2 unchanged sentences
We have evaluated, with the participation of our
−Removed: principal executive and our principle financial officer, the effectiveness of our disclosure controls and procedures as defined in Rules
−Removed: 13a-15(e) and 15(d)-15(e) under the Exchange Act as of the end of the period covered by this Form 10-K.
−Removed: Based on this evaluation, our
−Removed: principal executive officer and our principal financial officer have concluded that our disclosure controls and procedures were effective
−Removed: 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,
−Removed: summarized and reported, within the time periods specified in the Commission’s rules and forms, and is accumulated and communicated
−Removed: to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate
+Added: principal executive and our principal financial officer, the effectiveness of our disclosure controls and procedures as defined in Rules
+Added: 13a-15(e) and 15(d)-15(e) under the Exchange Act as of the end of the period covered by this report.
+Added: Based on this evaluation, our principal
+Added: executive officer and our principal financial officer have concluded that our disclosure controls and procedures were effective to ensure
+Added: that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized
+Added: and reported, within the time periods specified in the Commission’s rules and forms, and is accumulated and communicated to our
+Added: management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate
to allow timely decisions regarding required disclosure.
10 unchanged sentences
of the effectiveness of our internal control over financial reporting as of June 30, 2026 using the criteria established in Internal Control
−Removed: Integrated Framework issued by the Committee of Sponsoring Organization of the Treadway Commission.
+Added: Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission.
Based on our evaluation using those
13 unchanged sentences
EXECUTIVE COMPENSATION
−Removed: The information required by this item is included in our 2025 Proxy
−Removed: Statement and is incorporated herein by reference.
+Added: The information required by this item is included
+Added: in our 2026 Proxy Statement and is incorporated herein by reference.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
25 unchanged sentences
Amended and Restated Bylaws of the Company, adopted on May 28, 2025.
+Added: (incorporated by reference to Exhibit 3.9 to the Company’s Annual Report on Form 10-K filed on August 15, 2025).
Specimen Certificate representing shares of Class A Common Stock (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1 filed on April 26, 2019, File No.
14 unchanged sentences
Form of Placement Agent’s Warrant Agreement (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on October 29, 2024).
+Added: Form of Pre-Funded Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on August 11, 2025).
+Added: Form of Common Stock Purchase Warrant (incorporated by reference to reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on August 11, 2025).
+Added: Form of Representative’s Warrant Agreement (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on August 11, 2025)
Description of Securities (incorporated by reference to Exhibit 4.4 to the Company’s Annual Report on Form 10-K filed on August 30, 2021).
−Removed: 2019 Omnibus Equity Incentive Plan (Amended and Restated through August 28, 2024) (incorporated by reference to Appendix A to the Definitive Information Statement on Schedule 14A, filed on September 27, 2024).
+Added: 2019 Omnibus Equity Incentive Plan (Amended and Restated through November 10, 2025) (incorporated
+Added: by reference to Appendix A to the Definitive Information Statement on Schedule 14A, filed on September 25, 2025).
Asset Purchase Agreement, dated April 27, 2021, among the Company, NeurMedix, Inc.
22 unchanged sentences
and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed on November 4, 2022).
+Added: Warrant Agent Agreement, dated as of August 7, 2025, by and between the Company and the Warrant Agent (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on August 11, 2025).
Code of Conduct and Ethics of BioVie Inc.
(incorporated by reference to Exhibit 14.1 to the Company’s Registration Statement on Form S-1, File No.
−Removed: Insider Trading Policy
+Added: Insider Trading Policy (incorporated by reference to Exhibit 19.1 to the Company’s Annual Report on Form 10-K filed on August 15, 2025).
Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 to the Company's Registration Statement on Form S-1, File No.
Consent of Independent Registered Public Accounting Firm - EisnerAmper LLP
−Removed: Power of Attorney (included on signature page to this registration statement)
+Added: Power of Attorney (included on signature page to this report)
Rule 13a-14(a) Certification
2 unchanged sentences
Certification Pursuant to 18 U.S.C Section 1350, as Adopted Pursuant to section 906 of the Sarbanes-Oxley Act of 2002
−Removed: Clawback Policy
+Added: Clawback Policy (incorporated by reference to Exhibit 97.1 to the Company’s Annual Report on Form 10-K filed on August 15, 2025).
XBRL Instance Document
7 unchanged sentences
Furnished herewith.
+Added: FORM 10-K SUMMARY
+Added: Not applicable.
Pursuant to the requirements of Section 13 or
8 unchanged sentences
attorneys-in-fact and agents, with full power of substitution and re-substitution, for him or her and in his or her name, place, and stead,
−Removed: in any and all capacities, to sign any and all amendments (including post-effective amendments, exhibits thereto and other documents in
+Added: in any and all capacities, to sign any and all amendments (including exhibits thereto and other documents in
connection therewith) to this Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with
28 unchanged sentences
Balance Sheets
−Removed: Statements of Operations and Comprehensive Loss
+Added: Statements of Operations
Statements of Changes in Stockholders’ Equity
4 unchanged sentences
Opinion on the Financial Statements
−Removed: have audited the accompanying balance sheets of BioVie Inc.
−Removed: (the “Company”) as of June 30, 2025 and 2024, and the related
−Removed: statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the years then ended,
−Removed: and the related notes (collectively referred to as the “financial statements”).
−Removed: In our opinion, the financial statements
−Removed: present fairly, in all material respects, the financial position of the Company as of June 30, 2025 and 2024, and the results of its
−Removed: operations and its cash flows for of the years then ended, in conformity with accounting principles generally accepted in the United
−Removed: States of America.
−Removed: accompanying financial statements have been prepared assuming that the Company will continue as a going concern.
−Removed: As discussed in Note
−Removed: 2 to the financial statements, the Company‘s recurring losses from operations and negative cash flows from operating activities
−Removed: raise substantial doubt about its ability to continue as a going concern.
−Removed: Management’s plans regarding these matters are also described
−Removed: The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
−Removed: financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s
−Removed: financial statements based on our audits.
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight Board
−Removed: (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.
−Removed: securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: conducted our audits in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain
−Removed: reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
−Removed: is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
−Removed: As part of our audits,
−Removed: we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
−Removed: on the effectiveness of the Company’s internal control over financial reporting.
+Added: We have audited the accompanying balance sheets
+Added: of BioVie Inc.
+Added: (the “Company”) as of June 30, 2026 and 2025, and the related statements of operations, changes in stockholders’
+Added: equity, and cash flows for each of the years then ended, and the related notes (collectively referred to as the “financial statements”).
+Added: In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of June 30,
+Added: 2026 and 2025, and the results of its operations and its cash flows for of the years then ended, in conformity with accounting principles
+Added: generally accepted in the United States of America.
+Added: Going Concern
+Added: The accompanying financial statements have been
+Added: prepared assuming that the Company will continue as a going concern.
+Added: As discussed in Note 2 to the financial statements, the Company‘s
+Added: recurring losses from operations and negative cash flows from operating activities raise substantial doubt about its ability to continue
+Added: as a going concern.
+Added: Management’s plans regarding these matters are also described in Note 2.
+Added: The financial statements do not include
+Added: any adjustments that might result from the outcome of this uncertainty.
+Added: Basis for Opinion
+Added: These financial statements are the responsibility
+Added: of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s financial statements based on our
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
+Added: and are required to be independent with respect to the Company in accordance with the U.S.
+Added: federal securities laws and the applicable
+Added: rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audits in accordance with the
+Added: standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
+Added: statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we engaged
+Added: to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits, we are required to obtain an understanding
+Added: of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
+Added: internal control over financial reporting.
Accordingly, we express no such opinion.
−Removed: audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
−Removed: or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding
−Removed: the amounts and disclosures in the financial statements.
−Removed: Our audits also included evaluating the accounting principles used and significant
−Removed: estimates made by management, as well as evaluating the overall presentation of the financial statements.
−Removed: We believe that our audits
−Removed: provide a reasonable basis for our opinion.
−Removed: critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated
−Removed: or required to be communicated to the audit committee and that:
−Removed: (1) relates to accounts or disclosures that are material to the financial
−Removed: statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication of the critical audit matter
−Removed: does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit
−Removed: matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
−Removed: and development expenses and related accruals
−Removed: described in Note 3 to the accompanying financial statements, research and development expenses consist primarily of costs associated
−Removed: with the preclinical and/or clinical trials of drug candidates, compensation and other expenses for research and development, personnel,
−Removed: supplies and development materials, costs for consultants and related contract research costs.
−Removed: The amounts recorded for clinical trial
−Removed: expenses represent the Company’s estimates of clinical trial expenses based on facts and circumstances known to the Company at
−Removed: that time, and are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors.
−Removed: identified the accounting for the research and development expenses and related accruals to be a critical audit matter due to the degree
−Removed: of management judgement in ensuring they are complete, accurate and classified correctly, their significance, and the risk of material
−Removed: misstatement due to the nature and timing of these costs and accruals.
−Removed: This in turn led to a high degree of auditor judgment, subjectivity,
−Removed: and effort in applying the procedures related to their accounting.
−Removed: the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the financial
−Removed: These procedures included, obtaining an understanding of management’s process and evaluating the design of controls
−Removed: over research and development expense classification and the completeness and accuracy of related accruals, independently researching
−Removed: vendors, testing a selection of research and development expense transactions to determine, based on the underlying supporting documents,
−Removed: the mathematical accuracy of the expense and the appropriateness of the expense classification.
−Removed: In addition, we made inquiries of management
−Removed: and reviewed subsequent payments, invoices and agreements relating to certain research and development expenses to evaluate if the accruals
−Removed: were properly recorded as of June 30, 2025.
+Added: Our audits included performing procedures to assess
+Added: the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
+Added: to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
+Added: the overall presentation of the financial statements.
+Added: We believe that our audits provide a reasonable basis for our opinion.
+Added: Critical Audit Matter
+Added: The critical audit matter communicated below is
+Added: a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the
+Added: audit committee and that:
+Added: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially
+Added: challenging, subjective, or complex judgments.
+Added: The communication of the critical audit matter does not alter in any way our opinion on
+Added: the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion
+Added: on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Research and development expenses and related
+Added: As described in Note 3 to the accompanying financial
+Added: statements, research and development expenses consist primarily of costs associated with the preclinical and/or clinical trials of drug
+Added: candidates, compensation and other expenses for research and development, personnel, supplies and development materials, costs for consultants
+Added: and related contract research costs.
+Added: The amounts recorded for clinical trial expenses represent the Company’s estimates of clinical
+Added: trial expenses based on facts and circumstances known to the Company at that time, and are dependent upon the timely and accurate reporting
+Added: of contract research organizations and other third-party vendors.
+Added: We identified the accounting for the research
+Added: and development expenses and related accruals to be a critical audit matter due to the degree of management judgement in ensuring they
+Added: are complete, accurate and classified correctly, their significance, and the risk of material misstatement due to the nature and timing
+Added: of these costs and accruals.
+Added: This in turn led to a high degree of auditor judgment, subjectivity, and effort in applying the procedures
+Added: related to their accounting.
+Added: Addressing the matter involved performing procedures
+Added: and evaluating audit evidence in connection with forming our overall opinion on the financial statements.
+Added: These procedures included, obtaining
+Added: an understanding of management’s process and evaluating the design of controls over research and development expense classification
+Added: and the completeness and accuracy of related accruals, independently researching vendors, testing a selection of research and development
+Added: expense transactions to determine, based on the underlying supporting documents, the mathematical accuracy of the expense and the appropriateness
+Added: of the expense classification.
+Added: In addition, we made inquiries of management and reviewed subsequent payments, invoices and agreements
+Added: relating to certain research and development expenses to evaluate if the accruals were properly recorded as of June 30, 2026.
/s/ EisnerAmper LLP
2 unchanged sentences
Iselin , New Jersey
+Added: August 12, 2026
Balance Sheets
10 unchanged sentences
Current portion of operating lease liability
−Removed: Current portion of notes payable, net of financing cost, unearned premium and discount of $ 701,210 at June 30, 2024
−Removed: Warrant liability
Total current liabilities
9 unchanged sentences
800,000,000 shares authorized at June 30, 2026 and June 30, 2025;
−Removed: 1,917,061 shares issued of which 1,914,224 shares are outstanding at June 30, 2025;
−Removed: and 621,641 shares issued of which 619,008 shares outstanding at June 30, 2024
+Added: 7,545,474 shares issued of which 7,542,638 shares outstanding at June 30, 2026;
+Added: and 1,917,061 shares issued of which 1,914,224 shares are outstanding at June 30, 2025
Additional paid in capital
7 unchanged sentences
of the financial statements.
−Removed: Statements of Operations and Comprehensive Loss
+Added: Statements of Operations
June 30, 2026
3 unchanged sentences
Research and development expenses
−Removed: Selling, general and administrative expenses
+Added: General and administrative expenses
TOTAL OPERATING EXPENSES
2 unchanged sentences
( 18,066,200 )
−Removed: OTHER EXPENSE (INCOME):
+Added: OTHER (INCOME) EXPENSE:
Change in fair value of derivative liabilities
−Removed: ( 1,816,271 )
Interest expense
Interest income
−Removed: ( 1,136,703 )
TOTAL OTHER INCOME, NET
7 unchanged sentences
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
−Removed: NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
−Removed: $ ( 17,911,585 )
−Removed: $ ( 33,006,956 )
−Removed: Other comprehensive loss
−Removed: Reclassification of unrealized gains on available-for-sale investments upon settlement
−Removed: Total other comprehensive loss
−Removed: Comprehensive loss
−Removed: $ ( 17,911,585 )
−Removed: $ ( 33,183,547 )
The accompanying notes are an integral part
4 unchanged sentences
Treasury Stock
−Removed: Comprehensive
Stockholders'
1 unchanged sentence
$ 349,738,841
+Added: $ ( 334,232,661 )
Stock - based compensation - stock options
−Removed: Stock-based compensation - restricted stock units
+Added: Stock - based compensation - restricted stock units and restricted shares
Proceeds from issuance of common stock, net of costs of $3,240,288
1 unchanged sentence
Stock-based compensation - issuance of common stock for services rendered
+Added: Issuance of common stock from exercise of warrants
+Added: Issuance of common stock from cashless exercise of warrants
Deemed dividend for ratchet adjustment to warrants
−Removed: Reclassification of unrealized gains on available-for-sale investments upon settlement
Issuance of additional shares for fractional shares effected by the reverse split
8 unchanged sentences
Issuance of common stock from vesting of restricted stock units
−Removed: Stock-based compensation - issuance of common stock for services rendered
−Removed: Issuance of common stock from exercise of warrants
−Removed: Issuance of common stock from cashless exercise of warrants
Deemed dividend for ratchet adjustment to warrants
−Removed: Issuance of additional shares for fractional shares effected by the reverse split
( 22,072,863 )
19 unchanged sentences
Accretion of loan premium
−Removed: Realized gain on maturity of available-for sale
−Removed: Non-cash lease expense from right-of-use assets
−Removed: Gain on termination of operating lease
+Added: Non-cash lease expense from right-of-use asset
Change in fair value of derivative liabilities
−Removed: ( 1,816,271 )
Changes in operating assets and liabilities:
+Added: Grant receivable
( 2,104,050 )
Prepaid and other current assets
+Added: ( 1,463,458 )
Accounts payable and accrued expenses
( 1,386,592 )
−Removed: Operating lease liabilities
−Removed: Other current liabilities
+Added: Operating lease liability
Net cash used in operating activities
1 unchanged sentence
( 19,025,205 )
−Removed: CASH FLOWS FROM INVESTING ACTIVITIES:
−Removed: Proceeds from U.S.
−Removed: Treasury Bills (available-for-sale)
−Removed: Net cash provided by investing activities
CASH FLOWS FROM FINANCING ACTIVITIES:
1 unchanged sentence
Proceeds from exercise of warrants
−Removed: ( 10,000,000 )
Payment of loan premium
−Removed: Payments of note payable
+Added: Payment of note payable
( 5,000,000 )
2 unchanged sentences
( 8,567,177 )
+Added: ( 6,299,251 )
Cash and cash equivalents, beginning of period
2 unchanged sentences
Cash paid for interest
−Removed: SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING ACTIVITIES:
−Removed: Right of use assets obtained in exchange for lease obligations
−Removed: Reclassification of unrealized gains on U.S.
−Removed: Treasury Bills (available-for-sale investments) upon settlement
+Added: SUPPLEMENTAL DISCLOSURE OF NONCASH FINANCING ACTIVITIES:
Deemed dividend for ratchet adjustment to warrants
10 unchanged sentences
(“NeurMedix”), a privately held clinical-stage pharmaceutical company and a related party in June 2021.
−Removed: acquired assets included NE3107 (or “bezisterim”).
+Added: The acquired assets included NE3107 (“bezisterim”).
Bezisterim, the approved generic name for NE3107 is an investigational,
6 unchanged sentences
to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD, 1 million Americans suffering from
−Removed: PD and Long COVID affects approximately 20 million adults in the US, and millions more worldwide.
−Removed: In neurodegenerative disease, the Company’s
−Removed: drug candidate bezisterim is an orally bioavailable, Blood Brain Barrier (“BBB”)-permeable, insulin-sensitizer that is also
−Removed: anti-inflammatory.
−Removed: In addition, it is not immunosuppressive and has a low risk of drug-drug interaction.
−Removed: Bezisterim inhibits activation
−Removed: of inflammatory action extracellular single regulated kinase (“ERK”) and nuclear factor kappa-light-chain-enhancer of activated
−Removed: B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”) signaling and other relevant
−Removed: inflammatory pathways) that lead to neuroinflammation and insulin resistance.
+Added: PD, and approximately 20 million adults in the US suffering from Long COVID, with millions more affected worldwide.
+Added: With respect to the mechanism of action, we believe
+Added: bezisterim inhibits activation of inflammatory extracellular signal-regulated kinase (“ERK”) and nuclear factor kappa-light-chain-enhancer
+Added: of activated B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”) signaling and other
+Added: relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance.
By binding to ERK and selectively modulating NFκB
−Removed: activation and TNF-α production and not interfere with their homeostatic functions, BioVie believes that bezisterim may offer clinical
−Removed: improvements in several disease indications, including PD, AD and long COVID.
+Added: activation and TNF-α production without interfering with their homeostatic functions (e.g., insulin signaling and neuron growth
+Added: and survival), we believe that bezisterim may offer clinical improvements in several disease indications, including PD, AD and long COVID.
+Added: Chronic neuroinflammation, insulin resistance,
+Added: and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and
+Added: Amyotrophic lateral sclerosis.
+Added: Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential
+Added: anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated
+Added: inflammation.
+Added: Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s
+Added: work testing the molecule in AD, PD, and long COVID patients.
+Added: Bezisterim (NE3107) is patented in the United States, Australia, Canada,
+Added: Europe and South Korea.
Parkinson’s Disease
−Removed: The Company designed a new Phase 2b study of bezisterim
−Removed: as a potential first line therapy to treat patients with new onset PD.
−Removed: This trial will be evaluating the safety and efficacy of bezisterim
−Removed: on motor and non-motor symptoms in patients with PD who haven’t been treated with carbidopa/levodopa.
−Removed: The PD Phase 2b study, multicenter,
−Removed: randomized, double-blind, placebo-controlled trial with a hybrid decentralized design will last 20 weeks from the initial screening phase
−Removed: to the safety follow up.
−Removed: In July 2024, the Company submitted the new protocol and received a response from the FDA permitting the Company
−Removed: to proceed with the study.
−Removed: The trial commenced in April 2025.
−Removed: The Phase 2 study of bezisterim for the treatment
−Removed: of PD (NCT05083260) that completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics
−Removed: study in PD participants treated with carbidopa/levodopa and bezisterim.
−Removed: Forty-five patients with a defined L-dopa “off state”
−Removed: were randomized 1:1 to placebo:
−Removed: bezisterim 20 mg twice daily for 28 days.
+Added: PD is driven in large part by neuroinflammation
+Added: and activation of brain microglia, leading to increased proinflammatory cytokines (particularly TNF).
+Added: Multiple daily administrations of
+Added: levodopa (converted to dopamine in the brain) is the current standard of care treatment for this movement disorder.
+Added: However, levodopa
+Added: effectiveness diminishes over time necessitating increased dosage and prolonged daily administration leads to side effects of uncontrolled
+Added: movements called levodopa-induced dyskinesia, commonly referred to as LID, which is exacerbated by high dose levodopa.
+Added: Although levodopa
+Added: provides symptomatic benefit, it does not slow PD progression.
+Added: The Company recently
+Added: conducted a Phase 2b clinical trial of bezisterim as a potential first-line therapy for patients with newly diagnosed PD.
+Added: The SUNRISE-PD
+Added: trial was designed to evaluate the safety and efficacy of bezisterim on motor and non-motor symptoms in patients with PD who have not
+Added: been treated with carbidopa/levodopa.
+Added: The trial was a multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized
+Added: design and lasted 20 weeks from initial screening through safety follow-up for each participant.
+Added: The trial commenced in April 2025and
+Added: completed enrollment in December 2025.
+Added: In August 2026, the Company announced topline results of the trial.
+Added: The trial successfully met
+Added: prespecified endpoints and achieved its objectives, with topline results showing that bezisterim improved blood based inflammatory markers
+Added: of disease, along with a broad range of biological markers associated with overall cellular health and nerve cell damage.
+Added: treated with bezisterim experienced greater improvements than those receiving placebo across a series of clinical outcome measures of
+Added: daily living, motor symptoms, and nonmotor symptoms.
+Added: We intend to use these results to inform the design of a potentially pivotal Phase
+Added: 3 registrational trial of bezisterim in PD.
+Added: The previous Phase 2 study of bezisterim
+Added: (NE3107) for the treatment of PD (NCT05083260) that we completed in December 2022, was a double-blind, placebo-controlled, safety,
+Added: tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107).
+Added: patients with a defined L-dopa “off state” were randomized 1:1 to placebo:
+Added: bezisterim (NE3107) 20 mg twice daily for 28
This trial was launched with two design objectives:
−Removed: 1) the primary
−Removed: objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions of bezisterim
−Removed: with carbidopa/ levodopa;
−Removed: and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent
−Removed: enhancement of levodopa activity could be seen in humans.
+Added: 1) the primary objective was safety and a drug-drug interaction study as
+Added: requested by the FDA to measure the potential for adverse interactions of bezisterim (NE3107) with carbidopa/ levodopa;
+Added: secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity
+Added: could be seen in humans.
Both objectives were met.
6 unchanged sentences
trial grant of $13.1 million from the U.S.
−Removed: Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research
−Removed: Program of the Congressionally Directed Medical Research Programs.
−Removed: In August 2024, U.S.
−Removed: Army Medical Research and Development Command,
−Removed: Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim for the treatment of
−Removed: neurological symptoms that are associated with long COVID and the FDA authorized our Investigational New Drug (“IND”) application
−Removed: for bezisterim allowing the Company to study a novel, anti-inflammatory approach or the treatment of the debilitating neurocognitive symptoms
−Removed: associated with long COVID.
−Removed: The Phase 2 ADDRESS-LC study is a randomized (1:1),
−Removed: placebo-controlled, multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with long COVID
−Removed: who have cognitive impairment sequelae and fatigue.
−Removed: Individuals who have been diagnosed with long COVID and have neurocognitive dysfunction
−Removed: and self-reported fatigue may meet qualification criteria.
−Removed: The trial commenced in May 2025.
−Removed: As of June 30,
−Removed: 2025, the total cost incurred was approximately $5.3 million and as of August 4, 2025 approximately $5.3 million was reimbursed.
+Added: Department of War (“DOW”), formerly known as the Department of Defense, awarded
+Added: through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs.
+Added: In August 2024, the U.S.
+Added: Army Medical Research and Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan
+Added: to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID and the FDA authorized our Investigational
+Added: New Drug (“IND”) application for bezisterim allowing the Company to study a novel, anti-inflammatory approach for the treatment
+Added: of the debilitating neurocognitive symptoms associated with long COVID.
+Added: The Phase 2 ADDRESS-LC study is a randomized (1:1), placebo-controlled,
+Added: multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with long COVID who have cognitive
+Added: impairment sequelae and fatigue.
+Added: The trial commenced in May 2025 and completed enrollment in May 2026.
+Added: currently expects to report topline results in late summer 2026.
+Added: As of June 30, 2026, the total cost incurred was
+Added: approximately $ 12.9 million and as of August 7, 2026 the total cost reimbursed was $ 12.9 million.
+Added: Grant reimbursements recognized for the corresponding
+Added: research and development expenses in the accompanying statements of operations totaled approximately $ 7.6 million and $ 5.3 million for
+Added: the years ended June 30, 2026 and 2025, respectively.
Alzheimer’s Disease
+Added: In AD, BioVie has conducted both Phase 2 and Phase
+Added: Preliminary data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its
+Added: potential as a therapy for the six million Americans living with AD.
+Added: Results of a Phase 2 investigator-initiated
+Added: trial (NCT05227820) showing bezisterim treated patients experienced improved cognition and biomarker levels were presented at the
+Added: Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in December 2022.
On November 29, 2023, the Company announced the
1 unchanged sentence
to moderate AD.
−Removed: The study had co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive
+Added: 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).
16 unchanged sentences
to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing
−Removed: of cognitive loss;
+Added: of cognitive decline;
these same patients experienced an advantage in age deceleration vs.
−Removed: placebo as measured by DNA epigenetic change.
+Added: 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
1 unchanged sentence
This test was a non-primary/secondary
−Removed: endpoint, other-outcome measure, done via blood test collected at week 30 (end of study).
−Removed: Additional DNA methylation data continues to
−Removed: be collected and analyzed.
+Added: endpoint, other-outcome measure, done via blood collected at week 30 (end of study).
+Added: Additional DNA methylation data continues to be collected
+Added: and analyzed.
Liver Cirrhosis Program
In liver disease, our investigational drug candidate
−Removed: BIV201 (continuous infusion terlipressin), which was granted both FDA Fast Track designation status and FDA Orphan Drug Status, is being
−Removed: evaluated as a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis
−Removed: caused by non-alcoholic steatohepatitis (NASH), hepatitis, and alcoholism.
−Removed: The initial target for BIV201 therapy was refractory ascites.
−Removed: These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have
−Removed: an estimated 50% mortality rate within 6 to 12 months.
+Added: BIV201 (continuous infusion terlipressin) was granted both FDA Fast Track status and FDA Orphan Drug designation for ascites (due to all
+Added: etiologies except cancer), which is the most common complication related to liver cirrhosis and represents a significant unmet medical
+Added: BIV201 is being evaluated as a treatment option for patients suffering from life-threatening complications of liver cirrhosis and
+Added: ascites due to hepatitis, nonalcoholic steatohepatitis, and alcoholism.
+Added: treatment costs for liver cirrhosis, including ascites and
+Added: other complications, are estimated at more than $5 billion annually and have an estimated 50% mortality rate within 6 to 12 months.
+Added: FDA has never approved any drug specifically for treating ascites.
After receiving guidance from the FDA regarding
−Removed: the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is now targeting
−Removed: a broader ascites patient population.
−Removed: The Company is currently finalizing the protocol design for the Phase 3 study of BIV201 with a focus
−Removed: on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis
−Removed: and ascites who have recently recovered from acute kidney injury (“AKI”).
−Removed: This patient population is not limited to those
−Removed: having refractory ascites.
−Removed: Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of
−Removed: fluid in the abdomen, often exceeding five liters, due to liver and kidney dysfunction.
−Removed: BIV201 is administered in a continuous infusion
−Removed: of terlipressin as a patent-pending liquid formulation with patents issued in the U.S., China, Japan, Chile and India to date.
−Removed: Terlipressin,
−Removed: the drug is used in over 40 countries to treat related complications of liver cirrhosis (Type 1 hepatorenal syndrome and bleeding esophageal
−Removed: varices) that was approved in the U.S.
−Removed: in 2022 (to improve kidney function in adults with hepatorenal syndrome with rapid reduction in
−Removed: kidney function) but is not approved in Japan.
−Removed: The BIV201 development program was initiated by
−Removed: LAT Pharma LLC.
−Removed: On April 11, 2016, BioVie acquired LAT Pharma LLC and the rights to its BIV201 development program and currently owns
−Removed: all development and marketing rights to this drug candidate.
−Removed: Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016,
−Removed: between predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales
−Removed: of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.
−Removed: to the separation agreement to be entered into between the Company and BioVie, the Company will assume the royalty agreement and will
−Removed: be obligated to pay 5.0% on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation,
−Removed: and The Barrett Edge, Inc.
+Added: the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is currently finalizing
+Added: the protocol design for the Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint
+Added: of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from acute kidney injury (“AKI”).
+Added: Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often
+Added: exceeding five liters, due to liver and kidney dysfunction.
+Added: BIV201 is administered in a continuous infusion of terlipressin as a patent-pending
+Added: liquid formulation with patents issued in the U.S., China, Japan, Chile, Australia, Mexico and India to date.
+Added: Terlipressin is used in
+Added: over 40 countries to treat complications of liver cirrhosis, including Type 1 hepatorenal syndrome and bleeding esophageal varices, and
+Added: was approved in the U.S.
+Added: in 2022 to improve kidney function in adults with hepatorenal syndrome experiencing a rapid reduction in kidney
+Added: it is not currently approved in Japan.
+Added: In May 2025, the Company formed Option Therapeutics,
+Added: Inc., a Delaware corporation, as a wholly owned subsidiary with no discreet financial information.
+Added: In January 2026, the Company filed
+Added: a Form S-1 with carved out financial statements for Option Therapeutics, Inc.
Liquidity and Going Concern
13 unchanged sentences
course of business.
−Removed: As of June 30, 2025, the Company had working capital of approximately $ 18.4 million, cash and cash equivalents of
−Removed: approximately $ 17.5 million, stockholders’ equity of approximately $ 19.0 million, and an accumulated deficit of approximately $ 352.1
−Removed: The Company is in the pre-revenue stage and no revenues are expected in the foreseeable future.
−Removed: The Company’s future operations
−Removed: are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure
−Removed: additional financing as needed.
−Removed: Projected cash flows could be extended if further measures are taken to delay planned expenditures in
−Removed: our research protocols and slow the progress in the Company’s development and launch of next phase clinical programs.
+Added: As of June 30, 2026, the Company had working capital of approximately $ 9.8 million, cash and cash equivalents of approximately
+Added: $ 9.0 million, stockholders’ equity of approximately $ 10.3 million, and an accumulated deficit of approximately $ 374.3 million.
+Added: Company is in the pre-revenue stage and no revenues are expected in the foreseeable future.
+Added: The Company’s future operations are
+Added: dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure additional
+Added: financing as needed.
+Added: Projected cash flows could be extended if further measures are taken to delay planned expenditures in our research
+Added: 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
13 unchanged sentences
necessary for the fair presentation of the Company’s financial position for the periods presented.
−Removed: Reverse stock split up
−Removed: The Company effected a 1:10 reverse split of the issued and outstanding
−Removed: shares of its Common Stock which was approved by the board of directors after the approval obtained from shareholders at a special meeting
−Removed: on June 23, 2025 which became effective on July 7, 2025.
−Removed: All historical share and earnings per share amounts have been retroactively adjusted
−Removed: to reflect the split.
Use of Estimates
4 unchanged sentences
The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported
−Removed: for each of the periods presented in the statements of operations and comprehensive loss are affected by estimates and assumptions, which
−Removed: are used for, but not limited to, accounting for clinical accruals, share-based compensation, assumptions used in recording leases, the
−Removed: inputs used in the valuation of goodwill and intangible assets in connection with impairment testing and accounting for income taxes.
−Removed: Actual results could differ from those estimates.
+Added: for each of the periods presented in the statements of operations are affected by estimates and assumptions, which are used for, but not
+Added: limited to, accounting for clinical accruals, share-based compensation, assumptions used in recording leases, the inputs used in the valuation
+Added: of goodwill and intangible assets in connection with impairment testing and accounting for income taxes.
+Added: Actual results could differ from
+Added: those estimates.
Cash and cash equivalents
3 unchanged sentences
Treasury Bills with original maturities of three months or less.
−Removed: Investments in U.S.
−Removed: Treasury Bills
−Removed: Investments in U.S.
−Removed: Treasury Bills with maturities
−Removed: greater than three months, are accounted for as available-for-sale and are recorded at fair value.
−Removed: Unrealized gains were included in other
−Removed: comprehensive income in the accompanying statements of operations and comprehensive loss.
Concentration of Credit Risk in the Financial
30 unchanged sentences
The Company’s financial instruments include
−Removed: cash, accounts payable, the carrying value of the operating lease liabilities and notes payable.
−Removed: The carrying amounts of cash and accounts
−Removed: payable approximate their fair value, due to the short-term nature of these items.
−Removed: The carrying amounts of notes payable and operating
−Removed: lease liabilities approximate their fair values since they bear interest at rates which approximate market rates for similar debt instruments.
+Added: cash, accounts payable and the carrying value of the operating lease liabilities.
+Added: The carrying amounts of cash and accounts payable approximate
+Added: their fair value, due to the short-term nature of these items.
+Added: The carrying amounts of operating lease liabilities approximate their fair
+Added: values since they bear interest at rates which approximate market rates for similar debt instruments.
Prepaid and other assets
Prepaid and other assets consist of prepayments
−Removed: of certain expenses such as cost related to capital raise activities;
+Added: of certain expenses such as cost related to capital raise activities, insurance reimbursement;
and a security deposit paid in connection with a lease agreement.
36 unchanged sentences
The Company has opted to classify interest and penalties that would accrue,
−Removed: if any, according to the provisions of relevant tax law as general and administrative expenses, in the Statements of Operations and Comprehensive
−Removed: For the years ended June 30, 2025 and 2024, there was no such interest or penalties.
+Added: if any, according to the provisions of relevant tax law as general and administrative expenses, in the Statements of Operations.
+Added: years ended June 30, 2026 and 2025, there was no such interest or penalties.
Net Loss per Common Share
7 unchanged sentences
the net loss for the periods presented.
+Added: The weighted average number of common shares outstanding
+Added: for the year ended June 30, 2026 of 7,245,928 includes the weighted average effect of the pre-funded warrants issued in connection with
+Added: the August 2025 Offering, the exercise of which requires nominal consideration for the delivery of the shares of common stock (see Note
The table below shows the potential shares of
8 unchanged sentences
Restricted Stock Units
−Removed: Notes payable conversion option
Stock-based Compensation
15 unchanged sentences
at the time of grant for the period of the expected term.
−Removed: The Company recognizes forfeitures as they occur.
Goodwill is recorded when the purchase price paid
31 unchanged sentences
Grant program
−Removed: The Company records expenses related to the DOD Long Covid Program
−Removed: as such expenses are incurred.
−Removed: The reimbursement of such expenses is recognized upon receipt of the reimbursement, or when it is probable
−Removed: the reimbursement will be received, as a credit against the respective expense account.
+Added: The Company records expenses related to the DOD
+Added: Long Covid Program as such expenses are incurred.
+Added: The reimbursement of such expenses is recognized upon receipt of the reimbursement,
+Added: or when it is probable the reimbursement will be received, as a credit against the respective expense account.
Segment Reporting
10 unchanged sentences
In December 2023, the FASB issued ASU 2023-09,
−Removed: "Income Taxes (Topic 740):
−Removed: Improvements in Income Tax Disclosures" to enhance the transparency and decision usefulness of income
−Removed: tax disclosures.
−Removed: This amendment requires public companies to disclose specific categories in the rate reconciliation and provide additional
−Removed: information for reconciling items that meet a quantitative threshold.
−Removed: Additionally, under the amendment entities are required to disclose
−Removed: the amount of income taxes paid disaggregated by federal, state and foreign taxes, as well as disaggregated by material individual jurisdictions.
−Removed: Finally, the amendment requires entities to disclose income from continuing operations before income tax expense disaggregated between
−Removed: domestic and foreign and income tax expense from continuing operations disaggregated by federal, state and foreign.
−Removed: The new rules are
−Removed: effective for annual periods beginning after December 15, 2024.
−Removed: The standard will be adopted on a prospective basis and is not expected
−Removed: to have a material impact to our financial statements or disclosures.
−Removed: Segment Reporting Topic 280 - Improvements
−Removed: to Reportable Segment Disclosures.
−Removed: This update requires expanded annual and interim disclosures for significant segment expenses that
−Removed: are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss.
−Removed: update is effective for fiscal years beginning after December 15, 2023.
−Removed: The Company adopted ASU 2023-07 in the current fiscal year.
+Added: “Income Taxes (ASC 740):
+Added: Improvements to Income Tax Disclosures”, which requires disaggregated information about a reporting
+Added: entity’s effective tax rate reconciliation as well as information on income taxes paid.
+Added: ASU 2023-09 is effective for fiscal years
+Added: beginning after December 15, 2024.
+Added: The Company adopted this standard retroactively on July 1, 2025, which expanded the Company’s
+Added: disclosures beginning with its annual financial statements for the year ended June 30, 2026, but did not have an impact on the consolidated
+Added: financial results.
+Added: In November 2024, the Financial Accounting Standards
+Added: Board (“FASB”) issued Accounting Standards Update (“ASU”) 2024-03, Disaggregation of Income Statement Expenses
+Added: (“DISE”), which will require additional disclosure of the nature of expenses included in the income statement in response
+Added: to longstanding requests from investors for more information about an entity’s expenses.
+Added: The new standard requires disclosures about
+Added: specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about
+Added: selling expenses.
+Added: The new standard will be effective for public companies for fiscal years beginning after December 15, 2026, and interim
+Added: periods within fiscal years beginning after December 15, 2027.
+Added: The requirements will be applied prospectively with the option for retrospective
+Added: Early adoption is permitted.
+Added: The Company is currently evaluating the impact of this accounting standard update on its financial
Intangible Assets
12 unchanged sentences
Intellectual Property, net
−Removed: Amortization expense amounted to $ 229,377 for
−Removed: each of the years ended June 30, 2025 and 2024, respectively.
−Removed: The Company amortized intellectual property over the expected original useful
−Removed: lives of 10 years and the remaining amortization expense for the year ending June 30, 2026 is $ 178,341 .
−Removed: Related Party Transactions
−Removed: Equity Transactions with Acuitas
−Removed: On July 15, 2022, the Company entered into a securities
−Removed: purchase agreement with Acuitas Group Holdings, LLC (“Acuitas”), the Company’s largest stockholder, pursuant to which
−Removed: Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 36,364 shares of the Company’s Common Stock,
−Removed: at a price of $165.00 per share (the “PIPE Shares”), and (ii) a warrant to purchase 72,728 shares of Common Stock (“PIPE
−Removed: Warrant Shares”), at an original exercise price of $182.00, with a term of exercise of five years.
−Removed: As results of the Company’s capital raises
−Removed: further described in Note 8, the warrants’ down round features (the “rachet adjustment”) resulted in deemed dividends
−Removed: of $ 369,465 and $ 886,423 recognized in the accompanying statement of changes in stockholders’ equity for the years ended June 30,
−Removed: 2025 and 2024, respectively.
−Removed: For the year ended June 30, 2024, the deemed dividend
−Removed: of $886,423 recognized from the rachet adjustment resulting from the March 6, 2024 capital raise, reduced the exercise price to $100 per
−Removed: The fair value of the PIPE Warrant Shares was estimated using the Black Scholes Method with the following inputs, the stock price
−Removed: of $ 106.50 , exercise price of $ 182.00 and reduced exercise price of $ 100.00 , remaining term of 3.5 years, risk free rate of 4.4 % and volatility
−Removed: For the year ended June 30, 2025, the deemed dividend
−Removed: of $369,465 was recognized based on rachet adjustments from the September 25, 2024 and October 22, 2024 capital raises, that reduced the
−Removed: exercise prices to $15.30 per share and $13.70 per share, respectively.
−Removed: The fair value of the PIPE Warrant Shares were estimated using
−Removed: the Black Scholes Method with the following inputs at September 2024, the stock price of $ 12.00 , exercise price of $ 15.30 and $ 100.00 ,
−Removed: remaining term of 2.9 years, risk free rate of 3.5 % and volatility of 93.0 % , resulting in a $ 325,041 deemed dividend;
−Removed: and the following
−Removed: inputs at October 22, 2024, the stock price of $ 33.60 , exercise price of $ 15.30 and $ 13.70 , remaining term of 2.8 years, risk free rate
−Removed: of 4.0 % and volatility of 94.0 % , resulting in a $44,424 deemed dividend..
−Removed: Consulting expenses
−Removed: During the year ended June 30, 2025, the Company
−Removed: paid a Director of the Company $50,000 for consulting services which are reflected as a component of selling, general and administrative
−Removed: expenses on the accompanying statement of operations and comprehensive loss.
−Removed: Notes Payable
−Removed: On November 30, 2021 (the “Closing Date”),
−Removed: the Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and Promissory Notes (together,
−Removed: the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P.
−Removed: (“AVOPI”) and Avenue Venture Opportunities
−Removed: Fund II, L.P.
−Removed: (“AVOPII,” and together with AVOPI, “Avenue”) for growth capital loans in an aggregate commitment
−Removed: amount of up to $20 million (the “Loan”).
−Removed: On the Closing Date, $15 million of the Loan was funded (“Tranche 1”).
−Removed: The Loan bore interest at an annual rate equal to the greater of (a) the sum of 7.00 % plus the prime rate as reported in The Wall Street
−Removed: Journal and (b) 10.75%.
−Removed: The Loan was secured by a lien upon and security interest in all of the Company’s assets, including intellectual
−Removed: property, subject to agreed exceptions.
−Removed: The Loan was paid in full on its maturity date of December 1, 2024 along with a final payment
−Removed: equal to 4.25 % of the Loan commitment amount, or $850,000, the (“Loan Premium”) and the lien upon and security interest in
−Removed: all of the Company’s assets was released.
−Removed: The Loan Agreement included a conversion option
−Removed: to convert up to $5.0 million of the principal amount of the Loan outstanding at the option of Avenue, into shares of the Company’s
−Removed: Common Stock at a conversion price of $698.00 per share (the “Conversion Option”).
−Removed: On the Closing Date, the Company also issued to
−Removed: Avenue warrants to purchase 3,611 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share
−Removed: equal to $582.00.
−Removed: The Avenue Warrants are exercisable until November 30, 2026.
−Removed: The amount of the carrying value of the notes
−Removed: payable was determined by allocating portions of the outstanding principal of the notes, resulting in approximately $ 1.4 million allocated
−Removed: to the fair value of the Avenue Warrants, and approximately $ 2.2 million allocated to the fair value of the embedded Conversion Option.
−Removed: Accordingly, the total amount of unearned discount of approximately $3.6 million, the total direct financing cost of approximately $ 390,000
−Removed: and the Loan Premium of $ 850,000 were amortized using the effective interest method over the term of the Loan.
−Removed: Total interest expense associated with the Loan was approximately $ 312,000 ,
−Removed: which is reflected as a component of interest expense on the accompanying statements of operations and comprehensive loss for the year
−Removed: ended June 30, 2025.
−Removed: Interest expense associated with this loan was comprised of interest incurred on the outstanding principal of the
−Removed: loan of approximately $ 163,000 , amortization of financing costs of approximately $ 12,000 , amortization of the unearned discount of approximately
−Removed: $ 111,000 , and the accretion of the Loan Premium of approximately $ 26,000 .
−Removed: Total interest expense for the year ended June
−Removed: 30, 2024 was approximately $ 2.9 million on the accompanying statement of operations and comprehensive loss.
−Removed: Interest expense was comprised
−Removed: of interest incurred on the outstanding principal of the loan of approximately $ 1.5 million, amortization of financing costs of approximately
−Removed: $ 109,000 , amortization of the unearned discount of $ 1.0 million, and the accretion of the Loan Premium of approximately $ 237,000 .
−Removed: The following is a summary of the Notes Payable as of June 30, 2025
−Removed: Schedule of note payable
−Removed: June 30, 2025
−Removed: June 30, 2024
−Removed: Current portion of Notes Payable
−Removed: debt financing costs
−Removed: unearned discount
−Removed: accretion of Loan Premium
−Removed: Current portion of Notes Payable, net of financing costs, unearned premium and discount
+Added: Amortization expense was $ 178,341 and $ 229,377 for years ended June
+Added: 30, 2026 and 2025.
+Added: The Company amortized its intellectual property over an expected useful life of 10 years.
+Added: The asset is fully amortized,
+Added: leaving no remaining balance to amortize in subsequent periods.
Fair Value Measurements
−Removed: At June 30, 2025, there was no value ascribed to the derivative liabilities
−Removed: and as of June 30, 2024 the derivative liability related to warrants that was measured on a recurring basis was a level 3 liability and
−Removed: totaled $3,771.
−Removed: The following table presents the activity for level 3 liabilities measured
−Removed: at fair value using unobservable inputs for the years ended June 30, 2025 and 2024:
−Removed: Schedule of derivative liabilities at fair value
−Removed: Derivative liability - Avenue Warrants
−Removed: Derivative liability - Conversion Option
−Removed: Balance at June 30, 2023
−Removed: Additions to level 3 liabilities
−Removed: Change in fair value of level 3 liabilities
−Removed: Transfer in and/or out of level 3
−Removed: Balance at June 30, 2024
−Removed: Additions to level 3 liabilities
−Removed: Change in fair value of level 3 liabilities
−Removed: Transfer in and/or out of Level 3
−Removed: Balance at June 30, 2025
−Removed: The fair values of derivative liabilities for
−Removed: the Avenue Warrants and Conversion Option at June 30, 2024 in the accompanying balance sheet, were approximately $3,800 and zero, respectively.
−Removed: The total change in the fair value of the derivative liabilities totaled approximately $ 3,800 and $ 1.8 million for the years ended June
−Removed: 30, 2025, and 2024, respectively;
−Removed: and accordingly, was recorded in the accompanying statements of operations and comprehensive loss.
−Removed: The assumptions used in the Black Scholes model
−Removed: to value the Avenue Warrants at June 30, 2025 included the closing stock price of $ 9.25 per share;
−Removed: the exercise price of $ 582.00 , remaining
−Removed: term 1.4 years, risk free rate of 3.9 % and volatility of 81.0 % .
−Removed: The Conversion Option was nil as of June 30, 2025
−Removed: and June 30, 2024 as the corresponding debt matured and was repaid in December 2024.
−Removed: The assumptions used in the Black Scholes model
−Removed: to value the derivative liabilities at June 30, 2024 included the closing stock price of $ 40.00 per share;
−Removed: for the Avenue Warrants, the
−Removed: exercise price of $ 582.00 , remaining term 2.4 years, risk free rate of 4.6 % and volatility of 82.0 % ;
−Removed: and for the Conversion Option, the
−Removed: conversion price of $ 698.00 ;
−Removed: remaining term of 5 months, risk free rate of 5.38 % and volatility of 91.0 % .
Financial assets
12 unchanged sentences
Equity Transactions
+Added: Equity Transactions with Acuitas (former related
+Added: On July 15, 2022, the Company entered into a securities
+Added: purchase agreement with Acuitas Group Holdings, LLC (“Acuitas”), the Company’s largest stockholder, pursuant to which
+Added: Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 36,364 shares of the Company’s Common Stock,
+Added: at a price of $165.00 per share (the “PIPE Shares”), and (ii) a warrant to purchase 72,728 shares of Common Stock (“PIPE
+Added: Warrant Shares”), at an original exercise price of $182.00, with a term of exercise of five years.
+Added: As a result of the Company’s subsequent
+Added: capital raises, the warrants’ down round features (the “ratchet adjustment”) resulted in deemed dividends of $ 43,544
+Added: and $ 369,465 recognized in the accompanying statements of changes in stockholders’ equity for the years ended June 30, 2026 and
+Added: 2025, respectively.
+Added: For the year ended June 30, 2025, the deemed dividend
+Added: of $ 369,465 was recognized based on rachet adjustments from the September 25, 2024 and October 22, 2024 capital raises, that reduced the
+Added: exercise prices to $15.30 per share and $13.70 per share, respectively.
+Added: The fair value of the PIPE Warrant Shares were estimated using
+Added: the Black Scholes Method with the following inputs at September 2024, the stock price of $ 12.00 , exercise price of $ 15.30 and $ 100.00 ,
+Added: remaining term of 2.9 years, risk free rate of 3.5 % and volatility of 93.0 % , resulting in a $ 325,041 deemed dividend;
+Added: and the following
+Added: inputs at October 22, 2024, the stock price of $ 33.60 , exercise price of $ 15.30 and $ 13.70 , remaining term of 2.8 years, risk free rate
+Added: of 4.0 % and volatility of 94.0 % , resulting in a $44,424 deemed dividend.
+Added: For the year ended June 30, 2026, the deemed dividend
+Added: of $ 43,544 was recognized from the ratchet adjustment resulting from the August 2025 capital raise, which reduced the exercise price from
+Added: $ 13.70 to $ 2.50 per share.
+Added: The fair value of the PIPE Warrant Shares was estimated using the Black Scholes Method with the following inputs,
+Added: the stock price of $1.79, exercise price of $13.70 and reduced exercise price of $2.50, remaining term of 2.0 years, risk free rate of
+Added: 3.8 % and volatility of 94.0 % .
+Added: Consulting expenses
+Added: During the year ended June 30, 2025, the Company paid a Director of
+Added: the Company $50,000 for consulting services which are reflected as a component of general and administrative expenses on the accompanying
+Added: statement of operations.
Issuance of common stock for cash
8 unchanged sentences
Riley Securities, Inc.’s role as a sales agent under the Sales Agreement.
−Removed: the year ended June 30, 2024, the Company sold 33,375 shares of common stock under the Sales Agreement for total net proceeds of approximately
−Removed: $ 9.3 million after deducting 3 % commissions and expenses of approximately $ 377,000 .
−Removed: During the year ended June 30, 2025, the Company sold
−Removed: 215 shares of common stock under the Sales Agreement for total net proceeds of $ 6,400 after 3 % commissions and expenses of approximately
−Removed: On September 25, 2024, the Company suspended the sales agreement and terminated the continuous offering by us under the effective
−Removed: Prospectus Supplement filed January 19, 2024.
−Removed: On March 6, 2024, the Company closed a best efforts
−Removed: public offering (the “Offering”) of 150,000 shares (the “Shares”) of its common stock, par value $0.0001 per share
−Removed: (the “Common Stock”), pre-funded warrants (the “Pre-funded Warrants”) to purchase 60,000 shares of Common Stock,
−Removed: and warrants to purchase up to 105,000 shares of Common Stock (the “Common Warrants”) at a combined public offering price
−Removed: of $ 100.00 per Share, or Pre-funded Warrant, and the associated Common Warrant.
−Removed: The Common Warrants
−Removed: have an exercise price of $ 150.00 per share and are immediately exercisable upon issuance for a period of five years following the date
−Removed: The gross proceeds to the Company from the Offering were approximately $ 21.0 million, before deducting placement agent
−Removed: fees and offering expenses of approximately $2.5 million, resulting in net proceeds of approximately $18.5 million.
−Removed: Additionally, upon
−Removed: closing the Company issued the placement agent warrants (“Placement Agent’s warrants”) to purchase 10,500 shares of
−Removed: Common Stock exercisable at a per share price of $ 125.00 , which was equal to 125% of the public offering price per share.
−Removed: The Placement
−Removed: Agent’s Warrants are exercisable during a five-year period commencing 180 days from March 6, 2024.
−Removed: The Pre-Funded Warrants were
−Removed: exercised shortly after issuance and the 60,000 shares of Common Stock were issued during the year ended June 30, 2024.
+Added: the year ended June 30, 2025, the Company sold 215 shares of common stock under the Sales Agreement for total net proceeds of $ 6,400 after
+Added: 3 % commissions and expenses of approximately $ 200 .
+Added: On September 25, 2024, the Company suspended the sales agreement and terminated the
+Added: continuous offering by us under the effective Prospectus Supplement filed January 19, 2024.
On September 25, 2024, the Company closed a best
5 unchanged sentences
thereafter and reflected on the statement of changes in stockholders’ equity as a component of proceeds from issuance of common
−Removed: The September Common Warrants have an exercise price of $ 15.30 per share and were immediately
−Removed: exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date.
−Removed: The gross proceeds to the
−Removed: Company from the September 2024 Offering was approximately $ 3.0 million, before deducting placement agent fees and offering expenses of
−Removed: approximately $747,000.
+Added: The September Common Warrants have an exercise price of $ 15.30 per share and were
+Added: immediately exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date.
+Added: The gross proceeds
+Added: to the Company from the September 2024 Offering was approximately $ 3.0 million, before deducting placement agent fees and offering expenses
+Added: of approximately $747,000.
Additionally, upon closing, the Company issued the placement agent warrants (“September Placement Agent’s
3 unchanged sentences
from September 25, 2024.
+Added: During the year ended June 30, 2025, 189,630 common
+Added: warrants from the September 2024 Offering were exercised at $ 15.30 per share for proceeds totaling approximately $ 2.9 million, and 33,500
+Added: September Pre-funded Warrants were also exercised.
+Added: In addition, 667 September Placement Agent’s Warrants were exercised on a cashless
+Added: exercise basis and 422 common shares were issued.
In October 2024, the Company closed three registered
2 unchanged sentences
prices ranging from $ 15.00 to $ 28.30 per share (the “October Offerings”) .
−Removed: Common Warrants have exercise prices ranging from $ 13.70 to $ 21.20 per share and are exercisable beginning six months following issuance
−Removed: and will expire on the fifth anniversary date of the original issuance dates.
+Added: Common Warrants have exercise prices ranging from $ 13.70 to $ 21.20 per share and are exercisable beginning six months following
+Added: issuance and will expire on the fifth anniversary date of the original issuance dates.
The gross proceeds to the Company from the October
5 unchanged sentences
are exercisable during a five-year period commencing 180 days from each of the respective closing dates of the October Offerings.
−Removed: During the year ended June 30, 2025, 189,630 of
−Removed: common warrants from the September 2024 Offering were exercised at $ 15.30 per share for proceeds totaling approximately $ 2.9 million,
−Removed: and 33,500 September Pre-funded Warrants were also exercised.
−Removed: In addition, 667 September Placement Agent’s Warrants were exercised
−Removed: on a cashless exercise basis and 422 common shares were issued.
+Added: On August 11, 2025, the Company closed an underwritten
+Added: public offering of (i) 5,620,000 units (the “Units”), with each Unit consisting of one share of common stock and one warrant
+Added: (the “Warrants”) and (ii) 380,000 pre-funded units (the “Pre-Funded Units”), with each Pre-Funded Unit consisting
+Added: of one pre-funded warrant and one Warrant.
+Added: The underwriter also exercised its over-allotment option in part and purchased an additional
+Added: 667,300 Warrants.
+Added: The offering resulted in net proceeds of approximately $ 10.5 million, after deducting underwriting discounts and commissions
+Added: and other estimated offering expenses.
+Added: Each Unit was sold to the public at a price of $2.00 per Unit and each Pre-Funded Unit was sold
+Added: to the public at a price of $1.9999 per Pre-Funded Unit (which represents the public offering price of each Unit less the $0.0001 per
+Added: share nominal exercise price for each Pre-Funded Warrant).
+Added: On August 8, 2025, the Warrants commenced trading on The Nasdaq Capital Market
+Added: under the symbol “BIVIW.” Each Warrant is immediately exercisable, entitles the holder to purchase one share of common stock
+Added: at an exercise price of $ 2.50 per share and expires five years from the date of issuance.
+Added: Each Pre-Funded Warrant is immediately exercisable,
+Added: entitles the holder to purchase one share of common stock, and may be exercised at any time until exercised in full.
+Added: Additionally,
+Added: upon closing, the Company issued the underwriter warrants to purchase 300,000 shares of Common Stock exercisable at a per share price
+Added: of $2.50, which was equal to 125% of the public offering price per share.
+Added: The underwriter’s Warrants are exercisable during a five-year
+Added: period commencing 180 days from August 11, 2025.
Issuance of common stock for services
−Removed: On May 10, 2024, the Company awarded 1,500 shares
−Removed: of Common Stock to a vendor as part of their fees in exchange for services.
−Removed: The fair value of the Common Stock at the date of issuance
−Removed: was $ 48.60 per share.
−Removed: The stock-based compensation expense related to this Common Stock issuance was $ 72,900 for the year ended June 30,
On August 12, 2024, the Company awarded 1,500
11 unchanged sentences
stock options for the years ended June 30, 2026 and 2025:
−Removed: Schedule of summarizes the activity relating to the Company’s stock options
−Removed: Weighted-Average Exercise Price
−Removed: Weighted Remaining Average Contractual Term
−Removed: Aggregate Intrinsic Value
+Added: Schedule of stock options
Outstanding at June 30, 2024
+Added: Options Granted
Options Expired
3 unchanged sentences
Options Expired
−Removed: Options Canceled
Outstanding at June 30, 2026
Exercisable at June 30, 2026
−Removed: The fair value of each option grant on the date
−Removed: of grant is estimated using the Black-Scholes model.
−Removed: The following weighted-average assumptions were utilized for the years ended:
+Added: The Company recorded stock-based compensation expense relating to the
+Added: vesting of stock options of approximately $ 2.3 million and $ 1.2 million for the years ended June 30, 2026 and 2025, respectively.
+Added: The fair value of each option on the date of grant is estimated using
+Added: the Black-Scholes option pricing model.
+Added: The pricing model reflects the following weighted-average assumptions utilized for the years ended:
Schedule of assumptions used
5 unchanged sentences
Dividend Yield
−Removed: On October 3, 2023, the Company granted stock
−Removed: options to purchase 2,112 shares of Common Stock to new hire employees.
−Removed: 20 % of the shares underlying the options awarded vest on the one-year
−Removed: anniversary of the grant date, and the remaining 80 % will vest in equal monthly installments over 48 months each month thereafter.
−Removed: exercise price of the options is $ 341.00 , the grant date fair value, and the options terminate on the earlier of the tenth grant date
−Removed: anniversary or the date of which the options are fully exercised.
−Removed: In June 2024, the Company granted stock options
−Removed: to purchase 11,580 shares of Common Stock to employees.
−Removed: 33 % of the shares underlying the options awarded vest on the grant date, and the
−Removed: remaining 67 % will vest over 2 years on first and second anniversary of the grant date.
−Removed: The exercise price of the options is $ 47.00 , the
−Removed: grant date fair value, and the options terminate on the earlier of the tenth grant date anniversary or the date of which the options are
−Removed: fully exercised.
−Removed: On December 20, 2024, the Company granted to employees
−Removed: and directors stock options to purchase 20,893 and 11,308 shares of Common Stock, respectively.
−Removed: The options have an exercise price of
−Removed: $ 19.00 per share equal to the Company’s stock price at the close on December 20, 2024, the grant date.
−Removed: The fair value of the stock
−Removed: options issued to Directors were $ 12.00 per share.
−Removed: The fair value of the stock options issued to Management was $ 14.30 per share.
−Removed: The Company recorded stock based compensation
−Removed: expense relating to the vesting of stock options of approximately $ 1.2 million and $ 2.8 million for the years ended June 30, 2025 and
+Added: On December 20, 2024 (the “Grant Date”),
+Added: the Company granted to employees and directors stock options to purchase 20,893 and 11,308 shares of Common Stock, respectively.
+Added: have an exercise price of $ 19.00 per share equal to the Company’s stock price at the close on December 20, 2024, the grant date.
+Added: The fair value of the stock options issued to Directors were $ 12.00 per share.
+Added: The fair value of the stock options issued to Management
+Added: was $ 14.30 per share.
+Added: On January 5, 2026 (the “Grant Date”),
+Added: directors’ annual compensation was approved and the directors were granted stock options to purchase a total of 355,000 shares of
+Added: common stock, at an exercise price of $1.31 per share, the closing stock price on the grant date.
+Added: The stock options vest from the beginning
+Added: of service on November 11, 2025 in four equal installments on February 11, 2026, May 11, 2026, August 11, 2026 and the earlier of November
+Added: 11, 2026 or the 2026 annual shareholders' meeting.
+Added: On January 5, 2026 (the “Grant Date”),
+Added: the Company awarded bonus and retention incentive stock options to certain directors and employees to purchase a total of 812,700 and
1,538,850 , respectively;
+Added: shares of common stock, at an exercise price of $ 1.31 per share, the closing stock price on the Grant Date.
+Added: directors’ stock options vested 75 % on the Grant Date with the remaining balance vesting in equal installments on the first, second
+Added: and third Grant Date anniversary.
+Added: The employees’ stock options vested 55 % on grant date with the remaining balance vesting in equal
+Added: installments on the first, second and third Grant Date anniversary.
Issuance and modification of restricted stock units, restricted
shares and stock options:
−Removed: On November 9, 2023, the Company granted equity
−Removed: awards for the board of directors’ annual compensation.
−Removed: Four directors received 1,827 Restricted Stock Units (“RSUs”)
−Removed: with a grant date fair value of $ 301.00 per share.
−Removed: In addition, two directors received stock options to purchase 1,833 shares of common
−Removed: stock at an exercise price of $ 301.00 per share with a grant date fair value of $ 183.00 per share.
−Removed: The equity awards vest quarterly on
−Removed: February 9, 2024, May 9, 2024, August 9, 2024 and earlier of November 9, 2024 or the next annual shareholders’ meeting.
−Removed: year ended June 30, 2024, 457 of these RSUs vested.
−Removed: During the year ended June 30, 2025, 682 of these RSUs vested and 232 RSUs were cancelled
+Added: On November 9, 2023 (the “Grant Date”),
+Added: the Company granted equity awards for the board of directors’ annual compensation.
+Added: Four directors received 1,827 Restricted Stock
+Added: Units (“RSUs”) with a grant date fair value of $ 301.00 per share.
+Added: In addition, two directors received stock options to purchase
+Added: 1,833 shares of common stock at an exercise price of $ 301.00 per share with a grant date fair value of $ 183.00 per share.
+Added: The equity awards
+Added: vested quarterly on February 9, 2024, May 9, 2024, August 9, 2024 and earlier of November 9, 2024 or the next annual shareholders’
+Added: During the year ended June 30, 2024, 457 of these RSUs vested.
+Added: During the year ended June 30, 2025, 682 of these RSUs vested
+Added: and 232 RSUs were cancelled due to Mr.
Gorlin resigning from the Board of Directors.
−Removed: In December 2023, the Company terminated five
−Removed: employees and as part of their severance agreement modified their equity awards that had been granted pursuant to the 2019 Omnibus Plan.
−Removed: The modifications included the acceleration of certain stock option awards to purchase a total of 563 shares of common stock (“Accelerated
−Removed: Options”), effective on the December Separation Date, as defined in severance agreement (“Separation Date”), and extended
−Removed: the expiration date for one year from the Separation Date for both the Accelerated Options and any vested and unexercised stock options
−Removed: held by the terminated employees as of the Separation Date.
−Removed: Accordingly, the Company remeasured the Accelerated Options based on the stock
−Removed: price of $154.00 per share at the close on the Separation Date and a one-year extension of the term.
−Removed: The net adjustment for the modification
−Removed: was a net credit of $127,199 and was recognized as an adjustment to stock compensation expense during the year ended June 30, 2024.
−Removed: Additionally, 103 vesting RSUs were accelerated
−Removed: as of the Separation date.
−Removed: The modified RSUs were remeasured based on the stock price of $154.00 per share at close on the Separation
−Removed: Date and $15,865, was recorded to additional in stock-based compensation for the year ended June 30, 2024 as a result of the modification.
−Removed: On the Separation date, December 2023, the Company
−Removed: canceled 1,840 unvested stock options and 103 unvested RSUs.
−Removed: Additionally, the Company canceled an additional 1,342 unvested stock options
−Removed: for employees that voluntarily left the company.
−Removed: On June 24, 2024, the Company granted a total
−Removed: of 8,580 RSUs to employees, with a grant date fair value of $ 47.40 per share.
−Removed: The RSUs vested on the grant date.
−Removed: The Company delivered
−Removed: the vested portion of the RSU’s and issued 8,580 shares of Common Stock, of which 2,145 shares were withheld in Treasury stock in
−Removed: exchange for payment of withholding tax on behalf of the employees.
−Removed: On November 20, 2024, the Company granted equity
−Removed: awards as part of the board of directors’ annual compensation.
−Removed: Two directors received 6,690 RSUs with a grant date fair value of
−Removed: $ 33.60 per share and three directors received stock options to purchase 16,830 shares of Common Stock at an exercise price of $ 33.60 per
−Removed: share with a grant date fair value of $ 21.10 per share.
−Removed: The RSUs vest quarterly on February 8, 2025, May 8, 2025, August 8, 2025 and the
−Removed: earlier of November 8, 2025 or the next annual shareholders’ meeting.
−Removed: During the year ended June 30, 2025, 2,528 shares were issued
−Removed: related to the RSUs that vested and 2,415 shares were canceled due to departures.
−Removed: On January 1, 2025, the Company awarded 4,500
−Removed: shares of restricted common stock as part of a service agreement to a vendor.
−Removed: The restricted common shares fully vest on the first anniversary
−Removed: of the effective date.
−Removed: The total cost of the award was based on $ 21.80 per share as of the date of the award and related stock-based compensation
−Removed: expense for the year ended June 30, 2025 was $ 49,050 .
−Removed: On January 21, 2025, the Company granted a total
−Removed: of 10,500 RSUs to Advisory board members at the grant date fair value of $ 20.50 .
−Removed: Vesting of the RSUs are in five equal installments at
−Removed: the grant date and each calendar quarter end beginning March 31, 2025.
+Added: On November 20, 2024 (the “Grant Date”),
+Added: the Company granted equity awards as part of the board of directors’ annual compensation.
+Added: Two directors received 6,690 RSUs with
+Added: a grant date fair value of $ 33.60 per share and three directors received stock options to purchase 16,830 shares of Common Stock at an
+Added: exercise price of $ 33.60 per share with a grant date fair value of $ 21.10 per share.
+Added: The RSUs vested quarterly on February 8, 2025, May
+Added: 8, 2025, August 8, 2025 and the earlier of November 8, 2025 or the next annual shareholders’ meeting.
+Added: During the year ended June
+Added: 30, 2025, 2,528 shares were issued related to the RSUs that vested and 2,415 shares were canceled due to departures.
+Added: On January 1, 2025 (the “Grant Date”),
+Added: the Company awarded 4,500 shares of restricted common stock as part of a service agreement to a vendor.
+Added: The restricted common shares fully
+Added: vest on the first anniversary of the effective date.
+Added: The total cost of the award was based on $ 21.80 per share as of the date of the award
+Added: and related stock-based compensation expense for the year ended June 30, 2025 was $ 49,050 .
+Added: On January 21, 2025 (the “Grant Date”),
+Added: the Company granted a total of 10,500 RSUs to Advisory board members at the grant date fair value of $ 20.50 .
+Added: Vesting of the RSUs are in
+Added: five equal installments at the grant date and each calendar quarter end beginning March 31, 2025.
+Added: On September 2, 2025 (the “Grant Date”),
+Added: the Company granted a total of 1,500 RSUs to a consultant at the grant date fair value of $ 1.58 per RSU.
+Added: The RSUs vest in five equal installments
+Added: beginning on the Grant Date and over the following four calendar quarters beginning December 31, 2025.
The following table summarizes vesting of restricted
1 unchanged sentence
Number of Shares
−Removed: Weighted Average Grant Date Fair Value Per Share
Unvested at June 30, 2024
2 unchanged sentences
The total stock-based compensation expense from restricted stock units
−Removed: and restricted shares for the year ended June 30, 2025 and 2024 was approximately $ 1.2 million and $ 1.8 million, respectively.
+Added: and restricted shares for the year ended June 30, 2026 and 2025 was approximately $ 590,000 and $ 1.2 million, respectively.
Stock Warrants
3 unchanged sentences
Number of Shares
−Removed: Weighted Average Exercise Price
−Removed: Weighted Average Remaining Life (Years)
−Removed: Aggregate Intrinsic Value
Outstanding and exercisable at June 30, 2024
−Removed: $ 18,318,954 .00
Outstanding and exercisable at June 30, 2025
6 unchanged sentences
Total outstanding warrants
+Added: The warrants tables exclude 380,000 prefunded warrants with an exercise
+Added: price of $ 0.0001 and no expiration.
+Added: None of the prefunded warrants were exercised during the year ended June 30, 2026.
+Added: Notes Payable
+Added: On November 30, 2021 (the “Closing Date”),
+Added: the Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and Promissory Notes (together,
+Added: the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P.
+Added: (“AVOPI”) and Avenue Venture Opportunities
+Added: Fund II, L.P.
+Added: (“AVOPII,” and together with AVOPI, “Avenue”) for growth capital loans in an aggregate commitment
+Added: amount of up to $20 million (the “Loan”).
+Added: On the Closing Date, $15 million of the Loan was funded (“Tranche 1”).
+Added: The Loan bore interest at an annual rate equal to the greater of (a) the sum of 7.00 % plus the prime rate as reported in The Wall Street
+Added: Journal and (b) 10.75%.
+Added: The Loan was secured by a lien upon and security interest in all of the Company’s assets, including intellectual
+Added: property, subject to agreed exceptions.
+Added: The Loan was paid in full on its maturity date of December 1, 2024 along with a final payment
+Added: equal to 4.25 % of the Loan commitment amount, or $850,000, the (“Loan Premium”) and the lien upon and security interest in
+Added: all of the Company’s assets was released.
Office Leases
−Removed: The Company pays an annual rent of $ 2,200
−Removed: for its headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 89703.
−Removed: The rental agreement was for a one-year 1 term,
−Removed: commenced on October 1, 2022 and has been subsequently renewed at each annual maturity date at the same rate.
−Removed: The Company’s San Diego office lease at
−Removed: 5090 Shoreham Place Suite 212, San Diego, CA 92122 which commenced on March 1, 2022, was for a term of 38 months with a base monthly rate
−Removed: of $4,300, and annual increases of three percent.
−Removed: In February 2024, the Company amended the lease agreement which allowed the Company
−Removed: to vacate the then current space and move to a larger space at Suite 206.
−Removed: The current monthly base rate for the new office space is $ 10,024 ,
−Removed: with an annual increase of four percent.
−Removed: The term for the new office lease is 60 months and commenced on February 12, 2024.
−Removed: that was in place for the 5090 Shoreham Place Suite 212 office was effectively extinguished upon the commencement of the new office space
−Removed: lease on February 12, 2024, resulting in the write off of the corresponding remaining right-of-use asset and operating lease liability
−Removed: of $ 56,909 and $ 62,124 , respectively, and a gain to selling, general and administrative expenses of $ 5,215 for the year ended June 30,
−Removed: Total operating lease expense for the years ended
−Removed: June 30, 2025 and 2024 of approximately $ 127,000 and $ 78,000 , respectively, were included in the accompanying statements of operations
−Removed: and comprehensive loss as a component of selling, general and administrative expenses.
−Removed: The right-of-use asset, net and current and non-current
−Removed: portion of the operating lease liabilities included in the accompanying balance sheets are as follows:
+Added: The Company pays an annual rent of $ 2,200 for its headquarters at 680
+Added: W Nye Lane, Suite 201, Carson City Nevada 89703.
+Added: The rental agreement was for a one-year term, commenced on October 1, 2022 and has been
+Added: subsequently renewed at each annual maturity date at the same rate.
+Added: The Company’s San Diego office lease at 5090 Shoreham Place Suite
+Added: 206, San Diego, CA 92122 was amended on February 12, 2024 for a larger space.
+Added: The current monthly base rate for the office space is $ 10,375 ,
+Added: with annual increases of four percent.
+Added: The term of the lease is 60 months.
+Added: Total operating lease expense for the years ended June 30, 2026 and
+Added: 2025 of approximately $ 133,000 and $ 127,000 , respectively, were included in the accompanying statements of operations as a component of
+Added: general and administrative expenses.
+Added: The right-of-use asset, net and current and
+Added: long-term portion of the operating lease liability included in the accompanying balance sheets are as follows:
Schedule of deferred tax assets
8 unchanged sentences
Schedule of future estimated minimum lease payments under non-cancelable operating leases
−Removed: Year ending June 30
Total minimum lease payments
1 unchanged sentence
Present value of future minimum lease payments
−Removed: Total cash paid for amounts included in the measurement of lease liabilities
−Removed: were $ 117,915 and $ 83,910 for the years ended June 30, 2025 and 2024, respectively.
+Added: Total cash paid for amounts included in the measurement of lease liability
+Added: was $ 122,042 and $ 117,915 for the years ended June 30, 2026 and 2025, respectively.
The weighted average remaining lease term and
14 unchanged sentences
Pursuant to the Technology Transfer Agreement
−Removed: entered into on July 25, 2016, by and between the Company and the University of Padova (Italy), the Company is obligated to pay a low
−Removed: single digit royalty on net sales of all terlipressin products covered by US patent no.
−Removed: 9,655,645 and any future foreign issuances, capped
−Removed: at a maximum of $200,000 per year.
+Added: entered into on July 25, 2016, by and between the Company and the University of Padova (Italy), the Company was obligated to pay a 5%
+Added: royalty on net sales (capped at a maximum of $200,000 per year) of all terlipressin products covered by US Patent No.
+Added: 11364277, expiring
+Added: in 2036 and the European Patent No.
+Added: EP3347032, expiring in 2036 and pending patent applications in the U.S., Europe, China and Japan,
+Added: related to the administration of terlipressin as a continuous infusion for the treatment of ascites.
+Added: Pursuant to the Intellectual Property Rights Agreement
+Added: entered into on April 18, 2019, by and between the Company and DOCUCHEM SLU, the Company is obligated to pay DOCUCHEM SLU $25,000 on the
+Added: issuance of the U.S.
+Added: patent for terlipressin and $50,000 each calendar year in which the gross sales in the U.S.
+Added: of a product covered
+Added: by a claim of an issued U.S.
+Added: patent as directed to terlipressin exceeds $10,000,000.
Shareholder class action complaint and shareholder derivative complaints
−Removed: On January 19, 2024, a purported shareholder class
−Removed: action complaint, captioned Eric Olmstead v.
+Added: On January 19, 2024, a purported securities class action complaint, captioned Eric Olmstead v.
3:24-cv-00035, was filed in the U.S.
−Removed: District Court for
−Removed: the District of Nevada, naming the Company and certain of its officers as defendants.
−Removed: On February 22, 2024, a second, related
−Removed: putative securities class action was filed in the same court asserting similar claims against the same defendants, captioned Way v.
+Added: District Court for the District of Nevada, naming the Company and certain of its officers as defendants.
+Added: 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.
2:24-cv-00361.
−Removed: On April 15, 2024, the court consolidated these two actions under the caption In re BioVie
+Added: On April 15, 2024, the court consolidated these two actions under the caption In re BioVie Inc.
Securities Litigation , No.
−Removed: 3:24-cv-00035, appointed the lead plaintiff, and approved selection of the lead counsel.
−Removed: 2024, the lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of
−Removed: material fact relating to the Company’s business, operations, compliance, and prospects, including information related to the NM101
−Removed: Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable AD, in violation
−Removed: of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder.
−Removed: The class action is on behalf
−Removed: of purchasers of the Company’s securities during the period from December 7, 2022 through November 28, 2023, and seeks unspecified
−Removed: monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees.
−Removed: The defendants filed
−Removed: a motion to dismiss the amended complaint on August 21, 2024, and that motion was fully briefed as of December 5, 2024.
−Removed: On March 27, 2025,
−Removed: the court denied the defendants’ motion to dismiss, and the parties are now engaged in the early stages of fact discovery .
−Removed: On December 30, 2024, a shareholder derivative
−Removed: lawsuit was filed in the United States District Court for the District of Nevada by putative stockholder Andrew Hulm, allegedly on behalf
−Removed: of the Company, that piggy-backs on the securities class action also pending in that court.
−Removed: The derivative complaint names certain current
−Removed: and former officers and directors as defendants, and generally alleges that they breached their fiduciary duties by causing or failing
−Removed: to prevent the securities violations alleged in the securities class action.
−Removed: The derivative complaint also alleges claims for unjust enrichment,
−Removed: waste of corporate assets, gross mismanagement, and abuse of control as against all defendants.
−Removed: On March 18, 2025, the court ordered the
−Removed: Hulm derivative lawsuit stayed, pending resolution of the motion to dismiss the securities class action described above.
−Removed: On April 28, 2025, a second shareholder derivative
−Removed: lawsuit was filed in the United States District Court for the District of Nevada by putative stockholder William Settel, allegedly on
−Removed: behalf of the Company, that likewise piggy-backs on the securities class action.
−Removed: The Settel derivative complaint alleges essentially the
−Removed: same claims as the Hulm derivative action against the same defendants based on the same alleged conduct.
−Removed: The Company believes that the claims are without
−Removed: merit and intends to defend vigorously against them, but there can be no assurances as to the outcome.
+Added: 3:24-cv-00035 (the “Securities Class Action”), appointed the lead plaintiff, and approved selection of the lead counsel.
+Added: 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) of the Exchange Act, and Rule 10b-5 promulgated thereunder.
+Added: 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.
+Added: The defendants filed a motion to dismiss the amended complaint on August 21, 2024, and on March 27, 2025, the court denied that motion.
+Added: The parties are now engaged in fact discovery.
+Added: On February 13, 2026, the plaintiffs filed a motion for class certification and a motion for leave to file a second amended complaint.
+Added: Defendants opposed the motion for leave to amend.
+Added: 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.
+Added: 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.
+Added: The defendants answered the Second Amended Complaint on June 22, 2026.
+Added: 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:
+Added: Andrew Hulm on December 30, 2024;
+Added: William Settel on April 28, 2025 and Cline Wilkerson on September 11, 2025, (collectively the “Related Derivative Lawsuits”).
+Added: Each Related Derivative Lawsuit names the same current and former officers and directors as defendants and alleges essentially the same claims:
+Added: 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.
+Added: 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.
+Added: Derivative Litigation , Case No.
+Added: 3:24-cv-0602-CSD (the “Consolidated Derivative Action”).
+Added: 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.
+Added: The Company believes that the claims are
+Added: without merit and intends to defend vigorously against them, but there can be no assurances as to the outcome.
Employee Benefit Plan
7 unchanged sentences
and $ 152,400 , for the years ended June 30, 2026 and 2025, respectively.
+Added: and foreign components of pretax loss are as follows:
+Added: Schedule of foreign components
+Added: June 30, 2026
+Added: June 30, 2025
+Added: $ ( 22,072,863 )
+Added: $ ( 17,542,120 )
+Added: Total Pretax Loss
+Added: $ ( 22,072,863 )
+Added: $ ( 17,542,120 )
Significant components of the Company’s deferred tax assets (liabilities)
25 unchanged sentences
full valuation allowance.
+Added: The Company has not made payments or received refunds for income taxes for the years ended June 30, 2026 and
+Added: The state and local income tax reconciling item is primarily driven
+Added: by California state income taxes, which represented more than 50% of the total state and local income tax effect for the year ended June
+Added: The Company is incorporated in Nevada;
+Added: however, Nevada does not impose a corporate income tax.
+Added: Accordingly, the Company's state
+Added: income tax provision primarily reflects apportionment of taxable income to California based on the Company's operational footprint.
Reconciliation of the differences between income
−Removed: tax benefit computed at the federal and state statutory tax rates and the provision for income tax benefit for the years ended June 30,
−Removed: 2025 and 2024 is as follows:
+Added: tax benefit computed at the federal tax rates and the provision for income tax benefit for the years ended June 30, 2026 and 2025 is as
Schedule of effective income tax rate reconciliation
Income tax expense at federal statutory rate
+Added: $ ( 4,635,301 )
+Added: $ ( 3,683,845 )
State taxes, net of federal benefit
+Added: ( 1,545,100 )
+Added: ( 1,227,948 )
+Added: Effect of changes in tax laws enacted in current period
Change in valuation allowance
Effective tax rate
−Removed: On July 4, 2025, the U.S.
−Removed: enacted the One Big Beautiful Bill Act (the
−Removed: “Act”), which contains a broad range of tax reform provisions affecting businesses.
−Removed: The Company is currently evaluating
−Removed: the full effects of the Act and does not anticipate a material impact on the financial statements.
+Added: On July 4, 2025, the One Big Beautiful Bill Act was enacted into law.
+Added: Among other changes, the legislation permits immediate expensing of domestic research and experimental expenditures for tax years beginning after December 31, 2024.
+Added: In connection with enactment, the Company remeasured its deferred tax balances and recorded a discrete tax benefit of approximately $ 3.1 million during the year ended June 30, 2026, primarily related to a reduction in deferred tax assets associated with capitalized domestic research and experimental expenditures.
+Added: The effect of this remeasurement was offset by a corresponding change in the valuation allowance, and accordingly no net income tax expense or benefit was recognized.
Segment Reporting
−Removed: The Company operates as one operating segment with a focus on its efforts
−Removed: to develop drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease.
−Removed: The Company's
−Removed: CEO, as the chief operating decision maker, manages and allocates resources to the operations of the Company based on the line items included
−Removed: within these financial statements and segment performance is evaluated based on net loss.
−Removed: This enables the CEO to assess the overall level
−Removed: of available resources and determine how best to deploy these resources across functions, clinical trials, and development projects in
−Removed: line with the long-term company-wide strategic goals.
−Removed: The measurement of segment assets is reported on the balance sheet as total assets.
+Added: The Company operates as one operating segment
+Added: with a focus on its efforts to develop drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver
+Added: The Company's CEO, as the chief operating decision maker, manages and allocates resources to the operations of the Company based
+Added: on the line items included within these financial statements and segment performance is evaluated based on net loss.
+Added: This enables the
+Added: CEO to assess the overall level of available resources and determine how best to deploy these resources across functions, clinical trials,
+Added: and development projects in line with the long-term company-wide strategic goals.
+Added: The measurement of segment assets is reported on the
+Added: balance sheet as total assets.
All of the Company’s tangible assets are held in the United States.
−Removed: The following table
−Removed: presents selected financial information with respect to the Company’s single operating segment and its significant segment expenses
−Removed: for the years ended June 30, 2025 and 2024:
+Added: The following table presents selected financial
+Added: information with respect to the Company’s single operating segment and its significant segment approximated expenses for the years
+Added: ended June 30, 2026 and 2025:
Schedule of segment reporting information
−Removed: For the Year Ended
−Removed: For the Year Ended
June 30, 2026
4 unchanged sentences
Other research and development expenses
−Removed: Selling, general and administrative expenses
+Added: General and administrative expenses
Amortization of intangible assets
2 unchanged sentences
$ ( 17,542,000 )
−Removed: Subsequent Events
−Removed: August 11, 2025, the Company closed an underwritten public offering of (i) 5,620,000 units (the “Units”), with each Unit
−Removed: consisting of one share of common stock and one warrant (the “Warrants”) and (ii) 380,000 pre-funded units (the
−Removed: “Pre-Funded Units”), with each Pre-Funded Unit consisting of one pre-funded warrant and one Warrant.
−Removed: The underwriter
−Removed: also exercised its over-allotment option in part and purchased an additional 667,300 Warrants.
−Removed: The offering resulted in net proceeds
−Removed: of approximately $ 10.4 million, after deducting underwriting discounts and commissions and other estimated offering expenses.
−Removed: Unit was sold to the public at a price of $2.00 per Unit and each Pre-Funded Unit was sold to the public at a price of $1.999 per
−Removed: Pre-Funded Unit (which represents the public offering price of each Unit less the $0.0001 per share nominal exercise price for each
−Removed: Pre-Funded Warrant).
−Removed: On August 8, 2025, the Warrants commenced trading on The Nasdaq Capital Market under the symbol
−Removed: “BIVIW.” Each Warrant is immediately exercisable, entitles the holder to purchase one share of common stock at an
−Removed: exercise price of $ 2.50 per share and expires five years from the date of issuance.
−Removed: Each Pre-Funded Warrant is immediately
−Removed: exercisable, entitles the holder to purchase one share of common stock and may be exercised at any time until exercised in
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.