Item 9A. Controls and Procedures
ITEM 9A.
CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We have evaluated, with the participation of our
principal executive and our principal financial officer, the effectiveness of our disclosure controls and procedures as defined in Rules
13a-15(e) and 15(d)-15(e) under the Exchange Act as of the end of the period covered by this report. Based on this evaluation, our principal
executive officer and our principal financial officer have concluded that our disclosure controls and procedures were effective to ensure
that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized
and reported, within the time periods specified in the Commission’s rules and forms, and is accumulated and communicated to our
management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate
to allow timely decisions regarding required disclosure.
Management’s Report on Internal Control
Over Financial Reporting
Our management is responsible for establishing
and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of
any evaluation of the effectiveness of internal control to future periods are subject to the risk that controls may become inadequate
because of changes in conditions, or that the degree of compliance with policies or procedures may deteriorate. Under the supervision
and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation
of the effectiveness of our internal control over financial reporting as of June 30, 2026 using the criteria established in Internal Control
Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation using those
criteria, our management has concluded that, as of June 30, 2026, our internal control over financial reporting was effective to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
in accordance with generally accepted accounting principles for the reasons discussed above.
Changes in Internal Control Over Financial
Reporting
There were no changes in our internal controls
over financial reporting during the quarter ended June 30, 2026 that materially affected, or are reasonably likely to materially affect,
our internal controls over financial reporting.
ITEM 9B.
OTHER INFORMATION
None .
ITEM 9C.
DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
46
PART III.
ITEM 10.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item is included
in our 2026 Proxy Statement and is incorporated herein by reference.
ITEM 11.
EXECUTIVE COMPENSATION
The information required by this item is included
in our 2026 Proxy Statement and is incorporated herein by reference.
ITEM 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by this item is included
in our 2026 Proxy Statement and is incorporated herein by reference.
ITEM 13.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this item is included
in our 2026 Proxy Statement and is incorporated herein by reference.
ITEM 14.
PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required by this item is included
in our 2026 Proxy Statement and is incorporated herein by reference.
47
PART IV
ITEM 15.
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)(1),(2) Financial Statements
The Financial Statements listed on page F-1 of
this document are filed as part of this filing.
(a)(3) Exhibits
The following is a list of exhibits filed as a
part of this report:
Exhibit
Number
Description of Document
2.1
Agreement and Plan of Merger, dated April 11, 2016, among the Company, LAT Acquisition Corp and LAT Pharma, LLC (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on April 15, 2016).
3.1
Articles of Incorporation of the Company as filed with the Secretary of State of Nevada (incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form S-1 filed on August 15, 2013, File No. 333-190635).
3.2
Certificate of Amendment to Articles of Incorporation (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 22, 2016).
3.3
Certificate of Amendment to Articles of Incorporation (incorporated by reference to Appendix A to the Company’s Information Statement on Schedule 14C filed on July 13, 2018).
3.4
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 3, 2018).
3.5
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. 333-231136).
3.6
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).
3.7
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).
3.8
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).
3.9*
Amended and Restated Bylaws of the Company, adopted on May 28, 2025. (incorporated by reference to Exhibit 3.9 to the Company’s Annual Report on Form 10-K filed on August 15, 2025).
4.1
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. 333-231136).
48
4.2
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).
4.3
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).
4.4
Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K/A filed on July 18, 2022).
4.5
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).
4.6
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)
4.7
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).
4.8
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).
4.9
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).
4.10
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).
4.11
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).
4.12
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).
4.13
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).
4.14
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).
4.15
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).
4.16
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).
4.17
Form of Pre-Funded Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on August 11, 2025).
4.18
Form of Common Stock Purchase Warrant (incorporated by reference to reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed on August 11, 2025).
4.19
Form of Representative’s Warrant Agreement (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on August 11, 2025)
4.20
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).
10.1#
BioVie Inc. 2019 Omnibus Equity Incentive Plan (Amended and Restated through November 10, 2025) (incorporated
by reference to Appendix A to the Definitive Information Statement on Schedule 14A, filed on September 25, 2025).
10.2
Asset Purchase Agreement, dated April 27, 2021, among the Company, NeurMedix, Inc. and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on April 27, 2021).
10.3
Amendment No. 1 of the Asset Purchase Agreement, dated May 9, 2021, among the Company, NeurMedix, Inc. and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 2.2 to the Company’s Current Report on Form 8-K filed on May 10, 2021).
10.4
Amendment No. 2 to the Asset Purchase Agreement, dated January 13, 2023, among the Company, Acuitas Group Holdings, LLC and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed on May 12, 2023).
10.5#
Employment Offer & Agreement, between Chris Reading and the Company, dated June 18, 2021 (incorporated by reference to Exhibit 10.14 to the Company’s Quarterly Report on Form 10-Q filed on November 10, 2021).
10.6#
Employment Offer & Agreement, between Clarence Ahlem and the Company, dated June 18, 2021 (incorporated by reference to Exhibit 10.15 to the Company’s Quarterly Report on Form 10-Q filed on November 10, 2021).
10.7#
Employment Offer & Agreement, between Joanne Wendy Kim and the Company, dated June 26, 2021 (incorporated by reference to Exhibit 10.16 to the Company’s Quarterly Report on Form 10-Q filed on November 10, 2021).
49
10.8#
Employment Offer & Agreement, between Penelope Markham and the Company, dated September 7, 2021 (incorporated by reference to Exhibit 10.18 to the Company’s Quarterly Report on Form 10-Q filed on November 10, 2021).
10.9#
Employment Offer & Agreement, between Joseph Palumbo and the Company, dated September 3, 2021 (incorporated by reference to Exhibit 10.19 to the Company’s Quarterly Report on Form 10-Q filed on November 10, 2021).
10.10
Loan and Security Agreement, dated November 30, 2021, among the Company, Avenue Venture Opportunities Fund II, L.P. and Avenue Venture Opportunities Fund, L.P. (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed on December 1, 2021).
10.11
Supplement to Loan and Security Agreement, dated November 30, 2021, among the Company, Avenue Venture Opportunities Fund II, L.P. and Avenue Venture Opportunities Fund, L.P. (incorporated by reference to Exhibit 10.2 to the Company’s Form 8-K filed on December 1, 2021).
10.12
Securities Purchase Agreement, dated July 15, 2022, by and between the Company and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K/A filed on July 18, 2022).
10.13
Controlled Equity Offering SM Sales Agreement, dated August 31, 2022, among the Company, Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K filed on August 31, 2022).
10.14
Amended and Restated Registration Rights Agreement, dated August 15, 2022, by and between BioVie Inc. and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed on November 4, 2022).
10.15
Warrant Agent Agreement, dated as of August 7, 2025, by and between the Company and the Warrant Agent (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on August 11, 2025).
14.1
Code of Conduct and Ethics of BioVie Inc. (incorporated by reference to Exhibit 14.1 to the Company’s Registration Statement on Form S-1, File No. 333-231136).
19.1
BioVie Inc. Insider Trading Policy (incorporated by reference to Exhibit 19.1 to the Company’s Annual Report on Form 10-K filed on August 15, 2025).
21.1
Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 to the Company's Registration Statement on Form S-1, File No. 333-288525)
23.1*
Consent of Independent Registered Public Accounting Firm - EisnerAmper LLP
24.1*
Power of Attorney (included on signature page to this report)
31.1*
Rule 13a-14(a) Certification
31.2*
Rule 13a-14(a) Certification
32.1**
Certification Pursuant to 18 U.S.C Section 1350, as Adopted Pursuant to section 906 of the Sarbanes-Oxley Act of 2002
32.2**
Certification Pursuant to 18 U.S.C Section 1350, as Adopted Pursuant to section 906 of the Sarbanes-Oxley Act of 2002
97.1
BioVie Inc. Clawback Policy (incorporated by reference to Exhibit 97.1 to the Company’s Annual Report on Form 10-K filed on August 15, 2025).
101.INS
XBRL Instance Document
101.SCH
XBRL Taxonomy Extension Schema Document
101.CAL
XBRL Taxonomy Calculation Linkbase Document
101.LAB
XBRL Taxonomy Label Linkbase Document
101.PRE
XBRL Taxonomy Presentation Linkbase Document
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document
#
Indicates a management contract or compensatory plan or arrangement
*
Filed herewith.
**
Furnished herewith.
ITEM 16.
FORM 10-K SUMMARY
Not applicable.
50
SIGNATURES
Pursuant to the requirements of Section 13 or
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,
thereunto duly authorized.
Date: August 12, 2026
BIOVIE INC.
By:
/s/ Cuong Do
Name:
Cuong Do
Title:
Chief Executive Officer
(Principal Executive Officer)
POWER OF ATTORNEY
Each person whose signature appears below constitutes
and appoints Cuong Do and Joanne Wendy Kim, and each of them acting individually and without the other, as his or her true and lawful
attorneys-in-fact and agents, with full power of substitution and re-substitution, for him or her and in his or her name, place, and stead,
in any and all capacities, to sign any and all amendments (including exhibits thereto and other documents in
connection therewith) to this Report, and to file the same, with all exhibits thereto, and other documents in connection therewith, with
the Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and
every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might
or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or either of them individually, or
their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities
Exchange Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated.
Person
Capacity
Date
/s/ Cuong Do
Chief Executive Officer
August 12, 2026
Cuong Do
(Principal Executive Officer)
/s/ Joanne Wendy Kim
Chief Financial Officer
August 12, 2026
Joanne Wendy Kim
(Principal Financial and Accounting Officer)
/s/ Jim Lang
Director
August 12 , 2026
Jim Lang
/s/ Michael Sherman
Director
August 12, 2026
Michael Sherman
/s/ Amy Chappell
Director
August 12, 2026
Amy Chappell
/s/ Kameel Farag
Director
August 12, 2026
Kameel Farag
/s/ Sigmund Rogich
Director
August 12, 2026
Sigmund Rogich
51
BioVie Inc.
Index to Financial Statements
Report of Independent Registered Public Accounting Firm – EisnerAmper LLP (PCAOB Number 274 )
F-2
Financial Statements:
Balance Sheets
F-4
Statements of Operations
F-5
Statements of Changes in Stockholders’ Equity
F-6
Statements of Cash Flows
F-7
Notes to Financial Statements
F-8
F- 1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Board of Directors and Stockholders of
BioVie, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets
of BioVie Inc. (the “Company”) as of June 30, 2026 and 2025, and the related statements of operations, changes in stockholders’
equity, and cash flows for each of the years then ended, and the related notes (collectively referred to as the “financial statements”).
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of June 30,
2026 and 2025, and the results of its operations and its cash flows for of the years then ended, in conformity with accounting principles
generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company‘s
recurring losses from operations and negative cash flows from operating activities raise substantial doubt about its ability to continue
as a going concern. Management’s plans regarding these matters are also described in Note 2. The financial statements do not include
any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
F- 2
Critical Audit Matter
The critical audit matter communicated below is
a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the
audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially
challenging, subjective, or complex judgments. The communication of the critical audit matter 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 matter below, providing a separate opinion
on the critical audit matter or on the accounts or disclosures to which it relates.
Research and development expenses and related
accruals
As described in Note 3 to the accompanying financial
statements, research and development expenses consist primarily of costs associated with the preclinical and/or clinical trials of drug
candidates, compensation and other expenses for research and development, personnel, supplies and development materials, costs for consultants
and related contract research costs. The amounts recorded for clinical trial expenses represent the Company’s estimates of clinical
trial expenses based on facts and circumstances known to the Company at that time, and are dependent upon the timely and accurate reporting
of contract research organizations and other third-party vendors.
We identified the accounting for the research
and development expenses and related accruals to be a critical audit matter due to the degree of management judgement in ensuring they
are complete, accurate and classified correctly, their significance, and the risk of material misstatement due to the nature and timing
of these costs and accruals. This in turn led to a high degree of auditor judgment, subjectivity, and effort in applying the procedures
related to their accounting.
Addressing the matter involved performing procedures
and evaluating audit evidence in connection with forming our overall opinion on the financial statements. These procedures included, obtaining
an understanding of management’s process and evaluating the design of controls over research and development expense classification
and the completeness and accuracy of related accruals, independently researching vendors, testing a selection of research and development
expense transactions to determine, based on the underlying supporting documents, the mathematical accuracy of the expense and the appropriateness
of the expense classification. In addition, we made inquiries of management and reviewed subsequent payments, invoices and agreements
relating to certain research and development expenses to evaluate if the accruals were properly recorded as of June 30, 2026.
/s/ EisnerAmper LLP
We have served as the Company’s auditor
since 2019.
EISNERAMPER LLP
Iselin , New Jersey
August 12, 2026
F- 3
BioVie Inc.
Balance Sheets
June 30,
June 30,
2026
2025
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 8,977,370
$ 17,544,547
Grant receivable
2,151,440
2,104,050
Prepaid and other current assets
2,513,355
1,049,897
Total current assets
13,642,165
20,698,494
Operating lease right-of-use asset, net
262,586
339,653
Intangible assets, net
-
178,341
Goodwill
345,711
345,711
TOTAL ASSETS
$ 14,250,462
$ 21,562,199
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses
$ 3,704,762
$ 2,200,320
Current portion of operating lease liability
91,009
74,464
Total current liabilities
3,795,771
2,274,784
Operating lease liability, net of current portion
184,421
275,430
TOTAL LIABILITIES
3,980,192
2,550,214
Commitments and contingencies (Note 9)
STOCKHOLDERS' EQUITY:
Preferred stock; $ 0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding
-
-
Common stock, $ 0.0001 par value; 800,000,000 shares authorized at June 30, 2026 and June 30, 2025; 7,545,474 shares issued of which 7,542,638 shares outstanding at June 30, 2026; and 1,917,061 shares issued of which 1,914,224 shares are outstanding at June 30, 2025
754
192
Additional paid in capital
384,530,198
371,156,068
Accumulated deficit
( 374,260,653 )
( 352,144,246 )
Treasury stock
( 29 )
( 29 )
Total stockholders' equity
10,270,270
19,011,985
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$ 14,250,462
$ 21,562,199
The accompanying notes are an integral part
of the financial statements.
F- 4
BioVie Inc.
Statements of Operations
Year Ended
Year Ended
June 30, 2026
June 30, 2025
OPERATING EXPENSES:
Amortization of intangible assets
$ 178,341
$ 229,377
Research and development expenses
13,962,360
9,266,734
General and administrative expenses
8,511,032
8,570,089
TOTAL OPERATING EXPENSES
22,651,733
18,066,200
LOSS FROM OPERATIONS
( 22,651,733 )
( 18,066,200 )
OTHER (INCOME) EXPENSE:
Change in fair value of derivative liabilities
-
( 3,771 )
Interest expense
17,901
332,720
Interest income
( 596,771 )
( 853,029 )
TOTAL OTHER INCOME, NET
( 578,870 )
( 524,080 )
NET LOSS
$ ( 22,072,863 )
$ ( 17,542,120 )
Deemed dividend related to ratchet adjustment to warrants
43,544
369,465
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ ( 22,116,407 )
$ ( 17,911,585 )
NET LOSS PER COMMON SHARE
- Basic
$ ( 3.05 )
$ ( 12.12 )
- Diluted
$ ( 3.05 )
$ ( 12.12 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
- Basic
7,245,928
1,477,372
- Diluted
7,245,928
1,477,372
The accompanying notes are an integral part
of the financial statements.
F- 5
BioVie Inc.
Statements of Changes in Stockholders’
Equity
For the Years Ended June 30, 2026 and 2025
Additional
Total
Common Stock
Common Stock
Paid in
Treasury Stock
Treasury Stock
Accumulated
Stockholders'
Shares
Amount
Capital
Shares
Amount
Deficit
Equity
Balance, June 30, 2024
621,640
$ 62
$ 349,738,841
( 2,633 )
$ ( 27 )
$ ( 334,232,661 )
$ 15,506,215
Stock - based compensation - stock options
-
-
1,195,447
-
-
-
1,195,447
Stock - based compensation - restricted stock units and restricted shares
-
-
1,202,809
-
-
-
1,202,809
Proceeds from issuance of common stock, net of costs of $3,240,288
988,394
99
15,674,514
-
-
-
15,674,613
Issuance of common stock from vesting of restricted stock units
11,314
7
( 5 )
( 203 )
( 2 )
-
-
Stock-based compensation - issuance of common stock for services rendered
6,000
-
73,680
-
-
-
73,680
Issuance of common stock from exercise of warrants
223,130
22
2,901,319
-
-
-
2,901,341
Issuance of common stock from cashless exercise of warrants
422
-
-
-
-
-
-
Deemed dividend for ratchet adjustment to warrants
-
-
369,465
-
-
( 369,465 )
-
Issuance of additional shares for fractional shares effected by the reverse split
66,161
2
( 2 )
-
-
-
-
Net Loss
-
-
-
-
-
( 17,542,120 )
( 17,542,120 )
Balance, June 30, 2025
1,917,061
$ 192
$ 371,156,068
( 2,836 )
$ ( 29 )
$ ( 352,144,246 )
$ 19,011,985
Stock - based compensation - stock options
-
-
2,283,809
-
-
-
2,283,809
Stock - based compensation - restricted stock units and restricted shares
-
-
589,710
-
-
-
589,710
Proceeds from issuance of common stock, net of costs of $1,543,038
5,620,000
562
10,457,067
-
-
-
10,457,629
Issuance of common stock from vesting of restricted stock units
8,413
-
-
-
-
-
-
Deemed dividend for ratchet adjustment to warrants
-
-
43,544
-
-
( 43,544 )
-
Net Loss
-
-
-
-
-
( 22,072,863 )
( 22,072,863 )
Balance, June 30, 2026
7,545,474
$ 754
$ 384,530,198
( 2,836 )
$ ( 29 )
$ ( 374,260,653 )
$ 10,270,270
The accompanying notes are an integral part
of the financial statements.
F- 6
BioVie Inc.
Statements of Cash Flows
Year Ended
Year Ended
June 30, 2026
June 30, 2025
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 22,072,863 )
$ ( 17,542,120 )
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization of intangible assets
178,341
229,377
Stock based compensation - restricted stock units and restricted shares
589,710
1,202,809
Stock based compensation expense - stock options
2,283,809
1,195,447
Stock based compensation expense - issuance of common stock for services rendered
-
73,680
Amortization of financing costs
-
11,820
Accretion of unearned loan discount
-
111,212
Accretion of loan premium
-
25,758
Non-cash lease expense from right-of-use asset
77,067
67,073
Change in fair value of derivative liabilities
-
( 3,771 )
Changes in operating assets and liabilities:
Grant receivable
( 47,390 )
( 2,104,050 )
Prepaid and other current assets
( 1,463,458 )
( 845,505 )
Accounts payable and accrued expenses
1,504,442
( 1,386,592 )
Operating lease liability
( 74,464 )
( 60,343 )
Net cash used in operating activities
( 19,024,806 )
( 19,025,205 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from issuance of common stock
10,457,629
15,674,613
Proceeds from exercise of warrants
-
2,901,341
Payment of loan premium
-
( 850,000 )
Payment of note payable
-
( 5,000,000 )
Net cash provided by financing activities
10,457,629
12,725,954
Net change in cash and cash equivalents
( 8,567,177 )
( 6,299,251 )
Cash and cash equivalents, beginning of period
17,544,547
23,843,798
Cash and cash equivalents, end of period
$ 8,977,370
$ 17,544,547
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for interest
$ 17,901
$ 183,930
SUPPLEMENTAL DISCLOSURE OF NONCASH FINANCING ACTIVITIES:
Deemed dividend for ratchet adjustment to warrants
$ 43,544
$ 369,465
The accompanying notes are an integral part
of the financial statements.
F- 7
BioVie Inc.
Notes to Financial Statements
1.
Background Information
BioVie Inc. (the “Company” or “we”
or “our”) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative
disorders and advanced liver disease.
Neurodegenerative Disease Programs
The Company acquired the biopharmaceutical assets
of NeurMedix, Inc. (“NeurMedix”), a privately held clinical-stage pharmaceutical company and a related party in June 2021.
The acquired assets included NE3107 (“bezisterim”). Bezisterim, the approved generic name for NE3107 is an investigational,
novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory
cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play
fundamental roles in the development of Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”),
and bezisterim could, if approved by the U.S. Food and Drug Administration (“FDA”), represent an entirely new medical approach
to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD, 1 million Americans suffering from
PD, and approximately 20 million adults in the US suffering from Long COVID, with millions more affected worldwide.
With respect to the mechanism of action, we believe
bezisterim inhibits activation of inflammatory extracellular signal-regulated kinase (“ERK”) and nuclear factor kappa-light-chain-enhancer
of activated B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”) signaling and other
relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance. By binding to ERK and selectively modulating NFκB
activation and TNF-α production without interfering with their homeostatic functions (e.g., insulin signaling and neuron growth
and survival), we believe that bezisterim may offer clinical improvements in several disease indications, including PD, AD and long COVID.
Chronic neuroinflammation, insulin resistance,
and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and
Amyotrophic lateral sclerosis. Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential
anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated
inflammation. Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s
work testing the molecule in AD, PD, and long COVID patients. Bezisterim (NE3107) is patented in the United States, Australia, Canada,
Europe and South Korea.
Parkinson’s Disease
PD is driven in large part by neuroinflammation
and activation of brain microglia, leading to increased proinflammatory cytokines (particularly TNF). Multiple daily administrations of
levodopa (converted to dopamine in the brain) is the current standard of care treatment for this movement disorder. However, levodopa
effectiveness diminishes over time necessitating increased dosage and prolonged daily administration leads to side effects of uncontrolled
movements called levodopa-induced dyskinesia, commonly referred to as LID, which is exacerbated by high dose levodopa. Although levodopa
provides symptomatic benefit, it does not slow PD progression.
The Company recently
conducted a Phase 2b clinical trial of bezisterim as a potential first-line therapy for patients with newly diagnosed PD. The SUNRISE-PD
trial was designed to evaluate the safety and efficacy of bezisterim on motor and non-motor symptoms in patients with PD who have not
been treated with carbidopa/levodopa. The trial was a multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized
design and lasted 20 weeks from initial screening through safety follow-up for each participant. The trial commenced in April 2025and
completed enrollment in December 2025. In August 2026, the Company announced topline results of the trial. The trial successfully met
prespecified endpoints and achieved its objectives, with topline results showing that bezisterim improved blood based inflammatory markers
of disease, along with a broad range of biological markers associated with overall cellular health and nerve cell damage. Participants
treated with bezisterim experienced greater improvements than those receiving placebo across a series of clinical outcome measures of
daily living, motor symptoms, and nonmotor symptoms. We intend to use these results to inform the design of a potentially pivotal Phase
3 registrational trial of bezisterim in PD.
F- 8
The previous Phase 2 study of bezisterim
(NE3107) for the treatment of PD (NCT05083260) that we completed in December 2022, was a double-blind, placebo-controlled, safety,
tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five
patients with a defined L-dopa “off state” were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28
days. This trial was launched with two design objectives: 1) the primary objective was safety and a drug-drug interaction study as
requested by the FDA to measure the potential for adverse interactions of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the
secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity
could be seen in humans. Both objectives were met.
Long COVID Program
Long COVID is a condition in which symptoms of
COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period, generally three months or more.
Common symptoms include lingering loss of smell and taste, extreme fatigue, and “brain fog,” though persistent cardiovascular
and respiratory problems, muscle weakness, and neurologic issues have also been documented.
In April 2024, the Company was awarded a clinical
trial grant of $13.1 million from the U.S. Department of War (“DOW”), formerly known as the Department of Defense, awarded
through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, the U.S.
Army Medical Research and Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan
to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID and the FDA authorized our Investigational
New Drug (“IND”) application for bezisterim allowing the Company to study a novel, anti-inflammatory approach for the treatment
of the debilitating neurocognitive symptoms associated with long COVID. The Phase 2 ADDRESS-LC study is a randomized (1:1), placebo-controlled,
multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with long COVID who have cognitive
impairment sequelae and fatigue. The trial commenced in May 2025 and completed enrollment in May 2026. The Company
currently expects to report topline results in late summer 2026.
As of June 30, 2026, the total cost incurred was
approximately $ 12.9 million and as of August 7, 2026 the total cost reimbursed was $ 12.9 million. Grant reimbursements recognized for the corresponding
research and development expenses in the accompanying statements of operations totaled approximately $ 7.6 million and $ 5.3 million for
the years ended June 30, 2026 and 2025, respectively.
Alzheimer’s Disease
In AD, BioVie has conducted both Phase 2 and Phase
3 trials. Preliminary data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its
potential as a therapy for the six million Americans living with AD.
Results of a Phase 2 investigator-initiated
trial (NCT05227820) showing bezisterim treated patients experienced improved cognition and biomarker levels were presented at the
Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in December 2022.
On November 29, 2023, the Company announced the
analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim in the treatment of mild
to moderate AD. The study had co-primary endpoints measuring cognitive impairment using the Alzheimer’s Disease Assessment Scale-Cognitive
Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus
placebo, to receive sequentially 5 mg of bezisterim orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed
by 26 weeks of 20 mg orally twice daily.
Upon trial completion, as the Company began the
process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”)
violations at 15 study sites (virtually all of which were from one geographic area). This highly unusual level of suspected improprieties
led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”)
for potential further action. After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom
were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic
data.
F- 9
The trial was originally designed to be 80% powered
with 125 patients in each of the treatment and placebo arms. The unplanned exclusion of so many patients left the trial underpowered for
the primary endpoints. In the Per-Protocol population, which included those patients who completed the trial and who were further verified
to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing
of cognitive decline; these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic changes.
Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as
measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age. This test was a non-primary/secondary
endpoint, other-outcome measure, done via blood collected at week 30 (end of study). Additional DNA methylation data continues to be collected
and analyzed.
Liver Cirrhosis Program
In liver disease, our investigational drug candidate
BIV201 (continuous infusion terlipressin) was granted both FDA Fast Track status and FDA Orphan Drug designation for ascites (due to all
etiologies except cancer), which is the most common complication related to liver cirrhosis and represents a significant unmet medical
need. BIV201 is being evaluated as a treatment option for patients suffering from life-threatening complications of liver cirrhosis and
ascites due to hepatitis, nonalcoholic steatohepatitis, and alcoholism. U.S. treatment costs for liver cirrhosis, including ascites and
other complications, are estimated at more than $5 billion annually and have an estimated 50% mortality rate within 6 to 12 months. The
FDA has never approved any drug specifically for treating ascites.
After receiving guidance from the FDA regarding
the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is currently finalizing
the protocol design for the Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint
of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from acute kidney injury (“AKI”).
Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often
exceeding five liters, due to liver and kidney dysfunction. BIV201 is administered in a continuous infusion of terlipressin as a patent-pending
liquid formulation with patents issued in the U.S., China, Japan, Chile, Australia, Mexico and India to date. Terlipressin is used in
over 40 countries to treat complications of liver cirrhosis, including Type 1 hepatorenal syndrome and bleeding esophageal varices, and
was approved in the U.S. in 2022 to improve kidney function in adults with hepatorenal syndrome experiencing a rapid reduction in kidney
function; it is not currently approved in Japan.
In May 2025, the Company formed Option Therapeutics,
Inc., a Delaware corporation, as a wholly owned subsidiary with no discreet financial information. In January 2026, the Company filed
a Form S-1 with carved out financial statements for Option Therapeutics, Inc.
2.
Liquidity and Going Concern
The Company’s operations are subject to
a number of factors that can affect its operating results and financial conditions. Such factors include, but are not limited to: the
results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval
to market its products; competition from products manufactured and sold or being developed by other companies; the price of, and demand
for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for
its products; and the Company’s ability to raise capital. The Company’s financial statements have been prepared assuming the
Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal
course of business. As of June 30, 2026, the Company had working capital of approximately $ 9.8 million, cash and cash equivalents of approximately
$ 9.0 million, stockholders’ equity of approximately $ 10.3 million, and an accumulated deficit of approximately $ 374.3 million. The
Company is in the pre-revenue stage and no revenues are expected in the foreseeable future. The Company’s future operations are
dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure additional
financing as needed. Projected cash flows could be extended if further measures are taken to delay planned expenditures in our research
protocols and slow the progress in the Company’s development and launch of next phase clinical programs.
The future viability of the Company is largely
dependent upon its ability to raise additional capital to finance its operations. Management expects that future sources of funding may
include sales of equity, obtaining loans, or other strategic transactions.
F- 10
Although management continues to pursue the Company’s
strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the
Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue
as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
3.
Significant Accounting Policies
Basis of Presentation
The Company’s financial statements have
been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and include all adjustments
necessary for the fair presentation of the Company’s financial position for the periods presented.
Use of Estimates
The preparation of financial statements in conformity
with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying
notes. The Company bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the
circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported
for each of the periods presented in the statements of operations are affected by estimates and assumptions, which are used for, but not
limited to, accounting for clinical accruals, share-based compensation, assumptions used in recording leases, the inputs used in the valuation
of goodwill and intangible assets in connection with impairment testing and accounting for income taxes. Actual results could differ from
those estimates.
Cash and cash equivalents
Cash and cash equivalents consisted of cash deposits
and money market funds held at a bank and funds held in a brokerage account which included a U.S. treasury money market fund and U.S.
Treasury Bills with original maturities of three months or less.
Concentration of Credit Risk in the Financial
Service Industry
As of June 30, 2026, the Company had cash deposited
in a certain financial institution in excess of federally insured levels. The Company regularly monitors the financial stability of these
financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents. However, if liquidity
and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the
Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse
effect on its business, financial condition and results of operations.
Fair value measurement of assets and liabilities
We determine the fair values of our financial
instruments based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use
of unobservable inputs when measuring fair value. Fair value is defined as the price that would be received to sell an asset or paid to
transfer a liability in an orderly transaction between market participants at the measurement date. The fair value assumes that the transaction
to sell the asset or transfer the liability occurs in the principal or most advantageous market for the asset or liability and establishes
that the fair value of an asset or liability shall be determined based on the assumptions that market participants would use in pricing
the asset or liability. The classification of a financial asset or liability within the hierarchy is based upon the lowest level input
that is significant to the fair value measurement. The fair value hierarchy prioritizes the inputs into three levels that may be used
to measure fair value:
Level 1 - Inputs are unadjusted quoted prices
in active markets for identical assets or liabilities.
Level 2 - Inputs are quoted prices for similar
assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through
market corroboration, for substantially the full term of the financial instrument.
Level 3 - Inputs are unobservable inputs based
on our assumptions.
F- 11
The Company’s financial instruments include
cash, accounts payable and the carrying value of the operating lease liabilities. The carrying amounts of cash and accounts payable approximate
their fair value, due to the short-term nature of these items. The carrying amounts of operating lease liabilities approximate their fair
values since they bear interest at rates which approximate market rates for similar debt instruments.
Prepaid and other assets
Prepaid and other assets consist of prepayments
of certain expenses such as cost related to capital raise activities, insurance reimbursement; and a security deposit paid in connection with a lease agreement.
Leases
The Company determines whether an arrangement
contains a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current portion
of operating lease liabilities, and operating lease liabilities, net of current portion on our balance sheets. ROU assets represent the
Company’s right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments
arising from the lease. ROU assets and lease liabilities are recognized based on the present value of the future minimum lease payments
over the lease term at the commencement date. As the Company’s leases do not provide an implicit rate, an incremental borrowing
rate is used based on the information available at the commencement date in determining the present value of lease payments. The Company
does not include options to extend or terminate the lease term in its calculation unless it is reasonably certain that the Company will
exercise any such options. Rent expense is recognized under the operating leases on a straight-line basis. The Company does not recognize
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
will recognize lease payments as expense on a straight-line basis over the lease term.
Research and Development
Research and development expenses consist primarily
of costs associated with the preclinical and/or clinical trials of drug candidates, compensation and other expenses for research and development,
personnel, supplies and development materials, costs for consultants and related contracted research costs.
Income Taxes
The Company uses the asset and liability method of accounting for deferred
income taxes. Deferred income taxes are measured by applying enacted statutory rates to net operating loss carryforwards and to the differences
between the financial reporting and tax bases of assets and liabilities. Deferred tax assets are reduced, by a valuation allowance if
it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company decided to apply a full
valuation allowance against its deferred tax assets due to the continuing losses.
The Company recognizes uncertainty in income taxes
in the financial statements using a recognition threshold and measurement attribute of a tax position taken or expected to be taken in
a tax return. The Company applies the “more-likely-than-not” recognition threshold to all tax positions, commencing at the
adoption date of the applicable accounting guidance, which resulted in no unrecognized tax benefits as of such date. Additionally, there
have been no unrecognized tax benefits subsequent to adoption. The Company has opted to classify interest and penalties that would accrue,
if any, according to the provisions of relevant tax law as general and administrative expenses, in the Statements of Operations. For the
years ended June 30, 2026 and 2025, there was no such interest or penalties.
Net Loss per Common Share
Basic net loss per common share is computed by
dividing the net loss attributable to Common Stockholders by the weighted average number of shares of Common Stock outstanding during
the period. Diluted net loss per common share is computed by dividing the net loss attributable to Common Stockholders by the weighted
average number of shares of Common Stock outstanding and potentially outstanding shares of Common Stock during the period to reflect the
potential dilution that could occur from common shares issuable through stock options, warrants, and convertible debentures. For the years
ended June 30, 2026 and 2025, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to
the net loss for the periods presented.
F- 12
The weighted average number of common shares outstanding
for the year ended June 30, 2026 of 7,245,928 includes the weighted average effect of the pre-funded warrants issued in connection with
the August 2025 Offering, the exercise of which requires nominal consideration for the delivery of the shares of common stock (see Note
6).
The table below shows the potential shares of
common stock, presented based on amounts outstanding at each year end, that were excluded from the computation of diluted net loss per
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
June 30, 2026
June 30, 2025
Number of Shares
Number of Shares
Stock Options
2,785,363
84,872
Warrants
7,902,037
960,098
Restricted Stock Units
300
7,213
10,687,700
1,052,183
Stock-based Compensation
The Company has accounted for stock-based compensation
under the provisions of Accounting Standards Codification (“ASC”) Topic 718 – “Stock Compensation” (“ASC
718”) which requires the use of the fair-value based method to determine compensation for all arrangements under which employees
and others receive shares of stock or equity instruments (stock options and Common Stock purchase warrants). For employees and non-employees
awards, the fair value of each stock option award is estimated on the date of grant using the Black-Scholes valuation model that uses
assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate, and is generally recognized as
an expense over the requisite service period, net of forfeitures which are recorded as they occur. Expected volatilities are based on
historical volatility of peer companies and other factors estimated over the expected term of the stock options. For employee and non-employee
awards, the expected term of options granted is derived using the “simplified method” which computes expected term as the
average of the sum of the vesting term plus the contract term. The risk-free rate is based on the U.S. Treasury yield curve in effect
at the time of grant for the period of the expected term.
Goodwill
Goodwill is recorded when the purchase price paid
for an acquisition exceeds the fair value of the net identified tangible and intangible assets acquired. The Company performs an annual
impairment test of goodwill and further periodic tests to the extent indicators of impairment develop between annual impairment tests.
The Company’s impairment review process compares the fair value of the reporting unit to its carrying value, including the goodwill
related to the reporting unit. To determine the fair value of the reporting unit, the Company may use various approaches including an
asset or cost approach, market approach or income approach or any combination thereof. These approaches may require the Company to make
certain estimates and assumptions including future cash flows, revenue and expenses. These estimates and assumptions are reviewed each
time the Company tests goodwill for impairment and are typically developed as part of the Company’s routine business planning and
forecasting process. While the Company believes its estimates and assumptions are reasonable, variations from those estimates could produce
materially different results. The Company did not recognize any goodwill impairments for the years ended June 30, 2026 and 2025.
Impairment of Long-Lived Assets
Long-lived assets, including intangible assets,
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.
F- 13
If the carrying amount of an asset exceeds its
undiscounted estimated future cash flows, an impairment review is performed. An impairment charge is recognized in the amount by which
the carrying amount of the asset exceeds the fair value of the asset. Generally, fair value is determined using valuation techniques such
as expected discounted cash flows or appraisals, as appropriate. Assets to be disposed of would be separately presented in the balance
sheet and reported at the lower of the carrying amount or fair value less costs to sell, and are no longer depreciated or amortized. The
assets and liabilities of a disposed group classified as held for sale would be presented separately in the appropriate asset and liability
sections of the balance sheets. The Company did not recognize any long-lived asset impairments for the years ended June 30, 2026 and 2025.
Grant program
The Company records expenses related to the DOD
Long Covid Program as such expenses are incurred. The reimbursement of such expenses is recognized upon receipt of the reimbursement,
or when it is probable the reimbursement will be received, as a credit against the respective expense account.
Segment Reporting
The Company operates as one operating segment
with a focus on its efforts to develop drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver
disease. The Company's Chief Executive Officer (“CEO”), as the chief operating decision maker, manages and allocates resources
to the operations of the Company based on the line items included within these financial statements. This enables the CEO to assess the
overall level of available resources and determine how best to deploy these resources across functions, clinical trials, and development
projects in line with the long-term company-wide strategic goals.
Recent Accounting Pronouncements
The Company considers the applicability and impact
of all Accounting Standards Updates (“ASU’s”).
In December 2023, the FASB issued ASU 2023-09,
“Income Taxes (ASC 740): Improvements to Income Tax Disclosures”, which requires disaggregated information about a reporting
entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for fiscal years
beginning after December 15, 2024. The Company adopted this standard retroactively on July 1, 2025, which expanded the Company’s
disclosures beginning with its annual financial statements for the year ended June 30, 2026, but did not have an impact on the consolidated
financial results.
In November 2024, the Financial Accounting Standards
Board (“FASB”) issued Accounting Standards Update (“ASU”) 2024-03, Disaggregation of Income Statement Expenses
(“DISE”), which will require additional disclosure of the nature of expenses included in the income statement in response
to longstanding requests from investors for more information about an entity’s expenses. The new standard requires disclosures about
specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about
selling expenses. The new standard will be effective for public companies for fiscal years beginning after December 15, 2026, and interim
periods within fiscal years beginning after December 15, 2027. The requirements will be applied prospectively with the option for retrospective
application. Early adoption is permitted. The Company is currently evaluating the impact of this accounting standard update on its financial
statements.
4.
Intangible Assets
The Company’s intangible assets consist of intellectual property
acquired from LAT Pharma, Inc. and are amortized over their estimated useful lives. The following is a summary of the intangible assets
as of June 30, 2026 and 2025:
Schedule of intangible assets
June 30, 2026
June 30, 2025
Intellectual Property
$ 2,293,770
$ 2,293,770
Less: Accumulated Amortization
( 2,293,770 )
( 2,115,429 )
Intellectual Property, net
$ -
$ 178,341
F- 14
Amortization expense was $ 178,341 and $ 229,377 for years ended June
30, 2026 and 2025. The Company amortized its intellectual property over an expected useful life of 10 years. The asset is fully amortized,
leaving no remaining balance to amortize in subsequent periods.
5.
Fair Value Measurements
Financial assets
As of June 30, 2026, investments in U.S. Treasury Bills were valued
through use of quoted prices and are classified as Level 1. The following table presents information about our assets that are measured
at fair value on a recurring basis using the above input categories.
Measured at fair value on a recurring basis
Fair Value Measurements at
June 30, 2026
Level 1
Level 2
Level 3
Total
Cash
$ 3,560,168
$ -
$ -
$ 3,560,168
U.S. Treasury Bills due in 3 months or less at purchase
5,417,202
-
-
5,417,202
Total
$ 8,977,370
$ -
$ -
$ 8,977,370
Fair Value Measurements at
June 30, 2025
Level 1
Level 2
Level 3
Total
Cash
$ 3,978,271
$ -
$ -
$ 3,978,271
U.S. Treasury Bills due in 3 months or less at purchase
13,566,276
-
-
13,566,276
Total
$ 17,544,547
$ -
$ -
$ 17,544,547
6.
Equity Transactions
Equity Transactions with Acuitas (former related
party)
On July 15, 2022, the Company entered into a securities
purchase agreement with Acuitas Group Holdings, LLC (“Acuitas”), the Company’s largest stockholder, pursuant to which
Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 36,364 shares of the Company’s Common Stock,
at a price of $165.00 per share (the “PIPE Shares”), and (ii) a warrant to purchase 72,728 shares of Common Stock (“PIPE
Warrant Shares”), at an original exercise price of $182.00, with a term of exercise of five years.
As a result of the Company’s subsequent
capital raises, the warrants’ down round features (the “ratchet adjustment”) resulted in deemed dividends of $ 43,544
and $ 369,465 recognized in the accompanying statements of changes in stockholders’ equity for the years ended June 30, 2026 and
2025, respectively.
For the year ended June 30, 2025, the deemed dividend
of $ 369,465 was recognized based on rachet adjustments from the September 25, 2024 and October 22, 2024 capital raises, that reduced the
exercise prices to $15.30 per share and $13.70 per share, respectively. The fair value of the PIPE Warrant Shares were estimated using
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 ,
remaining term of 2.9 years, risk free rate of 3.5 % and volatility of 93.0 % , resulting in a $ 325,041 deemed dividend; and the following
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
of 4.0 % and volatility of 94.0 % , resulting in a $44,424 deemed dividend.
F- 15
For the year ended June 30, 2026, the deemed dividend
of $ 43,544 was recognized from the ratchet adjustment resulting from the August 2025 capital raise, which reduced the exercise price from
$ 13.70 to $ 2.50 per share. The fair value of the PIPE Warrant Shares was estimated using the Black Scholes Method with the following inputs,
the stock price of $1.79, exercise price of $13.70 and reduced exercise price of $2.50, remaining term of 2.0 years, risk free rate of
3.8 % and volatility of 94.0 % .
Consulting expenses
During the year ended June 30, 2025, the Company paid a Director of
the Company $50,000 for consulting services which are reflected as a component of general and administrative expenses on the accompanying
statement of operations.
Issuance of common stock for cash
On August 31, 2022, the Company entered into a
Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. and B. Riley Securities,
Inc. (collectively, the “Agents”), pursuant to which the Company may issue and sell from time-to-time shares of the Company’s
common stock through the Agents, subject to the terms and conditions of the Sales Agreement. On April 6, 2023, the Company and B. Riley
Securities, Inc. mutually agreed to terminate B. Riley Securities, Inc.’s role as a sales agent under the Sales Agreement. During
the year ended June 30, 2025, the Company sold 215 shares of common stock under the Sales Agreement for total net proceeds of $ 6,400 after
3 % commissions and expenses of approximately $ 200 . On September 25, 2024, the Company suspended the sales agreement and terminated the
continuous offering by us under the effective Prospectus Supplement filed January 19, 2024.
On September 25, 2024, the Company closed a best
efforts public offering (the “September 2024 Offering”) of 136,080 shares of its common stock, par value $ 0.0001 per share,
pre-funded warrants (the “September Pre-funded Warrants”) to purchase 60,000 shares of Common Stock, and warrants to purchase
up to 196,080 shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $ 15.30 per share,
or September Pre-funded Warrant, and the associated September Common Warrant. 26,500 September Pre-funded Warrants were exercised shortly
thereafter and reflected on the statement of changes in stockholders’ equity as a component of proceeds from issuance of common
stock. The September Common Warrants have an exercise price of $ 15.30 per share and were
immediately exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date. The gross proceeds
to the Company from the September 2024 Offering was approximately $ 3.0 million, before deducting placement agent fees and offering expenses
of approximately $747,000. Additionally, upon closing, the Company issued the placement agent warrants (“September Placement Agent’s
Warrants”) to purchase 981 shares of Common Stock exercisable at a per share price of $ 19.10 , which was equal to 125% of the public
offering price per share. The September Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days
from September 25, 2024.
During the year ended June 30, 2025, 189,630 common
warrants from the September 2024 Offering were exercised at $ 15.30 per share for proceeds totaling approximately $ 2.9 million, and 33,500
September Pre-funded Warrants were also exercised. In addition, 667 September Placement Agent’s Warrants were exercised on a cashless
exercise basis and 422 common shares were issued.
In October 2024, the Company closed three registered
direct offerings totaling 825,600 shares of its common stock, par value $ 0.0001 per share, and two concurrent private placements of warrants
to purchase up to 711,000 shares of Common Stock (the “October Common Warrants”) priced at-the-market under Nasdaq rules at
prices ranging from $ 15.00 to $ 28.30 per share (the “October Offerings”) . The October
Common Warrants have exercise prices ranging from $ 13.70 to $ 21.20 per share and are exercisable beginning six months following
issuance and will expire on the fifth anniversary date of the original issuance dates. The gross proceeds to the Company from the October
Offerings totaled approximately $ 15.9 million, before deducting placement agent fees and offering expenses of approximately $ 2.5 million.
Additionally, upon closing of the October Offerings, the Company issued placement agent warrants (the “October Placement Agent’s
Warrants”) to purchase 41,321 shares of Common Stock in the aggregate exercisable at a per share price ranging from $ 18.80 to $ 35.40 ,
which was equal to 125% of the offering price per share in the applicable October Offering. The October Placement Agent’s Warrants
are exercisable during a five-year period commencing 180 days from each of the respective closing dates of the October Offerings.
F- 16
On August 11, 2025, the Company closed an underwritten
public offering of (i) 5,620,000 units (the “Units”), with each Unit consisting of one share of common stock and one warrant
(the “Warrants”) and (ii) 380,000 pre-funded units (the “Pre-Funded Units”), with each Pre-Funded Unit consisting
of one pre-funded warrant and one Warrant. The underwriter also exercised its over-allotment option in part and purchased an additional
667,300 Warrants. The offering resulted in net proceeds of approximately $ 10.5 million, after deducting underwriting discounts and commissions
and other estimated offering expenses. Each Unit was sold to the public at a price of $2.00 per Unit and each Pre-Funded Unit was sold
to the public at a price of $1.9999 per Pre-Funded Unit (which represents the public offering price of each Unit less the $0.0001 per
share nominal exercise price for each Pre-Funded Warrant). On August 8, 2025, the Warrants commenced trading on The Nasdaq Capital Market
under the symbol “BIVIW.” Each Warrant is immediately exercisable, entitles the holder to purchase one share of common stock
at an exercise price of $ 2.50 per share and expires five years from the date of issuance. Each Pre-Funded Warrant is immediately exercisable,
entitles the holder to purchase one share of common stock, and may be exercised at any time until exercised in full. Additionally,
upon closing, the Company issued the underwriter warrants to purchase 300,000 shares of Common Stock exercisable at a per share price
of $2.50, which was equal to 125% of the public offering price per share. The underwriter’s Warrants are exercisable during a five-year
period commencing 180 days from August 11, 2025.
Issuance of common stock for services
On August 12, 2024, the Company awarded 1,500
shares of Common Stock to a vendor as part of their fees in exchange for services. The fair value of the Common Stock at the date of issuance
was $ 22.30 per share. The stock-based compensation expense related to this Common Stock issuance was $ 33,450 for the year ended June 30,
2025.
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. The fair value of the Common Stock at the date of issuance
was $ 8.94 per share. The stock-based compensation expense related to this Common Stock issuance was $ 40,230 for the year ended June 30,
2025.
Stock Options
The following table summarizes the activity relating to the Company’s
stock options for the years ended June 30, 2026 and 2025:
Schedule of stock options
Options
Weighted-
Average
Exercise
Price
Weighted
Remaining
Average
Contractual
Term
Aggregate
Intrinsic
Value
Outstanding at June 30, 2024
51,808
$ 541.10
6.1
$ -
Options Granted
49,031
24.01
7.1
-
Options Expired
( 7,725 )
553.23
-
-
Options Canceled
( 8,242 )
( 78.75 )
-
-
Outstanding at June 30, 2025
84,872
286.20
6.2
-
Options Granted
2,706,550
1.31
7.4
1,705,127
Options Expired
( 6,059 )
1,091.98
0.0
-
Outstanding at June 30, 2026
2,785,363
$ 7.62
7.3
$ 1,705,127
Exercisable at June 30, 2026
1,707,120
$ 10.32
7.0
$ 1,033,762
The Company recorded stock-based compensation expense relating to the
vesting of stock options of approximately $ 2.3 million and $ 1.2 million for the years ended June 30, 2026 and 2025, respectively.
The fair value of each option on the date of grant is estimated using
the Black-Scholes option pricing model. The pricing model reflects the following weighted-average assumptions utilized for the years ended:
F- 17
Schedule of assumptions used
June 30, 2026
June 30, 2025
Expected life of options (in years)
5
4
Expected volatility
89.31 %
93.44 %
Risk free interest rate
3.69 %
4.34 %
Dividend Yield
0 %
0 %
On December 20, 2024 (the “Grant Date”),
the Company granted to employees and directors stock options to purchase 20,893 and 11,308 shares of Common Stock, respectively. The options
have an exercise price of $ 19.00 per share equal to the Company’s stock price at the close on December 20, 2024, the grant date.
The fair value of the stock options issued to Directors were $ 12.00 per share. The fair value of the stock options issued to Management
was $ 14.30 per share.
On January 5, 2026 (the “Grant Date”),
directors’ annual compensation was approved and the directors were granted stock options to purchase a total of 355,000 shares of
common stock, at an exercise price of $1.31 per share, the closing stock price on the grant date. The stock options vest from the beginning
of service on November 11, 2025 in four equal installments on February 11, 2026, May 11, 2026, August 11, 2026 and the earlier of November
11, 2026 or the 2026 annual shareholders' meeting.
On January 5, 2026 (the “Grant Date”),
the Company awarded bonus and retention incentive stock options to certain directors and employees to purchase a total of 812,700 and
1,538,850 , respectively; shares of common stock, at an exercise price of $ 1.31 per share, the closing stock price on the Grant Date. The
directors’ stock options vested 75 % on the Grant Date with the remaining balance vesting in equal installments on the first, second
and third Grant Date anniversary. The employees’ stock options vested 55 % on grant date with the remaining balance vesting in equal
installments on the first, second and third Grant Date anniversary.
Issuance and modification of restricted stock units, restricted
shares and stock options:
On November 9, 2023 (the “Grant Date”),
the Company granted equity awards for the board of directors’ annual compensation. Four directors received 1,827 Restricted Stock
Units (“RSUs”) with a grant date fair value of $ 301.00 per share. In addition, two directors received stock options to purchase
1,833 shares of common stock at an exercise price of $ 301.00 per share with a grant date fair value of $ 183.00 per share. The equity awards
vested quarterly on February 9, 2024, May 9, 2024, August 9, 2024 and earlier of November 9, 2024 or the next annual shareholders’
meeting. During the year ended June 30, 2024, 457 of these RSUs vested. During the year ended June 30, 2025, 682 of these RSUs vested
and 232 RSUs were cancelled due to Mr. Gorlin resigning from the Board of Directors.
On November 20, 2024 (the “Grant Date”),
the Company granted equity awards as part of the board of directors’ annual compensation. Two directors received 6,690 RSUs with
a grant date fair value of $ 33.60 per share and three directors received stock options to purchase 16,830 shares of Common Stock at an
exercise price of $ 33.60 per share with a grant date fair value of $ 21.10 per share. The RSUs vested quarterly on February 8, 2025, May
8, 2025, August 8, 2025 and the earlier of November 8, 2025 or the next annual shareholders’ meeting. During the year ended June
30, 2025, 2,528 shares were issued related to the RSUs that vested and 2,415 shares were canceled due to departures.
On January 1, 2025 (the “Grant Date”),
the Company awarded 4,500 shares of restricted common stock as part of a service agreement to a vendor. The restricted common shares fully
vest on the first anniversary of the effective date. 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 expense for the year ended June 30, 2025 was $ 49,050 .
On January 21, 2025 (the “Grant Date”),
the Company granted a total of 10,500 RSUs to Advisory board members at the grant date fair value of $ 20.50 . Vesting of the RSUs are in
five equal installments at the grant date and each calendar quarter end beginning March 31, 2025.
On September 2, 2025 (the “Grant Date”),
the Company granted a total of 1,500 RSUs to a consultant at the grant date fair value of $ 1.58 per RSU. The RSUs vest in five equal installments
beginning on the Grant Date and over the following four calendar quarters beginning December 31, 2025.
The following table summarizes vesting of restricted
stock units:
F- 18
Schedule of unvested of restricted stock units
Number of Shares
Weighted
Average
Grant Date
Fair Value
Per Share
Unvested at June 30, 2024
4,030
$ 445.90
Issued
17,190
25.60
Vested
( 11,314 )
107.60
Canceled
( 2,693 )
70.75
Unvested at June 30, 2025
7,213
$ 116.41
Granted
1,500
1.58
Vested
( 8,413 )
100.09
Unvested at June 30, 2026
300
$ 1.58
The total stock-based compensation expense from restricted stock units
and restricted shares for the year ended June 30, 2026 and 2025 was approximately $ 590,000 and $ 1.2 million, respectively.
Stock Warrants
The following table summarizes the warrants activity during the years
ended June 30, 2026 and 2025:
Summary of warrants activity
Number of Shares
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Life (Years)
Aggregate
Intrinsic
Value
Outstanding and exercisable at June 30, 2024
193,203
$ 140.30
4.0
$ -
Granted
1,018,210
16.54
4.8
-
Exercised
( 250,297 )
15.31
-
-
Expired
( 1,018 )
218.81
-
-
Outstanding and exercisable at June 30, 2025
960,098
35.02
4.1
-
Granted
6,967,300
2.50
4.1
-
Canceled
( 25,001 )
150.00
-
-
Expired
( 360 )
1,250.00
-
-
Outstanding and exercisable at June 30, 2026
7,902,037
$ 5.82
4.0
$ -
The table below shows the expiration of the warrants
outstanding as of June 30, 2026:
Schedule of warrants outstanding
Number of Warrants
Expiring June 30,
2027
3,610
2028
72,728
2029
90,508
2030
767,891
2031
6,967,300
Total outstanding warrants
7,902,037
The warrants tables exclude 380,000 prefunded warrants with an exercise
price of $ 0.0001 and no expiration. None of the prefunded warrants were exercised during the year ended June 30, 2026.
F- 19
7.
Notes Payable
On November 30, 2021 (the “Closing Date”),
the Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and Promissory Notes (together,
the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (“AVOPI”) and Avenue Venture Opportunities
Fund II, L.P. (“AVOPII,” and together with AVOPI, “Avenue”) for growth capital loans in an aggregate commitment
amount of up to $20 million (the “Loan”). On the Closing Date, $15 million of the Loan was funded (“Tranche 1”).
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
Journal and (b) 10.75%. The Loan was secured by a lien upon and security interest in all of the Company’s assets, including intellectual
property, subject to agreed exceptions. The Loan was paid in full on its maturity date of December 1, 2024 along with a final payment
equal to 4.25 % of the Loan commitment amount, or $850,000, the (“Loan Premium”) and the lien upon and security interest in
all of the Company’s assets was released.
8.
Leases
Office Leases
The Company pays an annual rent of $ 2,200 for its headquarters at 680
W Nye Lane, Suite 201, Carson City Nevada 89703. The rental agreement was for a one-year term, 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 5090 Shoreham Place Suite
206, San Diego, CA 92122 was amended on February 12, 2024 for a larger space. The current monthly base rate for the office space is $ 10,375 ,
with annual increases of four percent. The term of the lease is 60 months.
Total operating lease expense for the years ended June 30, 2026 and
2025 of approximately $ 133,000 and $ 127,000 , respectively, were included in the accompanying statements of operations as a component of
general and administrative expenses.
The right-of-use asset, net and current and
long-term portion of the operating lease liability included in the accompanying balance sheets are as follows:
Schedule of deferred tax assets
June 30, 2026
June 30, 2025
Assets
Operating lease right-of-use asset, net
$ 262,586
$ 339,653
Liabilities
Current portion of operating lease liability
$ 91,009
$ 74,464
Operating lease liability, net of current portion
184,421
275,430
Total operating lease liability
$ 275,430
$ 349,894
At June 30, 2026, the future estimated minimum lease payments under
non-cancelable operating leases are as follows:
Schedule of future estimated minimum lease payments under non-cancelable operating leases
Year ending:
2027
$ 126,313
2028
130,734
2029
77,796
Total minimum lease payments
334,843
Less amount representing interest
( 59,413 )
Present value of future minimum lease payments
$ 275,430
Total cash paid for amounts included in the measurement of lease liability
was $ 122,042 and $ 117,915 for the years ended June 30, 2026 and 2025, respectively.
F- 20
The weighted average remaining lease term and
discount rate as of June 30, 2026 and 2025 were as follows:
Schedule of weighted average remaining lease term and discount rate
June 30, 2026
June 30, 2025
Weighted average remaining lease term (Years)
Operating lease
2.6
3.6
Weighted average discount rate
Operating lease
15.00 %
15.00 %
9.
Commitments and Contingencies
Royalty Agreements
Pursuant to the Agreement and Plan of Merger entered
into on April 11, 2016, by and between our predecessor entities, LAT Pharma and NanoAntibiotics, Inc., the Company is obligated to pay
a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared by the members of LAT Pharma Members,
PharmaIn Corporation, and The Barrett Edge, Inc.
Pursuant to the Technology Transfer Agreement
entered into on July 25, 2016, by and between the Company and the University of Padova (Italy), the Company was obligated to pay a 5%
royalty on net sales (capped at a maximum of $200,000 per year) of all terlipressin products covered by US Patent No. 11364277, expiring
in 2036 and the European Patent No. EP3347032, expiring in 2036 and pending patent applications in the U.S., Europe, China and Japan,
related to the administration of terlipressin as a continuous infusion for the treatment of ascites.
Pursuant to the Intellectual Property Rights Agreement
entered into on April 18, 2019, by and between the Company and DOCUCHEM SLU, the Company is obligated to pay DOCUCHEM SLU $25,000 on the
issuance of the U.S. patent for terlipressin and $50,000 each calendar year in which the gross sales in the U.S. of a product covered
by a claim of an issued U.S. patent as directed to terlipressin exceeds $10,000,000.
Shareholder class action complaint and shareholder derivative complaints
On January 19, 2024, a purported securities class action complaint, captioned Eric Olmstead v. BioVie Inc. et al. , No. 3:24-cv-00035, was filed in the U.S. District Court for the District of Nevada, naming the Company and certain of its officers as defendants. On February 22, 2024, a second, related putative securities class action was filed in the same court asserting similar claims against the same defendants, captioned Way v. BioVie Inc. et al. , No. 2:24-cv-00361. On April 15, 2024, the court consolidated these two actions under the caption In re BioVie Inc. Securities Litigation , No. 3:24-cv-00035 (the “Securities Class Action”), appointed the lead plaintiff, and approved selection of the lead counsel. On June 21, 2024, the lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact relating to the Company’s business, operations, compliance, and prospects, including information related to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable AD, in violation of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The class action is on behalf of purchasers of the Company’s securities during the period from December 7, 2022 through November 28, 2023, and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees. The defendants filed a motion to dismiss the amended complaint on August 21, 2024, and on March 27, 2025, the court denied that motion. The parties are now engaged in fact discovery. On February 13, 2026, the plaintiffs filed a motion for class certification and a motion for leave to file a second amended complaint. Defendants opposed the motion for leave to amend. On June 5, 2026, the court granted the plaintiffs’ motion for leave to amend, and the same day the plaintiffs filed their Second Amended Complaint. On June 15, 2026, the defendants filed a Notice of Non-Opposition and Reservation of Rights in response to the motion for class certification, and on June 18, 2026, the Court granted the plaintiffs’ motion and certified the class subject to the defendants’ reservation of rights. The defendants answered the Second Amended Complaint on June 22, 2026.
F- 21
Three shareholder derivative lawsuits piggy-backing on the Securities Class Action were filed in the United States District Court for the District of Nevada, allegedly on behalf of the Company, by three putative stockholders: Andrew Hulm on December 30, 2024; William Settel on April 28, 2025 and Cline Wilkerson on September 11, 2025, (collectively the “Related Derivative Lawsuits”). Each Related Derivative Lawsuit names the same current and former officers and directors as defendants and alleges essentially the same claims: that the defendants breached their fiduciary duties by causing or failing to prevent the securities violations alleged in the Securities Class Action, and related claims for unjust enrichment, waste of corporate assets, gross mismanagement, and abuse of control. On September 29, 2025, at the request of the parties, the court consolidated all three Related Derivative Lawsuits under the caption In re BioVie Inc. Derivative Litigation , Case No. 3:24-cv-0602-CSD (the “Consolidated Derivative Action”). On January 27, 2026, at the request of the parties, the court stayed the Consolidated Derivative Action pending resolution of a summary judgment motion by defendants in the Securities Class Action.
The Company believes that the claims are
without merit and intends to defend vigorously against them, but there can be no assurances as to the outcome.
10.
Employee Benefit Plan
On August 1, 2021, the Company began sponsoring
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.
Subject to certain limitations in the Internal Revenue Code, eligible
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
first 5% of an employee’s contributions to the 401K Plan. The Company made contributions into the plan of approximately $ 190,248
and $ 152,400 , for the years ended June 30, 2026 and 2025, respectively.
11.
Income Taxes
The U.S. and foreign components of pretax loss are as follows:
Schedule of foreign components
June 30, 2026
June 30, 2025
Pretax Loss
U.S.
$ ( 22,072,863 )
$ ( 17,542,120 )
Foreign
-
-
Total Pretax Loss
$ ( 22,072,863 )
$ ( 17,542,120 )
Significant components of the Company’s deferred tax assets (liabilities)
are as follows:
Schedule of deferred tax assets
June 30, 2026
June 30, 2025
Deferred tax assets (liabilities):
Tax loss carryforward
$ 68,090,002
$ 58,323,950
Intangible assets
-
( 49,935 )
Stock based compensation
7,336,369
6,531,784
R&D capitalized
6,933,926
10,134,322
Valuation Allowance
( 82,360,297 )
( 74,940,121 )
Net deferred tax assets
$ -
$ -
At June 30, 2026 and 2025, the Company has recorded a full valuation
against its net deferred tax assets of approximately $ 82.4 million and $ 74.9 million, respectively, since in the judgement of management,
these assets are not more than likely to be realized. The increase in the valuation allowance during the year ended June 30, 2026 was
approximately $ 7.4 million.
At June 30, 2026, the Company had a Net Operating
Loss (“NOL”) carryforward of approximately $ 243 million. NOL’s generated prior to 2018 have expiration dates ranging
from 2032 to 2037 . Utilization of the Company’s historical NOL are subject to limitations under Internal Revenue Code Section 382
as a result of multiple ownership changes through the Company’s capital raises.
F- 22
The Company has no current tax expense due to its net losses and a
full valuation allowance. The Company has not made payments or received refunds for income taxes for the years ended June 30, 2026 and
2025.
The state and local income tax reconciling item is primarily driven
by California state income taxes, which represented more than 50% of the total state and local income tax effect for the year ended June
30, 2026. The Company is incorporated in Nevada; however, Nevada does not impose a corporate income tax. Accordingly, the Company's state
income tax provision primarily reflects apportionment of taxable income to California based on the Company's operational footprint.
Reconciliation of the differences between income
tax benefit computed at the federal tax rates and the provision for income tax benefit for the years ended June 30, 2026 and 2025 is as
follows:
Schedule of effective income tax rate reconciliation
2026
2025
Income tax expense at federal statutory rate
$ ( 4,635,301 )
21 %
$ ( 3,683,845 )
21 %
State taxes, net of federal benefit
( 1,545,100 )
7 %
( 1,227,948 )
7 %
Effect of changes in tax laws enacted in current period
3,096,085
( 14 %)
-
0 %
Change in valuation allowance
3,084,316
( 14 %)
4,911,793
( 28 %)
Effective tax rate
$ -
-
$ -
-
On July 4, 2025, the One Big Beautiful Bill Act was enacted into law. Among other changes, the legislation permits immediate expensing of domestic research and experimental expenditures for tax years beginning after December 31, 2024. In connection with enactment, the Company remeasured its deferred tax balances and recorded a discrete tax benefit of approximately $ 3.1 million during the year ended June 30, 2026, primarily related to a reduction in deferred tax assets associated with capitalized domestic research and experimental expenditures. The effect of this remeasurement was offset by a corresponding change in the valuation allowance, and accordingly no net income tax expense or benefit was recognized.
12.
Segment Reporting
The Company operates as one operating segment
with a focus on its efforts to develop drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver
disease. The Company's CEO, as the chief operating decision maker, manages and allocates resources to the operations of the Company based
on the line items included within these financial statements and segment performance is evaluated based on net loss. This enables the
CEO to assess the overall level of available resources and determine how best to deploy these resources across functions, clinical trials,
and development projects in line with the long-term company-wide strategic goals. The measurement of segment assets is reported on the
balance sheet as total assets. All of the Company’s tangible assets are held in the United States.
The following table presents selected financial
information with respect to the Company’s single operating segment and its significant segment approximated expenses for the years
ended June 30, 2026 and 2025:
Schedule of segment reporting information
Year ended
Year ended
June 30, 2026
June 30, 2025
Clinical studies
$ 8,177,000
$ 3,660,000
Clinical teams
5,150,000
4,479,000
Chemistry, manufacturing and controls
188,000
834,000
Other research and development expenses
447,000
294,000
General and administrative expenses
8,511,000
8,570,000
Amortization of intangible assets
178,000
229,000
Other income, net
( 579,000 )
( 524,000 )
Net loss
$ ( 22,072,000 )
$ ( 17,542,000 )
F- 23
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.