What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-08-13 compared with 2025-08-15 · 194 added, 183 removed, 83 unchanged (82% of the section changed)

3 unchanged sentences

elsewhere in this report.

(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

The Company acquired the biopharmaceutical

assets of NeurMedix, Inc.

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

The acquired assets included NE3107 (or “bezisterim”).

Bezisterim, the approved generic name for NE3107 is

an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and

major pathological inflammatory cascades with a novel mechanism of action.

There is emerging scientific consensus that both

inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’s disease (“AD”)

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

Food and Drug Administration

(“FDA”), represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6

million Americans suffering from AD, 1 million Americans suffering from PD and Long COVID affects approximately 20 million adults in

the US, and millions more worldwide.

In neurodegenerative disease, bezisterim (NE3107)

inhibits activation of inflammatory ERK and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”)

(including interactions with TNF signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance.

Bezisterim (NE3107) does not interfere with their homeostatic functions (e.g., insulin signaling and neuron growth and survival).

inflammation and insulin resistance are drivers of AD and PD.

We are a clinical-stage company developing innovative

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

Neurodegenerative Disease Programs

The Company acquired the biopharmaceutical assets

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

The acquired assets included bezisterim.

Bezisterim, the approved generic name for NE3107 is an investigational, novel, orally administered small molecule that is thought to inhibit

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

There is emerging

scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of AD and PD, and bezisterim

could, if approved by the FDA, represent an entirely new medical approach to treating these devastating conditions affecting an estimated

6 million Americans suffering from AD, 1 million Americans suffering from PD, and approximately 20 million adults in the US suffering

from Long COVID, with millions more affected worldwide.

With respect to the mechanism of action, we believe

bezisterim inhibits activation of inflammatory ERK and NFκB (including interactions with TNF signaling and other relevant inflammatory

pathways) that lead to neuroinflammation and insulin resistance.

By binding to ERK and selectively modulating NFκB activation and

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

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

Chronic neuroinflammation, insulin resistance,

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provides symptomatic benefit, it does not slow PD progression.

The Phase 2 study of bezisterim (NE3107) for the

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

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

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

state” were randomized 1:1 to placebo:

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

This trial was launched with two design

1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for

adverse interactions of bezisterim (NE3107) with carbidopa/ levodopa;

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.

The Company recently

conducted a Phase 2b clinical trial of bezisterim as a potential first-line therapy for patients with newly diagnosed PD.

The SUNRISE-PD

trial was designed to evaluate the safety and efficacy of bezisterim on motor and non-motor symptoms in patients with PD who have not

been treated with carbidopa/levodopa.

The trial was a multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized

design and lasted 20 weeks from initial screening through safety follow-up for each participant.

The trial commenced in April 2025and

completed enrollment in December 2025.

In August 2026, the Company announced topline results of the trial.

The trial successfully met

prespecified endpoints and achieved its objectives, with topline results showing that bezisterim improved blood based inflammatory markers

of disease, along with a broad range of biological markers associated with overall cellular health and nerve cell damage.

treated with bezisterim experienced greater improvements than those receiving placebo across a series of clinical outcome measures of

daily living, motor symptoms, and nonmotor symptoms.

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

3 registrational trial of bezisterim in PD.

The previous Phase 2 study of bezisterim

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

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

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

bezisterim (NE3107) 20 mg twice daily for 28

This trial was launched with two design objectives:

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

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

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

could be seen in humans.

Both objectives were met.

To extend this Phase 2 data in progressed patients,

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

In July 2024, the Company submitted the new protocol and received a response from the FDA which permitted the Company to proceed with

The trial commenced in April 2025.

Long COVID Program

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.

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 trial commenced in May 2025.

Liver Disease Program

trial grant of $13.1 million from the DOW, awarded through the Peer Reviewed Medical Research Program of the Congressionally Directed

Medical Research Programs.

In August 2024, the U.S.

Army Medical Research and Development Command, OHRO approved the Company’s plan

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

for bezisterim allowing the Company to study a novel, anti-inflammatory approach for the treatment of the debilitating neurocognitive

symptoms associated with long COVID.

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

the efficacy, safety and tolerability of bezisterim in adult participants with long COVID who have cognitive impairment sequelae and fatigue.

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

The Company currently expects to report topline results

in late summer 2026.

As of June 30, 2026, the total cost incurred was

approximately $12.9 million and as of August 7, 2026 the total cost reimbursed was $12.9 million.

Grant reimbursements recognized for

the corresponding research and development expenses in the accompanying statements of operations totaled approximately $7.6 million and

$5.3 million for the years ended June 30, 2026 and 2025, respectively.

Alzheimer’s Disease

In AD, BioVie has conducted both Phase 2 and Phase 3 trials.

Preliminary data from these trials suggest improvements

in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with

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

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

December 2022.

On November 29, 2023, the Company announced the 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 cGCP 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 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 has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is

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

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

The initial target for BIV201 therapy was refractory ascites.

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

an estimated 50% mortality rate within 6 to 12 months.

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

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

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

ascites due to hepatitis, nonalcoholic steatohepatitis, and alcoholism.

treatment costs for liver cirrhosis, including ascites and

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

FDA has never approved any drug specifically for treating ascites.

After receiving guidance from the FDA regarding

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

a broader ascites patient population.

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

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

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

This patient population is not limited to those

having refractory ascites.

BIV201 is administered as a patent-pending liquid formulation with patents issued in US, China, Japan, Chile

and India to date.

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 looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive

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

Patients were randomly assigned, 1:1 versus

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

by 26 weeks of 20 mg orally twice daily.

Upon trial completion, as the Company began the

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

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

This highly unusual level of suspected improprieties

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

for potential further action.

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

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

The trial was originally designed to be 80% powered

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

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

the primary endpoints.

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

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

of cognitive loss;

these same patients experienced an advantage in age deceleration vs.

placebo as measured by DNA epigenetic change.

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

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

This test was a non-primary/secondary

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

Additional DNA methylation data continues to

be collected and analyzed.

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

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

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

Ascites is a common

complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often exceeding five liters,

due to liver and kidney dysfunction.

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

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

Terlipressin is used in over 40 countries to

treat complications of liver cirrhosis, including Type 1 hepatorenal syndrome and bleeding esophageal varices, and was approved in the

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

currently approved in Japan.

Results of Operations

3 unchanged sentences

was approximately $22.1 million as compared to the net loss of $17.5 million for the year ended June 30, 2025.

The net decrease of $14.6

million was primarily attributed to decline in research and development expenses of $13.8 million, and a net increase in other income,

net of approximately $465,000.

The net increase of $4.6

million was primarily attributed to increase in operating expenses of $4.6 million, offset by a net increase in other income, net of approximately

Total operating expenses for the years ended June

30, 2025 and 2024 were approximately $18.1 million and $32.2, respectively.

The net decrease of approximately $14.1 million was

primarily due to the decrease in research and development expenses as a result of the completion of clinical trials in the prior fiscal

30, 2026 and 2025 were approximately $22.7 million and $18.1 million, respectively.

The net increase of approximately $4.6 million

was comprised of net increased R&D expenses of approximately $4.7 million attributed to the increased activities in both the Sunrise

PD Phase 2 study and LC Phase 2 study offset by a decrease in general and administrative expenses of approximately $59,000.

Research and Development Expenses

Research and development expenses were approximately $9.3 million and

$23.1 million for the years ended June 30, 2025 and 2024, respectively.

The $13.8 million reduction was primarily attributed to the completion

of the clinical studies in the prior fiscal year and comprised of a declines in direct study costs of approximately $7.4 million, and

the related expenses such as the clinical team payroll of approximately $1.4 million, and consultants expenses of approximately $3.0 million,

reflecting a declining use of consultants and a reduction in the use of regulatory and other consultants totaling approximately $496,000.

Other decreases included a decrease in Chemistry, Manufacturing and Controls (“CMC”) and new drug discovery totaling approximately

$1.2 million, and a decrease in travel & conferences of approximately $123,000, as well as publications of approximately $166,000.

The decrease in clinical studies of approximately $7.4 million represented

the net decrease in clinical trial studies expense of approximately $10.8 million due to the completion of the clinical trials in the

prior fiscal year offset primarily by the planning, development and launch of the two new clinical studies, Sunrise PD Phase 2 and Long

Covid Program, totaling approximately $3.3 million.

The table below summarizes the approximate expense amounts for the years ended June

30, 2025 and 2024 by study:

For the Year Ended

R&D expenses were approximately $14.0 million

for the year ended June 30, 2026, an increase of approximately $4.7 million from $9.3 million for the year ended June 30, 2025.

increase in R&D expenses was attributed to increases in direct study costs of approximately $4.5 million;

clinical team compensation

of approximately $686,000 that was primarily comprised of stock based compensation and year-end bonuses;

and abstracts, publications and

conferences of approximately $141,000, offset by approximately $646,000 in Chemistry, Manufacturing and Controls and Discovery expenses

that were curtailed.

As the table indicates below, the increase in

clinical studies of approximately $4.5 million is attributed to increased activity in both our clinical studies.

Sunrise PD Phase 2 study

costs increased by approximately $4.0 million as the study completed enrollment in January 2026 and the study close process began with

the last patient treated in May 2026.

Long Covid Phase 2 study activities increased and the net increase in cost, net of reimbursements

totaled approximately $709,000.

The study reached full enrollment in May 2026 and the study is currently nearing completion.

30, 2026, the total cost incurred since inception was approximately $12.9 million and as of August 5, 2026 the total cost reimbursed

was $12.9 million.

June 30, 2026

June 30, 2025

Current Studies

Sunrise PD Phase 2

Liver Program Phase 3

Long COVID Program, net of $5.3 million reimbursement

Investigator-Initiated studies

Completed Studies

Ascites BIV201 Phase 2b

AD mild to moderate pivotal Phase 3

PD NM201 Phase 2

Investigator-Initiated studies

Other studies in development/canceled

$ (10,754,000 )

Selling, General and Administrative Expenses

Selling, general and administrative expenses for the year ended June

30, 2025, was approximately $8.6 million and was comparable to approximately $8.8 million for the year ended June 30, 2024.

The net fluctuations

in expenses were primarily comprised of decreases in stock-based compensation for the executive team and directors of approximately $436,000

and $595,000, respectively, and investor and public relation fees of $210,000, offset by increases in directors’ cash compensation

of approximately $101,000, other professional and consultancy fees of approximately $582,000, legal fees of approximately $468,000, and

audit and accounting fees of approximately $82,000.

Long COVID Phase 2

Long COVID Phase 2 - reimbursements

General and Administrative Expenses

General and administrative expenses were approximately

$8.5 million and $8.6 million for the year ended June 30, 2026 and 2025, respectively.

The net decrease of approximately $59,000 was primarily

attributed to increases in the executive team and directors compensation of approximately $344,000 and $179,000, respectively, primarily

comprised of stock based compensation and year end bonus;

legal expenses of approximately $30,000;

and insurance premiums of approximately

$80,000, offset by a decrease in consultancy fees of approximately $606,000 and a decline in other expenses such as meetings and travel

totaling $8,000, investor and public relations expense of approximately $9,000, shareholder meeting and filing fees of approximately $30,000

and accounting and auditing fees of approximately $29,000.

Other Income and Expense

Other income, net was approximately $579,000 for

the year ended June 30, 2025, compared to approximately $59,000 for the year ended June 30, 2024.

The net increase in other income of

approximately $465,000 was comprised of a decrease in the change in fair value of the related derivative liabilities of approximately

$1.8 million, offset by the decline in interest expense, net $2.6 million due to the payoff of the notes payable on December 1, 2024 and

decline in interest income of approximately $284,000.

the year ended June 30, 2026 compared to other income, net of $524,000, for the year ended June 30, 2025.

The net increase in other income

of approximately $55,000 was comprised of a reduction in interest expense of approximately $314,000 due to the payoff of the notes payable

on December 1, 2024, offset by decline in interest income of approximately $256,000.

Capital Resources and Liquidity

2 unchanged sentences

million, and an accumulated deficit of approximately $374.3 million.

Additionally, the Company had a net loss of approximately $17.5

million and net cash used in operating activities of approximately $19.0 million during the year ended June 30, 2025.

The Company has

not generated any revenues to date and no revenues are expected in the foreseeable future.

The Company’s future operations are dependent

on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure additional financing

Additionally, the Company had a net loss of approximately $22.1 million

and net cash used in operating activities of approximately $19.0 million during the year ended June 30, 2026.

The Company has not generated

any revenues to date and no revenues are expected in the foreseeable future.

The Company’s future operations are dependent on the

success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure additional financing

The future viability of the Company is largely dependent upon its ability

7 unchanged sentences

as a going concern.

The financial statements included elsewhere in this Form 10-K do not include any adjustments that might result from

the outcome of this uncertainty.

Registered Direct Offerings

On September 25, 2024, the Company closed a best

efforts public offering (the “September 2024 Offering”) of 136,080 shares of its common stock, par value $0.0001 per share,

pre-funded warrants (the “September Pre-funded Warrants”) to purchase 60,000 shares of Common Stock, and warrants to purchase

up to 196,080 shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $15.30 per share,

or September Pre-funded Warrant, and the associated September Common Warrant.

26,500 September Pre-funded Warrants were exercised shortly

thereafter and reflected on the statement of changes in stockholders’ equity as a component of proceeds from issuance of common

The September Common Warrants have an exercise price of $15.30 per share and were immediately

exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date.

The gross proceeds to the

Company from the September 2024 Offering was approximately $3.0 million, before deducting placement agent fees and offering expenses of

approximately $747,000.

Additionally, upon closing, the Company issued the placement agent warrants (“September Placement Agent’s

Warrants”) to purchase 9,809 shares of Common Stock exercisable at a per share price of $19.10, which was equal to 125% of the public

offering price per share.

The September Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days

from September 25, 2024.

Subsequently, 189,630 of common warrants from the September 2024 Offering were exercised at $15.30 per

share for proceeds totaling approximately $2.9 million, and 33,500 September Pre-funded Warrants were also exercised.

In addition, 667

September Placement Agent’s Warrants were exercised on a cashless exercise basis and 422 common shares were issued.

In October 2024, the Company closed three registered

direct offerings totaling 825,600 shares of its common stock, par value $0.0001 per share, and two concurrent private placements of warrants

to purchase up to 711,000 shares of Common Stock (the “October Common Warrants”) priced at-the-market under Nasdaq rules at

prices ranging from $15.00 to $28.30 per share (the “October Offerings”) .

Common Warrants have exercise prices ranging from $13.70 to $21.20 per share and are exercisable beginning six months following issuance

and will expire on the fifth anniversary date of the original issuance dates.

The gross proceeds to the Company from the October

Offerings totaled approximately $15.9 million, before deducting placement agent fees and offering expenses of approximately $2.5 million.

Additionally, upon closing of the October Offerings, the Company issued placement agent warrants (the “October Placement Agent’s

Warrants”) to purchase 41,321 shares of Common Stock in the aggregate exercisable at a per share price ranging from $18.80 to $35.40,

which was equal to 125% of the offering price per share in the applicable October Offering.

The October Placement Agent’s Warrants

are exercisable during a five-year period commencing 180 days from each of the respective closing dates of the October Offerings.

The financial statements included elsewhere in this report do not include any adjustments that might result from the

outcome of this uncertainty.

Registered Direct Offerings [TO BE UPDATED FOR SUBSEQUENT

CLOSE OF CAP RAISE]

On August 11, 2025, the Company closed an underwritten

public offering of (i) 5,620,000 units (the “Units”), with each Unit consisting of one share of common stock and one warrant

(the “Warrants”) and (ii) 380,000 pre-funded units (the “Pre-Funded Units”), with each Pre-Funded Unit consisting

of one pre-funded warrant and one Warrant.

The underwriter also exercised its over-allotment option in part and purchased an additional

667,300 Warrants.

The offering resulted in net proceeds of approximately $10.5 million, after deducting underwriting discounts and commissions

and other estimated offering expenses.

Each Unit was sold to the public at a price of $2.00 per Unit and each Pre-Funded Unit was sold

to the public at a price of $1.9999 per Pre-Funded Unit (which represents the public offering price of each Unit less the $0.0001 per

share nominal exercise price for each Pre-Funded Warrant).

On August 8, 2025, the Warrants commenced trading on The Nasdaq Capital Market

under the symbol “BIVIW.” Each Warrant is immediately exercisable, entitles the holder to purchase one share of common stock

at an exercise price of $2.50 per share and expires five years from the date of issuance.

Each Pre-Funded Warrant is immediately exercisable,

entitles the holder to purchase one share of common stock, and may be exercised at any time until exercised in full.

Additionally,

upon closing, the Company issued the underwriter warrants to purchase 300,000 shares of Common Stock exercisable at a per share price

of $2.50, which was equal to 125% of the public offering price per share.

The underwriter’s Warrants are exercisable during a five-year

period commencing 180 days from August 11, 2025.

Off-Balance Sheet Arrangements

27 unchanged sentences

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 7. Management’s Discussion and Analysis