NASDAQ: BIVI

BioVie has conducted and reported efficacy data
on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who
have mild-to-moderate AD (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients
experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference
in December 2022. A Phase 2 study of bezisterim in PD (NCT05083260) has been completed, and data presented at the AD/PD™ 2023 International
Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders in Gothenburg, Sweden in March 2023
showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients
treated with a combination of bezisterim and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events.

In long COVID, bezisterim has the potential to
reduce neurological symptoms including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to
trigger TLR-4 driven activation of NFκB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg).

A. Parkinson’s Disease (NCT05083260)

Parkinson’s disease (PD) is a progressive
neurodegenerative disease most often characterized by tremors, muscle rigidity, slowness of movement, postural instability, and difficulties
with speech. Compelling evidence implicates inflammation and insulin resistance in the initiation and progression of the disease –
likely both due to their respective roles in dopamine dysfunction in the brain and neurodegeneration. Current therapeutic approaches provide
only symptomatic relief, but do not modify disease progression.

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PD is driven in large part by neuroinflammation
and activation of brain microglia, leading to increased proinflammatory cytokines (particularly TNF). Multiple daily administrations of
levodopa (converted to dopamine in the brain) is the current standard of care treatment for this movement disorder. However, levodopa
effectiveness diminishes over time necessitating increased dosage and prolonged daily administration leads to side effects of uncontrolled
movements called levodopa-induced dyskinesia, commonly referred to as LID, which is exacerbated by high dose levodopa. Although levodopa
provides symptomatic benefit, it does not slow PD progression.

The Company designed a new Phase 2b study of bezisterim
as a potential first line therapy to treat patients with new onset PD. This trial will be evaluating the safety and efficacy of bezisterim
on motor and non-motor symptoms in patients with PD who haven’t been treated with carbidopa/levodopa. The PD Phase 2b study comprises
a multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design will last 20 weeks from the initial
screening phase to the safety follow up. In July 2024, the Company submitted the new protocol and received a response from the FDA permitting
the Company to proceed with the study. The trial commenced in April 2025.

The Phase 2 study of bezisterim for the treatment
of PD (NCT05083260) that completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics
study in PD participants treated with carbidopa/levodopa and bezisterim. Forty-five patients with a defined L-dopa “off state”
were randomized 1:1 to placebo: bezisterim 20 mg twice daily for 28 days. This trial was launched with two design objectives: 1) the primary
objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions of bezisterim
with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent
enhancement of levodopa activity could be seen in humans. Both objectives were met.

B. Long COVID Program

About Long COVID

Long COVID is a condition in which symptoms of
COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period, generally three months or more.
Common symptoms include lingering loss of smell and taste, extreme fatigue, and “brain fog,” though persistent cardiovascular
and respiratory problems, muscle weakness, and neurologic issues have also been documented.

Approximately 20 million individuals in the U.S.
currently or previously have long COVID, with millions more impacted worldwide. Studies estimate that approximately 10-30% of individuals
who contract COVID-19 experience lingering symptoms for months or even years, with fatigue, brain fog, and cognitive impairment significantly
impacting daily functioning and quality of life. Despite the growing recognition of long COVID as a serious condition, treatment options
remain limited, and many patients struggle to find effective relief for their symptoms. The loss in quality of life and earnings and increased
medical costs has an enormous economic impact estimated to be $3.7 trillion. To date there are no non-pharmacological or pharmacological
therapies proven effective for treatment of long COVID.

In April 2024, the Company was awarded a clinical
trial grant of $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research
Program of the Congressionally Directed Medical Research Programs. In August 2024, the FD&A and the U.S. Army Medical Research and
Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan, including the FDA approving
the associated Investigation New Drug Application (“IND”), to evaluate bezisterim for the treatment of neurological symptoms
that are associated with long COVID.

The Phase 2 ADDRESS-LC study, which is fully funded
by a grant from the DOD, is a randomized (1:1), placebo-controlled, multicenter trial evaluating the efficacy, safety and tolerability
of bezisterim in adult participants with long COVID who have cognitive impairment sequelae and fatigue. Individuals who have been diagnosed
with long COVID and have neurocognitive dysfunction and self-reported fatigue may meet qualification criteria and can visit www.addressLC.com
to learn more. The trial commenced in May 2025.

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C. Alzheimer’s Disease (NCT05083260)

On November 29, 2023, the Company announced the
analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim in the treatment of mild
to moderate AD. The study had co-primary endpoints measuring cognitive impairment using the Alzheimer’s Disease Assessment Scale-Cognitive
Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus
placebo, to receive sequentially 5 mg of bezisterim orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed
by 26 weeks of 20 mg orally twice daily.

Upon trial completion, as the Company began the
process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”)
violations at 15 study sites (virtually all of which were from one geographic area). This highly unusual level of suspected improprieties
led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”)
for potential further action. After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom
were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic
data.

The trial was originally designed to be 80% powered
with 125 patients in each of the treatment and placebo arms. The unplanned exclusion of so many patients left the trial underpowered for
the primary endpoints. In the Per-Protocol population, which included those patients who completed the trial and who were further verified
to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing
of cognitive decline; these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic changes.
Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as
measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age. This test was a non-primary/secondary
endpoint, other-outcome measure, done via blood collected at week 30 (end of study). Additional DNA methylation data continues to be collected
and analyzed.

Liver Cirrhosis Program

In liver disease, our investigational drug candidate
BIV201 (continuous infusion terlipressin), which was granted both FDA Fast Track designation status and FDA Orphan Drug Status, is being
evaluated as a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis
caused by non-alcoholic steatohepatitis (NASH), hepatitis, and alcoholism. The initial target for BIV201 therapy was refractory ascites.
These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have
an estimated 50% mortality rate within 6 to 12 months.

After receiving guidance from the FDA regarding
the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is now targeting
a broader ascites patient population. The Company is currently finalizing the protocol design for the Phase 3 study of BIV201 with a focus
on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis
and ascites who have recently recovered from acute kidney injury (“AKI”). This patient population is not limited to those
having refractory ascites. BIV201 is administered as a patent-pending liquid formulation with patents issued in the U.S., China, Japan,
Chile and India to date. Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid
in the abdomen, often exceeding five liters, due to liver and kidney dysfunction. BIV201 is a continuous infusion of terlipressin, a drug
used in over 40 countries to treat related complications of liver cirrhosis (Type 1 hepatorenal syndrome and bleeding esophageal varices)
that was approved in the U.S. in 2022 (to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function)
but is not approved in Japan. With its novel room temperature stable formulation in a pre-filled syringe, we believe BIV201 could potentially
provide a superior terlipressin drug delivery system throughout the world. The goal of BIV201 therapy is to target the pathophysiology
that contributes to ascites production, acute kidney injury and complications of cirrhosis that are associated with significant mortality.

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In June 2021, BioVie initiated a Phase 2 study
(NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment
cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites. The primary
endpoints of the study were the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared
to a pre-treatment period. By October 12, 2022, there were 15 patients enrolled for treatment and the last patient completed treatment
on May 8, 2023. In March 2023, enrollment was paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to
show at least a 30% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment.
The change in ascites volume was significantly different from those patients receiving SOC treatment. Patients who completed the treatment
with BIV201 experienced a 53% reduction in ascites fluid, which was sustained (43% reduction) during the three months after treatment
initiation as compared to the three-month pre-treatment period. In June 2023 and December 2024, BioVie received guidance from the FDA
regarding the design and endpoints for definitive Phase 3 clinical testing of BIV201.

Our proprietary novel liquid formulation of terlipressin
is designed to improve convenience for outpatient administration and avoid potential formulation errors when pharmacists reconstitute
the current powder version of terlipressin. To date, analytical testing results have confirmed room temperature stability of the prefilled
syringe in storage for 2 years, with the potential for up two years stability. Room temperature storage presents a key product differentiation
versus terlipressin products in countries where the drug is approved. To the best of the Company’s knowledge, all other terlipressin
products sold globally must be stored under refrigeration and there is no prefilled syringe format of terlipressin available for treating
patients in these countries. BioVie has also filed a Patent Cooperation Treaty (“PCT”) application covering our novel liquid
formulations of terlipressin (international patent application PCT/US2020/034269, published as WO2020/237170) and to date patents have
been granted in the U.S. (Patent no. 12,156,898), India (Patent No. 540813), Chile (Patent No. 68.965), China (Patent No. ZL 202080050758.X),
and Japan (7579811).

We believe BIV201 (continuous infusion terlipressin)
has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due
to hepatitis, nonalcoholic steatohepatitis, and alcoholism. The FDA has granted Fast-Track status and Orphan Drug designation for ascites
(due to all etiologies except cancer), which is the most common complication related to liver cirrhosis and represents a significant unmet
medical need. Patients with cirrhosis and ascites account for an estimated 116,000 U.S. hospital discharges annually, with frequent early
readmissions. According to the HCUP Nationwide Readmissions Database 2016, those requiring paracentesis (removal of ascites fluid) experience
an average hospital stay lasting eight days incurring over $86,000 in medical costs. This translates into a total potentially addressable
ascites market size for BIV201 therapy exceeding $650 million based on Company estimates.

The FDA has never approved any drug specifically
for treating ascites. After receiving guidance from FDA in 2023 and again in 2025, the Company is currently finalizing the protocol design
for a Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint of complications and
disease progression in patients with cirrhosis and ascites who have recently recovered from AKI.

The BIV201 development program was initiated by
LAT Pharma LLC. On April 11, 2016, BioVie acquired LAT Pharma LLC and the rights to its BIV201 development program and currently owns
all development and marketing rights to this drug candidate. Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016,
between predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales
of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc. Pursuant
to the separation agreement to be entered into between the Company and BioVie, the Company will assume the royalty agreement and will
be obligated to pay 5.0% on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation,
and The Barrett Edge, Inc.

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Intellectual Property

BIV201

BioVie relies on a combination of patent, trade
secret, other intellectual property laws (such as FDA data exclusivity), nondisclosure agreements, and other measures to protect our proposed
products. We require our employees, consultants, and advisors to execute confidentiality agreements and to agree to disclose and assign
to us all inventions conceived during the workday, using our property, or which relate to our business. Despite any measures taken to
protect our intellectual property (IP), unauthorized parties may attempt to copy aspects of our products or to obtain and use information
that we regard as proprietary.

BIV201 was awarded Orphan Drug Designations in
the U.S. for the treatment of hepatorenal syndrome on November 21, 2018 and treatment of ascites due to all etiologies except cancer on
September 8, 2016. We also filed a PCT application covering our novel liquid formulations of terlipressin (international patent application
PCT/US2020/034269, published as WO2020/237170) and are seeking patent protection in U.S., Europe, China, Japan and other jurisdictions.
To date patents have been granted in U.S. (Patent no. 12,156,898), India (Patent No. 540813), Chile (Patent No. 68.965), China (Patent
No. ZL 202080050758.X), and Japan (7579811) Also, we own U.S. Patent 11,364,277, and European patent EP3347032, which is directed to a
method of treating ascites with BIV201, and we are pursuing additional patent coverage in U.S., Japan, Europe, and China.

Bezisterim (NE3107) and related compounds

As of July 31, 2025, we have twelve (12) issued
U.S. patents, six (6) pending U.S. patent applications, three (3) pending U.S. PCT applications, six (6) issued foreign patents, and six
(6) pending foreign patent applications directed to protecting NE3107 and related compounds and methods of making and using thereof. The
U.S. patents and pending patent applications and their projected expiration dates are provided below.

Title

Patent Application

Number

Patent

Number

Expiration

Date

Unsaturated Steroid Compounds

13/030,326

8,586,770

6/2/2026

Solid State Forms of a Pharmaceutical

12/418,559

8,252,947
*

4/18/2030

Crystalline Anhydrate Forms of a Pharmaceutical

14/459,528

15/348,107

16/598,694

17/240,728

9,555,046

9,850,271

10,995,112

pending

4/3/2029

4/3/2029

4/3/2029

—

Pharmaceutical Solid State Forms

12/370,510

8,518,922

9/24/2031

Methods of Preparing Pharmaceutical Solid State Forms

13/919,593

9,314,471

6/28/2029

Steroid Tetrol Solid State Forms

12/272,767

8,486,926

1/10/2030

Drug Identification and Treatment Method

11/941,936

8,354,396

7/7/2031

Method For Preparing Substituted 3,7-Dihydroxy Steroids

13/664,304

14/886,738

9,163,059**

9,994,608

6/5/2029

6/5/2029

Treatment Methods Using Pharmaceutical Solid State Forms

14/459,493

9,877,972

4/3/2029

Compositions for Treatment of Neurodegenerative Conditions

18/511,027

pending

—

Methods of Treating Long COVID

63/621,280

pending

—

Modified C19 Steroids and Methods of Using the Same

63/610,915

pending

—

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

63/592,364

pending

—

Methods for the Treatment of Biological Aging

63/561,157

pending

—

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

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

5

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 the development
of drugs and biologic products under the Federal Food, Drug and Cosmetic Act (“FDCA”) and the Public Health Services Act ("PHSA"),
respectively. Drugs, biologics and medical devices are also subject to other federal, state and local statutes and regulations.

Biologics are subject to regulation by the FDA
under the FDCA, the PHSA and related regulations, and other federal, state and local statutes and regulations. The process of obtaining
regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require
the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time
during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions.
FDA sanctions could include refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product
recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts,
restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect
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 (“IND”), which must become effective before human clinical trials may begin;

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

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

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

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

●
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 inclusion and exclusion criteria, and
the parameters to be used to monitor subject safety. Each protocol must be submitted to the FDA as part of the IND. Clinical trials must
be conducted in accordance with the FDA’s cGCP requirements. Further, each clinical trial must be reviewed and approved by an independent
institutional review board (“IRB”), at or servicing each institution at which the clinical trial will be conducted. An IRB
is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating
in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent
form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until
it is completed.

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

●
Phase 1. 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.

●
Phase 2. The drug or biologic is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine optimal dosage and dosing schedule for patients having the specific disease.

●
Phase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials, which usually involve more subjects than earlier trials, are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA or BLA.

Post-approval studies, or Phase 4 clinical
trials, may be conducted after initial marketing approval. These studies are used to gain additional experience from the treatment of
patients in the intended therapeutic indication and may be required by the FDA as part of the approval process.

Progress reports detailing the results of the
clinical trials must be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA by the investigators
for serious and unexpected adverse events or any finding from tests in laboratory animals that suggests a significant risk for human subjects.
Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.
The FDA or the sponsor or its data safety monitoring board may suspend a clinical trial at any time on various grounds, including a finding
that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval
of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or
if the drug or biologic has been associated with unexpected serious harm to patients.

Concurrent with clinical trials, companies usually
complete additional animal studies and develop additional information about the chemistry and physical characteristics of the drug or
biologic as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The
manufacturing process must be capable of consistently producing quality batches of the drug or biological candidate and, among other things,
must include methods for testing the identity, strength, quality and purity of the final drug or biologic. Additionally, appropriate packaging
must be selected and tested and stability studies must be conducted to demonstrate that the drug or biological candidate does not undergo
unacceptable deterioration over its shelf life.

U.S. Review and Approval Processes

The results of product development, preclinical
studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the
drug or biologic, proposed labeling and other relevant information are submitted to the FDA as part of an NDA or BLA requesting approval
to market the product. The submission of an NDA or BLA is subject to the payment of substantial user fees; a waiver of such fees may be
obtained under certain limited circumstances.

The FDA reviews all NDAs and BLAs submitted before
it accepts them for filing and may request additional information rather than accepting an NDA or BLA for filing. Once the submission
is accepted for filing, the FDA begins an in-depth review of the NDA or BLA.

After the NDA or BLA submission is accepted for
filing, the FDA reviews the NDA to determine, among other things, whether the proposed product is safe and effective for its intended
use, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, strength,
quality and purity. The FDA reviews a BLA to determine, among other things, whether the product is safe, pure and potent and the facility
in which it is manufactured, processed, packaged or held meets standards designed to assure the product’s continued safety, purity
and potency. In addition to its own review, the FDA may refer applications for novel drug or biological products or drug or biological
products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians
and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions.
The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
During the approval process, the FDA also will determine whether a risk evaluation and mitigation strategy, or REMS, is necessary to assure
the safe use of the drug or biologic. If the FDA concludes that a REMS is needed, the sponsor of the NDA or BLA must submit a proposed
REMS; the FDA will not approve the NDA or BLA without a REMS, if required.

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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 information. Even if such data and information is submitted, the FDA may ultimately decide that the
NDA or BLA does not satisfy the criteria for approval. Data obtained from clinical trials are not always conclusive and may be susceptible
to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA will issue a “complete response”
letter if the agency decides not to approve the NDA or BLA. The complete response letter describes all of the specific deficiencies in
the NDA or BLA identified by the FDA. The deficiencies identified may be minor, for example, requiring labeling changes, or major, for
example, requiring additional clinical trials. Additionally, the complete response letter may include recommended actions that the applicant
might take to place the application in a condition for approval. If a complete response letter is issued, the applicant may either resubmit
the NDA or BLA, addressing all of the deficiencies identified in the letter, or withdraw the application.

If a product receives regulatory approval, the
approval may be limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the
commercial value of the product. Further, the FDA may require that certain contraindications, warnings or precautions be included in the
product labeling. In addition, the FDA may require Phase 4 testing which involves clinical trials designed to further assess a product’s
safety and effectiveness and may require testing and surveillance programs to monitor the safety of approved products that have been commercialized.

Orphan Drug Designation

Under the Orphan Drug Act, the FDA may grant orphan
designation to a drug or biological product intended to treat a rare disease or condition, which is generally a disease or condition that
affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there
is no reasonable expectation that the cost of developing and making a drug or biological product available in the United States for this
type of disease or condition will be recovered from sales of the product. Orphan product designation must be requested before submitting
an NDA or BLA. After the FDA grants orphan product designation, the identity of the therapeutic agent and its potential orphan use are
disclosed publicly by the FDA. Orphan product designation does not convey any advantage in or shorten the duration of the regulatory review
and approval process.

If a product that has Orphan designation subsequently
receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan product
exclusivity, which means that the FDA may not approve any other applications to market the same drug or biological product for the same
indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity.
Competitors, however, may receive approval of different products for the indication for which the Orphan product has exclusivity or obtain
approval for the same product but for a different indication for which the Orphan product has exclusivity. Orphan product exclusivity
also could block the approval of one of our products for seven years if a competitor obtains approval of the same drug or biological product
as defined by the FDA or if our drug or biological candidate is determined to be contained within the competitor’s product for the
same indication or disease. If a drug or biological product designated as an orphan product receives marketing approval for an indication
broader than what is designated, it may not be entitled to orphan product exclusivity. Orphan Drug status in the European Union has similar
but not identical benefits in the European Union.

Expedited Development and Review Programs

The FDA has a Fast Track program that is intended
to expedite or facilitate the process for reviewing new drug and biological products that meet certain criteria. Specifically, new drug
and biological products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening condition
and demonstrate the potential to address unmet medical needs for the condition. Fast Track designation applies to the combination of the
product and the specific indication for which it is being studied. Unique to a Fast Track product, the FDA may consider for review sections
of the NDA or BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission
of the sections of the NDA or BLA, the FDA agrees to accept sections of the NDA or BLA and determines that the schedule is acceptable,
and the sponsor pays any required user fees upon submission of the first section of the NDA or BLA.

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Any product submitted to the FDA for marketing
approval, including those submitted to a Fast Track program, may also be eligible for other types of FDA programs intended to expedite
development and review, such as priority review and accelerated approval. Any product is eligible for priority review if it has the potential
to provide safe and effective therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment,
diagnosis or prevention of a disease compared with marketed products. The FDA will attempt to direct additional resources to the evaluation
of an application for a new drug or biological product designated for priority review in an effort to facilitate the review. Additionally,
a product may be eligible for accelerated approval. Drug or biological products studied for their safety and effectiveness in treating
serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated
approval, which means that they may be approved on the basis of adequate and well-controlled clinical studies establishing that the product
has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an effect on a clinical
endpoint other than survival or irreversible morbidity. As a condition of approval, the FDA generally requires that a sponsor of a drug
or biological product receiving accelerated approval perform adequate and well-controlled post-marketing clinical studies to establish
safety and efficacy for the approved indication. Failure to conduct such studies or conducting such studies that do not establish the
required safety and efficacy may result in revocation of the original approval. In addition, the FDA currently requires as a condition
for accelerated approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch or subsequent
marketing of the product. Fast Track designation, priority review and accelerated approval do not change the standards for approval but
may expedite the development or approval process.

Post-Approval Requirements

Any drug or biological products for which we receive
FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of
adverse experiences with the product, providing the FDA with updated safety and efficacy information on an annual basis or as required
more frequently for specific events, product sampling and distribution requirements, complying with certain electronic records and signature
requirements and complying with FDA promotion and advertising requirements, which include, among others, standards for direct-to-consumer
advertising, prohibitions against promoting drugs and biologics for uses or in patient populations that are not described in the drug’s
or biologic’s approved labeling (known as “off-label use”), rules for conducting industry-sponsored scientific and educational
activities, and promotional activities involving the internet. Failure to comply with FDA requirements can have negative consequences,
including the immediate discontinuation of noncomplying materials, adverse publicity, enforcement letters from the FDA, mandated corrective
advertising or communications with doctors, and civil or criminal penalties. Although physicians may prescribe legally available drugs
and biologics for off-label uses, manufacturers may not market or promote such off-label uses.

We will need to rely on third parties for the
production of our product candidates. Manufacturers of our product candidates are required to comply with applicable FDA manufacturing
requirements contained in the FDA’s cGMP regulations. cGMP regulations require among other things, quality control and quality assurance
as well as the corresponding maintenance of comprehensive records and documentation. Drug and biologic manufacturers and other entities
involved in the manufacture and distribution of approved drugs and biologics are also required to register their establishments and list
any products made there with the FDA and comply with related requirements in certain states, and are subject to periodic unannounced inspections
by the FDA and certain state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time,
money and effort in the area of production and quality control to maintain cGMP compliance. Discovery of problems with a product after
approval may result in serious and extensive restrictions on a product, manufacturer, or holder of an approved NDA or BLA, including suspension
of a product until the FDA is assured that quality standards can be met, continuing oversight of manufacturing by the FDA under a “consent
decree,” which frequently includes the imposition of costs and continuing inspections over a period of many years, and possible
withdrawal of the product from the market. In addition, changes to the manufacturing process generally require prior FDA approval before
being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are
also subject to further FDA review and approval.

The FDA also may require post-marketing testing,
known as Phase 4 testing, risk minimization action plans and surveillance to monitor the effects of an approved product or place
conditions on an approval that could otherwise restrict the distribution or use of the product.

Employees

Our business is managed by our officers who consist
of Mr. Cuong Do, Chief Executive Officer & President; Dr. Joseph M Palumbo, 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 13 employees which are all full time. We also rely on a team of highly experienced scientific, medical, and regulatory
consultants to conduct product development activities.

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Available Information

We maintain a website at www.biovie.com.
Information on our website is not incorporated by reference into this Form 10-K and does not constitute a part of this Form 10-K.
We make available, free of charge, on our website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports
on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act
of 1934, as amended, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. These
reports are also available at the SEC’s website at www.sec.gov.

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