What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-11 compared with 2026-02-06 · 139 added, 138 removed, 144 unchanged (66% of the section changed)

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disorders and advanced liver disease.

Neurodegenerative Disease Program

Neurodegenerative Disease Programs

The Company acquired the biopharmaceutical assets

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

PD and Long COVID (“LC”) 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.

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

With respect to the mechanism of action, we believe

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

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

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

By binding to ERK and selectively modulating NFκB

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

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

Chronic neuroinflammation, insulin resistance,

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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

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).

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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 Company is conducting a Phase 2b clinical

trial of bezisterim as a potential first-line therapy for patients with newly diagnosed PD.

The trial is 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.

Phase 2b study is a multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design, and is expected

to span approximately 20 weeks from initial screening through safety follow-up for each participant.

The trial commenced in April 2025

and completed enrollment of 60 patients in December 2025.

The Company currently expects to report topline results from the trial in mid-year

2026, although the timing of results is subject to change and there can be no assurance that the trial will yield favorable results or

support further development.

Long COVID Program

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Program of the Congressionally Directed Medical Research Programs.

In August 2024, the FDA 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.

In August 2024, U.S.

Army Medical Research and Development Command,

Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim for the treatment of

neurological symptoms that are associated with long COVID and the FDA authorized our Investigational New Drug (“IND”) application

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

symptoms associated with long COVID.

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

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

The trial commenced in May 2025.

Liver Disease Program

Alzheimer’s Disease

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

data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy

for the six million Americans living with AD.

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.

After receiving guidance from the FDA regarding

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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

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.

Comparison of the three months ended December 31, 2025 to the three

months ended December 31, 2024

The net loss for the three months ended

December 31, 2025 was approximately $6.1 million as compared to the net loss of approximately $7.1 million for the three months

ended December 31, 2024.

The net decrease of $1.0 million for the three months ended December 31, 2025 was comprised of a net

decrease in research and development ("R&D") expenses of approximately $435,000, and a net decrease in general and

administrative expenses of approximately $595,000.

Total operating expenses for the three

months ended December 31, 2025 were approximately $6.3 million as compared to $7.3 million for the three months ended December 31,

The net decrease of approximately $1.0 million for the three months ended December 31, 2025, was comprised of a net

decrease in R&D expenses of approximately $435,000 and a net decrease in general and administrative expenses of approximately

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 and India to date.

Terlipressin is used in over 40 countries to treat complications of liver cirrhosis, including

Type 1 hepatorenal syndrome and bleeding esophageal varices, and was approved in the U.S.

in 2022 to improve kidney function in adults

with hepatorenal syndrome experiencing a rapid reduction in kidney function;

it is not currently approved in Japan.

Comparison of the three months ended March 31, 2026 to the three

months ended March 31, 2025

Net loss for the three months ended March 31, 2026 was approximately

$5.3 million as compared to the net loss of approximately $2.8 million for the three months ended March 31, 2025.

The net increase of

$2.5 million for the three months ended March 31, 2026 was comprised of a net increase in research and development ("R&D")

expenses of approximately $1.9 million, and a net increase in general and administrative expenses of approximately $565,000.

Total operating expenses for the three months

ended March 31, 2026 were approximately $5.4 million as compared to $3.0 million for the three months ended March 31, 2025.

increase of approximately $2.4 million for the three months ended March 31, 2026 was comprised of a net increase in R&D expenses of

approximately $1.9 million and a net increase in general and administrative expenses of approximately $565,000.

Research and Development Expenses

expenses were approximately $4.3 million and $4.7 million for the three months ended December 31, 2025 and 2024, respectively.

decrease of approximately $435,000 was primarily attributed to the Long COVID (“LC”) studies’ decline in net expenses

due to the large start-up contractual payments made to the Contract Research Organizations (“CRO”) and no reimbursements received

during the three months ended December 31, 2024;

offset by increased cost from the Sunrise PD Phase 2 study, from the increased activities

in the Sunrise PD Phase 2 study became fully enrolled.

The table below indicates the cost incurred by study program.

R&D expenses were approximately $3.2 million

and $1.3 million for the three months ended March 31, 2026 and 2025, respectively.

The net increase of approximately $1.9 million was

primarily attributed to the increased activities in our clinical studies of approximately $1.1 million in the sunrise PD Phase 2 study

as it became fully enrolled and nearing completion and the Long COVID (“LC”) Phase 2 study of a net increase of approximately

The net increase in the LC study was caused by the timing of reimbursements as amounts submitted for reimbursement are recorded

on a cash basis or when recoverability is determined to be probable.

The table below indicates the approximate cost

incurred by study program.

Three months ended

December 31, 2025

December 31, 2024

March 31, 2026

March 31, 2025

Sunrise PD Phase 2

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General and Administrative Expenses

General and administrative expenses were approximately $1.9 million

and $2.5 million for the three months ended December 31, 2025 and 2024, respectively.

The net decrease of approximately $595,000 was primarily

attributed to decreases in stock-based compensation for the executive team and directors of approximately $154,000 and $58,000, respectively,

consultancy fees of approximately $593,000, investor and public relation fees of approximately $30,000, filing fees of approximately $41,000,

offset by increased legal fees related to the class action litigation of approximately $331,000, and insurance premiums of approximately

General and administrative expenses were approximately

$2.2 million and $1.6 million for the three months ended March 31, 2026 and 2025, respectively.

The net increase of approximately $565,000

was primarily attributed to increases in the executive team and directors compensation of approximately $313,000 and $401,000, respectively,

primarily in the form of stock-based compensation, increased insurance premiums of approximately $20,000 and accounting and auditing fees

of approximately $16,000;

offset by a decrease in legal fees expense of approximately $123,000, as the Company met its required insurance

retention limit for the litigation costs of shareholders class action complaint, other professional and consultancy fees of approximately

$38,000 and investor and public relation expense of approximately $24,000.

Other Income and Expense

Other income, net was approximately $193,000

compared to other income, net of approximately $180,000, for the three months ended December 31, 2025 and 2024, respectively.

increase in other income of approximately $13,000 was primarily comprised of a reduction in interest expense of approximately $61,000

due to the payoff of the notes payable on December 1, 2024, offset by a reduction in interest income of approximately $54,000.

Comparison of the six months ended December 31, 2025 to the six

months ended December 31, 2024

The net loss for the six months ended December

31, 2025 was approximately $11.2 million comparable to the net loss of approximately $11.3 million for the six months ended December 31,

The net decrease of approximately $108,000 for the six months ended December 31, 2025 was comprised of the net increase in operating

expenses of approximately $132,000 offset by the increase in other income, net of approximately $240,000.

Total operating expenses for the six months

ended December 31, 2025 were approximately $11.5 million as compared to $11.4 million for the six months ended December 31,

The net R&D increase of approximately $132,000 for the six months ended December 31, 2025, was comprised of net

increased research and development expenses of approximately $511,000 primarily attributed to the development and launch of both the

Long COVID program in April 2025 and Sunrise PD Phase 2 studies in May 2025 offset by the decline in general and administrative

expenses of approximately $379,000.

Other income, net was approximately $115,000 compared

to other income, net of approximately $200,000, for the three months ended March 31, 2026 and 2025, respectively.

The net decrease in

other income of approximately $85,000 was primarily due to a interest income of approximately $76,000.

Comparison of the nine months ended March 31, 2026 to the nine months

ended March 31, 2025

Net loss for the nine months ended March 31, 2026

was approximately $16.4 million comparable to the net loss of approximately $14.1 million for the nine months ended March 31, 2025.

net increase of approximately $2.3 million for the nine months ended March 31, 2026 was comprised of the net increase in operating expenses

of approximately $2.5 million offset by the increase in other income, net of approximately $155,000.

Total operating expenses for the nine months ended

March 31, 2026 were approximately $16.9 million as compared to $14.4 million for the nine months ended March 31, 2025.

The net operating

expense increase of approximately $2.5 million for the nine months ended March 31, 2026, was comprised of net increased R&D expenses

of approximately $2.4 million attributed to the increased activities in both the Sunrise PD Phase 2 study and LC Phase 2 study and an

increase in general and administrative expenses of approximately $189,000.

Research and Development Expenses

R&D expenses were approximately

$7.2 million for the six months ended December 31, 2025, an increase of approximately $511,000 from $6.7 million for six months ended

December 31, 2024.

The net increase in R&D expenses of approximately $511,000 is comprised of increased direct study costs of approximately

$818,000, clinical team compensation of approximately $88,000, travel and conferences of approximately $153,000, offset by approximately

$541,000 of Chemistry, Manufacturing and Controls (“CMC”) expenses that have been temporarily curtailed.

R&D expenses were approximately $10.4 million

for the nine months ended March 31, 2026, an increase of approximately $2.4 million from $8.0 million for nine months ended March 31,

The net increase in R&D expenses is comprised of increased direct study costs of approximately $2.5 million, clinical team compensation

of approximately $282,000, abstracts, publications and conferences of approximately $176,000, offset by approximately $619,000 in Chemistry,

Manufacturing and Controls (“CMC”) and Discovery expenses that have been curtailed.

As the table indicates below, the increase in

clinical studies of approximately $818,000 were comprised of the increased Sunrise PD Phase 2 study cost of approximately $2.3 million

and the decline in Long Covid Phase 2 study cost of net of reimbursements totaling approximately $1.5 million that consisted of the large

contractual start-up fee paid the CRO and the lag in receiving the reimbursements during the six months ended December 31, 2024.

Six months ended

December 31, 2025

December 31, 2024

clinical studies of approximately $2.5 million is attributed to increased activity in both our clinical studies.

Sunrise PD Phase 2 study

costs increased by approximately $3.4 million as the study completed enrollment in January 2026 and the study is currently nearing completion.

Long Covid Phase 2 study activities decreased and the net decrease in cost, net of reimbursements totaled approximately $786,000.

net decrease in costs is caused by the timing of reimbursements as amounts submitted for reimbursement are recorded on a cash basis or

when recoverability is determined to be probable.

As of March 31, 2026, the total cost incurred since inception was approximately $9.4

million and as of May 4, 2026 the total cost reimbursed was $9.4 million.

Nine months ended

March 31, 2026

March 31, 2025

Sunrise PD Phase 2

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General and Administrative Expenses

General and administrative expenses were approximately $4.2 million

and $4.6 million for the six months ended December 31, 2025 and 2024, respectively.

The net decrease of approximately $379,000 was primarily

attributed to decreases in stock-based compensation for the executive team and directors of approximately $238,000 and $151,000, respectively

and consultancy fees of approximately $565,000;

offset by a net increase in legal fee expenses of approximately $546,000 that primarily

represented legal fees related to the class action litigation.

General and administrative expenses were approximately

$6.4 million and $6.2 million for the nine months ended March 31, 2026 and 2025, respectively.

The net increase of approximately $189,000

was primarily attributed to increases in the executive team and directors compensation of approximately $78,000 and $214,000, respectively,

primarily comprised of stock based compensation;

legal expenses of approximately $423,000 primarily attributed to the class action litigation;

investor and public relations expenses of $71,000;

and insurance premiums of approximately $55,000, offset by a decrease in consultancy

fees of approximately $603,000 and a decline in other expenses such as meetings and travel totaling $24,000 and accounting and auditing

fees of approximately $14,000.

Other Income and Expense

Other income, net was approximately $505,000 compared

to other income, net of $150,000, for the six months ended December 31, 2025 and 2024, respectively.

The net increase in other income

of approximately $240,000 was comprised of a reduction in interest expense of approximately $315,000 due to the payoff of the notes payable

on December 1, 2024, offset by a reduction in interest income of approximately $79,000.

to other income, net of $350,000, for the nine months ended March 31, 2026 and 2025, respectively.

The net increase in other income of

approximately $155,000 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 $155,000.

Capital Resources and Liquidity

As of December 31, 2025, the Company had working capital of approximately

$18.8 million, cash and cash equivalents totaling approximately $20.5 million, stockholders’ equity of approximately $19.3 million,

and an accumulated deficit of approximately $363.3 million.

As of March 31, 2026, the Company had working

capital of approximately $15.2 million, cash and cash equivalents totaling approximately $13.1 million, stockholders’ equity of

approximately $15.6 million, and an accumulated deficit of approximately $368.6 million.

The Company used net cash in operations totaling

approximately $7.5 million and net cash provided by financing activities was comprised of net proceeds from capital raise activities of

$10.5 million.

approximately $14.9 million and net cash provided by financing activities was comprised of net proceeds from capital raise activities

of approximately $10.5 million.

The Company has not generated any revenue and

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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

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

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.

Critical Accounting Policies and Estimates

There were no significant changes to the Company's critical accounting policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2025 (the "2025 Form 10-K").

There were no significant changes to the Company's

critical accounting policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2025 (the "2025 Form

New Accounting Pronouncements

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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-Q

Item 2. Management’s Discussion and Analysis