1 unchanged sentence
Evaluation of Disclosure Controls and Procedures
−Removed: We have evaluated, with the participation of our principal
−Removed: executive and our principle financial officer, the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e)
−Removed: and 15(d)-15(e) under the Exchange Act as of the end of the period covered by this Annual Report on Form 10-K.
−Removed: Based on this evaluation,
−Removed: our principal executive officer and our principal financial officer have concluded that our disclosure controls and procedures were effective
+Added: We have evaluated, with the participation of our
+Added: principal executive and our principle 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 Form 10-K.
+Added: Based on this evaluation, our
+Added: principal executive officer and our principal financial officer have concluded that our disclosure controls and procedures were effective
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,
4 unchanged sentences
Over Financial Reporting
−Removed: Our management is responsible for establishing and
−Removed: maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act.
−Removed: of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
−Removed: Projections of any evaluation
−Removed: of the effectiveness of internal control to future periods are subject to the risk that controls may become inadequate because of changes
−Removed: in conditions, or that the degree of compliance with policies or procedures may deteriorate.
−Removed: Under the supervision and with the
−Removed: participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the
−Removed: effectiveness of our internal control over financial reporting as of June 30, 2024 using the criteria established in Internal Control
+Added: Our management is responsible for establishing
+Added: and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act.
+Added: Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
+Added: Projections of
+Added: any evaluation of the effectiveness of internal control to future periods are subject to the risk that controls may become inadequate
+Added: because of changes in conditions, or that the degree of compliance with policies or procedures may deteriorate.
+Added: Under the supervision
+Added: and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation
+Added: of the effectiveness of our internal control over financial reporting as of June 30, 2025 using the criteria established in Internal Control
Integrated Framework issued by the Committee of Sponsoring Organization of the Treadway Commission.
3 unchanged sentences
in accordance with generally accepted accounting principles for the reasons discussed above.
−Removed: Changes in Internal Control Over Financial Reporting
−Removed: There were no changes in our internal controls over
−Removed: financial reporting during the quarter ended June 30, 2024, that materially affected, or are reasonably likely to materially affect our
−Removed: internal controls over financial reporting.
+Added: Changes in Internal Control Over Financial
+Added: There were no changes in our internal controls
+Added: over financial reporting during the quarter ended June 30, 2025 that materially affected, or are reasonably likely to materially affect
+Added: our internal controls over financial reporting.
OTHER INFORMATION
2 unchanged sentences
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
−Removed: The information required by this item is
−Removed: included in our 2024 Proxy Statement and is
−Removed: incorporated herein by reference.
+Added: The information required by this item is included
+Added: in our 2025 Proxy Statement and is incorporated herein by reference.
EXECUTIVE COMPENSATION
−Removed: The information required by this item is
−Removed: included in our 2024 Proxy Statement and is
−Removed: incorporated herein by reference.
+Added: The information required by this item is included in our 2025 Proxy
+Added: Statement and is incorporated herein by reference.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
−Removed: The information required by this item is
−Removed: included in our 2024 Proxy Statement and is
−Removed: incorporated herein by reference.
+Added: The information required by this item is included
+Added: in our 2025 Proxy Statement and is incorporated herein by reference.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
−Removed: The information required by this item is
−Removed: included in our 2024 Proxy Statement and is
−Removed: incorporated herein by reference.
+Added: The information required by this item is included
+Added: in our 2025 Proxy Statement and is incorporated herein by reference.
PRINCIPAL ACCOUNTANT FEES AND SERVICES
−Removed: The information required by this item is
−Removed: included in our 2024 Proxy Statement and is
−Removed: incorporated herein by reference.
+Added: The information required by this item is included
+Added: in our 2025 Proxy Statement and is incorporated herein by reference.
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)(1),(2) Financial Statements
−Removed: The Financial Statements listed on page F-1 of this
−Removed: document are filed as part of this filing.
+Added: The Financial Statements listed on page F-1 of
+Added: this document are filed as part of this filing.
(a)(3) Exhibits
−Removed: The following is a list of exhibits filed as a part
−Removed: of this report:
+Added: The following is a list of exhibits filed as a
+Added: part of this report:
Description of Document
5 unchanged sentences
Certificate of Amendment to Articles of Incorporation (incorporated by reference to Exhibit 3.6 to the Company’s Registration Statement on Form S-1 filed on November 22, 2019, File No.
−Removed: Amended and Restated Bylaws of the Company, dated June 16, 2020 (incorporated by reference to Exhibit 3.5 to the Company’s Quarterly Report on Form 10-Q filed on November 10, 2021).
−Removed: First Amendment to the Amended and Restated Bylaws of the Company, dated March 12, 2023 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on March 13, 2023).
Certificate of Change (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on August 1, 2024) .
−Removed: Termination of Amendment/Certificate (incorporated by reference to Exhibit 3.1 to the Company’s Current Report, as amended, on Form 8-K/A filed on August 6, 2024)
+Added: Certificate of Termination (incorporated by reference to Exhibit 3.1 to the Company’s Current Report, as amended, on Form 8-K/A filed on August 6, 2024).
Certificate of Amendment (incorporated by reference to Exhibit 3.2 to the Company’s Current Report, as amended, on Form 8-K/A filed on August 6, 2024) .
+Added: Amended and Restated Bylaws of the Company, adopted on May 28, 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.
Form of Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on September 25, 2019).
−Removed: Form of Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on September 25, 2019).
Form of 10% OID Convertible Delayed Draw Debenture (incorporated by reference to Exhibit 4.1 the Company’s Current Report on Form 8-K filed on September 25, 2019).
1 unchanged sentence
Form of Warrant to Purchase Shares of Class A Common Stock of the Company (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on December 1, 2021).
+Added: Form of Pre-Funded Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on March 4, 2024)
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on March 4, 2024).
−Removed: Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on March 4, 2024).
−Removed: 2019 Omnibus Equity Incentive Plan (incorporated by reference to Appendix D to the Definitive Information Statement on Schedule 14C, filed on May 8, 2019).
+Added: Form of Placement Agent Warrant Agreement (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on March 4, 2024).
+Added: Form of Pre-Funded Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on September 24, 2024).
+Added: Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on September 24, 2024).
+Added: Form of Placement Agent’s Warrant Agreement (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on September 24, 2024).
+Added: Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on October 22, 2024).
+Added: Form of Placement Agent’s Warrant Agreement (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on October 22, 2024).
+Added: Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on October 24, 2024).
+Added: Form of Placement Agent’s Warrant Agreement (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on October 24, 2024).
+Added: 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: 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).
+Added: 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).
Asset Purchase Agreement, dated April 27, 2021, among the Company, NeurMedix, Inc.
25 unchanged sentences
Insider Trading Policy
+Added: 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
11 unchanged sentences
XBRL Taxonomy Extension Definition Linkbase Document
−Removed: # Indicates a management contract or compensatory
−Removed: plan or arrangement
+Added: # Indicates a management contract or compensatory plan or arrangement
* Filed herewith.
** Furnished herewith.
−Removed: Pursuant to the requirements of Section 13 or 15(d)
−Removed: of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto
−Removed: duly authorized.
−Removed: September 30, 2024
+Added: Pursuant to the requirements of Section 13 or
+Added: 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned,
+Added: thereunto duly authorized.
+Added: August 15, 2025
Chief Executive Officer
10 unchanged sentences
their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
−Removed: Pursuant to the requirements of the Securities Exchange
−Removed: Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated.
+Added: Pursuant to the requirements of the Securities
+Added: Exchange Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated.
Chief Executive Officer
−Removed: September 30, 2024
+Added: August 15, 2025
(Principal Executive Officer)
1 unchanged sentence
Chief Financial Officer
−Removed: September 30, 2024
+Added: August 15, 2025
Joanne Wendy Kim
−Removed: (Principal Financial Officer)
−Removed: September 30, 2024
+Added: (Principal Financial and Accounting Officer)
+Added: August 15, 2025
/s/ Michael Sherman
−Removed: September 30, 2024
+Added: August 15, 2025
Michael Sherman
−Removed: /s/ Richard J.
−Removed: September 30, 2024
−Removed: /s/ Robert Hariri
−Removed: September 30, 2024
−Removed: Robert Hariri
+Added: /s/ Amy Chappell
+Added: August 15, 2025
+Added: /s/ Kameel Farag
+Added: August 15, 2025
/s/ Sigmund Rogich
−Removed: September 30, 2024
+Added: August 15, 2025
Sigmund Rogich
10 unchanged sentences
Opinion on the Financial Statements
−Removed: We have audited the accompanying balance sheets of
−Removed: (the “Company”) as of June 30, 2024 and 2023, and the related statements of operations and comprehensive loss,
−Removed: changes in stockholders’ equity, and cash flows for each of the years then ended, and the related notes (collectively referred to
−Removed: as the “financial statements”).
−Removed: In our opinion, the financial statements present fairly, in all material respects, the financial
−Removed: position of the Company as of June 30, 2024 and 2023, and the results of its operations and its cash flows for of the years then ended,
−Removed: in conformity with accounting principles generally accepted in the United States of America.
−Removed: Going Concern
−Removed: The accompanying financial statements have been prepared
−Removed: assuming that the Company will continue as a going concern.
−Removed: As discussed in Note 2 to the financial statements, the Company‘s recurring
−Removed: losses from operations and negative cash flows from operating activities raise substantial doubt about its ability to continue as a going
−Removed: Management’s plans regarding these matters are also described in Note 2.
−Removed: The financial statements do not include any adjustments
−Removed: that might result from the outcome of this uncertainty.
−Removed: Basis for Opinion
−Removed: These financial statements are the responsibility
−Removed: of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s financial statements based on our
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
−Removed: and are required to be independent with respect to the Company in accordance with the U.S.
−Removed: federal securities laws and the applicable
−Removed: rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with the standards
−Removed: of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements
−Removed: are free of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have, nor were we engaged to perform,
−Removed: an audit of its internal control over financial reporting.
−Removed: As part of our audits, we are required to obtain an understanding of internal
−Removed: control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
−Removed: control over financial reporting.
+Added: have audited the accompanying balance sheets of BioVie Inc.
+Added: (the “Company”) as of June 30, 2025 and 2024, and the related
+Added: statements of operations and comprehensive loss, changes in stockholders’ equity, and cash flows for each of the years then ended,
+Added: and the related notes (collectively referred to as the “financial statements”).
+Added: In our opinion, the financial statements
+Added: present fairly, in all material respects, the financial position of the Company as of June 30, 2025 and 2024, and the results of its
+Added: operations and its cash flows for of the years then ended, in conformity with accounting principles generally accepted in the United
+Added: States of America.
+Added: accompanying financial statements have been prepared assuming that the Company will continue as a going concern.
+Added: As discussed in Note
+Added: 2 to the financial statements, the Company‘s recurring losses from operations and negative cash flows from operating activities
+Added: raise substantial doubt about its ability to continue as a going concern.
+Added: Management’s plans regarding these matters are also described
+Added: The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
+Added: financial statements are the responsibility of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s
+Added: financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board
+Added: (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: conducted our audits in accordance with the standards of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain
+Added: reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
+Added: is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits,
+Added: we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
+Added: on the effectiveness of the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
−Removed: Our audits included performing procedures to assess
−Removed: the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
−Removed: to those risks.
−Removed: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
−Removed: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
−Removed: the overall presentation of the financial statements.
−Removed: We believe that our audits provide a reasonable basis for our opinion.
−Removed: Critical Audit Matter
−Removed: The critical audit matter communicated below is a
−Removed: matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit
−Removed: committee and that:
−Removed: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially
−Removed: challenging, subjective, or complex judgments.
−Removed: The communication of the critical audit matter does not alter in any way our opinion on
−Removed: the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion
−Removed: on the critical audit matter or on the accounts or disclosures to which it relates.
−Removed: Research and development expenses and related accruals
−Removed: As described in Note 3 to the accompanying financial
−Removed: statements, research and development expenses consist primarily of costs associated with the preclinical and/or clinical trials of drug
−Removed: candidates, compensation and other expenses for research and development, personnel, supplies and development materials, costs for consultants
−Removed: and related contract research and third-party facility costs.
−Removed: The amounts recorded for clinical trial expenses represent the Company’s
−Removed: estimates of clinical trial expenses based on facts and circumstances known to the Company at that time, and are dependent upon the timely
−Removed: and accurate reporting of contract research organizations and other third-party vendors.
−Removed: We identified the accounting for the research and
−Removed: development expenses and related accruals to be a critical audit matter due to the degree of management judgement in ensuring they are
−Removed: complete, accurate and classified correctly, their significance, and the risk of material misstatement due to the nature and timing of
−Removed: these costs and accruals.
−Removed: This in turn led to a high degree of auditor judgment, subjectivity, and effort in applying the procedures related
−Removed: to their accounting.
−Removed: Addressing the matter involved performing procedures
−Removed: and evaluating audit evidence in connection with forming our overall opinion on the financial statements.
−Removed: These procedures included, obtaining
−Removed: an understanding of management’s process and evaluating the design of controls over research and development expense classification
−Removed: and the completeness and accuracy of related accruals, independently researching vendors, testing a selection of research and development
−Removed: expense transactions to determine, based on the underlying supporting documents, the mathematical accuracy of the expense and the appropriateness
−Removed: of the expense classification.
−Removed: In addition, we made inquiries of management and reviewed subsequent payments, invoices and agreements
−Removed: relating to certain research and development expenses to ensure that accruals were properly recorded as of June 30, 2024.
+Added: audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
+Added: or fraud, and performing procedures that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding
+Added: the amounts and disclosures in the financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant
+Added: estimates made by management, as well as evaluating the overall presentation of the financial statements.
+Added: We believe that our audits
+Added: provide a reasonable basis for our opinion.
+Added: critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated
+Added: or required to be communicated to the audit committee and that:
+Added: (1) relates to accounts or disclosures that are material to the financial
+Added: statements and (2) involved our especially challenging, subjective, or complex judgments.
+Added: The communication of the critical audit matter
+Added: 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
+Added: matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: and development expenses and related accruals
+Added: described in Note 3 to the accompanying financial statements, research and development expenses consist primarily of costs associated
+Added: with the preclinical and/or clinical trials of drug candidates, compensation and other expenses for research and development, personnel,
+Added: supplies and development materials, costs for consultants and related contract research costs.
+Added: The amounts recorded for clinical trial
+Added: expenses represent the Company’s estimates of clinical trial expenses based on facts and circumstances known to the Company at
+Added: that time, and are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors.
+Added: identified the accounting for the research and development expenses and related accruals to be a critical audit matter due to the degree
+Added: of management judgement in ensuring they are complete, accurate and classified correctly, their significance, and the risk of material
+Added: misstatement due to the nature and timing of these costs and accruals.
+Added: This in turn led to a high degree of auditor judgment, subjectivity,
+Added: and effort in applying the procedures related to their accounting.
+Added: the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the financial
+Added: These procedures included, obtaining an understanding of management’s process and evaluating the design of controls
+Added: over research and development expense classification and the completeness and accuracy of related accruals, independently researching
+Added: vendors, testing a selection of research and development expense transactions to determine, based on the underlying supporting documents,
+Added: the mathematical accuracy of the expense and the appropriateness of the expense classification.
+Added: In addition, we made inquiries of management
+Added: and reviewed subsequent payments, invoices and agreements relating to certain research and development expenses to evaluate if the accruals
+Added: were properly recorded as of June 30, 2025.
/s/ EisnerAmper LLP
−Removed: We have served as the Company’s auditor since
+Added: We have served as the Company’s auditor
EISNERAMPER LLP
Iselin , New Jersey
−Removed: September 30, 2024
Balance Sheets
−Removed: and cash equivalents
−Removed: Treasury Bills (available-for-sale)
−Removed: and other current assets
CURRENT ASSETS:
−Removed: lease right-of-use assets, net
−Removed: AND STOCKHOLDERS' EQUITY
−Removed: payable and accrued expenses
−Removed: current liabilities
−Removed: portion of operating lease liabilities
−Removed: portion of note payable, net of financing cost, unearned premium and discount of $ 701,210 at June 30, 2024 and $ 894,926 at June 30,
−Removed: derivative liability
+Added: Cash and cash equivalents
+Added: Grant receivable
+Added: Prepaid and other current assets
+Added: Total current assets
+Added: Operating lease right-of-use asset, net
+Added: Intangible assets, net
+Added: LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
−Removed: lease liabilities, net of current portion
−Removed: Note payable,
−Removed: net of current portion, financing cost, unearned premium and discount of $ 0 and $ 227,268 at June 30, 2024 and June 30,
−Removed: 2023, respectively.
−Removed: Commitments and contingencies
−Removed: STOCKHOLDERS'
+Added: Accounts payable and accrued expenses
+Added: Current portion of operating lease liability
+Added: Current portion of notes payable, net of financing cost, unearned premium and discount of $ 701,210 at June 30, 2024
+Added: Warrant liability
+Added: Total current liabilities
+Added: Operating lease liability, net of current portion
+Added: TOTAL LIABILITIES
+Added: Commitments and contingencies (Note 10)
+Added: STOCKHOLDERS' EQUITY:
+Added: Preferred stock;
$ 0.001 par value;
1 unchanged sentence
0 shares issued and outstanding
−Removed: Common stock, $ 0.0001 par
−Removed: 800,000,000 shares authorized at June 30, 2024 and June 30, 2023, respectively;
−Removed: 6,216,398 shares issued of which 6,190,072
−Removed: shares are outstanding at June 30, 2024;
+Added: Common stock, $ 0.0001 par value;
+Added: 800,000,000 shares authorized at June 30, 2025 and June 30, 2024;
+Added: 1,917,061 shares issued of which 1,914,224 shares are outstanding at June 30, 2025;
and 621,641 shares issued of which 619,008 shares outstanding at June 30, 2024
−Removed: paid in capital
−Removed: other comprehensive income
+Added: Additional paid in capital
+Added: Accumulated deficit
( 352,144,246 )
( 334,232,661 )
−Removed: stockholders' equity
−Removed: LIABILITIES AND STOCKHOLDERS' EQUITY
−Removed: The accompanying notes are an integral part of the
−Removed: financial statements.
+Added: Treasury stock
+Added: Total stockholders' equity
+Added: TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
+Added: The accompanying notes are an integral part
+Added: of the financial statements.
Statements of Operations and Comprehensive Loss
9 unchanged sentences
( 32,179,585 )
−Removed: OTHER (INCOME) EXPENSE:
+Added: OTHER EXPENSE (INCOME):
Change in fair value of derivative liabilities
3 unchanged sentences
( 1,136,703 )
−Removed: TOTAL OTHER (INCOME) EXPENSE, NET
+Added: TOTAL OTHER INCOME , NET
$ ( 17,542,120 )
9 unchanged sentences
$ ( 33,006,956 )
−Removed: Other comprehensive (loss) income
−Removed: Unrealized gain on available-for-sale investments
+Added: Other comprehensive loss
Reclassification of unrealized gains on available-for-sale investments upon settlement
−Removed: Total other comprehensive (loss) income
+Added: Total other comprehensive loss
Comprehensive loss
1 unchanged sentence
$ ( 33,183,547 )
−Removed: The accompanying notes are an integral part of the
−Removed: financial statements.
−Removed: Statements of Changes in Stockholders’ Equity
+Added: The accompanying notes are an integral part
+Added: of the financial statements.
+Added: Statements of Changes in Stockholders’
For the Years Ended June 30, 2025 and 2024
5 unchanged sentences
( 301,225,705 )
−Removed: $ ( 250,969,890 )
−Removed: Stock option-based compensation
+Added: Stock - based compensation - stock options
Stock-based compensation - restricted stock units
−Removed: Stock-based compensation - issuance of common stock for services rendered
−Removed: Cashless exercise of options
−Removed: Cashless exercise of warrants
−Removed: Proceeds from exercise of options
−Removed: Proceeds from issuance of common stock, net costs of $2,008,898
Proceeds from issuance of common stock, net of costs of $2,908,141
−Removed: - Related Party
−Removed: Unrealized gain on available-for-sale investments
+Added: Issuance of common stock from vesting of restricted stock units
+Added: Stock-based compensation - issuance of common stock for services rendered
+Added: Deemed dividend for ratchet adjustment to warrants
+Added: Reclassification of unrealized gains on available-for-sale investments upon settlement
+Added: Issuance of additional shares for fractional shares effected by the reverse split
( 32,120,533 )
2 unchanged sentences
$ 349,732,674
+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: Relcassification of unrealized gains on available-for-sale investments
−Removed: upon settlement
−Removed: Issuance of additional shares for fractional shares effected by the reverse
+Added: Issuance of additional shares for fractional shares effected by the reverse split
( 17,542,120 )
3 unchanged sentences
$ ( 352,144,246 )
−Removed: The accompanying notes are an integral part of the
−Removed: financial statements.
+Added: The accompanying notes are an integral part
+Added: of the financial statements.
Statements of Cash Flows
6 unchanged sentences
Amortization of intangible assets
−Removed: Stock based compensation - restricted stock units
+Added: Stock based compensation - restricted stock units and restricted shares
Stock based compensation expense - stock options
−Removed: Stock based compensation expense - stock issued
+Added: Stock based compensation expense - issuance of common stock for services rendered
Amortization of financing costs
7 unchanged sentences
Changes in operating assets and liabilities:
−Removed: Prepaid and other assets
+Added: ( 2,104,050 )
+Added: Prepaid and other current assets
Accounts payable and accrued expenses
+Added: ( 1,386,592 )
Operating lease liabilities
Other current liabilities
−Removed: ( 1,304,925 )
Net cash used in operating activities
2 unchanged sentences
CASH FLOWS FROM INVESTING ACTIVITIES:
−Removed: Proceeds from (purchases of) U.S.
+Added: Proceeds from U.S.
Treasury Bills (available-for-sale)
−Removed: ( 14,301,135 )
−Removed: Net cash provided by (used in) investing activities
−Removed: ( 14,301,135 )
+Added: Net cash provided by investing activities
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from issuance of common stock
+Added: Proceeds from exercise of warrants
+Added: ( 10,000,000 )
+Added: Payment of loan premium
Payments of note payable
( 5,000,000 )
−Removed: Proceeds from exercise of stock options
−Removed: Net proceeds from issuance of common stock - Related Party
Net cash provided by financing activities
−Removed: Net increase in cash and cash equivalents
+Added: Net change in cash and cash equivalents
+Added: ( 6,299,251 )
Cash and cash equivalents, beginning of period
2 unchanged sentences
Cash paid for interest
−Removed: SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING ACTIVITIES:
+Added: SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING ACTIVITIES:
Right of use assets obtained in exchange for lease obligations
−Removed: Unrealized gain on U.S.
−Removed: Treasury Bills (available-for-sale)
Reclassification of unrealized gains on U.S.
Treasury Bills (available-for-sale investments) upon settlement
−Removed: Deemed dividend of ratchet adjustment to warrants
−Removed: The accompanying notes are an integral part of the
−Removed: financial statements.
+Added: Deemed dividend for ratchet adjustment to warrants
+Added: The accompanying notes are an integral part
+Added: of the financial statements.
Notes to Financial Statements
1 unchanged sentence
(the “Company” or “we”
−Removed: or “our”) is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including
−Removed: neurological and neuro-degenerative disorders and liver disease.
+Added: or “our”) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative
+Added: disorders and advanced liver disease.
+Added: Neurodegenerative Disease Programs
The Company acquired the biopharmaceutical assets
1 unchanged sentence
(“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021.
−Removed: acquired assets included NE3107.
−Removed: NE3107 is an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven
−Removed: insulin resistance and major pathological inflammatory cascades with a novel mechanism of action.
−Removed: There is emerging scientific consensus
−Removed: that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’s disease (“AD”)
−Removed: and Parkinson’s disease (“PD”), and NE3107 could, if approved by the U.S.
−Removed: Food and Drug Administration (“FDA”),
−Removed: represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering
−Removed: from AD and 1 million Americans suffering from PD.
−Removed: Neurodengenerative Disease Program
+Added: acquired assets included NE3107 (or “bezisterim”).
+Added: Bezisterim, the approved generic name for NE3107 is an investigational,
+Added: novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory
+Added: cascades with a novel mechanism of action.
+Added: There is emerging scientific consensus that both inflammation and insulin resistance may play
+Added: fundamental roles in the development of Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”),
+Added: and bezisterim could, if approved by the U.S.
+Added: Food and Drug Administration (“FDA”), represent an entirely new medical approach
+Added: to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD, 1 million Americans suffering from
+Added: PD and Long COVID affects approximately 20 million adults in the US, and millions more worldwide.
In neurodegenerative disease, the Company’s
−Removed: drug candidate NE3107 inhibits activation of inflammatory actions extracellular single-regulated kinase (“ERK”) and nuclear
−Removed: factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”)
−Removed: signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance.
−Removed: NE3107 does not interfere with
−Removed: their homeostatic functions (e.g., insulin signaling and neuron growth and survival).
−Removed: Both inflammation and insulin resistance are drivers
−Removed: of AD and PD.
−Removed: Alzheimer’s Disease (NCT05083260)
−Removed: On November 29, 2023, the Company announced the analysis
−Removed: of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate AD.
−Removed: The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog
−Removed: 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB).
−Removed: Patients were randomly assigned, 1:1 versus placebo, to receive
−Removed: sequentially 5 mg of NE3107 orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally
−Removed: Upon trial completion, as the Company began the
−Removed: process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices
−Removed: (“cGCPs”) violations at 15 study sites (virtually all of which were from one geographic area).
−Removed: This highly unusual level
−Removed: of suspected improprieties led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of
−Removed: Scientific Investigations (“OSI”) for potential further action.
−Removed: After the patient exclusions, 81 patients remained in
−Removed: the Modified Intent to Treat population, 57 of whom were in the Per-Protocol population which included those who completed the trial
−Removed: and were verified to take study drug from pharmacokinetic data.
−Removed: The trial was originally designed to be 80% powered
−Removed: with 125 patients in each of the treatment and placebo arms.
−Removed: The unplanned exclusion of so many patients has left the trial underpowered
−Removed: for the primary endpoints.
−Removed: In the Per-Protocol population, which included those patients who completed the trial and who were further
−Removed: verified to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest
−Removed: a slowing of cognitive loss;
−Removed: these same patients experienced an advantage in age deceleration vs.
−Removed: placebo as measured by DNA epigenetic
−Removed: Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this
−Removed: case as measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age.
−Removed: was a non-primary/secondary endpoint, other-outcome measure, done via blood test collected at week 30 (end of study).
−Removed: Additional DNA methylation
−Removed: data continues to be collected and analyzed.
−Removed: Parkinson’s Disease (NCT05083260)
−Removed: The Phase 2 study of bezisterim (NE3107) for the treatment
−Removed: of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study
−Removed: in PD participants treated with carbidopa/levodopa and bezisterim (NE3107).
+Added: drug candidate bezisterim is an orally bioavailable, Blood Brain Barrier (“BBB”)-permeable, insulin-sensitizer that is also
+Added: anti-inflammatory.
+Added: In addition, it is not immunosuppressive and has a low risk of drug-drug interaction.
+Added: Bezisterim inhibits activation
+Added: of inflammatory action extracellular single regulated kinase (“ERK”) and nuclear factor kappa-light-chain-enhancer of activated
+Added: B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”) signaling and other relevant
+Added: inflammatory pathways) that lead to neuroinflammation and insulin resistance.
+Added: By binding to ERK and selectively modulating NFκB
+Added: activation and TNF-α production and not interfere with their homeostatic functions, BioVie believes that bezisterim may offer clinical
+Added: improvements in several disease indications, including PD, AD and long COVID.
+Added: Parkinson’s Disease
+Added: The Company designed a new Phase 2b study of bezisterim
+Added: as a potential first line therapy to treat patients with new onset PD.
+Added: This trial will be evaluating the safety and efficacy of bezisterim
+Added: on motor and non-motor symptoms in patients with PD who haven’t been treated with carbidopa/levodopa.
+Added: The PD Phase 2b study, multicenter,
+Added: randomized, double-blind, placebo-controlled trial with a hybrid decentralized design will last 20 weeks from the initial screening phase
+Added: to the safety follow up.
+Added: In July 2024, the Company submitted the new protocol and received a response from the FDA permitting the Company
+Added: to proceed with the study.
+Added: The trial commenced in April 2025.
+Added: The Phase 2 study of bezisterim for the treatment
+Added: of PD (NCT05083260) that completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics
+Added: study in PD participants treated with carbidopa/levodopa and bezisterim.
Forty-five patients with a defined L-dopa “off state”
were randomized 1:1 to placebo:
−Removed: bezisterim (NE3107) 20 mg twice daily for 28 days.
+Added: bezisterim 20 mg twice daily for 28 days.
This trial was launched with two design objectives:
−Removed: 1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions
−Removed: of bezisterim (NE3107) with carbidopa/ levodopa;
−Removed: and 2) the secondary objective was to determine if preclinical indications of promotoric
−Removed: activity and apparent enhancement of levodopa activity could be seen in humans.
+Added: 1) the primary
+Added: objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions of bezisterim
+Added: with carbidopa/ levodopa;
+Added: and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent
+Added: enhancement of levodopa activity could be seen in humans.
Both objectives were met.
−Removed: Background Information (continued)
Long COVID Program
−Removed: In April 2024, the Company announced the grant of
−Removed: a clinical trial award of up to $13.1 million from the DOD, awarded through the Peer Reviewed
−Removed: Medical Research Program (“PRMRP”) of the Congressionally Directed Medical Research Programs (“CDMRP”).
−Removed: can provide up to 2 years of non-dilutive funding for a Phase 2b clinical trial that will assess bezisterim (NE3107) for the treatment
−Removed: of neurological symptoms that are associated with long COVID.
−Removed: The Company anticipates the trial to commence by early 2025.
−Removed: Liver Disease Program
+Added: Long COVID is a condition in which symptoms of
+Added: COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period, generally three months or more.
+Added: Common symptoms include lingering loss of smell and taste, extreme fatigue, and “brain fog,” though persistent cardiovascular
+Added: and respiratory problems, muscle weakness, and neurologic issues have also been documented.
+Added: In April 2024, the Company was awarded a clinical
+Added: trial grant of $13.1 million from the U.S.
+Added: Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research
+Added: Program of the Congressionally Directed Medical Research Programs.
+Added: In August 2024, U.S.
+Added: Army Medical Research and Development Command,
+Added: Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim for the treatment of
+Added: neurological symptoms that are associated with long COVID and the FDA authorized our Investigational New Drug (“IND”) application
+Added: for bezisterim allowing the Company to study a novel, anti-inflammatory approach or the treatment of the debilitating neurocognitive symptoms
+Added: associated with long COVID.
+Added: The Phase 2 ADDRESS-LC study is a randomized (1:1),
+Added: placebo-controlled, multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with long COVID
+Added: who have cognitive impairment sequelae and fatigue.
+Added: Individuals who have been diagnosed with long COVID and have neurocognitive dysfunction
+Added: and self-reported fatigue may meet qualification criteria.
+Added: The trial commenced in May 2025.
+Added: As of June 30,
+Added: 2025, the total cost incurred was approximately $5.3 million and as of August 4, 2025 approximately $5.3 million was reimbursed.
+Added: Alzheimer’s Disease
+Added: On November 29, 2023, the Company announced the
+Added: analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim in the treatment of mild
+Added: to moderate AD.
+Added: The study had co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive
+Added: Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB).
+Added: Patients were randomly assigned, 1:1 versus
+Added: placebo, to receive sequentially 5 mg of bezisterim orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed
+Added: by 26 weeks of 20 mg orally twice daily.
+Added: Upon trial completion, as the Company began the
+Added: process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”)
+Added: violations at 15 study sites (virtually all of which were from one geographic area).
+Added: This highly unusual level of suspected improprieties
+Added: led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”)
+Added: for potential further action.
+Added: After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom
+Added: were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic
+Added: The trial was originally designed to be 80% powered
+Added: with 125 patients in each of the treatment and placebo arms.
+Added: The unplanned exclusion of so many patients left the trial underpowered for
+Added: the primary endpoints.
+Added: In the Per-Protocol population, which included those patients who completed the trial and who were further verified
+Added: to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing
+Added: of cognitive loss;
+Added: these same patients experienced an advantage in age deceleration vs.
+Added: placebo as measured by DNA epigenetic change.
+Added: Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as
+Added: measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age.
+Added: This test was a non-primary/secondary
+Added: endpoint, other-outcome measure, done via blood test collected at week 30 (end of study).
+Added: Additional DNA methylation data continues to
+Added: be collected and analyzed.
+Added: Liver Cirrhosis Program
In liver disease, our investigational drug candidate
−Removed: BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is
−Removed: being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the
−Removed: treatment of ascites due to chronic liver cirrhosis.
−Removed: BIV201 is administered as a patent-pending liquid formulation.
−Removed: In June 2021, the Company initiated a Phase 2 study
−Removed: (NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment
−Removed: cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites.
−Removed: endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared
−Removed: to a pre-treatment period.
−Removed: In March 2023, the Company announced enrollment was
−Removed: paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid
−Removed: during the 28 days after treatment initiation compared to the 28 days prior to treatment.
−Removed: The change in ascites volume was significantly
−Removed: different from those patients receiving SOC treatment.
−Removed: Patients who completed the treatment with BIV201 experienced a 53% reduction in
−Removed: ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment
−Removed: In June 2023, the Company requested and subsequently
−Removed: received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites
−Removed: due to chronic liver cirrhosis.
−Removed: The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment
−Removed: of ascites due to chronic liver cirrhosis.
−Removed: The BIV201 development program was initiated by LAT
−Removed: On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program.
−Removed: The Company currently
−Removed: owns all development and marketing rights to this drug candidate.
+Added: BIV201 (continuous infusion terlipressin), which was granted both FDA Fast Track designation status and FDA Orphan Drug Status, is being
+Added: evaluated as a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis
+Added: caused by non-alcoholic steatohepatitis (NASH), hepatitis, and alcoholism.
+Added: The initial target for BIV201 therapy was refractory ascites.
+Added: These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have
+Added: an estimated 50% mortality rate within 6 to 12 months.
+Added: After receiving guidance from the FDA regarding
+Added: the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is now targeting
+Added: a broader ascites patient population.
+Added: The Company is currently finalizing the protocol design for the Phase 3 study of BIV201 with a focus
+Added: on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis
+Added: and ascites who have recently recovered from acute kidney injury (“AKI”).
+Added: This patient population is not limited to those
+Added: having refractory ascites.
+Added: Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of
+Added: fluid in the abdomen, often exceeding five liters, due to liver and kidney dysfunction.
+Added: BIV201 is administered in a continuous infusion
+Added: of terlipressin as a patent-pending liquid formulation with patents issued in the U.S., China, Japan, Chile and India to date.
+Added: Terlipressin,
+Added: the drug is used in over 40 countries to treat related complications of liver cirrhosis (Type 1 hepatorenal syndrome and bleeding esophageal
+Added: varices) that was approved in the U.S.
+Added: in 2022 (to improve kidney function in adults with hepatorenal syndrome with rapid reduction in
+Added: kidney function) but is not approved in Japan.
+Added: The BIV201 development program was initiated by
+Added: LAT Pharma LLC.
+Added: On April 11, 2016, BioVie acquired LAT Pharma LLC and the rights to its BIV201 development program and currently owns
+Added: all development and marketing rights to this drug candidate.
Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016,
−Removed: 2016, between our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty
−Removed: on net sales of BIV201 (continuous infusion terlipressin).
−Removed: to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett
+Added: between predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales
+Added: of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.
+Added: to the separation agreement to be entered into between the Company and BioVie, the Company will assume the royalty agreement and will
+Added: be obligated to pay 5.0% on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation,
+Added: and The Barrett Edge, Inc.
Liquidity and Going Concern
−Removed: The Company’s operations are subject to a number
−Removed: of factors that can affect its operating results and financial conditions.
+Added: The Company’s operations are subject to
+Added: a number of factors that can affect its operating results and financial conditions.
Such factors include, but are not limited to:
−Removed: the results of
−Removed: clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market
−Removed: its products;
+Added: results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval
+Added: to market its products;
competition from products manufactured and sold or being developed by other companies;
−Removed: the price of, and demand for, Company
−Removed: the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products;
+Added: the price of, and demand
+Added: for, Company products;
+Added: the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for
+Added: its products;
and the Company’s ability to raise capital.
−Removed: The Company’s financial statements have been prepared assuming the Company will
−Removed: continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of
−Removed: As of June 30, 2024, the Company had working capital of approximately $ 14.7 million, cash and cash equivalents of approximately
−Removed: $ 23.8 million, stockholders’ equity of approximately $ 15.5 million, and an accumulated deficit of approximately $ 334.2 million.
+Added: The Company’s financial statements have been prepared assuming the
+Added: Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal
+Added: course of business.
+Added: As of June 30, 2025, the Company had working capital of approximately $ 18.4 million, cash and cash equivalents of
+Added: approximately $ 17.5 million, stockholders’ equity of approximately $ 19.0 million, and an accumulated deficit of approximately $ 352.1
The Company is in the pre-revenue stage and no revenues are expected in the foreseeable future.
4 unchanged sentences
our research protocols and slow the progress in the Company’s development and launch of next phase clinical programs.
−Removed: The future viability of the Company is largely dependent
−Removed: upon its ability to raise additional capital to finance its operations.
−Removed: Management expects that future sources of funding may include
−Removed: sales of equity, obtaining loans, or other strategic transactions.
−Removed: Liquidity and Going Concern (continued)
+Added: The future viability of the Company is largely
+Added: dependent upon its ability to raise additional capital to finance its operations.
+Added: Management expects that future sources of funding may
+Added: include sales of equity, obtaining loans, or other strategic transactions.
Although management continues to pursue the Company’s
6 unchanged sentences
Basis of Presentation
−Removed: The Company’s financial statements have been
−Removed: prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and include all adjustments
+Added: The Company’s financial statements have
+Added: been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and include all adjustments
necessary for the fair presentation of the Company’s financial position for the periods presented.
+Added: Reverse stock split up
+Added: The Company effected a 1:10 reverse split of the issued and outstanding
+Added: shares of its Common Stock which was approved by the board of directors after the approval obtained from shareholders at a special meeting
+Added: on June 23, 2025 which became effective on July 7, 2025.
+Added: All historical share and earnings per share amounts have been retroactively adjusted
+Added: to reflect the split.
Use of Estimates
5 unchanged sentences
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, accounting for derivatives, assumptions
−Removed: used in recording leases, the inputs used in the valuation of goodwill and intangible assets in connection with impairment testing and
−Removed: accounting for income taxes.
+Added: are used for, but not limited to, accounting for clinical accruals, share-based compensation, assumptions used in recording leases, the
+Added: inputs used in the valuation of goodwill and intangible assets in connection with impairment testing and accounting for income taxes.
Actual results could differ from those estimates.
11 unchanged sentences
comprehensive income in the accompanying statements of operations and comprehensive loss.
−Removed: Concentration of Credit Risk in the Financial Service
+Added: Concentration of Credit Risk in the Financial
+Added: Service Industry
As of June 30, 2025, the Company had cash deposited
−Removed: in certain financial institutions in excess of federally insured levels.
+Added: in a certain financial institution in excess of federally insured levels.
The Company regularly monitors the financial stability of these
financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents.
−Removed: However, in March
−Removed: and April 2023, certain U.S.
−Removed: government banking regulators took steps to intervene in the operations of certain financial institutions
−Removed: due to liquidity concerns, which caused general heightened uncertainties in financial markets.
−Removed: While these events have not had a material
−Removed: direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and
−Removed: financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing
−Removed: arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.
−Removed: Significant Accounting Policies (continued)
+Added: However, if liquidity
+Added: and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the
+Added: Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse
+Added: effect on its business, financial condition and results of operations.
Fair value measurement of assets and liabilities
−Removed: We determine the fair values of our financial instruments
−Removed: based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable
−Removed: inputs when measuring fair value.
−Removed: Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability
−Removed: in an orderly transaction between market participants at the measurement date.
−Removed: The fair value assumes that the transaction to sell the
−Removed: asset or transfer the liability occurs in the principal or most advantageous market for the asset or liability and establishes that the
−Removed: fair value of an asset or liability shall be determined based on the assumptions that market participants would use in pricing the asset
−Removed: or liability.
−Removed: The classification of a financial asset or liability within the hierarchy is based upon the lowest level input that is significant
−Removed: to the fair value measurement.
−Removed: The fair value hierarchy prioritizes the inputs into three levels that may be used to measure fair value:
−Removed: Level 1 - Inputs are unadjusted quoted prices in active
−Removed: markets for identical assets or liabilities.
−Removed: Level 2 - Inputs are quoted prices for similar assets
−Removed: and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market
−Removed: corroboration, for substantially the full term of the financial instrument.
−Removed: Level 3 - Inputs are unobservable inputs based on
−Removed: our assumptions.
+Added: We determine the fair values of our financial
+Added: instruments based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use
+Added: of unobservable inputs when measuring fair value.
+Added: Fair value is defined as the price that would be received to sell an asset or paid to
+Added: transfer a liability in an orderly transaction between market participants at the measurement date.
+Added: The fair value assumes that the transaction
+Added: to sell the asset or transfer the liability occurs in the principal or most advantageous market for the asset or liability and establishes
+Added: that the fair value of an asset or liability shall be determined based on the assumptions that market participants would use in pricing
+Added: the asset or liability.
+Added: The classification of a financial asset or liability within the hierarchy is based upon the lowest level input
+Added: that is significant to the fair value measurement.
+Added: The fair value hierarchy prioritizes the inputs into three levels that may be used
+Added: to measure fair value:
+Added: Level 1 - Inputs are unadjusted quoted prices
+Added: in active markets for identical assets or liabilities.
+Added: Level 2 - Inputs are quoted prices for similar
+Added: assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through
+Added: market corroboration, for substantially the full term of the financial instrument.
+Added: Level 3 - Inputs are unobservable inputs based
+Added: on our assumptions.
The Company’s financial instruments include
5 unchanged sentences
Prepaid and other assets
−Removed: Prepaid and other assets consist of prepayments of
−Removed: certain expenses and a security deposit paid in connection with a lease agreement.
−Removed: The Company determines whether an arrangement contains
−Removed: a lease at inception.
−Removed: Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion of operating
−Removed: lease liabilities, and operating lease liabilities, net of current portion on our balance sheets.
−Removed: ROU assets represent the Company’s
−Removed: right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from
−Removed: ROU assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease
−Removed: term at the commencement date.
−Removed: As the Company’s leases do not provide an implicit rate, an incremental borrowing rate is used based
−Removed: on the information available at the commencement date in determining the present value of lease payments.
−Removed: The Company does not include
−Removed: options to extend or terminate the lease term in its calculation unless it is reasonably certain that the Company will exercise any such
+Added: Prepaid and other assets consist of prepayments
+Added: of certain expenses such as cost related to capital raise activities;
+Added: and a security deposit paid in connection with a lease agreement.
+Added: The Company determines whether an arrangement
+Added: contains a lease at inception.
+Added: Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion
+Added: of operating lease liabilities, and operating lease liabilities, net of current portion on our balance sheets.
+Added: ROU assets represent the
+Added: Company’s right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments
+Added: arising from the lease.
+Added: ROU assets and lease liabilities are recognized based on the present value of the future minimum lease payments
+Added: over the lease term at the commencement date.
+Added: As the Company’s leases do not provide an implicit rate, an incremental borrowing
+Added: rate is used based on the information available at the commencement date in determining the present value of lease payments.
+Added: does not include options to extend or terminate the lease term in its calculation unless it is reasonably certain that the Company will
+Added: exercise any such options.
Rent expense is recognized under the operating leases on a straight-line basis.
−Removed: The Company does not recognize right-of-use assets
−Removed: or lease liabilities for short-term leases, which have a lease term of 12 months or less at inception, and instead will recognize lease
−Removed: payments as expense on a straight-line basis over the lease term.
+Added: The Company does not recognize
+Added: right-of-use assets or lease liabilities for short-term leases, which have a lease term of 12 months or less at inception, and instead
+Added: will recognize lease payments as expense on a straight-line basis over the lease term.
Research and Development
1 unchanged sentence
of costs associated with the preclinical and/or clinical trials of drug candidates, compensation and other expenses for research and development,
−Removed: personnel, supplies and development materials, costs for consultants and related contract research and facility costs.
−Removed: The Company uses the asset and liability method of
−Removed: accounting for deferred income taxes.
−Removed: Deferred income taxes are measured by applying enacted statutory rates to net operating loss carryforwards
−Removed: and to the differences between the financial reporting and tax bases of assets and liabilities.
−Removed: Deferred tax assets are reduced, by a
−Removed: valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized.
−Removed: decided to apply a full valuation allowance against its deferred tax assets due to the continuing losses.
−Removed: Significant Accounting Policies (continued)
+Added: personnel, supplies and development materials, costs for consultants and related contracted research costs.
+Added: The Company uses the asset and liability method of accounting for deferred
+Added: income taxes.
+Added: Deferred income taxes are measured by applying enacted statutory rates to net operating loss carryforwards and to the differences
+Added: between the financial reporting and tax bases of assets and liabilities.
+Added: Deferred tax assets are reduced, by a valuation allowance if
+Added: it is more likely than not that some portion or all of the deferred tax assets will not be realized.
+Added: The Company decided to apply a full
+Added: valuation allowance against its deferred tax assets due to the continuing losses.
The Company recognizes uncertainty in income taxes
7 unchanged sentences
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, 2024 and 2023, there was no such interest or penalty.
+Added: For the years ended June 30, 2025 and 2024, there was no such interest or penalties.
Net Loss per Common Share
−Removed: Basic net loss per common share is computed by dividing
−Removed: the net loss attributable to Common Stockholders by the weighted average number of shares of Common Stock outstanding during the period.
−Removed: Diluted net loss per common share is computed by dividing the net loss attributable to Common Stockholders by the weighted average number
−Removed: of shares of Common Stock outstanding and potentially outstanding shares of Common Stock during the period to reflect the potential dilution
−Removed: that could occur from common shares issuable through stock options, warrants, and convertible debentures.
−Removed: For the years ended June 30,
−Removed: 2024 and 2023, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to the net loss for
−Removed: the periods presented.
−Removed: The table below shows the potential shares of common stock, presented based on amounts outstanding
−Removed: at each year end, that were excluded from the computation of diluted net loss per share attributable to common stockholders because including
−Removed: them would have had an anti-dilutive effect:
+Added: Basic net loss per common share is computed by
+Added: dividing the net loss attributable to Common Stockholders by the weighted average number of shares of Common Stock outstanding during
+Added: Diluted net loss per common share is computed by dividing the net loss attributable to Common Stockholders by the weighted
+Added: average number of shares of Common Stock outstanding and potentially outstanding shares of Common Stock during the period to reflect the
+Added: potential dilution that could occur from common shares issuable through stock options, warrants, and convertible debentures.
+Added: For the years
+Added: ended June 30, 2025 and 2024, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to
+Added: the net loss for the periods presented.
+Added: The table below shows the potential shares of
+Added: common stock, presented based on amounts outstanding at each year end, that were excluded from the computation of diluted net loss per
+Added: share attributable to common stockholders because including them would have had an anti-dilutive effect:
Schedule of dilutive securities were excluded from the computation of diluted loss per share
13 unchanged sentences
awards, the fair value of each stock option award is estimated on the date of grant using the Black-Scholes valuation model that uses
−Removed: assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate.
−Removed: For non-employees, the Company
−Removed: utilizes the graded vesting attribution method under which the entity treats each separately vesting portion (tranche) as a separate award
−Removed: and recognizes compensation cost for each tranche over its separate vesting schedule.
−Removed: Expected volatilities are based on historical volatility
−Removed: of peer companies and other factors estimated over the expected term of the stock options.
−Removed: For employee and non-employee awards, the expected
−Removed: term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of
−Removed: the vesting term plus the contract term.
+Added: assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate, and is generally recognized as
+Added: an expense over the requisite service period, net of forfeitures which are recorded as they occur.
+Added: Expected volatilities are based on
+Added: historical volatility of peer companies and other factors estimated over the expected term of the stock options.
+Added: For employee and non-employee
+Added: awards, the expected term of options granted is derived using the “simplified method” which computes expected term as the
+Added: average of the sum of the vesting term plus the contract term.
The risk-free rate is based on the U.S.
−Removed: Treasury yield curve in effect at the time of grant for
−Removed: the period of the expected term.
+Added: Treasury yield curve in effect
+Added: at the time of grant for the period of the expected term.
The Company recognizes forfeitures as they occur.
15 unchanged sentences
The Company did not recognize any goodwill impairments for the years ended June 30, 2025 and 2024.
−Removed: Significant Accounting Policies (continued)
Impairment of Long-Lived Assets
−Removed: Long-lived assets, including intangible assets, are
−Removed: reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
+Added: Long-lived assets, including intangible assets,
+Added: are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted
future cash flows expected to be generated by the asset.
−Removed: If the carrying amount of an asset exceeds its undiscounted
−Removed: estimated future cash flows, an impairment review is performed.
−Removed: An impairment charge is recognized in the amount by which the carrying
−Removed: amount of the asset exceeds the fair value of the asset.
−Removed: Generally, fair value is determined using valuation techniques such as expected
−Removed: discounted cash flows or appraisals, as appropriate.
−Removed: Assets to be disposed of would be separately presented in the balance sheet and reported
−Removed: at the lower of the carrying amount or fair value less costs to sell, and are no longer depreciated or amortized.
−Removed: The assets and liabilities
−Removed: of a disposed group classified as held for sale would be presented separately in the appropriate asset and liability sections of the balance
+Added: If the carrying amount of an asset exceeds its
+Added: undiscounted estimated future cash flows, an impairment review is performed.
+Added: An impairment charge is recognized in the amount by which
+Added: the carrying amount of the asset exceeds the fair value of the asset.
+Added: Generally, fair value is determined using valuation techniques such
+Added: as expected discounted cash flows or appraisals, as appropriate.
+Added: Assets to be disposed of would be separately presented in the balance
+Added: sheet and reported at the lower of the carrying amount or fair value less costs to sell, and are no longer depreciated or amortized.
+Added: assets and liabilities of a disposed group classified as held for sale would be presented separately in the appropriate asset and liability
+Added: sections of the balance sheets.
The Company did not recognize any long-lived asset impairments for the years ended June 30, 2025 and 2024.
−Removed: Reverse stock split up
−Removed: The company effected a 1:10 reverse split of the issued and outstanding
−Removed: shares of its Class A commons stock which was approved by the board of director after the approval obtained from shareholders at a special
−Removed: meeting on July 29, 2024 which became effective on Nasdaq on August 6, 2024, 5 trading days after the shareholders’ approval was
−Removed: All historical share and earnings per share amounts have been retroactively adjusted to reflect the split.
+Added: Grant program
+Added: The Company records expenses related to the DOD Long Covid Program
+Added: as such expenses are incurred.
+Added: The reimbursement of such expenses is recognized upon receipt of the reimbursement, or when it is probable
+Added: the reimbursement will be received, as a credit against the respective expense account.
+Added: Segment Reporting
+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 Chief Executive Officer (“CEO”), as the chief operating decision maker, manages and allocates resources
+Added: to the operations of the Company based on the line items included within these financial statements.
+Added: This enables the CEO to assess the
+Added: overall level of available resources and determine how best to deploy these resources across functions, clinical trials, and development
+Added: projects in line with the long-term company-wide strategic goals.
Recent Accounting Pronouncements
1 unchanged sentence
of all Accounting Standards Updates (“ASU’s”).
−Removed: There were no recent ASU’s that are expected to have a material
−Removed: impact on our balance sheets or statements of operations and comprehensive loss.
−Removed: In June 2016, the Financial Accounting Standards Board
−Removed: (“FASB”) issued ASU No.
−Removed: 2016-13, “Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on
−Removed: Financial Instruments” (“ASU 2016-13”).
−Removed: This amendment replaces the incurred loss impairment methodology in current
−Removed: GAAP with a methodology that reflects expected credit losses on instruments within its scope, including trade receivables.
−Removed: is intended to provide financial statement users with more decision-useful information about the expected credit losses.
−Removed: The Company adopted
−Removed: ASU 2016-13 effective July 1, 2023 and the adoption had an insignificant impact on the accompanying financial statements.
−Removed: In November 2023, the FASB issued Accounting Standards Update (ASU) 2023-07, "Segment Reporting (Topic 280):
−Removed: Improvements to Reportable
−Removed: Segment Disclosures," to enhance disclosures for significant segment expenses for all public entities required to report segment information
−Removed: in accordance with ASC 280.
−Removed: The standard did not change the definition of a segment, the method for determining segments or the criteria
−Removed: for aggregating operating segments into reportable segments.
−Removed: The amendments are effective for fiscal years beginning after December 15,
−Removed: 2023, and interim periods within fiscal years beginning after December 15, 2024.
−Removed: Retrospective adoption is required for all prior periods
−Removed: presented in the financial statements.
−Removed: The adoption is not expected to have a material impact to our financial statements or disclosures.
−Removed: In December 2023, the FASB issued ASU 2023-09, "Income
−Removed: Taxes (Topic 740):
−Removed: Improvements in Income Tax Disclosures" to enhance the transparency and decision usefulness of income tax disclosures.
−Removed: This amendment requires public companies to disclose specific categories in the rate reconciliation and provide additional information
−Removed: for reconciling items that meet a quantitative threshold.
−Removed: Additionally, under the amendment entities are required to disclose the amount
−Removed: of income taxes paid disaggregated by federal, state and foreign taxes, as well as disaggregated by material individual jurisdictions.
+Added: In December 2023, the FASB issued ASU 2023-09,
+Added: "Income Taxes (Topic 740):
+Added: Improvements in Income Tax Disclosures" to enhance the transparency and decision usefulness of income
+Added: tax disclosures.
+Added: This amendment requires public companies to disclose specific categories in the rate reconciliation and provide additional
+Added: information for reconciling items that meet a quantitative threshold.
+Added: Additionally, under the amendment entities are required to disclose
+Added: the amount of income taxes paid disaggregated by federal, state and foreign taxes, as well as disaggregated by material individual jurisdictions.
Finally, the amendment requires entities to disclose income from continuing operations before income tax expense disaggregated between
2 unchanged sentences
effective for annual periods beginning after December 15, 2024.
−Removed: We will adopt this standard on a prospective basis as allowed by the standard.
−Removed: The adoption of this standard is not expected to have a material impact on our financial statements.
−Removed: Investments in U.S.
−Removed: Treasury Bills available-for-sale
−Removed: The following is a summary of the U.S.
−Removed: Treasury Bills
−Removed: held at June 30, 2023:
−Removed: Schedule of U.S.
−Removed: treasury bills held
−Removed: Unrealized Gain
−Removed: Unrealized loss
−Removed: Accumulated Other Comprehensive Income
−Removed: Bills due in 3 - 6 months
−Removed: During the fiscal year ended June 30, 2023, the Company
−Removed: purchased a total of approximately $ 46 million of U.S.
−Removed: Treasury Bills.
−Removed: All outstanding investments in U.S.
−Removed: Treasury Bills available-for-sale
−Removed: held at June 30, 2023 matured during the three months ended September 30, 2023 and were settled, resulting in a realized gain of $ 223,865
−Removed: recorded as a component of interest income on the accompanying statement of operations and comprehensive loss.
+Added: The standard will be adopted on a prospective basis and is not expected
+Added: to have a material impact to our financial statements or disclosures.
+Added: Segment Reporting Topic 280 - Improvements
+Added: to Reportable Segment Disclosures.
+Added: This update requires expanded annual and interim disclosures for significant segment expenses that
+Added: are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss.
+Added: update is effective for fiscal years beginning after December 15, 2023.
+Added: The Company adopted ASU 2023-07 in the current fiscal year.
Intangible Assets
12 unchanged sentences
Intellectual Property, net
−Removed: Amortization expense amounted to $ 229,377 for each
−Removed: of the years ended June 30, 2024 and 2023, respectively.
−Removed: The Company amortizes intellectual property over the expected original useful
−Removed: lives of 10 years.
−Removed: Estimated future amortization expense is as follows:
−Removed: Schedule of future amortization expense
−Removed: Year ending June 30,
−Removed: Finite lived intangible assets, net
+Added: Amortization expense amounted to $ 229,377 for
+Added: each of the years ended June 30, 2025 and 2024, respectively.
+Added: The Company amortized intellectual property over the expected original useful
+Added: lives of 10 years and the remaining amortization expense for the year ending June 30, 2026 is $ 178,341 .
Related Party Transactions
2 unchanged sentences
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 363,636 shares of the Company’s Common
−Removed: Stock, at a price of $16.50 per share (the “PIPE Shares”), and (ii) a warrant to purchase 727,273 shares of Common Stock (“PIPE
−Removed: Warrant Shares”), at an exercise price of $18.20, with a term of exercise of five years.
−Removed: The down round feature reduced the exercise
−Removed: price of the PIPE Warrant Shares to $10.00 per share on March 6, 2024 in connection with the offering further described in Note 9 as the
−Removed: Company sold stock at a price lower than its initial exercise price.
−Removed: The Company calculated the difference in fair value of the PIPE Warrant
−Removed: Shares between the stated exercise price and the reduced exercise price and recorded $ 886,423 as a deemed dividend.
−Removed: The fair value of
−Removed: the PIPE Warrant Shares were estimated using the Black Scholes Method with the following inputs, the stock price of $ 10.65 , exercise price
−Removed: of $ 18.20 and $ 10.00 , remaining term of 3.5 years, risk free rate of 4.4 % and volatility of 95.0 % .
−Removed: On August 15, 2022, the Company received net proceeds of approximately
−Removed: $5.9 million, net of costs of approximately $94,000, and entered into an amended and restated registration agreement with Acuitas, which
−Removed: amended and restated that certain registration rights agreement, dated as of June 10, 2021, by and between the Company and Acuitas (the
−Removed: “Existing Registration Rights Agreement”), to amend the definition of “Registrable Securities” in the Existing
−Removed: Registration Rights Agreement to include the PIPE Shares and the PIPE Warrant Shares as Registrable Securities thereunder.
+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 results of the Company’s capital raises
+Added: further described in Note 8, the warrants’ down round features (the “rachet adjustment”) resulted in deemed dividends
+Added: of $ 369,465 and $ 886,423 recognized in the accompanying statement of changes in stockholders’ equity for the years ended June 30,
+Added: 2025 and 2024, respectively.
+Added: For the year ended June 30, 2024, the deemed dividend
+Added: of $886,423 recognized from the rachet adjustment resulting from the March 6, 2024 capital raise, reduced the exercise price to $100 per
+Added: The fair value of the PIPE Warrant Shares was estimated using the Black Scholes Method with the following inputs, the stock price
+Added: 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
+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: Consulting expenses
+Added: During the year ended June 30, 2025, the Company
+Added: paid a Director of the Company $50,000 for consulting services which are reflected as a component of selling, general and administrative
+Added: expenses on the accompanying statement of operations and comprehensive loss.
Notes Payable
−Removed: On November 30, 2021 (the “Closing
−Removed: Date”), the Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and
−Removed: Promissory Notes (together, the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P.
−Removed: (“AVOPI”) and
−Removed: Avenue Venture Opportunities Fund II, L.P.
−Removed: (“AVOPII,” and together with AVOPI, “Avenue”) for growth capital
−Removed: loans in an aggregate commitment amount of up to $20 million (the “Loan”).
−Removed: On the Closing Date, $15 million of the Loan
−Removed: was funded (“Tranche 1”).
−Removed: The Loan provided for an additional $5 million to be available to the Company on or prior to
−Removed: September 15, 2022, subject to the Company’s achievement of certain milestones with respect to certain of its ongoing clinical
−Removed: trials, which were not achieved.
−Removed: The Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.00 %
−Removed: plus the prime rate as reported in The Wall Street Journal and (b) 10.75%.
−Removed: The prime rate at June 30, 2024 was 8.50 % .
−Removed: The Loan is secured by a lien upon and security interest in all of the Company’s assets, including intellectual property,
−Removed: subject to agreed exceptions.
−Removed: The maturity date of the Loan is December 1, 2024.
−Removed: The Loan Agreement required monthly interest-only
−Removed: payments during the first eighteen months of the term of the Loan.
−Removed: Following the interest-only period, on July 1, 2023, the Company pays
−Removed: equal monthly payments of principal, plus accrued interest, until the Loan’s maturity date when all remaining principal and accrued
−Removed: interest is due.
−Removed: If the Company prepays the Loan, it will be required to pay (a) a prepayment fee in an amount equal to 3.0% of the principal
−Removed: amount of the Loan that is prepaid during the interest-only period;
−Removed: and (b) a prepayment fee in an amount equal to 1.0% of the principal
−Removed: amount of the Loan that is prepaid after the interest-only period.
−Removed: At the Loan’s maturity date, or on the date of the prepayment
−Removed: of the Loan, the Company will be obligated to pay a final payment equal to 4.25% of the Loan commitment amount, the sum of Tranche 1 and
−Removed: Tranche 2, which amounts to $850,000 (the “Loan Premium”).
−Removed: The Loan Agreement includes a conversion option to
−Removed: 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
+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.
+Added: The Loan Agreement included a conversion option
+Added: 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
Common Stock at a conversion price of $698.00 per share (the “Conversion Option”).
−Removed: On the Closing Date, the Company issued to Avenue
−Removed: warrants to purchase 36,101 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share equal
+Added: On the Closing Date, the Company also issued to
+Added: Avenue warrants to purchase 3,611 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share
+Added: equal to $582.00.
The Avenue Warrants are exercisable until November 30, 2026.
−Removed: The amount of the carrying value of the notes payable
−Removed: was determined by allocating portions of the outstanding principal of the notes, approximately $ 1.4 million, to the fair value of the
−Removed: Avenue Warrants, and approximately $ 2.2 million to the fair value of the embedded Conversion Option.
−Removed: Accordingly, the total amount of
−Removed: unearned discount of approximately $ 3.6 million, the total direct financing cost of approximately $ 390,000 and the Loan Premium of $ 850,000
−Removed: are being amortized using the effective interest method over the term of the Loan.
−Removed: The adjusted effective interest rate is 27%.
−Removed: Total interest expense for the year ended June 30,
−Removed: 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 .
+Added: The amount of the carrying value of the notes
+Added: payable was determined by allocating portions of the outstanding principal of the notes, resulting in approximately $ 1.4 million allocated
+Added: to the fair value of the Avenue Warrants, and approximately $ 2.2 million allocated to the fair value of the embedded Conversion Option.
+Added: Accordingly, the total amount of unearned discount of approximately $3.6 million, the total direct financing cost of approximately $ 390,000
+Added: and the Loan Premium of $ 850,000 were amortized using the effective interest method over the term of the Loan.
+Added: Total interest expense associated with the Loan was approximately $ 312,000 ,
+Added: which is reflected as a component of interest expense on the accompanying statements of operations and comprehensive loss for the year
+Added: ended June 30, 2025.
+Added: Interest expense associated with this loan was comprised of interest incurred on the outstanding principal of the
+Added: loan of approximately $ 163,000 , amortization of financing costs of approximately $ 12,000 , amortization of the unearned discount of approximately
+Added: $ 111,000 , and the accretion of the Loan Premium of approximately $ 26,000 .
Total interest expense for the year ended June
3 unchanged sentences
$ 109,000 , amortization of the unearned discount of $ 1.0 million, and the accretion of the Loan Premium of approximately $ 237,000 .
−Removed: As of June 30, 2024, the remaining principal balance
−Removed: of $ 5.0 million under the Loan is payable in 6 monthly equal installments.
−Removed: For the year ended June 30, 2024, the Company paid back $ 10
−Removed: million, of the original loan of $15 million.
−Removed: Notes Payable (continued)
−Removed: The following is a summary of the Notes Payable as of June 30, 2024 and
−Removed: Current portion of Notes Payable
+Added: The following is a summary of the Notes Payable as of June 30, 2025
Schedule of note payable
4 unchanged sentences
unearned discount
−Removed: ( 1,023,145 )
accretion of Loan Premium
Current portion of Notes Payable, net of financing costs, unearned premium and discount
−Removed: Non-current portion of Notes Payable
−Removed: June 30, 2024
−Removed: June 30, 2023
−Removed: Notes Payable
−Removed: debt financing costs
−Removed: unearned discount
−Removed: accretion of Loan Premium
−Removed: Notes Payable, net of the current portion financing costs, unearned premium and discount
−Removed: Estimated future amortization expense and accretion of Loan Premium is
−Removed: Schedule of estimated future amortization expense and accretion of premium
−Removed: Unearned Discount
−Removed: Debt Financing Costs
−Removed: Year ending June 30,
Fair Value Measurements
−Removed: At June 30, 2024 and 2023, the estimated fair value of derivative liabilities
−Removed: measured on a recurring basis are as follows:
−Removed: Schedule of derivative liabilities at fair value
−Removed: Fair Value Measurements at
−Removed: June 30, 2024
−Removed: Derivative liability - Warrants
−Removed: Derivative liability - Conversion Option
−Removed: Total derivative liabilities
−Removed: Fair Value Measurements at
−Removed: June 30, 2023
−Removed: Derivative liability - Warrants
−Removed: Derivative liability - Conversion option
−Removed: Total derivative liabilities
+Added: At June 30, 2025, there was no value ascribed to the derivative liabilities
+Added: 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
+Added: totaled $3,771.
The following table presents the activity for level 3 liabilities measured
at fair value using unobservable inputs for the years ended June 30, 2025 and 2024:
−Removed: Fair value, liabilities measured on recurring basis
−Removed: Derivative liability - Warrants
+Added: Schedule of derivative liabilities at fair value
+Added: Derivative liability - Avenue Warrants
Derivative liability - Conversion Option
1 unchanged sentence
Additions to level 3 liabilities
−Removed: Change in in fair value of level 3 liabilities
+Added: Change in fair value of level 3 liabilities
Transfer in and/or out of level 3
1 unchanged sentence
Additions to level 3 liabilities
−Removed: Change in in fair value of level 3 liabilities
+Added: Change in fair value of level 3 liabilities
Transfer in and/or out of Level 3
Balance at June 30, 2025
−Removed: The fair values of derivative liabilities for the
−Removed: Avenue Warrants and Conversion Option at June 30, 2024 in the accompanying balance sheet, were approximately $3,800 and approximately
−Removed: zero, respectively.
−Removed: The total change in the fair value of the derivative liabilities totaled approximately $(1.8) million and $1.4 million
−Removed: for the years ended June 30, 2024, and 2023, respectively;
−Removed: and accordingly, was recorded in the accompanying statements of operations
−Removed: and comprehensive loss.
−Removed: The assumptions used in the Black Scholes model to value the derivative liabilities at June 30, 2024 included
−Removed: the closing stock price of $ 4.00 per share;
−Removed: for the Avenue Warrants, the exercise price of $ 58.20 , remaining term 2.4 year, risk free
−Removed: rate of 4.6 % and volatility of 82.0 % ;
−Removed: and for the Conversion Option, the conversion price of $ 69.80 ;
−Removed: remaining term of 5 months, risk
−Removed: free rate of 5.38 % and volatility of 91.0 % .
−Removed: Derivative liability – Avenue Warrants
−Removed: The Avenue Warrants were not considered to be indexed
−Removed: to the Company’s own stock, and accordingly, were recorded as a derivative liability at fair value in the accompanying balance sheets
−Removed: at June 30, 2024 and 2023.
−Removed: The Black Scholes model was used to calculate the
−Removed: fair value of the warrant derivative to bifurcate the warrant derivative amount from the Avenue Loan amount funded.
−Removed: The Avenue Warrants
−Removed: are recorded at their fair values at the date of issuance and remeasured at each subsequent reporting period end date.
−Removed: Fair Value Measurements (continued)
−Removed: Embedded derivative liability – Conversion
−Removed: The Conversion Option is accounted for as an embedded
−Removed: derivative liability and required bifurcation from the Loan amount.
−Removed: The Black Scholes model was used to calculate the fair value of the
−Removed: Conversion Option to bifurcate it from the Loan.
+Added: The fair values of derivative liabilities for
+Added: the Avenue Warrants and Conversion Option at June 30, 2024 in the accompanying balance sheet, were approximately $3,800 and zero, respectively.
+Added: The total change in the fair value of the derivative liabilities totaled approximately $ 3,800 and $ 1.8 million for the years ended June
+Added: 30, 2025, and 2024, respectively;
+Added: and accordingly, was recorded in the accompanying statements of operations and comprehensive loss.
+Added: The assumptions used in the Black Scholes model
+Added: to value the Avenue Warrants at June 30, 2025 included the closing stock price of $ 9.25 per share;
+Added: the exercise price of $ 582.00 , remaining
+Added: term 1.4 years, risk free rate of 3.9 % and volatility of 81.0 % .
+Added: The Conversion Option was nil as of June 30, 2025
+Added: and June 30, 2024 as the corresponding debt matured and was repaid in December 2024.
+Added: The assumptions used in the Black Scholes model
+Added: to value the derivative liabilities at June 30, 2024 included the closing stock price of $ 40.00 per share;
+Added: for the Avenue Warrants, the
+Added: exercise price of $ 582.00 , remaining term 2.4 years, risk free rate of 4.6 % and volatility of 82.0 % ;
+Added: and for the Conversion Option, the
+Added: conversion price of $ 698.00 ;
+Added: remaining term of 5 months, risk free rate of 5.38 % and volatility of 91.0 % .
Financial assets
As of June 30, 2025, investments in U.S.
−Removed: Treasury Bills were valued through
−Removed: use of quoted prices and are classified as Level 1.
−Removed: The following table presents information about our assets that are measured at fair
−Removed: value on a recurring basis using the above input categories.
+Added: Treasury Bills were valued
+Added: through use of quoted prices and are classified as Level 1.
+Added: The following table presents information about our assets that are measured
+Added: at fair value on a recurring basis using the above input categories.
Measured at fair value on a recurring basis
5 unchanged sentences
Treasury Bills due in 3 months or less at purchase
−Removed: Treasury Bills due in 3 - 6 months at purchase
Equity Transactions
Issuance of common stock for cash
−Removed: On August 31, 2022, the Company entered into a Controlled
−Removed: Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.
−Removed: Riley Securities, Inc.
−Removed: (collectively,
−Removed: the “Agents”), pursuant to which the Company may issue and sell from time-to-time shares of the Company’s common stock
−Removed: through the Agents, subject to the terms and conditions of the Sales Agreement.
−Removed: On April 6, 2023, the Company and B.
+Added: On August 31, 2022, the Company entered into a
+Added: Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co.
Riley Securities,
+Added: (collectively, the “Agents”), pursuant to which the Company may issue and sell from time-to-time shares of the Company’s
+Added: common stock through the Agents, subject to the terms and conditions of the Sales Agreement.
+Added: On April 6, 2023, the Company and B.
+Added: Securities, Inc.
mutually agreed to terminate B.
Riley Securities, Inc.’s role as a sales agent under the Sales Agreement.
−Removed: During the year ended
−Removed: June 30, 2024, the Company sold 333,749 shares of common stock under the Sales Agreement for total net proceeds of approximately $ 9.3
+Added: 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
$ 9.3 million after deducting 3 % commissions and expenses of approximately $ 377,000 .
During the year ended June 30, 2025, the Company sold
−Removed: shares of common stock under the Sales Agreement for total net proceeds of approximately $ 49.5 million after 3 % commissions and expenses
−Removed: of approximately $ 2.0 million.
+Added: 215 shares of common stock under the Sales Agreement for total net proceeds of $ 6,400 after 3 % commissions and expenses of approximately
+Added: On September 25, 2024, the Company suspended the sales agreement and terminated the continuous offering by us under the effective
+Added: Prospectus Supplement filed January 19, 2024.
On March 6, 2024, the Company closed a best efforts
−Removed: public offering (the “Offering”) of 1,500,000 shares (the “Shares”) of its common stock, par value $ 0.001 per
−Removed: share (the “Common Stock”), pre-funded warrants (the “Pre-funded Warrants”) to purchase 600,000 shares of Common
−Removed: Stock, and warrants to purchase up to 1,050,000 shares of Common Stock (the “Common Warrants”) at a combined public offering
−Removed: price of $ 10.00 per Share, or Pre-funded Warrant, and the associated Common Warrant.
−Removed: Warrants have an exercise price of $15.00 per share and are immediately exercisable upon issuance for a period of five years following
−Removed: the date of issuance.
−Removed: The gross proceeds to the Company from the Offering were approximately $21.0 million, before deducting placement
−Removed: agent fees and offering expenses of approximately $2.5 million, resulting in net proceeds of approximately $18.5 million.
−Removed: Additionally,
−Removed: upon closing the Company issued the placement agent warrants (“Placement Agent’s warrants”) to purchase 105,000 shares
−Removed: of Common Stock exercisable at a per share price of $12.50, which was equal to 125% of the public offering price per share.
+Added: public offering (the “Offering”) of 150,000 shares (the “Shares”) of its common stock, par value $0.0001 per share
+Added: (the “Common Stock”), pre-funded warrants (the “Pre-funded Warrants”) to purchase 60,000 shares of Common Stock,
+Added: and warrants to purchase up to 105,000 shares of Common Stock (the “Common Warrants”) at a combined public offering price
+Added: of $ 100.00 per Share, or Pre-funded Warrant, and the associated Common Warrant.
+Added: The Common Warrants
+Added: have an exercise price of $ 150.00 per share and are immediately exercisable upon issuance for a period of five years following the date
+Added: The gross proceeds to the Company from the Offering were approximately $ 21.0 million, before deducting placement agent
+Added: fees and offering expenses of approximately $2.5 million, resulting in net proceeds of approximately $18.5 million.
+Added: Additionally, upon
+Added: closing the Company issued the placement agent warrants (“Placement Agent’s warrants”) to purchase 10,500 shares of
+Added: Common Stock exercisable at a per share price of $ 125.00 , which was equal to 125% of the public offering price per share.
The Placement
2 unchanged sentences
exercised shortly after issuance and the 60,000 shares of Common Stock were issued during the year ended June 30, 2024.
−Removed: Equity Transactions (continued)
+Added: On September 25, 2024, the Company closed a best
+Added: efforts public offering (the “September 2024 Offering”) of 136,080 shares of its common stock, par value $ 0.0001 per share,
+Added: pre-funded warrants (the “September Pre-funded Warrants”) to purchase 60,000 shares of Common Stock, and warrants to purchase
+Added: up to 196,080 shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $ 15.30 per share,
+Added: or September Pre-funded Warrant, and the associated September Common Warrant.
+Added: 26,500 September Pre-funded Warrants were exercised shortly
+Added: thereafter and reflected on the statement of changes in stockholders’ equity as a component of proceeds from issuance of common
+Added: The September Common Warrants have an exercise price of $ 15.30 per share and were immediately
+Added: exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date.
+Added: The gross proceeds to the
+Added: Company from the September 2024 Offering was approximately $ 3.0 million, before deducting placement agent fees and offering expenses of
+Added: approximately $747,000.
+Added: Additionally, upon closing, the Company issued the placement agent warrants (“September Placement Agent’s
+Added: Warrants”) to purchase 981 shares of Common Stock exercisable at a per share price of $ 19.10 , which was equal to 125% of the public
+Added: offering price per share.
+Added: The September Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days
+Added: from September 25, 2024.
+Added: In October 2024, the Company closed three registered
+Added: direct offerings totaling 825,600 shares of its common stock, par value $ 0.0001 per share, and two concurrent private placements of warrants
+Added: to purchase up to 711,000 shares of Common Stock (the “October Common Warrants”) priced at-the-market under Nasdaq rules at
+Added: prices ranging from $ 15.00 to $ 28.30 per share (the “October Offerings”) .
+Added: Common Warrants have exercise prices ranging from $ 13.70 to $ 21.20 per share and are exercisable beginning six months following issuance
+Added: and will expire on the fifth anniversary date of the original issuance dates.
+Added: The gross proceeds to the Company from the October
+Added: Offerings totaled approximately $ 15.9 million, before deducting placement agent fees and offering expenses of approximately $ 2.5 million.
+Added: Additionally, upon closing of the October Offerings, the Company issued placement agent warrants (the “October Placement Agent’s
+Added: Warrants”) to purchase 41,321 shares of Common Stock in the aggregate exercisable at a per share price ranging from $ 18.80 to $ 35.40 ,
+Added: which was equal to 125% of the offering price per share in the applicable October Offering.
+Added: The October Placement Agent’s Warrants
+Added: are exercisable during a five-year period commencing 180 days from each of the respective closing dates of the October Offerings.
+Added: During the year ended June 30, 2025, 189,630 of
+Added: common warrants from the September 2024 Offering were exercised at $ 15.30 per share for proceeds totaling approximately $ 2.9 million,
+Added: and 33,500 September Pre-funded Warrants were also exercised.
+Added: In addition, 667 September Placement Agent’s Warrants were exercised
+Added: on a cashless exercise basis and 422 common shares were issued.
Issuance of common stock for services
−Removed: On April 6, 2023, the Company awarded 5,000 shares
+Added: On May 10, 2024, the Company awarded 1,500 shares
of Common Stock to a vendor as part of their fees in exchange for services.
1 unchanged sentence
was $ 48.60 per share.
−Removed: The stock-based compensation expense related to this Common Stock issuance was $ 372,500 .
−Removed: On May 10, 2024, the Company awarded 15,000 shares
+Added: The stock-based compensation expense related to this Common Stock issuance was $ 72,900 for the year ended June 30,
+Added: On August 12, 2024, the Company awarded 1,500
+Added: shares of Common Stock to a vendor as part of their fees in exchange for services.
+Added: The fair value of the Common Stock at the date of issuance
+Added: was $ 22.30 per share.
+Added: The stock-based compensation expense related to this Common Stock issuance was $ 33,450 for the year ended June 30,
+Added: On April 24, 2025, the Company awarded 4,500 shares
of Common Stock to a vendor as part of their fees in exchange for services.
1 unchanged sentence
was $ 8.94 per share.
−Removed: The stock-based compensation expense related to this Common Stock issuance was $ 72,900 .
+Added: The stock-based compensation expense related to this Common Stock issuance was $ 40,230 for the year ended June 30,
Stock Options
8 unchanged sentences
Options Canceled
−Removed: Options Exercised
Outstanding at June 30, 2024
+Added: Options Granted
Options Expired
2 unchanged sentences
Exercisable at June 30, 2025
−Removed: The fair value of each option grant on the date of
−Removed: grant is estimated using the Black-Scholes model.
+Added: The fair value of each option grant on the date
+Added: of grant is estimated using the Black-Scholes model.
The following weighted-average assumptions were utilized for the years ended:
6 unchanged sentences
Dividend Yield
−Removed: The Company recorded stock based compensation expense
−Removed: relating to the vesting of stock options of approximately $ 2.8 million and $ 4.2 million for the years ended June 30, 2024 and 2023, respectively.
−Removed: Issuance and modification of restricted stock units and options:
−Removed: On June 21, 2022, the Company awarded 12,452 restricted
−Removed: stock units (“RSUs”) to the President and CEO under the Company’s 2019 Omnibus Plan.
−Removed: Each RSU awarded to the CEO entitles
−Removed: him to receive one share of Common Stock upon vesting.
−Removed: The RSUs vest in three equal annual installments beginning on the first anniversary
−Removed: 4,151 and 4,151 RSUs vested in June 2023 and 2024, respectively.
−Removed: On November 23, 2022, the Company awarded 38,198 RSUs
−Removed: to certain employees and a consultant, with a grant date fair value of $ 61.20 per share.
−Removed: 25% of these RSUs vested on the grant date and
−Removed: the remaining RSUs vest in three equal installments over three years beginning on the first anniversary of the grant date.
−Removed: year ended June 30, 2023, 9,550 of these RSUs vested, of which 2,288 shares were withheld in Treasury stock in exchange for payment of
−Removed: withholding tax on behalf of the employees.
−Removed: Equity Transactions (continued)
−Removed: On November 23, 2022, the Company issued equity awards
−Removed: for the board of directors’ annual compensation.
−Removed: Four directors received 15,564 RSUs with a grant date fair value of $ 61.20 per
−Removed: In addition, three directors received stock options to purchase 19,500 shares of common stock at an exercise price of $ 61.20 per
−Removed: share with a grant date fair value of $40.60 per share.
−Removed: The equity awards vest quarterly on February 23, 2023, May 23, 2023, August 23,
−Removed: 2023 and earlier of November 23, 2023 or the next annual shareholders’ meeting.
−Removed: During the year ended June 30, 2024, 7,746 of these
−Removed: These RSUs and options contain certain contractual vesting terms where the vesting can be accelerated outside the Company’s
−Removed: control and as a result, for accounting purposes, are assumed to have been fully vested on the grant date, and accordingly, the Company
−Removed: recognized the total compensation cost of $ 1,744,192 on November 23, 2022.
−Removed: On November 9, 2023, the Company issued equity awards
−Removed: for the board of directors’ annual compensation.
−Removed: Four directors received 18,270 RSUs with a grant date fair value of $ 30.10 per
−Removed: In addition, two directors received stock options to purchase 18,325 shares of common stock at an exercise price of $ 30.10 per
−Removed: share with a grant date fair value of $18.30 per share.
−Removed: The equity awards vest quarterly on February 9, 2024, May 9, 2024, August 9, 2024
−Removed: and earlier of November 9, 2024 or the next annual shareholders’ meeting.
−Removed: During the year ended June 30, 2024, 4,568 of these RSUs
−Removed: In December 2023, the Company terminated five employees
−Removed: and as part of their severance agreement modified their equity awards that had been granted pursuant to the 2019 Omnibus Plan.
−Removed: The modifications
−Removed: included the acceleration of certain stock option awards to purchase a total of 5,623 shares of common stock (“Accelerated Options”),
−Removed: effective on the December Separation Date, as defined in severance agreement (“Separation Date”), and extended the expiration
−Removed: date for one year from the Separation Date for both the Accelerated Options and any vested and unexercised stock options held by the terminated
−Removed: employees as of the Separation Date.
−Removed: Accordingly, the Company remeasured the Accelerated Options based on the stock price of $15.40 per
−Removed: share at the close on the Separation Date and a one-year extension of the term.
−Removed: The net adjustment for the modification was a net credit
−Removed: of $127,199 and was recognized as an adjustment to stock compensation expense during the year ended June 30, 2024.
+Added: On October 3, 2023, the Company granted stock
+Added: options to purchase 2,112 shares of Common Stock to new hire employees.
+Added: 20 % of the shares underlying the options awarded vest on the one-year
+Added: anniversary of the grant date, and the remaining 80 % will vest in equal monthly installments over 48 months each month thereafter.
+Added: 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
+Added: anniversary or the date of which the options are fully exercised.
+Added: In June 2024, the Company granted stock options
+Added: to purchase 11,580 shares of Common Stock to employees.
+Added: 33 % of the shares underlying the options awarded vest on the grant date, and the
+Added: remaining 67 % will vest over 2 years on first and second anniversary of the grant date.
+Added: The exercise price of the options is $ 47.00 , the
+Added: 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
+Added: fully exercised.
+Added: On December 20, 2024, the Company granted to employees
+Added: and directors stock options to purchase 20,893 and 11,308 shares of Common Stock, respectively.
+Added: The options have an exercise price of
+Added: $ 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
+Added: options issued to Directors were $ 12.00 per share.
+Added: The fair value of the stock options issued to Management was $ 14.30 per share.
+Added: The Company recorded stock based compensation
+Added: 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: 2024, respectively.
+Added: Issuance and modification of restricted stock units, restricted
+Added: shares and stock options:
+Added: On November 9, 2023, the Company granted equity
+Added: awards for the board of directors’ annual compensation.
+Added: Four directors received 1,827 Restricted Stock Units (“RSUs”)
+Added: with a grant date fair value of $ 301.00 per share.
+Added: In addition, two directors received stock options to purchase 1,833 shares of common
+Added: 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 vest quarterly on
+Added: February 9, 2024, May 9, 2024, August 9, 2024 and earlier of November 9, 2024 or the next annual shareholders’ meeting.
+Added: year ended June 30, 2024, 457 of these RSUs vested.
+Added: During the year ended June 30, 2025, 682 of these RSUs vested and 232 RSUs were cancelled
+Added: Gorlin resigning from the Board of Directors.
+Added: In December 2023, the Company terminated five
+Added: employees and as part of their severance agreement modified their equity awards that had been granted pursuant to the 2019 Omnibus Plan.
+Added: The modifications included the acceleration of certain stock option awards to purchase a total of 563 shares of common stock (“Accelerated
+Added: Options”), effective on the December Separation Date, as defined in severance agreement (“Separation Date”), and extended
+Added: the expiration date for one year from the Separation Date for both the Accelerated Options and any vested and unexercised stock options
+Added: held by the terminated employees as of the Separation Date.
+Added: Accordingly, the Company remeasured the Accelerated Options based on the stock
+Added: price of $154.00 per share at the close on the Separation Date and a one-year extension of the term.
+Added: The net adjustment for the modification
+Added: was a net credit of $127,199 and was recognized as an adjustment to stock compensation expense during the year ended June 30, 2024.
Additionally, 103 vesting RSUs were accelerated
as of the Separation date.
−Removed: The modified RSUs were remeasured based on the stock price of $15.40 per share at close on the Separation Date
−Removed: 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: In connection with the separation, the Company canceled
−Removed: 18,396 unvested stock options and 1,030 unvested RSUs.
+Added: The modified RSUs were remeasured based on the stock price of $154.00 per share at close on the Separation
+Added: 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.
+Added: On the Separation date, December 2023, the Company
+Added: canceled 1,840 unvested stock options and 103 unvested RSUs.
Additionally, the Company canceled an additional 1,342 unvested stock options
for employees that voluntarily left the company.
−Removed: In June 2023, the Company issued 14,950 RSUs with
−Removed: a grant date fair value of $ 41.10 per share to the President and CEO under the Company’s 2019 Omnibus Plan.
−Removed: The RSUs vest in three
−Removed: equal annual installments beginning on the first anniversary grant date.
−Removed: 4,983 RSUs vested in June 2024.
−Removed: In June 2024, the Company issued 85,800 RSUs to employees,
−Removed: with a grant date fair value of $ 4.74 per share.
+Added: On June 24, 2024, the Company granted a total
+Added: of 8,580 RSUs to employees, with a grant date fair value of $ 47.40 per share.
The RSUs vested on the grant date.
−Removed: The Company delivered the vested portion of the RSU’s
−Removed: and issued 85,800 shares of Common Stock, of which 21,450 shares were withheld in Treasury stock in exchange for payment of withholding
−Removed: tax on behalf of the employees.
+Added: The Company delivered
+Added: 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
+Added: exchange for payment of withholding tax on behalf of the employees.
+Added: On November 20, 2024, the Company granted equity
+Added: awards as part of the board of directors’ annual compensation.
+Added: Two directors received 6,690 RSUs with a grant date fair value of
+Added: $ 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
+Added: share with a grant date fair value of $ 21.10 per share.
+Added: The RSUs vest quarterly on February 8, 2025, May 8, 2025, August 8, 2025 and the
+Added: earlier of November 8, 2025 or the next annual shareholders’ meeting.
+Added: During the year ended June 30, 2025, 2,528 shares were issued
+Added: related to the RSUs that vested and 2,415 shares were canceled due to departures.
+Added: On January 1, 2025, the Company awarded 4,500
+Added: shares of restricted common stock as part of a service agreement to a vendor.
+Added: The restricted common shares fully vest on the first anniversary
+Added: 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 and related stock-based compensation
+Added: expense for the year ended June 30, 2025 was $ 49,050 .
+Added: On January 21, 2025, the Company granted a total
+Added: of 10,500 RSUs to Advisory board members at the grant date fair value of $ 20.50 .
+Added: Vesting of the RSUs are in five equal installments at
+Added: the grant date and each calendar quarter end beginning March 31, 2025.
The following table summarizes vesting of restricted
−Removed: Schedule of vesting of restricted common stock
+Added: Schedule of unvested of restricted stock units
Number of Shares
3 unchanged sentences
Unvested at June 30, 2025
−Removed: Equity Transactions (continued)
−Removed: The total stock-based compensation expense from restricted
−Removed: stock units for the year ended June 30, 2024 and 2023 was approximately $ 1.8 million and $ 1.8 million, respectively.
−Removed: Issuance of Common Stock through exercise of Stock Options and Warrants
−Removed: In December 2022, the Company issued 2,209 shares
−Removed: of Common Stock pursuant to a cashless exercise of stock options to purchase 9,930 shares at an average exercise price of $ 76.40 .
−Removed: In November 2022, the Company issued 80 shares of
−Removed: Common Stock pursuant to a cash exercise of stock options to purchase 80 shares at an average exercise price of $ 28.00 per share.
−Removed: In October 2022, the Company issued 359 shares of
−Removed: Common Stock pursuant to a cashless exercise of warrants to purchase 800 shares at an average exercise price of $ 22.50 .
−Removed: In May 2023, the Company issued 48 shares of Common
−Removed: Stock pursuant to a cashless exercise of stock options to purchase 80 shares at an average exercise price of $ 31.30 .
−Removed: Issuance of Stock Options under the 2019 Omnibus Plan.
−Removed: Pursuant to a former employee’s Separation Agreement,
−Removed: dated April 11, 2022, the Company modified their stock option award granted on August 20, 2021, pursuant to the 2019 Omnibus Plan (“2021
−Removed: Options Grant”).
−Removed: Pursuant to the terms of the Separation Agreement, effective July 8, 2022 (the “Separation Date”),
−Removed: the Company accelerated the vesting of options scheduled to vest on the first and second anniversary of the grant date as deemed vested
−Removed: (“Accelerated Options”) and after giving effect to the Accelerated Options, extended the exercise period of the total vested
−Removed: outstanding and unexercised options (totaling 7,450 options) to one year following the Separation Date.
−Removed: The unvested portion of the 2021
−Removed: Option Grant (totaling 4,967 options) was canceled.
−Removed: The modification was remeasured as of July 8, 2022, and the incremental difference
−Removed: in fair value resulted in a net credit to stock based compensation expense of $181,154, due to the original exercise price of $77.40 being
−Removed: greater than the stock price of $18.00 on the remeasurement date, and accordingly was recognized on July 8, 2022.
−Removed: On June 7, 2023, the Company granted stock options
−Removed: to purchase 14,800 shares of Common Stock to certain employees.
−Removed: 20 % of the shares underlying the options awarded vested on the grant date,
−Removed: and the remaining 80 % will vest in four equal annual installments beginning, on the first grant date anniversary.
−Removed: The exercise price of
−Removed: the options is $ 57.80 per share, the grant date fair value and the options terminate on the earlier of the tenth grant date anniversary
−Removed: or the date of which the options are fully exercised.
−Removed: During the fiscal year ended June 30, 2023, the Company
−Removed: granted stock options to purchase a total of 28,617 shares of Common Stock in connection with compensation packages of three new employees.
−Removed: The exercise prices were set at the grant date fair value with vesting terms over a five year period and the options terminate on the
−Removed: earlier of tenth grant date anniversary or the date of which the options are fully exercised.
−Removed: On October 3, 2023, the Company granted stock options
−Removed: to purchase 21,117 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 $ 34.10 , the grant date fair value, and the options terminate on the earlier of the tenth grant date anniversary
−Removed: or the date of which the options are fully exercised.
−Removed: In June 2024, the Company granted stock options to
−Removed: purchase 115,800 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 $ 4.70 , 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: Equity Transactions (continued)
+Added: The total stock-based compensation expense from restricted stock units
+Added: and restricted shares for the year ended June 30, 2025 and 2024 was approximately $ 1.2 million and $ 1.8 million, respectively.
Stock Warrants
−Removed: The following table summarizes the warrants activity during the years ended
−Removed: June 30, 2024 and 2023:
+Added: The following table summarizes the warrants activity during the years
+Added: ended June 30, 2025 and 2024:
Summary of warrants activity
4 unchanged sentences
Outstanding and exercisable at June 30, 2023
+Added: $ 18,318,954 .00
Outstanding and exercisable at June 30, 2024
Outstanding and exercisable at June 30, 2025
−Removed: Of the above warrants outstanding at June 30, 2024,
−Removed: 10,138 expire in the fiscal year ending June 30, 2025, 3,518 expire in the fiscal year ending June 30, 2026, 763,373 expire in the fiscal
−Removed: year ending June 30, 2027 and 1,155,000 expire in the fiscal year ending June 30, 2029.
+Added: The table below shows the expiration of the warrants
+Added: outstanding as of June 30, 2025:
+Added: Schedule of warrants outstanding
+Added: Number of Warrants
+Added: Expiring June 30,
+Added: Total outstanding warrants
Office Leases
−Removed: The Company pays an annual rent of $2,200 for its
−Removed: headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 89703.
−Removed: The rental agreement was for a one-year term, commenced on October
−Removed: 1, 2022 and has been subsequently renewed for another year at the same rate.
+Added: The Company pays an annual rent of $ 2,200
+Added: for its headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 89703.
+Added: The rental agreement was for a one-year 1 term,
+Added: commenced on October 1, 2022 and has been subsequently renewed at each annual maturity date at the same rate.
The Company’s San Diego office lease at
−Removed: 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 of
−Removed: $4,300, and annual increases of three percent.
−Removed: In February 2024, the Company amended the lease agreement which allowed the Company to
−Removed: vacate the then current space and move to a larger space at Suite 206.
+Added: 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
+Added: of $4,300, and annual increases of three percent.
+Added: In February 2024, the Company amended the lease agreement which allowed the Company
+Added: to vacate the then current space and move to a larger space at Suite 206.
The current monthly base rate for the new office space is $ 10,024 ,
5 unchanged sentences
Total operating lease expense for the years ended
−Removed: June 30, 2024 and 2023 of approximately $ 78,000 and $ 52,000 , respectively were included in the accompanying statements of operations and
−Removed: comprehensive loss as a component of selling, general and administrative expenses.
+Added: June 30, 2025 and 2024 of approximately $ 127,000 and $ 78,000 , respectively, were included in the accompanying statements of operations
+Added: and comprehensive loss as a component of selling, general and administrative expenses.
The right-of-use asset, net and current and non-current
portion of the operating lease liabilities included in the accompanying balance sheets are as follows:
−Removed: Leases (continued)
Schedule of deferred tax assets
5 unchanged sentences
Total operating lease liability
−Removed: At June 30, 2024, the future estimated minimum lease payments under non-cancelable
−Removed: operating leases are as follows:
−Removed: Schedule of future estimated minimum lease payments
−Removed: under non-cancelable operating leases
+Added: At June 30, 2025, the future estimated minimum lease payments under
+Added: non-cancelable operating leases are as follows:
+Added: Schedule of future estimated minimum lease payments under non-cancelable operating leases
Year ending June 30
2 unchanged sentences
Present value of future minimum lease payments
−Removed: Less current portion of operating lease liability
−Removed: Operating lease liability, net of current portion
Total cash paid for amounts included in the measurement of lease liabilities
were $ 117,915 and $ 83,910 for the years ended June 30, 2025 and 2024, respectively.
−Removed: The weighted average remaining lease term and discount
−Removed: rate as of June 30, 2024 and 2023 were as follows:
+Added: The weighted average remaining lease term and
+Added: discount rate as of June 30, 2025 and 2024 were as follows:
Schedule of weighted average remaining lease term and discount rate
11 unchanged sentences
PharmaIn Corporation, and The Barrett Edge, Inc.
−Removed: Pursuant to the Technology Transfer Agreement entered
−Removed: into on July 25, 2016, by and between the Company and the University of Padova (Italy), the Company is obligated to pay a low single digit
−Removed: royalty on net sales of all terlipressin products covered by US patent no.
−Removed: 9,655,645 and any future foreign issuances, capped at a maximum
−Removed: of $200,000 per year.
−Removed: Shareholder class action complaint
−Removed: On January 19, 2024, a purported shareholder class action complaint,
−Removed: captioned Eric Olmstead v.
+Added: Pursuant to the Technology Transfer Agreement
+Added: 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
+Added: single digit royalty on net sales of all terlipressin products covered by US patent no.
+Added: 9,655,645 and any future foreign issuances, capped
+Added: at a maximum of $200,000 per year.
+Added: Shareholder class action complaint and shareholder derivative complaints
+Added: On January 19, 2024, a purported shareholder class
+Added: action complaint, captioned Eric Olmstead v.
3:24-cv-00035, was filed in the U.S.
−Removed: District Court for the District of
−Removed: Nevada, naming the Company and certain of its officers as defendants.
−Removed: On February 22, 2024, a second, related putative securities class
−Removed: action was filed in the same court asserting similar claims against the same defendants, captioned Way v.
+Added: District Court for
+Added: the District of Nevada, naming the Company and certain of its officers as defendants.
+Added: On February 22, 2024, a second, related
+Added: 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 Inc.
−Removed: Securities Litigation ,
+Added: On April 15, 2024, the court consolidated these two actions under the caption In re BioVie
+Added: Securities Litigation , No.
3:24-cv-00035, appointed the lead plaintiff, and approved selection of the lead counsel.
−Removed: On June 21, 2024, the lead plaintiff filed
−Removed: an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact relating to the
−Removed: Company’s business, operations, compliance, and prospects, including information related to the NM101 Phase 3 study and trial of
−Removed: bezisterim (NE3107) in mild to moderate probable AD, in violation of Sections 10(b) and 20(a)
−Removed: of the Exchange Act, and Rule 10b-5 promulgated thereunder.
−Removed: The class action is on behalf of purchasers of the Company’s
−Removed: securities during the period from December 7, 2022 through November 28, 2023 and seeks unspecified monetary damages on behalf of the putative
−Removed: class and an award of costs and expenses, including attorney’s fees.
−Removed: The defendants filed a motion to dismiss the amended complaint
−Removed: on August 21, 2024.
−Removed: The Company believes the lawsuit is without merit
−Removed: and intends to defend the case vigorously.
−Removed: At this early stage of the proceedings, the Company is unable to make any prediction regarding
−Removed: the outcome of the litigation.
−Removed: No adjustment or accruals have been reflected in the accompanying financial statements.
+Added: 2024, the lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of
+Added: material fact relating to the Company’s business, operations, compliance, and prospects, including information related to the NM101
+Added: Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable AD, in violation
+Added: of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder.
+Added: The class action is on behalf
+Added: of purchasers of the Company’s securities during the period from December 7, 2022 through November 28, 2023, and seeks unspecified
+Added: monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees.
+Added: The defendants filed
+Added: a motion to dismiss the amended complaint on August 21, 2024, and that motion was fully briefed as of December 5, 2024.
+Added: On March 27, 2025,
+Added: the court denied the defendants’ motion to dismiss, and the parties are now engaged in the early stages of fact discovery .
+Added: On December 30, 2024, a shareholder derivative
+Added: lawsuit was filed in the United States District Court for the District of Nevada by putative stockholder Andrew Hulm, allegedly on behalf
+Added: of the Company, that piggy-backs on the securities class action also pending in that court.
+Added: The derivative complaint names certain current
+Added: and former officers and directors as defendants, and generally alleges that they breached their fiduciary duties by causing or failing
+Added: to prevent the securities violations alleged in the securities class action.
+Added: The derivative complaint also alleges claims for unjust enrichment,
+Added: waste of corporate assets, gross mismanagement, and abuse of control as against all defendants.
+Added: On March 18, 2025, the court ordered the
+Added: Hulm derivative lawsuit stayed, pending resolution of the motion to dismiss the securities class action described above.
+Added: On April 28, 2025, a second shareholder derivative
+Added: lawsuit was filed in the United States District Court for the District of Nevada by putative stockholder William Settel, allegedly on
+Added: behalf of the Company, that likewise piggy-backs on the securities class action.
+Added: The Settel derivative complaint alleges essentially the
+Added: same claims as the Hulm derivative action against the same defendants based on the same alleged conduct.
+Added: The Company believes that the claims are without
+Added: merit and intends to defend vigorously against them, but there can be no assurances as to the outcome.
Employee Benefit Plan
−Removed: On August 1, 2021, the Company began sponsoring an
−Removed: employee benefit plan subject to Section 401(K) of the Internal Revenue Service Code (the “401K Plan”) pursuant to which,
+Added: On August 1, 2021, the Company began sponsoring
+Added: an employee benefit plan subject to Section 401(K) of the Internal Revenue Service Code (the “401K Plan”) pursuant to which,
all employees meeting eligibility requirements are able to participate.
−Removed: Subject to certain limitations in the Internal Revenue Code, eligible employees
−Removed: are permitted to make contributions to the 401K Plan on a pre-tax salary reduction basis and the Company will match 5% of the first 5%
−Removed: of an employee’s contributions to the 401K Plan.
−Removed: The Company made contributions into the plan of approximately $ 153,200 and $ 171,900 ,
−Removed: for the years ended June 30, 2024 and 2023, respectively.
+Added: Subject to certain limitations in the Internal Revenue Code, eligible
+Added: employees are permitted to make contributions to the 401K Plan on a pre-tax salary reduction basis and the Company will match 5% of the
+Added: first 5% of an employee’s contributions to the 401K Plan.
+Added: The Company made contributions into the plan of approximately $ 152,400
+Added: and $ 153,200 , for the years ended June 30, 2025 and 2024, respectively.
Significant components of the Company’s deferred tax assets (liabilities)
13 unchanged sentences
At June 30, 2025 and 2024, the Company has recorded a full valuation
−Removed: against its net deferred tax assets of approximately $ 69.6 million
−Removed: and $ 60.6 million,
−Removed: respectively, since in the judgement of management, these assets are not more than likely to be realized.
−Removed: The increase in the
−Removed: valuation allowance during the year ended June 30, 2024 was approximately $ 9.0 million.
+Added: against its net deferred tax assets of approximately $ 74.9 million and $ 69.6 million, respectively, since in the judgement of management,
+Added: these assets are not more than likely to be realized.
+Added: The increase in the valuation allowance during the year ended June 30, 2025 was
+Added: approximately $ 5.3 million.
At June 30, 2025, the Company had a Net Operating
2 unchanged sentences
from 2032 to 2037 .
−Removed: The Company has no current tax expense due to its net losses and a full
−Removed: valuation allowance.
−Removed: Reconciliation of the differences between income tax
−Removed: benefit computed at the federal and state statutory tax rates and the provision for income tax benefit for the years ended June 30, 2024
+Added: Utilization of the Company’s historical NOL are subject to limitations under Internal Revenue Code Section 382
+Added: as a result of multiple ownership changes through the Company’s capital raises.
+Added: The Company has no current tax expense due to its net losses and a
+Added: full valuation allowance.
+Added: Reconciliation of the differences between income
+Added: tax benefit computed at the federal and state statutory tax rates and the provision for income tax benefit for the years ended June 30,
2025 and 2024 is as follows:
4 unchanged sentences
Effective tax rate
+Added: On July 4, 2025, the U.S.
+Added: enacted the One Big Beautiful Bill Act (the
+Added: “Act”), which contains a broad range of tax reform provisions affecting businesses.
+Added: The Company is currently evaluating
+Added: the full effects of the Act and does not anticipate a material impact on the financial statements.
+Added: Segment Reporting
+Added: The Company operates as one operating segment with a focus on its efforts
+Added: to develop drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease.
+Added: The Company's
+Added: CEO, as the chief operating decision maker, manages and allocates resources to the operations of the Company based on the line items included
+Added: within these financial statements and segment performance is evaluated based on net loss.
+Added: This enables the CEO to assess the overall level
+Added: of available resources and determine how best to deploy these resources across functions, clinical trials, and development projects in
+Added: line with the long-term company-wide strategic goals.
+Added: The measurement of segment assets is reported on the balance sheet as total assets.
+Added: All of the Company’s tangible assets are held in the United States.
+Added: The following table
+Added: presents selected financial information with respect to the Company’s single operating segment and its significant segment expenses
+Added: for the years ended June 30, 2025 and 2024:
+Added: Schedule of segment reporting information
+Added: For the Year Ended
+Added: For the Year Ended
+Added: June 30, 2025
+Added: June 30, 2024
+Added: Clinical studies
+Added: Clinical teams
+Added: Chemistry, manufacturing and controls
+Added: Other research and development expenses
+Added: Selling, general and administrative expenses
+Added: Amortization of intangible assets
+Added: Other income, net
+Added: $ ( 17,542,000 )
+Added: $ ( 32,121,000 )
Subsequent Events
−Removed: On September 25, 2024, the Company closed a best
−Removed: efforts public offering (the “September 2024 Offering”) of 1,360,800
−Removed: shares of its common stock, par value $ 0.0001
−Removed: per share, pre-funded warrants (the “September Pre-funded Warrants”) to purchase 600,000
−Removed: shares of Common Stock, and warrants to purchase up to 1,960,800
−Removed: shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $ 1.53
−Removed: per Share, or September Pre-funded Warrant, and the associated September Common Warrant.
−Removed: The September Common
−Removed: Warrants have an exercise price of $ 1.53
−Removed: per share and are immediately exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date.
−Removed: gross proceeds to the Company from the September 2024 Offering were approximately $ 3.0
−Removed: million, before deducting placement agent fees and offering expenses of approximately $ 560,000 .
−Removed: Additionally, upon closing the Company issued the placement agent warrants (“September Placement Agent’s
−Removed: Warrants”) to purchase 98,040
−Removed: shares of Common Stock exercisable at a per share price of $ 1.91 ,
−Removed: which was equal to 125% of the public offering price per share.
−Removed: The September Placement Agent’s Warrants are exercisable
−Removed: during a five-year period commencing 180 days from September 25, 2024.
+Added: August 11, 2025, the Company closed an underwritten public offering of (i) 5,620,000 units (the “Units”), with each Unit
+Added: consisting of one share of common stock and one warrant (the “Warrants”) and (ii) 380,000 pre-funded units (the
+Added: “Pre-Funded Units”), with each Pre-Funded Unit consisting of one pre-funded warrant and one Warrant.
+Added: The underwriter
+Added: also exercised its over-allotment option in part and purchased an additional 667,300 Warrants.
+Added: The offering resulted in net proceeds
+Added: of approximately $ 10.4 million, after deducting underwriting discounts and commissions and other estimated offering expenses.
+Added: 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
+Added: Pre-Funded Unit (which represents the public offering price of each Unit less the $0.0001 per share nominal exercise price for each
+Added: Pre-Funded Warrant).
+Added: On August 8, 2025, the Warrants commenced trading on The Nasdaq Capital Market under the symbol
+Added: “BIVIW.” Each Warrant is immediately exercisable, entitles the holder to purchase one share of common stock at an
+Added: exercise price of $ 2.50 per share and expires five years from the date of issuance.
+Added: Each Pre-Funded Warrant is immediately
+Added: 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.