Biovie reported a net loss of $5.61 million for fiscal Q1 2027.

Cover page 37 changes

2 unchanged paragraphs

FOR THE FISCAL YEAR ENDED JUNE 30 , 2026

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended: September 30, 2026

ANNUAL REPORT UNDER PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

2 unchanged paragraphs

(Exact name of registrant as specified in its charter)

2 unchanged paragraphs

680 W Nye Lane Suite 2014 201

3 unchanged paragraphs

Securities registered pursuant to Section 12(b) of

Name of each exchange on which registered==

Class A Common Stock, $0.0001 par value per share

1 unchanged paragraph

Warrants to purchase Class A Common Stock, $0.0001 par value per share

1 unchanged paragraph

Securities registered pursuant to Section 12(g)

Indicate by check mark if the registrant is a

well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Indicate by check mark if the registrant is not

required to file reports pursuant to Section 13 or Section 15(d) of the Act

Indicate by check mark whether the registrant (1)

(1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Indicate by check mark whether the registrant has

has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Indicate by check mark whether the registrant is

is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.

8 unchanged paragraphs

Indicate by check mark if the registrant has filed

a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7362(b)) by the registered public accounting firm that prepared or issued its audit report.

If securities are registered pursuant to Section

12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error

corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

The aggregate market value of the voting and non-voting

common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant's most recently completed second fiscal quarter was $ 8,454,444 .

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the Registrant's definitive proxy statement relating to its 2026 annual meeting of stockholders (the "2026 Proxy Statement") are incorporated by reference into Part III of this

Annual Report on Form 10-K where indicated.

Indicate by check mark whether the registrant is

is a shell company (as defined in Rule 12b-2 of the Exchange Act).

There were 7,542,638 10,724,724 shares of the Registrant's

Class A Common Stock, $0.0001 par value per share, outstanding as of August 10, November 5, 2026.

PART I – FINANCIAL INFORMATION

Forward-looking statements 14 changes

This Annual Report on Form 10-K (this "report")

When used in this report, the terms "BioVie",

This report contains forward-looking statements within

contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Section 27A of the

Act"), and Section 27A of the Securities Act of 1933, as amended (the "Securities Act"). Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words "intends," "estimates," "predicts,"

"estimates," "predicts," "potential," "continues," "anticipates," "plans," "expects," "believes,"

"expects," "believes," "should," "could," "may," "will" or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors include our research and development activities, distributor channel; compliance with regulatory impositions; and our capital needs. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

Except as may be required by applicable law, we do

do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange

Commission (the "Commission") that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business.

All statements other than statements of historical

fact are statements that could be deemed forward-looking statements. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law. When used in this report, the terms "BioVie", "Company",

"Company", "we", "our", and "us" refer to BioVie Inc.

PART I – FINANCIAL INFORMATION

Financial statements 75 changes

Our financial information required to be filed

hereunder are indexed under Item 15 of this report and are incorporated herein by reference.

Condensed Balance Sheets

Cash and cash equivalents

Prepaid and other current assets

Total current assets

Operating lease right-of-use asset, net

LIABILITIES AND STOCKHOLDERS' EQUITY

CURRENT LIABILITIES:

Accounts payable and accrued expenses

Current portion of operating lease liability

Total current liabilities

Operating lease liability, net of current portion

Commitments and contingencies (Note 7)

STOCKHOLDERS' EQUITY:

Preferred stock; $ 0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding

Common stock, $ 0.0001 par value; 800,000,000 shares authorized at September 30, 2026 and June 30, 2026; 8,694,224 shares issued of which 8,691,388 shares outstanding at September 30, 2026; and 7,545,474 shares issued of which 7,542,638 shares are outstanding at June 30, 2026

Additional paid in capital

Total stockholders' equity

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

See accompanying notes to unaudited condensed financial

Condensed Statements of Operations

Amortization of intangible assets

Research and development expenses

General and administrative expenses

TOTAL OPERATING EXPENSES

LOSS FROM OPERATIONS

OTHER (INCOME) EXPENSE:

TOTAL OTHER INCOME, NET

Deemed dividend related to ratchet adjustment to warrants

NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS

NET LOSS PER COMMON SHARE

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

See accompanying notes to unaudited condensed financial

Condensed Statements of Changes in Stockholders'

Balance, June 30, 2025

Stock - based compensation - stock options

Stock-based compensation - restricted stock units and restricted shares

Proceeds from issuance of common stock, net of costs of $1,543,038

Issuance of common stock from vesting of restricted stock units

Stock-based compensation - issuance of common stock for services rendered

Deemed dividend for ratchet adjustment to warrants

Balance, September 30, 2025

Balance, June 30, 2026

Stock - based compensation - stock options

Proceeds from issuance of common stock, net of costs of $143,393

Issuance of common stock from vesting of restricted stock units ( 1 )

Cashless exercise of warrants

Proceeds from exercise of warrants

Balance, September 30, 2026

See accompanying notes to unaudited condensed financial

Condensed Statements of Cash Flows

CASH FLOWS FROM OPERATING ACTIVITIES:

Adjustments to reconcile net loss to net cash used in operating activities:

Amortization of intangible assets

Stock based compensation - restricted stock units and restricted shares

Stock based compensation expense - stock options

Non-cash lease expense from right-of-use asset

Changes in operating assets and liabilities:

Prepaid and other current assets

Accounts payable and accrued expenses

Operating lease liability

Net cash used in operating activities

CASH FLOWS FROM FINANCING ACTIVITIES:

Net proceeds from issuance of common stock

Proceeds from exercise of warrants

Net cash provided by financing activities

Net change in cash and cash equivalents

Cash and cash equivalents, beginning of period

Cash and cash equivalents, end of period

SUPPLEMENTAL CASH FLOW INFORMATION:

Cash paid for interest

SUPPLEMENTAL DISCLOSURE OF NONCASH FINANCING ACTIVITIES:

Deemed dividend for ratchet adjustment to warrants

See accompanying notes to unaudited condensed financial

Notes to the financial statements 318 changes

Background Information

BioVie Inc. (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 Programs

The Company acquired the biopharmaceutical assets

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

The acquired assets included NE3107 ("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 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,

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

Amyotrophic lateral sclerosis. Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation. Bezisterim's (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company's work testing the molecule in AD, PD, and long COVID patients. Bezisterim (NE3107) is patented in the United States, Australia, Canada,

Europe and South Korea.

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 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. Participants 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). 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 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; 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.

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 War ("DOW"), formerly known as the Department of Defense, 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, 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 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.

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 AD.

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 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) 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 need. 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. U.S. 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. The

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 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").

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 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.

In May 2025, the Company formed Option Therapeutics,

Inc., a Delaware corporation, as a wholly owned subsidiary with no discreet financial information. In January 2026, the Company filed a Form S-1 with carved out financial statements for Option Therapeutics, Inc.

Liquidity and Going Concern

The Company's operations are subject to

a number of factors that can affect its operating results and financial conditions. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company's products, the Company's ability to obtain regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company's ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company's ability to raise capital. The Company's financial statements have been prepared assuming the

Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As of June 30, 2026, the Company had working capital of approximately $ 9.8 million, cash and cash equivalents of approximately

$ 9.0 million, stockholders' equity of approximately $ 10.3 million, and an accumulated deficit of approximately $ 374.3 million. The

Company is in the pre-revenue stage 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 as needed. Projected cash flows could be extended if further measures are taken to delay planned expenditures in our research protocols and slow the progress in the Company's development and launch of next phase clinical programs.

The future viability of the Company is largely

dependent upon its ability to raise additional capital to finance its operations. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.

Although management continues to pursue the Company's

strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the

Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company's ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Significant Accounting Policies

Basis of Presentation

The Company's financial statements have

been prepared in accordance with accounting principles generally accepted in the United States ("GAAP") and include all adjustments necessary for the fair presentation of the Company's financial position for the periods presented.

The preparation of financial statements in conformity

with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances. The amounts of assets and liabilities reported in the Company's balance sheets and the amounts of expenses reported for each of the periods presented in the statements of operations are affected by estimates and assumptions, which are used for, but not limited to, accounting for clinical accruals, share-based compensation, assumptions used in recording leases, the inputs used in the valuation of goodwill and intangible assets in connection with impairment testing and accounting for income taxes. Actual results could differ from those estimates.

Cash and cash equivalents

Cash and cash equivalents consisted of cash deposits

and money market funds held at a bank and funds held in a brokerage account which included a U.S. treasury money market fund and U.S.

Treasury Bills with original maturities of three months or less.

Concentration of Credit Risk in the Financial

As of June 30, 2026, the Company had cash deposited

in a certain financial institution in excess of federally insured levels. The Company regularly monitors the financial stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents. However, if liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the

Company's ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.

Fair value measurement of assets and liabilities

and 238 more changes in the filing

MD&A 115 changes

We are a clinical-stage company developing innovative

This report contains forward-looking statements within

the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended.

Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words "intends," "estimates," "predicts," "potential," "continues," "anticipates,"

"plans," "expects," "believes," "should," "could," "may," "will"

or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors include, among others: our research and development activities and distributor channel; compliance with regulatory requirements; and our ability to satisfy our capital needs. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

You are cautioned not to place undue reliance on

the forward-looking statements in this report, which speak only as of the date of this report. Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments, except as required by law. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission (the "SEC") that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business.

The following discussion of the Company's financial

financial condition and the results of operations should be read in conjunction with the Financial Statements and Notes thereto appearing elsewhere in this report.

Management's Discussion

BioVie Inc. (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 Programs Program

2 unchanged paragraphs

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

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.

3 unchanged paragraphs

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

Europe and South Korea.

3 registrational trial of bezisterim in PD.

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

Chronic neuroinflammation, insulin resistance, and

oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic lateral sclerosis. Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation. Bezisterim's (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company's work testing the molecule in AD, PD, and long COVID patients. Bezisterim (NE3107) is patented in the United States, Australia, Canada,

Bezisterim's (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company's work testing the molecule in AD, PD, and long COVID patients. Bezisterim (NE3107) is patented in the United States, Australia, Canada, Europe and South Korea.

PD is driven in large part by neuroinflammation and

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 recently conducted a Phase 2b

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 2025 and 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. Participants 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)

(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). 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 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; 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.

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 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; 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.

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.

1 unchanged paragraph

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

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

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

trial grant of $13.1 $13.2 million from the U.S. Department of War ("DOW"), formerly known as the Department of Defense, awarded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, the U.S.

Medical Research Programs. In August 2024, the 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 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. 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 and the Company reported topline results in September 2026.

approximately $12.9 million and As of August 7, September 30, 2026, the total direct study cost reimbursed incurred and submitted for reimbursement under the DOW grant was $12.9 approximately $13.2 million, of which approximately $218,000 was outstanding. Grant reimbursements recognized for the corresponding research and development expenses in the accompanying statements of operations totaled approximately $7.6 million and

$218,000 and $336,000 for the three months ended September 30, 2026 and 2025, respectively.

In AD, BioVie has conducted both Phase 2 and Phase

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 AD.

Results of a Phase 2 investigator-initiated trial

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

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

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

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

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

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.

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.

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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.

Results of Operations

Comparison of the Year Ended June 30, 2026

to the Year Ended June 30, 2025

Total operating expenses for the years ended June

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.

After receiving guidance from the FDA regarding the

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 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 September 30, 2026 to the three months ended September 30, 2025

The net loss for the year three months ended June September 30, 2026 was approximately

was approximately $22.1 $5.6 million as compared to the net loss of $17.5 $5.1 million for the year three months ended June September 30, 2025. 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

$500,000 for the three months ended September 30, 2026 was comprised of the net increase in research and development expenses of approximately

$401,000, net increase in general and administrative expenses of approximately $22,000 and a decrease in other income, net of approximately

$152,000, partially offset by a decrease in amortization of intangible assets of approximately $57,000.

Total operating expenses for the three months ended September 30, 2026 were approximately $5.6 million as compared to $5.3 million for the three months ended September 30, 2025. The net increase of approximately

$300,000 for the three months ended September 30, 2026 was comprised of net increased research and development expenses of approximately

$401,000 primarily attributed to the Long COVID Phase 2 program, which commenced in May 2025 and the net increase in general and administrative expenses of approximately $22,000, partially offset by a decrease in amortization of intangible assets of approximately $57,000 as the intangible asset was fully amortized as of June 30, 2026.

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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. The net 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. As of June

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.

Research and development ("R&D")

expenses were approximately $3.3 million for the three months ended September 30, 2026, as compared to $2.9 million for three months ended September 30, 2025. The net increase in R&D expenses of approximately $401,000 is comprised of net increases in direct study costs of approximately $423,000, clinical team compensation of approximately $35,000, Chemistry, Manufacturing and Controls of approximately

$16,000, offset by publications and conferences of approximately $69,000.

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and 35 more changes in the filing

Market risk 1 change

Not applicable to smaller reporting companies.

Controls and procedures 16 changes

We have evaluated, with the participation of our

principal executive and our principal financial officer, the effectiveness of our disclosure controls and procedures as defined in Rules

Management's Report on Internal Control

Over Financial Reporting

Our management is responsible for establishing

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of the effectiveness of internal control to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with policies or procedures may deteriorate. Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of June 30, 2026 using the criteria established in Internal Control

Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation using those criteria, our management has concluded that, as of June 30, 2026, our internal control over financial reporting was effective to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles for the reasons discussed above.

Evaluation of We maintain "disclosure controls and procedures." Such term

is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of the end of the period covered by this report. Based on this evaluation, our principal executive officer and our principal financial officer have concluded that our disclosure controls and procedures were effective are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the Commission's Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our principal Chief Executive Officer and principal Chief Financial officers, or persons performing similar functions, Officer, as appropriate, to allow timely decisions regarding required disclosure.

In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures have been designed to meet reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure and procedures. The design of disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

Based on their evaluation as of the end of the period

covered by this Quarterly Report on Form 10-Q, our Chief Executive Officer and Chief Financial Officer have concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control over Financial Reporting

There were no changes in our internal controls control over

and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended September

over financial reporting during the quarter ended June 30, 2026, that have materially affected, or are reasonably likely to materially affect, our internal controls control over financial reporting.

Legal proceedings 18 changes

On January 19, 2024, a purported securities class

No. 2:24-cv-00361. On April 15, 2024, the court consolidated these two actions under the caption In re BioVie Inc. Securities Litigation ,

No. 3:24-cv-00035 (the "Securities Class Action"), appointed the lead plaintiff, and approved selection of the lead counsel.

of the Exchange Act, and Rule 10b-5 promulgated thereunder. The class action is on behalf of purchasers of the Company's securities during the period from December 7, 2022 through November 28, 2023, and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney's fees. The defendants filed a motion to dismiss the amended complaint on

Three shareholder derivative lawsuits piggy-backing

Action pending resolution of a summary judgment motion by defendants in the Securities Class Action.

To our knowledge, other than described below, neither

neither the Company nor any of its officers or directors is a party to any material legal proceeding or litigation and such persons know of no material legal proceeding or contemplated or threatened litigation, other than as described below. There are no judgments against us or our officers or directors. None of our officers or directors has been convicted of a felony or misdemeanor relating to securities or performance in corporate office.

January 19, 2024, a purported securities class action complaint, captioned Eric Olmstead v. BioVie Inc. et al., , No. 3:24-cv-00035, was filed in the U.S. District Court for the District of Nevada, naming the Company and certain of its officers as defendants. On February

District of Nevada, naming the Company and certain of its officers as defendants. On February 22, 2024, a second, related putative securities class action was filed in the same court asserting similar claims against the same defendants, captioned Way v. BioVie Inc. et al., , No. 2:24-cv-00361. On April 15, 2024, the court consolidated these two actions under the caption

In re BioVie Inc. Securities Litigation, No. 3:24-cv-00035 (the "Securities Class Action"), appointed the lead plaintiff, and approved selection of the lead counsel. On June 21, 2024, the lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact relating to the Company's business, operations, compliance, and prospects, including information related to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable AD, in violation of Sections 10(b) and 20(a)

AD, in violation of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The class action is on behalf of purchasers of the Company's securities during the period from December 7, 2022 through November 28, 2023, and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney's fees. The defendants filed a motion to dismiss the amended complaint on August 21, 2024, and on March 27, 2025, the court denied that motion. The parties are now engaged in fact discovery. On February 13, 2026, the plaintiffs filed a motion for class certification and a motion for leave to file a second amended complaint. Defendants opposed the motion for leave to amend. On June 5, 2026, the court granted the plaintiffs' motion for leave to amend, and the same day the plaintiffs filed their Second Amended Complaint. On June 15, 2026, the defendants filed a Notice of Non-Opposition and Reservation of Rights in response to the motion for class certification, and on June 18, 2026, the Court granted the plaintiffs' motion and certified the class subject to the defendants' reservation of rights. The defendants answered the Second Amended Complaint on June 22, 2026.

shareholder derivative lawsuits piggy-backing on the Securities Class Action were filed in the United States District Court for the District of Nevada, allegedly on behalf of the Company, by three putative stockholders: Andrew Hulm on December 30, 2024; William Settel on April 28, 2025 and Cline Wilkerson on September 11,

28, 2025 and Clint Wilkerson on September 11, 2025, (collectively the "Related Derivative Lawsuits"). Each Related Derivative

2025, (collectively the "Related Derivative Lawsuits"). Each Related Derivative Lawsuit names the same current and former officers and directors as defendants and alleges essentially the same claims: that the defendants breached their fiduciary duties by causing or failing to prevent the securities violations alleged in the Securities Class Action, and related claims for unjust enrichment, waste of corporate assets, gross mismanagement, and abuse of control. On September 29, 2025, at the request of the parties, the court consolidated all three Related Derivative Lawsuits under the caption In re BioVie Inc. Derivative Litigation , Case No. 3:24-cv-0602-CSD (the

Litigation, Case No. 3:24-cv-0602-CSD (the "Consolidated Derivative Action"). On January 27, 2026, at the request of the parties, the court stayed the Consolidated Derivative Action pending resolution of a summary judgment motion by defendants in the Securities

Class Action. In addition, on October 26, 2026, putative stockholder Arthur Padilla filed a related derivative action in the United States

District Court for the District of Nevada (Case No. 26-cv-0841), and on November 2, 2026, putative stockholder Brian Do filed a related derivative action in the same court (Case No. 26-cv-3623), both allegedly on behalf of the Company, and both alleging similar derivative claims against the same current and former officers and directors as in the Consolidated Derivative Action.

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Risk factors 494 changes

Our business, financial condition, operating results

and prospects are subject to the following risks. Additional risks and uncertainties not presently foreseeable to us may also impair our business operations. If any of the following risks or the risks described elsewhere in this report actually occur, our business, financial condition or operating results could be materially adversely affected. In such case, the trading price of our Class A Common Stock, par value $0.0001 ("Common Stock") could decline, and our stockholders may lose all or part of their investment.

Our business operations are subject to numerous

risks, factors and uncertainties, including those outside of our control, which could cause our actual results to be harmed, including risks regarding the following:

Risks Relating to Our Business and Industry

· If our third party contractors do not successfully carry out their contractual duties or meet expected deadlines or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize our product candidates.

· Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control.

· The concentration of our assets within a certain financial institution could have a material adverse effect on its business, financial condition and results of operations.

· We are currently subject to securities class action litigation and may be subject to similar or other litigation in the future, which may have a material adverse effect on our business.

· We have no products approved for commercial sale, have never generated any revenues, and may never achieve revenues or profitability, which could cause us to cease operations.

· We are a development stage company with a limited operating history, making it difficult for you to evaluate our business and your investment.

· If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not grant our products sufficient, or any, periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.

· If we fail to obtain or maintain Orphan Drug exclusivity for BIV201, we will have to rely on other potential marketing exclusivity and on our intellectual property rights.

· We will need to raise substantial additional capital in the future to fund our operations, which could have a materially adverse effect on our business.

· We have limited experience in drug development and may not be able to successfully develop any drugs, which would cause us to cease operations.

· Development of pharmaceutical products is a time-consuming process, subject to a number of risks, many of which are outside of our control.

· We may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success.

· We have no manufacturing experience, and the failure to comply with all applicable manufacturing regulations and requirements could have a materially adverse effect on our business.

· We do not currently have the sales and marketing personnel necessary to sell products, and the failure to hire and retain such staff could have a materially adverse effect on our business.

· Even if we were to successfully develop approvable drugs, we will not be able to sell these drugs if we or our third-party manufacturers fail to comply with manufacturing regulations.

· We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our product candidates.

· The loss or unavailability of our management could put us at a competitive disadvantage.

· We may not be able to attract and retain highly skilled personnel.

· We may be unable to compete with enterprises in the highly competitive biotechnology and biopharmaceutical industries and those equipped with more substantial resources than us.

· There may be conflicts of interest among our officers, directors and stockholders.

· We indemnify our officers and directors against liability to us and our security holders, and such indemnification could increase our operating costs.

Risks Relating to Our Intellectual Property

· We may be unable to obtain or protect intellectual property rights relating to our product candidates.

· If we fail to comply with our obligations in the licensing and collaboration agreements, our competitive position, business, financial condition, results of operations and prospects could be harmed.

· Compliance with federal regulations such as "march-in" rights may limit our exclusive rights and our ability to contract with non-U.S. manufacturers.

· Patent terms may be inadequate to establish our competitive position on our drug candidates for an adequate amount of time.

· We may not be able to protect our intellectual property rights throughout the world.

· Changes in patent law could diminish the value of our patents and impair our ability to protect our drug candidate.

· We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and our patents could be found invalid or unenforceable.

· Our failure to identify relevant third-party patents or correctly interpret the relevance, scope or expiration of patents, we may be subject to infringement claims or may not be able to develop our drug candidates.

· Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights.

· We may be subject to claims by third parties asserting that we or our employees have infringed, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property.

· We may be subject to claims challenging the inventorship of our patents and other intellectual property.

· Intellectual property rights do not necessarily address all potential threats.

· Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of shares of our Common Stock to decline.

Risks Relating to Our Common Stock

· Our stock price is and may continue to be volatile and you may not be able to resell our Common Stock at or above the price you paid.

· You may experience future dilution as a result of future equity offerings or if we issue shares subject to options, warrants, stock awards or other arrangements.

· The market price and trading volume of our Common Stock may be volatile.

· Any failure to maintain effective internal control over financial reporting could harm us.

· Limited trading market for our Common Stock could make it difficult to liquidate an investment.

· The lack of public company experience of our management team could negatively affect our business.

· Investors may be less attracted to our Common Stock because we are a smaller reporting company.

· Additional audit and legal costs associated with periodic reporting requirements of the Exchange Act will negatively affect our ability to earn a profit.

· Because we do not intend to pay any cash dividends on our Common Stock, our stockholders will not be able to receive a return on their shares unless they sell them.

· We are authorized to issue "blank check" preferred stock without stockholder approval, which could adversely impact the rights of holders of our securities.

· Provisions in our Articles of Incorporation, our Bylaws, and Nevada law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our Common Stock.

Except as described below, there have been no material changes to the Risk Factors previously disclosed in our 2026 Form 10-K. The risks described in our 2026 Form 10-K and below are not the only risks facing our company.

Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results.

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to depend, on third parties, including, but not limited to, contract research organizations ("CROs"), clinical trial sites and clinical trial principal investigators, contract laboratories, independent institutional review boards ("IRBs"), manufacturers, suppliers, and other third parties to conduct our clinical trials, including those for our drug candidates bezisterim (NE3107) and BIV201.

We rely heavily on these third parties over the course of our clinical trials, and we control only certain aspects of their activities.

Successful development of biopharmaceuticals

is highly uncertain and is dependent on numerous factors, many of which are beyond our control.

Product candidates that appear promising in the

early phases of development may fail to reach the market for several reasons. Pre-clinical study results may show the product candidate to be less effective than desired (e.g., the study failed to meet its primary endpoints) or to have harmful or problematic side effects.

Product candidates may fail to receive the necessary regulatory approvals or may be delayed in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies; length of time to achieve study endpoints; additional time requirements for data analysis; IND and later new drug application preparation; discussions with the FDA; an FDA request for additional pre-clinical or clinical data; unexpected safety or manufacturing issues; manufacturing costs; pricing or reimbursement issues; clinical sites deviating from the trial protocol, committing scientific misconduct, or other violations of regulatory requirements - which can render data from those sites unusable in support of regulatory approval; or other factors that make the product not economical. Proprietary rights of others and their competing products and technologies may also prevent the product from being commercialized.

Success in pre-clinical and early clinical studies

does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product to the next, and may be difficult to predict. There can be no assurance that any of our products will develop successfully, and the failure to develop our products will have a materially adverse effect on our business and will cause you to lose all of your investment.

The concentration of our assets within a

certain financial institution could have a material adverse effect on its business, financial condition and results of operations.

As of June 30, 2026, we had cash deposited in

a certain financial institution in excess of federally insured levels. We regularly monitor the financial stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents. Bank failures, events involving limited liquidity, defaults, non-performance, or other adverse developments that affect financial institutions, or concerns or rumors about such events, may lead to liquidity constraints. In 2023, certain U.S. government banking regulators took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened uncertainties in financial markets.

While previous bank failures have not had a material direct impact on our operations, if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, our ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.

We are currently subject to securities class

action litigation and may be subject to similar or other litigation in the future, all of which will require significant management time and attention, result in significant legal expenses and may result in unfavorable outcomes, which may have a material adverse effect on our business, operating results and financial condition, and negatively affect the price of our Common Stock.

We are, and may in the future become, subject

to various legal proceedings and claims that arise in or outside the ordinary course of business. For example, on January 19, 2024, a purported securities class action complaint, captioned Eric Olmstead v. BioVie Inc. et al. , No. 3:24-cv-00035, was filed in the

U.S. District Court for the District of Nevada, naming us and certain of our officers as defendants. On February 22, 2024, a second, related putative securities class action was filed in the same court asserting similar claims against the same defendants, captioned Way v.

BioVie Inc. et al. , No. 2:24-cv-00361. On April 15, 2024, the court consolidated these two actions under the caption In re BioVie

Inc. Securities Litigation , No. 3:24-cv-00035 (the "Securities Class Action"), appointed the lead plaintiff, and approved selection of the lead counsel. On June 21, 2024, the lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact relating to our business, operations, compliance, and prospects, including information related to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable AD, in violation of Sections 10(b) and

20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The class action is on behalf of purchasers of our securities during the period from December 7, 2022 through November 28, 2023 and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney's fees. The defendants filed a motion to dismiss the amended complaint on August

21, 2024, and on March 27, 2025, the court denied that motion. The parties are now engaged in fact discovery. On February 13, 2026, the plaintiffs filed a motion for class certification and a motion for leave to file a second amended complaint. Defendants opposed the motion for leave to amend. On June 5, 2026, the court granted the plaintiffs' motion for leave to amend, and the same day the plaintiffs filed their Second Amended Complaint. On June 15, 2026, the defendants filed a Notice of Non-Opposition and Reservation of Rights in response to the motion for class certification, and on June 18, 2026, the Court granted the plaintiffs' motion and certified the class subject to the defendants' reservation of rights. The defendants answered the Second Amended Complaint on June 22, 2026. The Company believes that the claims are without merit and intends to defend vigorously against them, but there can be no assurances as to the outcome.

Three shareholder derivative lawsuits piggy-backing

on the Securities Class Action were filed in the United States District Court for the District of Nevada, allegedly on behalf of the Company, by three putative stockholders: Andrew Hulm on December 30, 2024; William Settel on April 28, 2025 and Cline Wilkerson on September 11,

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and 415 more changes in the filing

Exhibits 87 changes

and 87 more changes in the filing