appeared to show that treatment

with BIV201 plus standard-of-care (“SOC”) resulted in a reduction in ascites fluid accumulation during treatment versus pre-treatment.

In June 2023, we requested 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.

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.

FDA has not approved any drug to treat

refractory ascites.

BIV201 development program was initiated by LAT Pharma LLC.

On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to

its BIV201 development program.

The Company 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 our 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.

Neurodegenerative

Disease Program

The Company is conducting a potentially pivotal

Phase 3 randomized, double blind, placebo controlled, parallel group, multicenter study to evaluate NE3107 in patients who have mild to

moderate AD (NCT04669028).

The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive

Scale (ADAS-Cog 12) and function using the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC).

The program is fully enrolled and is targeting primary completion in the fourth quarter of the calendar 2023 year.

The Company supported a Phase 2 exploratory biomarker

study (Investigator-Initiated Trial in MCI and Mild Alzheimer’s Disease, NCT05227820) showing that patients treated with NE3107

experienced improved cognition as measured by a modified ADAS-Cog12 score, reduced TNF- a (i.e.,

inflammation) in a manner that’s correlated to improvements in cognition, reduced CSF p-tau levels and the ratio of p-tau to A b 42 ,

and imaging findings suggestive of improved neuronal health.

Despite the open-label nature of the exploratory study, the emerging data

and correlations provide encouraging signs of what we may see in the upcoming Phase 3 data reveal.

The Phase 2 Study enrolled a total

of 23 patients – 17 patients with Mini-Mental State Examination (“MMSE”) scores greater than or equal to 20 (i.e., MCI

to mild AD) and 6 patients with MMSE <20 (i.e., moderate AD) – with an average age of 71.1 years.

This open-label, single arm

study was designed to measure changes in cognition through verbal and visual test procedures and changes in biomarkers of AD and inflammation

that can be measured in cerebral spinal fluid (“CSF”), blood samples, and functional magnetic resonance imaging in patients

before and after treatment with 20 mg of NE3107 twice daily for 3 months.

This data showed the following among patients with MMSE<20

(i.e., mild cognitive impairment and mild AD):

showed the potential to enhance cognition as measured by multiple assessment tools, including

a 2.1 point improvement (p=0.0173) on the modified ADAS-Cog12 scale equating to a 21.1% (p=0.0079)

change compared to baseline, a 0.11 point improvement (p=0.0416) on the Clinical Dementia

Rating scale (CDR), equating to 19.4% (p=0.0416) change from baseline, and a 0.07 point improvement

in the ADCOMS scale, equating to 27.4% improvement (p=0.009).

reduced CSF phospho-tau levels by -1.66 pg/mL (p=0.0343) and the ratio of p-tau to A b 42

by -0.0024 (p=0.0401)

of 22 patients with abnormal baseline scans showed improvement in one or more brain regions

as seen from advanced functional MRI studies.

drug-related adverse events were observed.

Other potential NE3107 effects on biomarkers of

aging-related disease states were indicated.

Blood samples were taken from the patients who participated in the investigator-initiated

Alzheimer’s Phase 2 trial before and after three months of treatment with NE3107, and these samples were analyzed to assess NE3107’s

potential to alter DNA methylation associated with epigenetic biological clocks.

The resulting data for patients

treated with NE3107 for three months showed an average reduction of 3.3 years (p=0.0021) on the Horvath DNA methylation SkinBlood clock.

Furthermore, 19 out of the 22 patients experienced a reduction in the SkinBlood clock score.

In July 2023, the Company presented a poster detailing

the epigenetic basis for how its drug candidate NE3107 may have the potential to regulate methylation of specific genes in a manner that

significantly correlated with observed cognitive and biomarker improvements at the Alzheimer’s Associate’s International Conference

(AAIC) held in Amsterdam from July 16 through July 20, 2023.

The poster presentation titled Treatment-Induced

Epigenetic Modifications in MCI and Probable Alzheimer’s (Reading C, et al.), showed how patients with clinical dementia treated

with NE3107 for three months saw significant reductions in the level of DNA methylation, and that such reductions were, in some cases,

significantly correlated with observed improvements in various cognitive measures (e.g., ADAS-Cog11, CDR, ADCOMS, QDRS) and biomarkers

(including TNFα, CSF p-Tau/Aβ 42 , precuneus glutathione).

Inflammation has been shown to be associated with

the hypermethylation of our DNA, [1] which in turn has been shown to impact a wide range of diseases, including various forms

of cancers, [2] age-related cognitive impairment and dementia, [3] Parkinson’s disease, [4] cardiovascular

disease, [3,5] COPD and respiratory disease, [6] chronic kidney disease, [7] inflammatory bowel disease, [8]

sepsis, [9] and many others.

The new data to be presented details how NE3107 may potentially change or affect the degree of

methylation of specific genes that are correlated with various markers of disease.

Inflammation and NE3107s Mechanism of Action

Neuroinflammation,

insulin resistance, and oxidative stress are common features in the major neurodegenerative diseases, including Alzheimers Disease

(AD), Parkinsons Disease (PD), frontotemporal lobar dementia, and Amyotrophic lateral sclerosis (ALS).

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.

NE3107s potential to inhibit

neuroinflammation and insulin resistance forms the basis for the Companys 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 resistance.

In preclinical and clinical studies, NE3107 reduced inflammation and enhanced insulin sensitivity,

both of which are important to PD pathology.

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

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

When NE3107 was administered

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

Furthermore, in the marmoset study, 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.

disease (AD), which affects an estimated 6 million Americans, is a neuroinflammatory and neurodegenerative condition characterized by

progressive deterioration of cognitive function and loss of short-term memory and executive function.

Cognitive tests quantifying AD

severity have been exhaustively developed.

Formal diagnosis of AD has historically been dependent on the presence of extraneuronal amyloid

beta (Aβ) plaques, which can only be observed at autopsy or with the aid of sophisticated radioimaging techniques.

However, diagnostic

methods have recently been approved that quantify Aβ in peripheral blood and correlate well with imaging results.

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

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.

The link between these factors and cognitive impairment are described by relatively new terms,

type 3 diabetes and metabolic-cognitive syndrome.

10.1111/j.1365-2796.2007.01777.x

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9, 18511 (2019)

A large body of evidence supports inflammation

as a primary driver of pathology in AD.

The major inflammation signaling node, NFkB, and the cytokine tumor necrosis factor (TNF) are

important initiators of inflammatory signaling in AD pathology.

NE3107 is believed to inhibit extracellular signal regulated kinase (ERK)/NFkB

activation and TNF production stimulated by inflammatory mediators, such as lipopolysaccharide.

Inhibition of NFkB activation and TNF

production from this type of stimulation has broad potential implications for reduction of pathological peripheral and central nervous

system (CNS) inflammatory signaling in AD, which include reduction of inflammation-driven insulin resistance, decreased inflammatory cell

infiltration into the CNS, and decreased microglia activation.

Reduction of systemic inflammation and inflammation-driven insulin resistance

are also predicted to have beneficial effects on hypothalamus-pituitary-adrenal (HPA) axis dysregulation and hippocampal dysregulation

of cortisol secretion that are consequences of adipose inflammation and insulin resistance, and are known to promote cognitive impairment,

and are also forward-feeding for insulin resistance.

Inflammation, insulin resistance, and associated

metabolic dysregulation in the brain contribute to Aβ oligomerization and aggregation, phospho-tau formation, reduced neuron survival

stimulus, and a forward-feeding cycle of neuronal energy deficit and oxidative stress, causing neuronal dysfunction (cognitive impairment)

and neurodegeneration.

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

disrupt this forward-feeding cycle of AD pathology.

Insulin has a major role in metabolic regulation

and neuron survival, while insulin resistance and T2D are closely linked to AD pathology.

Insulin signaling is involved in synaptic plasticity,

learning, and memory.

Exogenous insulin enhances cognition in normal and cognitively impaired subjects.

Insulin resistance is linked to cognitive impairment.

The multifactorial influence of insulin signaling on neuron survival and

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

on both cognition and disease progression.

Additional rationale for targeting metabolic dysregulation with NE3107 has come from recent

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

There is also 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 11 β -hydroxysteroid

dehydrogenase type 1 and adipocyte mineralocorticoid receptor activation.

Inflamed adipose tissue interacts with the HPA axis and hippocampus

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

blood-brain barrier.

Hyperglycemia (secondary to insulin resistance) exacerbates adrenal cortisol production and promotes forward feeding

of inflammation and HPA-hippocampal dysregulation.

Systemic inflammation from inflamed adipose and associated mononuclear

cells, promotes CNS inflammation with associated cognitive decline and neurodegeneration.

NE3107’s anti-inflammatory activity against

systemic/adipose inflammation and factors that dysregulate cortisol secretion, such as hyperglycemia, has the potential to decrease cognitive

impairment and neurodegenerative mechanisms that have been linked to cortisol excess.

Parkinson’s Disease

The Company initiated a study by treating the first patient, in its Phase

2 study assessing NE3107’s safety and tolerability and potential pro-motoric impact in Parkinson’s disease patients on January

The NM201 study (NCT05083260) is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinson’s

Disease (PD).

Participants will be treated with carbidopa/levodopa and NE3107 or placebo.

Forty patients with a defined PD medication “off state” will

be randomized 1:1 placebo to active NE3107 20 mg twice daily for 28 days.

Safety assessments will look at standard measures of patient

health and potential for drug-drug interactions affecting L-dopa pharmacokinetics and activity.

Exploratory efficacy assessments will

use the Motor Disease Society Unified Parkinson’s Disease Rating (MDS-UPDRS) parts 1-3, ON/OFF Diary, and Non-Motor Symptom Scale.

Neuroinflammation and activation of brain microglia, leading to increased

proinflammatory cytokines (particularly TNF) which play a pivotal role in Parkinson’s Disease (PD), which affects an estimated 1

million Americans.

Daily administration of levodopa (converted to dopamine in the brain) is the current standard of care treatment for

Insulin resistance is linked to

cognitive impairment.

The multifactorial influence of insulin signaling

on neuron survival and cognition suggests that correction of insulin signaling deficits with NE3107 in the target population may provide

significant benefits on both cognition and disease progression.

Additional rationale for targeting metabolic dysregulation with NE3107

has come from recent work showing that peripheral insulin resistance promotes insulin resistance and senescence in the CNS.

There is also 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

Hyperglycemia (secondary to insulin resistance) exacerbates adrenal cortisol production and promotes forward feeding of inflammation

and HPA-hippocampal dysregulation.

Systemic inflammation from inflamed adipose and

associated mononuclear cells, promotes CNS inflammation with associated cognitive decline and neurodegeneration.

We believe NE3107’s

anti-inflammatory activity against systemic/adipose inflammation and factors that dysregulate cortisol secretion, such as hyperglycemia,

has the potential to decrease cognitive impairment and neurodegenerative mechanisms that have been linked to cortisol excess.

The Company completed its Phase 2 study assessing

NE3107 in Parkinson’s disease patients in the fourth quarter of calendar year 2022.

The NM201 study (NCT05083260) was a double-blind,

placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinson’s disease (PD) participants treated with carbidopa/levodopa

Forty-five patients with a defined L-dopa morning “off state” were randomized 1:1 to placebo:NE3107 20 mg twice

daily for 28 days.

The trial was launched with two design objectives:

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

study (as requested by FDA) to demonstrate the absence of adverse interactions of NE3107 with levodopa;

and 2) the secondary objective

was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity observed in a PD model

in monkeys can be seen in humans.

Both objectives were met.

Highlighted results of the study were:

treated with NE3107 + C/L experienced greater improvements in their Motor Disease Society-

Unified Parkinsons 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

<70 years old treated with NE3107 + C/L experienced improvements that were ~6 points better

than those who received placebo + C/L.

(26%) of the 19 patients treated with NE3107, compared to none of the 19 placebo treated

patients, who had a baseline of morning OFF experienced a morning ON state prior to receiving

their morning medications on day 28;

this difference was statistically significant (p=0.046).

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.

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.

Neuroinflammation and activation of brain microglia,

leading to increased proinflammatory cytokines (particularly TNF) that play a pivotal role in PD, which affects an estimated 1 million

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

this movement disorder, but prolonged daily administration leads to side effects of uncontrolled movements called levodopa-induced dyskinesia,

2 unchanged sentences

activation, and TNF inflammatory damage in neurons.

We have shown in a mouse model that PD NE3107 decreases inflammation and

TNF in the brain and increases neuron survival (Nicoletti, 2012 Parkinson’s Disease 969418.) In this neurotoxin induced model, NE3107

decreased clinical signs of disease and neuronal death compared to placebo treated mice.

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

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

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

treated with NE3107 developed less LID.

NE3107-treated monkeys also exhibited neuroprotective activity that promoted the survival of twice

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

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

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

If approved as a promotoric agent, NE3107 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 imply

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

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

Parkinsons Disease 969418.) In this neurotoxin induced model, NE3107 decreased clinical signs of disease and neuronal death compared

to placebo treated mice.

unpublished study in a neurotoxin induced marmoset model of Parkinsons disease reported that administration of NE3107 decreased

movement abnormalities that are the clinical signs of the disease.

In the same study, NE3107 in combination with levodopa had a stronger

effect on clinical signs of disease than levodopa or NE3107 alone, while marmosets treated with NE3107 developed less LID.

NE3107-treated

monkeys also exhibited neuroprotective activity that promoted the survival of twice as many neurons in the substantia nigra (primary

region of the brain that degenerates to cause parkinsonism) as monkeys treated with placebo.

The results from the marmoset study suggest

that NE3107 may decrease clinical signs of disease in humans (improve motor function), which if true could enable a straightforward clinical

development strategy to test NE3107 in PD patients needing promotoric therapy.

approved as a promotoric agent, NE3107 would provide a non-dopaminergic alternative to Parkinsons patients, and an opportunity

to significantly delay the need to start levodopa therapy.

This could represent a first step toward supplanting levodopa as the primary

PD therapy, and in addition to delaying the emergence of LID, could also imply a slowing of disease progression, the most important and

still unmet objective of PD drug development.

Liver Cirrhosis Program

BioVie’s orphan drug candidate BIV201 (continuous

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

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.

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 a series of interactions between June

2019 and April 2020, representatives of BioVie and the FDA communicated regarding the design and endpoints for the Phase 2 study (NCT04112199).

In June 2021, the Company 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

to a pre-treatment period.

In March 2023 the company announced enrolment

was paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show a 34% reduction in ascites fluid during

the 28 days after treatment initiation compared to the 28 days prior to treatment (p=0.0046).

This improvement was significantly different

from those patients receiving SOC treatment.

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

(p=0.001), which was sustained during the three months after treatment initiation as compared to the three-month pre-treatment period

(43% reduction, p=0.06).

In June 2023, the Company requested guidance from

the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites due to chronic liver

FDA accepted the request and intends to send written comments in the third quarter of calendar year 2023.

Our proprietary novel liquid formulation of terlipressin

in a prefilled syringe 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 18 months, 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 we plan to seek 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 (“NASH”), and alcoholism.

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

the most common of these complications, ascites, which represents a significant unmet medical need.

Patients with cirrhosis and ascites

account for an estimated 116,000 U.S.

hospital discharges annually, with frequent early readmissions.

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.

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

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.

Ascites Development Pathway

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 patients abdomen.

BIV201 Proposed Mechanism of Action

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.

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.

Intellectual Property

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

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

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

conceived during the workday, using our property, or which relate to our business.

Despite any measures taken to protect our intellectual

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

BIV201 was awarded Orphan Drug Designations in the U.S.

for the treatment

of hepatorenal syndrome (received November 21, 2018) and treatment of ascites due to all etiologies except cancer (received September

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 at least the United States, Europe, China, Japan and other jurisdictions.

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.

BIV201 was awarded Orphan Drug Designations in

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

cancer (received September 8, 2016).

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

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

Japan and other jurisdictions.

Also, we own U.S.

Patent 11,364,277, which is directed to a method of treating ascites with BIV201, and we are pursuing similar patent

coverage in Japan, Europe, and China.

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

patents, one (1)

patent application, one (1) pending U.S.

PCT application and six (6) issued foreign patents 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

Steroids Having 7-Oxygen and 17-Heteroaryl Substitution

Unsaturated Steroid Compounds

Solid State Forms of a Pharmaceutical

Crystalline Anhydrate Forms of a Pharmaceutical

Pharmaceutical Solid State Forms

Methods of Preparing Pharmaceutical Solid State Forms

Steroid Tetrol Solid State Forms

Drug Identification and Treatment Method

Method For Preparing Substituted 3,7-Dihydroxy Steroids

Treatment Methods Using Pharmaceutical Solid State Forms

Compositions for Treatment of Neurodegenerative Conditions

Patent 11,364,277, which is directed to a method of treating ascites with BIV201, and

we are pursuing similar patent coverage in Japan, Europe, and China.

NE3107 and related compounds

of August 15, 2023, we have fifteen (15) issued U.S.

patents, six (6) pending U.S.

patent applications, one (1) pending U.S.

PCT application

and six (6) issued foreign patents 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.

Having 7-Oxygen and 17-Heteroaryl Substitution

Steroid Compounds

State Forms of a Pharmaceutical

Anhydrate Forms of a Pharmaceutical

Pharmaceutical

Solid State Forms

of Preparing Pharmaceutical Solid State Forms

Tetrol Solid State Forms

Identification and Treatment Method

For Preparing Substituted 3,7-Dihydroxy Steroids

Methods Using Pharmaceutical Solid State Forms

for Treatment of Neurodegenerative Conditions

PCT/US2022/027294

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

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

Government Regulation

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

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

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

marketing and export and import of products such as those we are developing.

Any pharmaceutical candidate that we develop must be approved

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

marketed in foreign countries.

United States Drug Development Process

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

and Cosmetic Act, or FDCA, and 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, or the PHSA, and related regulations, and

other federal, state and local statutes and regulations.

Biological products include, among other things, viruses, therapeutic serums,

vaccines and most protein products.

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal,

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

Failure to comply

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

may subject an applicant to administrative or judicial sanctions.

FDA sanctions could include refusal to approve pending applications,

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

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

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:

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, or an 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 current good clinical practices, or 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, or an NDA, for a new drug product, or a Biologics License Application, or 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;

FDA review and approval of the NDA or BLA.

The lengthy process of seeking required approvals and the continuing need

for compliance with applicable statutes and regulations require the expenditure of substantial resources.

There can be no certainty that

approvals will be granted.

Clinical trials involve the administration of the drug or biological candidate

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

not employed by or under the trial sponsor’s control.

Clinical trials are conducted under protocols detailing, among other things,

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

subject safety.

Each protocol must be submitted to the FDA as part of the IND.

Clinical trials must be conducted in accordance with the

FDA’s good clinical practices requirements.

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

review board, or IRB, at or servicing each institution at which the clinical trial will be conducted.

An IRB is charged with protecting

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

trials are minimized and are reasonable in relation to anticipated benefits.

The IRB also approves the informed consent form that must

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

Human clinical trials prior to approval are typically conducted in three

sequential phases that may overlap or be combined:

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 dosage tolerance, 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, at least 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 for serious and unexpected

adverse events or any finding from tests in laboratory animals that suggests a significant risk for human subjects.

Phase 1, Phase 2

and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.

The FDA or the sponsor or its

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

or patients are being exposed to an unacceptable health risk.

Similarly, an IRB can suspend or terminate approval of a clinical trial

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

has been associated with unexpected serious harm to patients.

Concurrent with clinical trials, companies usually complete additional

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

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

The manufacturing process

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

for testing the identity, strength, quality and purity of the final drug or biologic.

Additionally, appropriate packaging must be selected

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

deterioration over its shelf life.

for the Treatment of Mild Cognitive Impairment

and Methods for Drug Discovery

for the Treatment of Biological Aging

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

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

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.

States Drug Development Process

the United States, the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act, or FDCA, and implements regulations.

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

Biologics are subject to regulation by the FDA under the

FDCA, the Public Health Service Act, or the PHSA, and related regulations, and other federal, state and local statutes and regulations.

Biological products include, among other things, viruses, therapeutic serums, vaccines and most protein products.

The process of obtaining

regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require

the expenditure of substantial time and financial resources.

Failure to comply with the applicable United States requirements at any

time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial

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.

process required by the FDA before a drug or biological product may be marketed in the United States generally involves the following:

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

to the FDA of an Investigational New Drug Application, or an IND, which must become effective before human clinical trials may begin;

of adequate and well-controlled human clinical trials according to the FDAs current good clinical practices, or GCPs, to establish

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

to the FDA of a New Drug Application, or an NDA, for a new drug product, or a Biologics License Application, or a BLA, for a new

biological product;

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 FDAs current good manufacturing practice standards, or cGMP, to assure that the facilities, methods and

controls are adequate to preserve the drugs or biologics identity, strength, quality and purity;

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

review and approval of the NDA or BLA.

lengthy process of seeking required approvals and the continuing need for compliance with applicable statutes and regulations require

the expenditure of substantial resources.

There can be no certainty that approvals will be granted.

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 sponsors control.

trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject

selection and exclusion criteria, and the parameters to be used to monitor subject safety.

Each protocol must be submitted to the FDA

as part of the IND.

Clinical trials must be conducted in accordance with the FDAs good clinical practices requirements.

each clinical trial must be reviewed and approved by an independent institutional review board, or IRB, at or servicing each institution

at which the clinical trial will be conducted.

An IRB is charged with protecting the welfare and rights of trial participants and considers

such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated

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.

clinical trials prior to approval are typically conducted in three sequential phases that may overlap or be combined:

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.

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 dosage tolerance, optimal dosage and dosing

schedule for patients having the specific disease.

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, at least 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

reports detailing the results of the clinical trials must be submitted at least annually to the FDA and written IND safety reports must

be submitted to the FDA by the investigators for serious and unexpected adverse events or any finding from tests in laboratory animals

that suggests a significant risk for human subjects.

Phase 1, Phase 2 and Phase 3 clinical trials may not be completed

successfully within any specified period, if at all.

The FDA or the sponsor or its data safety monitoring board may suspend a clinical

trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable

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 IRBs requirements or if the drug or biologic has been associated with unexpected serious

harm to patients.

with clinical trials, companies usually complete additional animal studies and develop additional information about the chemistry and

physical characteristics of the drug or biologic as well as finalize a process for manufacturing the product in commercial quantities

in accordance with cGMP requirements.

The manufacturing process must be capable of consistently producing quality batches of the drug

or biological candidate and, among other things, must include methods for testing the identity, strength, quality and purity of the final

drug or biologic.

Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate

that the drug or biological candidate does not undergo unacceptable deterioration over its shelf life.

Review and Approval Processes

The results of product development, preclinical studies and clinical trials,

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

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

The submission

of an NDA or BLA is subject to the payment of substantial user fees;

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

a waiver of such fees may be obtained under certain limited circumstances.

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

filing and may request additional information rather than accepting an NDA or BLA for filing.

Once the submission is accepted for filing,

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

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

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

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

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

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

In addition to

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

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

and a recommendation as to whether the application should be approved and under what conditions.

The FDA is not bound by the recommendations

of an advisory committee, but it considers such recommendations carefully when making decisions.

During the approval process, the FDA

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

If the FDA concludes that a REMS is needed, the sponsor of the NDA or BLA must submit a proposed REMS;

the FDA will not approve the NDA

or BLA without a REMS, if required.

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

which the product is to be manufactured.

The FDA will not approve the product unless it determines that the manufacturing processes and

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

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

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

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

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

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

data or other data and information.

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

does not satisfy the criteria for approval.

Data obtained from clinical trials are not always conclusive and may be susceptible to varying

interpretations, which could delay, limit or prevent regulatory approval.

The FDA will issue a “complete response” letter

if the agency decides not to approve the NDA or BLA.

The complete response letter usually describes all of the specific deficiencies in

the NDA or BLA identified by the FDA.

The deficiencies identified may be minor, for example, requiring labeling changes, or major, for

example, requiring additional clinical trials.

Additionally, the complete response letter may include recommended actions that the applicant

might take to place the application in a condition for approval.

If a complete response letter is issued, the applicant may either resubmit

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

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

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

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

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

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

Orphan Drug Designation

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

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

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

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

will be recovered from sales of the product.

Orphan product designation must be requested before submitting an NDA or BLA.

After the FDA

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

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

If a product that has Orphan designation subsequently receives the first

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

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

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

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

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

Orphan product exclusivity also could

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

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

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

what is designated, it may not be entitled to orphan product exclusivity.

Orphan Drug status in the European Union has similar but not

identical benefits in the European Union.

Expedited Development and Review Programs

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

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

Specifically, new drug and biological products

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

to address unmet medical needs for the condition.

Fast Track designation applies to the combination of the product and the specific indication

for which it is being studied.

Unique to a Fast Track product, the FDA may consider for review sections of the NDA or BLA on a rolling

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

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

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

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

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

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

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

of the original approval.

In addition, the FDA currently requires as a condition for accelerated approval pre-approval of promotional

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

Fast Track designation,

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

Post-Approval Requirements

Any drug or biological products for which we receive FDA approvals are

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

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

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

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

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

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

and promotional activities involving the internet.

Failure to comply with FDA requirements can have negative consequences, including the

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

or communications with doctors, and civil or criminal penalties.

Although physicians may prescribe legally available drugs and biologics

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

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

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

the FDA’s cGMP regulations.

cGMP regulations require among other things, quality control and quality assurance as well as the corresponding

maintenance of comprehensive records and documentation.

Drug and biologic manufacturers and other entities involved in the manufacture

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

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

state agencies for compliance with cGMP and other laws.

Accordingly, manufacturers must continue to expend time, money and effort in the

area of production and quality control to maintain cGMP compliance.

Discovery of problems with a product after approval may result in

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

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

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

product from the market.

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

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

further FDA review and approval.

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

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

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

Our business is managed by our officers who consist of Mr.

Cuong Do, Chief

Executive Officer & President;

Dr Joseph M Columbo, Chief Medical Officer, who joined the Company on November 1, 2021;

and Wendy Kim,

our Chief Financial Officer and Corporate Secretary;

along with Penelope Markham, PhD, Executive Vice President - Liver Cirrhosis R&D;

Chris Reading, PhD, Executive Vice President - Neuroscience R&D;

and Clarence Ahlem, Executive Vice President - Neuroscience Product

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

The company has 13 employees which are all full

We also rely on a team of highly experienced scientific, medical, and regulatory consultants to conduct its product development

FDA reviews all NDAs and BLAs submitted before it accepts them for filing and may request additional information rather than accepting

an NDA or BLA for filing.

Once the submission is accepted for filing, the FDA begins an in-depth review of the NDA or BLA.

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 products 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 products continued safety, purity and potency.

In addition to its own review, the FDA may refer applications for novel drug

or biological products or drug or biological products which present difficult questions of safety or efficacy to an advisory committee,

typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application

should be approved and under what conditions.

The FDA is not bound by the recommendations of an advisory committee, but it considers

such recommendations carefully when making decisions.

During the approval process, the FDA also will determine whether a risk evaluation

and mitigation strategy, or REMS, is necessary to assure the safe use of the drug or biologic.

If the FDA concludes that a REMS is needed,

the sponsor of the NDA or BLA must submit a proposed REMS;

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

approving an NDA or BLA, the FDA will inspect the facilities at which the product is to be manufactured.

The FDA will not approve the

product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to

assure consistent production of the product within required specifications.

Additionally, before approving an NDA or BLA, the FDA will

typically inspect one or more clinical sites to assure compliance with cGMP.

If the FDA determines the application, manufacturing process

or manufacturing facilities are not acceptable it will outline the deficiencies in the submission and often will request additional testing

or information.

NDA or BLA review and approval process is lengthy and difficult and the FDA may refuse to approve an NDA or BLA if the applicable regulatory

criteria are not satisfied or may require additional clinical data or other data and information.

Even if such data and information is

submitted, the FDA may ultimately decide that the NDA or BLA does not satisfy the criteria for approval.

Data obtained from clinical

trials are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval.

The FDA will issue a complete response letter if the agency decides not to approve the NDA or BLA.

The complete response

letter usually describes all of the specific deficiencies in the NDA or BLA identified by the FDA.

The deficiencies identified may be

minor, for example, requiring labeling changes, or major, for example, requiring additional clinical trials.

Additionally, the complete

response letter may include recommended actions that the applicant might take to place the application in a condition for approval.

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.

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 products safety and effectiveness and may require testing and surveillance programs to monitor the

safety of approved products that have been commercialized.

Drug Designation

the Orphan Drug Act, the FDA may grant orphan designation to a drug or biological product intended to treat a rare disease or condition,

which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals

in the United States and for which there is no reasonable expectation that the cost of developing and making a drug or biological product

available in the United States for this type of disease or condition will be recovered from sales of the product.

Orphan product designation

must be requested before submitting an NDA or BLA.

After the FDA grants orphan product designation, the identity of the therapeutic agent

and its potential orphan use are disclosed publicly by the FDA.

Orphan product designation does not convey any advantage in or shorten

the duration of the regulatory review and approval process.

a product that has Orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such

designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to

market the same drug or biological product for the same indication for seven years, except in limited circumstances, such as a showing

of clinical superiority to the product with orphan exclusivity.

Competitors, however, may receive approval of different products for

the indication for which the Orphan product has exclusivity or obtain approval for the same product but for a different indication for

which the Orphan product has exclusivity.

Orphan product exclusivity also could block the approval of one of our products for seven years

if a competitor obtains approval of the same drug or biological product as defined by the FDA or if our drug or biological candidate

is determined to be contained within the competitors product for the same indication or disease.

If a drug or biological product

designated as an orphan product receives marketing approval for an indication broader than what is designated, it may not be entitled

to orphan product exclusivity.

Orphan Drug status in the European Union has similar but not identical benefits in the European Union.

Development and Review Programs

FDA has a Fast Track program that is intended to expedite or facilitate the process for reviewing new drug and biological products that

meet certain criteria.

Specifically, new drug and biological products are eligible for Fast Track designation if they are intended to

treat a serious or life-threatening condition and demonstrate the potential to address unmet medical needs for the condition.

designation applies to the combination of the product and the specific indication for which it is being studied.

Unique to a Fast Track

product, the FDA may consider for review sections of the NDA or BLA on a rolling basis before the complete application is submitted,

if the sponsor provides a schedule for the submission of the sections of the NDA or BLA, the FDA agrees to accept sections of the NDA

or BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section

of the NDA or BLA.

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

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

drug or biological products for which we receive FDA approvals are subject to continuing regulation by the FDA, including, among other

things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy

information on an annual basis or as required more frequently for specific events, product sampling and distribution requirements, complying

with certain electronic records and signature requirements and complying with FDA promotion and advertising requirements, which include,

among others, standards for direct-to-consumer advertising, prohibitions against promoting drugs and biologics for uses or in patient

populations that are not described in the drugs or biologics approved labeling (known as off-label use),

rules for conducting industry-sponsored scientific and educational activities, and promotional activities involving the internet.

to comply with FDA requirements can have negative consequences, including the immediate discontinuation of noncomplying materials, adverse

publicity, enforcement letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties.

Although physicians may prescribe legally available drugs and biologics for off-label uses, manufacturers may not market or promote such

off-label uses.

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 FDAs 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

Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain

cGMP compliance.

Discovery of problems with a product after approval may result in serious and extensive restrictions on a product, manufacturer,

or holder of an approved NDA or BLA, including suspension of a product until the FDA is assured that quality standards can be met, continuing

oversight of manufacturing by the FDA under a consent decree, which frequently includes the imposition of costs and continuing

inspections over a period of many years, and possible withdrawal of the product from the market.

In addition, changes to the manufacturing

process generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding

new indications and additional labeling claims, are also subject to further FDA review and approval.

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.

business is managed by our officers who consist of Mr.

Cuong Do, Chief Executive Officer & President;

Dr Joseph M Columbo, Executive

Vice President -Chief Medical Officer;

and Wendy Kim, our Chief Financial Officer and Corporate Secretary.

These individuals devote their

full-time efforts to the Company activities.

The Company has 18 employees which are all full time.

We also rely on a team of highly experienced

scientific, medical, and regulatory consultants to conduct its product development activities.

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