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 principle 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 Form 10-K. 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.
45
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, 2025 using the criteria established in Internal Control
Integrated Framework issued by the Committee of Sponsoring Organization of the Treadway Commission. Based on our evaluation using those
criteria, our management has concluded that, as of June 30, 2025, 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, 2025 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 2025 Proxy Statement and is incorporated herein by reference.
ITEM 11.
EXECUTIVE COMPENSATION
The information required by this item is included in our 2025 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 2025 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 2025 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 2025 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.
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).
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).
48
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
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 August 28, 2024) (incorporated by reference to Appendix A to the Definitive Information Statement on Schedule 14A, filed on September 27, 2024).
49
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).
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).
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
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 registration statement)
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
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.
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 15, 2025
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 post-effective amendments, 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 15, 2025
Cuong Do
(Principal Executive Officer)
/s/ Joanne Wendy Kim
Chief Financial Officer
August 15, 2025
Joanne Wendy Kim
(Principal Financial and Accounting Officer)
/s/ Jim Lang
Director
August 15, 2025
Jim Lang
/s/ Michael Sherman
Director
August 15, 2025
Michael Sherman
/s/ Amy Chappell
Director
August 15, 2025
Amy Chappell
/s/ Kameel Farag
Diretor
August 15, 2025
Kameel Farag
/s/ Sigmund Rogich
Director
August 15, 2025
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-3
Statements of Operations and Comprehensive Loss
F-4
Statements of Changes in Stockholders’ Equity
F-5
Statements of Cash Flows
F-6
Notes to Financial Statements
F-7
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, 2025 and 2024, and the related
statements of operations and comprehensive loss, 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, 2025 and 2024, 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.
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, 2025.
/s/ EisnerAmper LLP
We have served as the Company’s auditor
since 2019.
EISNERAMPER LLP
Iselin , New Jersey
August
15, 2025
F- 2
BioVie Inc.
Balance Sheets
June 30,
June 30,
2025
2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 17,544,547
$ 23,843,798
Grant receivable
2,104,050
-
Prepaid and other current assets
1,049,897
204,392
Total current assets
20,698,494
24,048,190
Operating lease right-of-use asset, net
339,653
406,726
Intangible assets, net
178,341
407,718
Goodwill
345,711
345,711
TOTAL ASSETS
$ 21,562,199
$ 25,208,345
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses
$ 2,200,320
$ 3,586,912
Current portion of operating lease liability
74,464
60,343
Current portion of notes payable, net of financing cost, unearned premium and discount of $ 701,210 at June 30, 2024
-
5,701,210
Warrant liability
-
3,771
Total current liabilities
2,274,784
9,352,236
Operating lease liability, net of current portion
275,430
349,894
TOTAL LIABILITIES
2,550,214
9,702,130
Commitments and contingencies (Note 10)
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, 2025 and June 30, 2024; 1,917,061 shares issued of which 1,914,224 shares are outstanding at June 30, 2025; and 621,641 shares issued of which 619,008 shares outstanding at June 30, 2024
7,476
6,229
Additional paid in capital
371,148,784
349,732,674
Accumulated deficit
( 352,144,246 )
( 334,232,661 )
Treasury stock
( 29 )
( 27 )
Total stockholders' equity
19,011,985
15,506,215
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$ 21,562,199
$ 25,208,345
The accompanying notes are an integral part
of the financial statements.
F- 3
BioVie Inc.
Statements of Operations and Comprehensive Loss
Year Ended
Year Ended
June 30, 2025
June 30, 2024
OPERATING EXPENSES:
Amortization of intangible assets
$ 229,377
$ 229,377
Research and development expenses
9,266,734
23,100,394
Selling, general and administrative expenses
8,570,089
8,849,814
TOTAL OPERATING EXPENSES
18,066,200
32,179,585
LOSS FROM OPERATIONS
( 18,066,200 )
( 32,179,585 )
OTHER EXPENSE (INCOME):
Change in fair value of derivative liabilities
( 3,771 )
( 1,816,271 )
Interest expense
332,720
2,893,922
Interest income
( 853,029 )
( 1,136,703 )
TOTAL OTHER INCOME , NET
( 524,080 )
( 59,052 )
NET LOSS
$ ( 17,542,120 )
$ ( 32,120,533 )
Deemed dividend related to ratchet adjustment to warrants
369,465
886,423
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ ( 17,911,585 )
$ ( 33,006,956 )
NET LOSS PER COMMON SHARE
- Basic
$ ( 12.12 )
$ ( 73.05 )
- Diluted
$ ( 12.12 )
$ ( 73.05 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
- Basic
1,477,372
451,853
- Diluted
1,477,372
451,853
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ ( 17,911,585 )
$ ( 33,006,956 )
Other comprehensive loss
Reclassification of unrealized gains on available-for-sale investments upon settlement
-
( 176,591 )
Total other comprehensive loss
-
( 176,591 )
Comprehensive loss
$ ( 17,911,585 )
$ ( 33,183,547 )
The accompanying notes are an integral part
of the financial statements.
F- 4
BioVie Inc.
Statements of Changes in Stockholders’
Equity
For the Years Ended June 30, 2025 and 2024
Accumulated
Additional
Other
Total
Common Stock
Common Stock
Paid in
Treasury Stock
Treasury Stock
Comprehensive
Accumulated
Stockholders'
Shares
Amount
Capital
Shares
Amount
Income
Deficit
Equity
Balance, June 30, 2023
364,519
3,643
316,385,759
( 229 )
( 2 )
176,591
( 301,225,705 )
15,340,286
Stock - based compensation - stock options
-
-
2,823,764
-
-
-
-
2,823,764
Stock-based compensation - restricted stock units
-
-
1,763,450
-
-
-
-
1,763,450
Proceeds from issuance of common stock, net of costs of $2,908,141
243,375
2,449
27,800,490
-
-
-
-
27,802,939
Issuance of common stock from vesting of restricted stock units
12,240
122
( 97 )
( 2,404 )
( 25 )
-
-
-
Stock-based compensation - issuance of common stock for services rendered
1,500
15
72,885
-
-
-
-
72,900
Deemed dividend for ratchet adjustment to warrants
-
-
886,423
-
-
-
( 886,423 )
-
Reclassification of unrealized gains on available-for-sale investments upon settlement
-
-
-
-
-
( 176,591 )
-
( 176,591 )
Issuance of additional shares for fractional shares effected by the reverse split
7
-
-
-
-
-
-
-
Net Loss
-
-
-
-
-
-
( 32,120,533 )
( 32,120,533 )
Balance, June 30, 2024
621,641
$ 6,229
$ 349,732,674
( 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
988,395
989
15,673,624
-
-
-
-
15,674,613
Issuance of common stock from vesting of restricted stock units
11,314
11
( 9 )
( 204 )
( 2 )
-
-
-
Stock-based compensation - issuance of common stock for services rendered
6,000
6
73,674
-
-
-
-
73,680
Issuance of common stock from exercise of warrants
223,130
224
2,901,117
-
-
-
-
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
66,159
17
( 17 )
-
-
-
-
-
Net Loss
-
-
-
-
-
-
( 17,542,120 )
( 17,542,120 )
Balance, June 30, 2025
1,917,061
$ 7,476
$ 371,148,784
( 2,837 )
$ ( 29 )
$ -
$ ( 352,144,246 )
$ 19,011,985
The accompanying notes are an integral part
of the financial statements.
F- 5
BioVie Inc.
Statements of Cash Flows
Year Ended
Year Ended
June 30, 2025
June 30, 2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 17,542,120 )
$ ( 32,120,533 )
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization of intangible assets
229,377
229,377
Stock based compensation - restricted stock units and restricted shares
1,202,809
1,763,450
Stock based compensation expense - stock options
1,195,447
2,823,764
Stock based compensation expense - issuance of common stock for services rendered
73,680
72,900
Amortization of financing costs
11,820
108,751
Accretion of unearned loan discount
111,212
1,023,145
Accretion of loan premium
25,758
236,970
Realized gain on maturity of available-for sale
-
( 223,865 )
Non-cash lease expense from right-of-use assets
67,073
49,346
Gain on termination of operating lease
-
( 5,215 )
Change in fair value of derivative liabilities
( 3,771 )
( 1,816,271 )
Changes in operating assets and liabilities:
Grant
receivable
( 2,104,050 )
-
Prepaid and other current assets
( 845,505 )
( 101,866 )
Accounts payable and accrued expenses
( 1,386,592 )
110,653
Operating lease liabilities
( 60,343 )
( 47,245 )
Other current liabilities
-
( 48,385 )
Net cash used in operating activities
( 19,025,205 )
( 27,945,024 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from U.S. Treasury Bills (available-for-sale)
-
14,525,000
Net cash provided by investing activities
-
14,525,000
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from issuance of common stock
15,674,613
27,802,939
Proceeds from exercise of warrants
2,901,341
( 10,000,000 )
Payment of loan premium
( 850,000 )
-
Payments of note payable
( 5,000,000 )
-
Net cash provided by financing activities
12,725,954
17,802,939
Net change in cash and cash equivalents
( 6,299,251 )
4,382,915
Cash and cash equivalents, beginning of period
$ 23,843,798
$ 19,460,883
Cash and cash equivalents, end of period
$ 17,544,547
$ 23,843,798
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for interest
$ 183,930
$ 1,525,056
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING ACTIVITIES:
Right of use assets obtained in exchange for lease obligations
$ -
$ 432,192
Reclassification of unrealized gains on U.S. Treasury Bills (available-for-sale investments) upon settlement
$ -
$ 176,591
Deemed dividend for ratchet adjustment to warrants
$ 369,465
$ 886,423
The accompanying notes are an integral part
of the financial statements.
F- 6
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 (or “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 Long COVID affects approximately 20 million adults in the US, and millions more worldwide.
In neurodegenerative disease, the Company’s
drug candidate bezisterim is an orally bioavailable, Blood Brain Barrier (“BBB”)-permeable, insulin-sensitizer that is also
anti-inflammatory. In addition, it is not immunosuppressive and has a low risk of drug-drug interaction. Bezisterim inhibits activation
of inflammatory action extracellular single 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 and not interfere with their homeostatic functions, BioVie believes that bezisterim may offer clinical
improvements in several disease indications, including PD, AD and long COVID.
Parkinson’s Disease
The Company designed a new Phase 2b study of bezisterim
as a potential first line therapy to treat patients with new onset PD. This trial will be evaluating the safety and efficacy of bezisterim
on motor and non-motor symptoms in patients with PD who haven’t been treated with carbidopa/levodopa. The PD Phase 2b study, multicenter,
randomized, double-blind, placebo-controlled trial with a hybrid decentralized design will last 20 weeks from the initial screening phase
to the safety follow up. In July 2024, the Company submitted the new protocol and received a response from the FDA permitting the Company
to proceed with the study. The trial commenced in April 2025.
The Phase 2 study of bezisterim for the treatment
of PD (NCT05083260) that completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics
study in PD participants treated with carbidopa/levodopa and bezisterim. Forty-five patients with a defined L-dopa “off state”
were randomized 1:1 to placebo: bezisterim 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
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 Defense (“DOD”), awarded through the Peer Reviewed Medical Research
Program of the Congressionally Directed Medical Research Programs. In August 2024, U.S. Army Medical Research and Development Command,
Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim for the treatment of
neurological symptoms that are associated with long COVID and the FDA authorized our Investigational New Drug (“IND”) application
for bezisterim allowing the Company to study a novel, anti-inflammatory approach or the treatment of the debilitating neurocognitive symptoms
associated with long COVID.
F- 7
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. Individuals who have been diagnosed with long COVID and have neurocognitive dysfunction
and self-reported fatigue may meet qualification criteria.
The trial commenced in May 2025. As of June 30,
2025, the total cost incurred was approximately $5.3 million and as of August 4, 2025 approximately $5.3 million was reimbursed.
Alzheimer’s Disease
On November 29, 2023, the Company announced the
analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim in the treatment of mild
to moderate AD. The study had co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive
Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus
placebo, to receive sequentially 5 mg of bezisterim orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed
by 26 weeks of 20 mg orally twice daily.
Upon trial completion, as the Company began the
process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”)
violations at 15 study sites (virtually all of which were from one geographic area). This highly unusual level of suspected improprieties
led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”)
for potential further action. After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom
were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic
data.
The trial was originally designed to be 80% powered
with 125 patients in each of the treatment and placebo arms. The unplanned exclusion of so many patients left the trial underpowered for
the primary endpoints. In the Per-Protocol population, which included those patients who completed the trial and who were further verified
to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing
of cognitive loss; these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic change.
Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as
measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age. This test was a non-primary/secondary
endpoint, other-outcome measure, done via blood test collected at week 30 (end of study). Additional DNA methylation data continues to
be collected and analyzed.
Liver Cirrhosis Program
In liver disease, our investigational drug candidate
BIV201 (continuous infusion terlipressin), which was granted both FDA Fast Track designation status and FDA Orphan Drug Status, is being
evaluated as a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis
caused by non-alcoholic steatohepatitis (NASH), hepatitis, and alcoholism. The initial target for BIV201 therapy was refractory ascites.
These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have
an estimated 50% mortality rate within 6 to 12 months.
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 now targeting
a broader ascites patient population. 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”). This patient population is not limited to those
having refractory ascites. Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of
fluid in the abdomen, often exceeding five liters, due to liver and kidney dysfunction. BIV201 is administered in a continuous infusion
of terlipressin as a patent-pending liquid formulation with patents issued in the U.S., China, Japan, Chile and India to date. Terlipressin,
the drug is used in over 40 countries to treat related complications of liver cirrhosis (Type 1 hepatorenal syndrome and bleeding esophageal
varices) that was approved in the U.S. in 2022 (to improve kidney function in adults with hepatorenal syndrome with rapid reduction in
kidney function) but is not approved in Japan.
The BIV201 development program was initiated by
LAT Pharma LLC. On April 11, 2016, BioVie acquired LAT Pharma LLC and the rights to its BIV201 development program and currently owns
all development and marketing rights to this drug candidate. Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016,
between predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales
of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc. Pursuant
to the separation agreement to be entered into between the Company and BioVie, the Company will assume the royalty agreement and will
be obligated to pay 5.0% on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation,
and The Barrett Edge, Inc.
F- 8
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, 2025, the Company had working capital of approximately $ 18.4 million, cash and cash equivalents of
approximately $ 17.5 million, stockholders’ equity of approximately $ 19.0 million, and an accumulated deficit of approximately $ 352.1
million. The Company is in the pre-revenue stage and no revenues are expected in the foreseeable future. The Company’s future operations
are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure
additional financing as needed. Projected cash flows could be extended if further measures are taken to delay planned expenditures in
our research protocols and slow the progress in the Company’s development and launch of next phase clinical programs.
The future viability of the Company is largely
dependent upon its ability to raise additional capital to finance its operations. Management expects that future sources of funding may
include sales of equity, obtaining loans, or other strategic transactions.
Although management continues to pursue the Company’s
strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the
Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue
as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
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.
Reverse stock split up
The Company effected a 1:10 reverse split of the issued and outstanding
shares of its Common Stock which was approved by the board of directors after the approval obtained from shareholders at a special meeting
on June 23, 2025 which became effective on July 7, 2025. All historical share and earnings per share amounts have been retroactively adjusted
to reflect the split.
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 and comprehensive loss 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.
Investments in U.S. Treasury Bills
Investments in U.S. Treasury Bills with maturities
greater than three months, are accounted for as available-for-sale and are recorded at fair value. Unrealized gains were included in other
comprehensive income in the accompanying statements of operations and comprehensive loss.
Concentration of Credit Risk in the Financial
Service Industry
As of June 30, 2025, 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.
F- 9
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.
The Company’s financial instruments include
cash, accounts payable, the carrying value of the operating lease liabilities and notes payable. 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 notes payable and 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; 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 and Comprehensive
Loss. For the years ended June 30, 2025 and 2024, there was no such interest or penalties.
F- 10
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, 2025 and 2024, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to
the net loss for the periods presented.
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, 2025
June 30, 2024
Number of Shares
Number of Shares
Stock Options
84,872
51,808
Warrants
960,098
193,203
Restricted Stock Units
7,212
4,030
Notes payable conversion option
-
7,164
1,052,182
256,205
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. The Company recognizes forfeitures as they occur.
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, 2025 and 2024.
F- 11
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.
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, 2025 and 2024.
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 (Topic 740): Improvements in Income Tax Disclosures" to enhance the transparency and decision usefulness of income
tax disclosures. This amendment requires public companies to disclose specific categories in the rate reconciliation and provide additional
information for reconciling items that meet a quantitative threshold. Additionally, under the amendment entities are required to disclose
the amount of income taxes paid disaggregated by federal, state and foreign taxes, as well as disaggregated by material individual jurisdictions.
Finally, the amendment requires entities to disclose income from continuing operations before income tax expense disaggregated between
domestic and foreign and income tax expense from continuing operations disaggregated by federal, state and foreign. The new rules are
effective for annual periods beginning after December 15, 2024. The standard will be adopted on a prospective basis and is not expected
to have a material impact to our financial statements or disclosures.
ASU 2023-07: Segment Reporting Topic 280 - Improvements
to Reportable Segment Disclosures. This update requires expanded annual and interim disclosures for significant segment expenses that
are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss. This
update is effective for fiscal years beginning after December 15, 2023. The Company adopted ASU 2023-07 in the current fiscal year.
F- 12
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, 2025 and 2024:
Schedule of intangible assets
June 30, 2025
June 30, 2024
Intellectual Property
$ 2,293,770
$ 2,293,770
Less: Accumulated Amortization
( 2,115,429 )
( 1,886,052 )
Intellectual Property, net
$ 178,341
$ 407,718
Amortization expense amounted to $ 229,377 for
each of the years ended June 30, 2025 and 2024, respectively. The Company amortized intellectual property over the expected original useful
lives of 10 years and the remaining amortization expense for the year ending June 30, 2026 is $ 178,341 .
5.
Related Party Transactions
Equity Transactions with Acuitas
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 results of the Company’s capital raises
further described in Note 8, the warrants’ down round features (the “rachet adjustment”) resulted in deemed dividends
of $ 369,465 and $ 886,423 recognized in the accompanying statement of changes in stockholders’ equity for the years ended June 30,
2025 and 2024, respectively.
For the year ended June 30, 2024, the deemed dividend
of $886,423 recognized from the rachet adjustment resulting from the March 6, 2024 capital raise, reduced the exercise price to $100 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 $ 106.50 , exercise price of $ 182.00 and reduced exercise price of $ 100.00 , remaining term of 3.5 years, risk free rate of 4.4 % and volatility
of 95.0 % .
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..
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 selling, general and administrative
expenses on the accompanying statement of operations and comprehensive loss.
6.
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.
F- 13
The Loan Agreement included a conversion option
to convert up to $5.0 million of the principal amount of the Loan outstanding at the option of Avenue, into shares of the Company’s
Common Stock at a conversion price of $698.00 per share (the “Conversion Option”).
On the Closing Date, the Company also issued to
Avenue warrants to purchase 3,611 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share
equal to $582.00. The Avenue Warrants are exercisable until November 30, 2026.
The amount of the carrying value of the notes
payable was determined by allocating portions of the outstanding principal of the notes, resulting in approximately $ 1.4 million allocated
to the fair value of the Avenue Warrants, and approximately $ 2.2 million allocated to the fair value of the embedded Conversion Option.
Accordingly, the total amount of unearned discount of approximately $3.6 million, the total direct financing cost of approximately $ 390,000
and the Loan Premium of $ 850,000 were amortized using the effective interest method over the term of the Loan.
Total interest expense associated with the Loan was approximately $ 312,000 ,
which is reflected as a component of interest expense on the accompanying statements of operations and comprehensive loss for the year
ended June 30, 2025. Interest expense associated with this loan was comprised of interest incurred on the outstanding principal of the
loan of approximately $ 163,000 , amortization of financing costs of approximately $ 12,000 , amortization of the unearned discount of approximately
$ 111,000 , and the accretion of the Loan Premium of approximately $ 26,000 .
Total interest expense for the year ended June
30, 2024 was approximately $ 2.9 million on the accompanying statement of operations and comprehensive loss. Interest expense was comprised
of interest incurred on the outstanding principal of the loan of approximately $ 1.5 million, amortization of financing costs of approximately
$ 109,000 , amortization of the unearned discount of $ 1.0 million, and the accretion of the Loan Premium of approximately $ 237,000 .
The following is a summary of the Notes Payable as of June 30, 2025
and 2024:
Schedule of note payable
June 30, 2025
June 30, 2024
Current portion of Notes Payable
$ -
$ 5,000,000
Less: debt financing costs
-
( 11,820 )
Less: unearned discount
-
( 111,212 )
Plus: accretion of Loan Premium
-
824,242
Current portion of Notes Payable, net of financing costs, unearned premium and discount
$ -
$ 5,701,210
F- 14
7.
Fair Value Measurements
At June 30, 2025, there was no value ascribed to the derivative liabilities
and as of June 30, 2024 the derivative liability related to warrants that was measured on a recurring basis was a level 3 liability and
totaled $3,771.
The following table presents the activity for level 3 liabilities measured
at fair value using unobservable inputs for the years ended June 30, 2025 and 2024:
Schedule of derivative liabilities at fair value
Derivative liability - Avenue Warrants
Derivative liability - Conversion Option
Balance at June 30, 2023
$ 894,280
$ 925,762
Additions to level 3 liabilities
-
-
Change in fair value of level 3 liabilities
( 890,509 )
( 925,762 )
Transfer in and/or out of level 3
-
-
Balance at June 30, 2024
$ 3,771
$ -
Additions to level 3 liabilities
-
-
Change in fair value of level 3 liabilities
( 3,771 )
-
Transfer in and/or out of Level 3
-
-
Balance at June 30, 2025
$ -
$ -
The fair values of derivative liabilities for
the Avenue Warrants and Conversion Option at June 30, 2024 in the accompanying balance sheet, were approximately $3,800 and zero, respectively.
The total change in the fair value of the derivative liabilities totaled approximately $ 3,800 and $ 1.8 million for the years ended June
30, 2025, and 2024, respectively; and accordingly, was recorded in the accompanying statements of operations and comprehensive loss.
The assumptions used in the Black Scholes model
to value the Avenue Warrants at June 30, 2025 included the closing stock price of $ 9.25 per share; the exercise price of $ 582.00 , remaining
term 1.4 years, risk free rate of 3.9 % and volatility of 81.0 % .
The Conversion Option was nil as of June 30, 2025
and June 30, 2024 as the corresponding debt matured and was repaid in December 2024.
The assumptions used in the Black Scholes model
to value the derivative liabilities at June 30, 2024 included the closing stock price of $ 40.00 per share; for the Avenue Warrants, the
exercise price of $ 582.00 , remaining term 2.4 years, risk free rate of 4.6 % and volatility of 82.0 % ; and for the Conversion Option, the
conversion price of $ 698.00 ; remaining term of 5 months, risk free rate of 5.38 % and volatility of 91.0 % .
Financial assets
As of June 30, 2025, investments in U.S. 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.
F- 15
Measured at fair value on a recurring basis
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
Fair Value Measurements at
June 30, 2024
Level 1
Level 2
Level 3
Total
Cash
$ 12,763,941
$ -
$ -
$ 12,763,941
U.S. Treasury Bills due in 3 months or less at purchase
11,079,857
-
-
11,079,857
Total
$ 23,843,798
$ -
$ -
$ 23,843,798
8.
Equity Transactions
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, 2024, the Company sold 33,375 shares of common stock under the Sales Agreement for total net proceeds of approximately
$ 9.3 million after deducting 3 % commissions and expenses of approximately $ 377,000 . During the year ended June 30, 2025, the Company sold
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 March 6, 2024, the Company closed a best efforts
public offering (the “Offering”) of 150,000 shares (the “Shares”) of its common stock, par value $0.0001 per share
(the “Common Stock”), pre-funded warrants (the “Pre-funded Warrants”) to purchase 60,000 shares of Common Stock,
and warrants to purchase up to 105,000 shares of Common Stock (the “Common Warrants”) at a combined public offering price
of $ 100.00 per Share, or Pre-funded Warrant, and the associated Common Warrant. The Common Warrants
have an exercise price of $ 150.00 per share and are immediately exercisable upon issuance for a period of five years following the date
of issuance. The gross proceeds to the Company from the Offering were approximately $ 21.0 million, before deducting placement agent
fees and offering expenses of approximately $2.5 million, resulting in net proceeds of approximately $18.5 million. Additionally, upon
closing the Company issued the placement agent warrants (“Placement Agent’s warrants”) to purchase 10,500 shares of
Common Stock exercisable at a per share price of $ 125.00 , which was equal to 125% of the public offering price per share. The Placement
Agent’s Warrants are exercisable during a five-year period commencing 180 days from March 6, 2024. The Pre-Funded Warrants were
exercised shortly after issuance and the 60,000 shares of Common Stock were issued during the year ended June 30, 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.
F- 16
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.
During the year ended June 30, 2025, 189,630 of
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.
Issuance of common stock for services
On May 10, 2024, the Company awarded 1,500 shares
of Common Stock to a vendor as part of their fees in exchange for services. The fair value of the Common Stock at the date of issuance
was $ 48.60 per share. The stock-based compensation expense related to this Common Stock issuance was $ 72,900 for the year ended June 30,
2024.
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, 2025 and 2024:
Schedule of summarizes the activity relating to the Company’s stock options
Options
Weighted-Average Exercise Price
Weighted Remaining Average Contractual Term
Aggregate Intrinsic Value
Outstanding at June 30, 2023
39,529
$ 710.00
6.3
$ 1,067,966
Granted
15,525
117.00
9.8
-
Options Expired
( 64 )
460.90
-
-
Options Canceled
( 3,182 )
571.90
-
-
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
$ -
Exercisable at June 30, 2025
49,920
$ 387.85
5.4
$ -
F- 17
The fair value of each option grant on the date
of grant is estimated using the Black-Scholes model. The following weighted-average assumptions were utilized for the years ended:
Schedule of assumptions used
June 30, 2025
June 30, 2024
Expected life of options (in years)
4
6
Expected volatility
93.44 %
86.28 %
Risk free interest rate
4.34 %
4.40 %
Dividend Yield
0 %
0 %
On October 3, 2023, the Company granted stock
options to purchase 2,112 shares of Common Stock to new hire employees. 20 % of the shares underlying the options awarded vest on the one-year
anniversary of the grant date, and the remaining 80 % will vest in equal monthly installments over 48 months each month thereafter. The
exercise price of the options is $ 341.00 , the grant date fair value, and the options terminate on the earlier of the tenth grant date
anniversary or the date of which the options are fully exercised.
In June 2024, the Company granted stock options
to purchase 11,580 shares of Common Stock to employees. 33 % of the shares underlying the options awarded vest on the grant date, and the
remaining 67 % will vest over 2 years on first and second anniversary of the grant date. The exercise price of the options is $ 47.00 , the
grant date fair value, and the options terminate on the earlier of the tenth grant date anniversary or the date of which the options are
fully exercised.
On December 20, 2024, 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.
The Company recorded stock based compensation
expense relating to the vesting of stock options of approximately $ 1.2 million and $ 2.8 million for the years ended June 30, 2025 and
2024, respectively.
Issuance and modification of restricted stock units, restricted
shares and stock options:
On November 9, 2023, 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 vest 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.
In December 2023, the Company terminated five
employees and as part of their severance agreement modified their equity awards that had been granted pursuant to the 2019 Omnibus Plan.
The modifications included the acceleration of certain stock option awards to purchase a total of 563 shares of common stock (“Accelerated
Options”), effective on the December Separation Date, as defined in severance agreement (“Separation Date”), and extended
the expiration date for one year from the Separation Date for both the Accelerated Options and any vested and unexercised stock options
held by the terminated employees as of the Separation Date. Accordingly, the Company remeasured the Accelerated Options based on the stock
price of $154.00 per share at the close on the Separation Date and a one-year extension of the term. The net adjustment for the modification
was a net credit of $127,199 and was recognized as an adjustment to stock compensation expense during the year ended June 30, 2024.
Additionally, 103 vesting RSUs were accelerated
as of the Separation date. The modified RSUs were remeasured based on the stock price of $154.00 per share at close on the Separation
Date and $15,865, was recorded to additional in stock-based compensation for the year ended June 30, 2024 as a result of the modification.
F- 18
On the Separation date, December 2023, the Company
canceled 1,840 unvested stock options and 103 unvested RSUs. Additionally, the Company canceled an additional 1,342 unvested stock options
for employees that voluntarily left the company.
On June 24, 2024, the Company granted a total
of 8,580 RSUs to employees, with a grant date fair value of $ 47.40 per share. The RSUs vested on the grant date. The Company delivered
the vested portion of the RSU’s and issued 8,580 shares of Common Stock, of which 2,145 shares were withheld in Treasury stock in
exchange for payment of withholding tax on behalf of the employees.
On November 20, 2024, 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 vest 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 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 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.
The following table summarizes vesting of restricted
stock units:
Schedule of unvested of restricted stock units
Number of Shares
Weighted Average Grant Date Fair Value Per Share
Unvested at June 30, 2023
5,965
$ 524.00
Issued
10,407
91.60
Vested
( 12,240 )
169.40
Canceled
( 103 )
612.00
Unvested at June 30, 2024
4,029
$ 445.90
Issued
17,190
25.60
Vested
( 11,314 )
107.60
Canceled
( 2,693 )
70.75
Unvested at June 30, 2025
7,212
$ 116.41
The total stock-based compensation expense from restricted stock units
and restricted shares for the year ended June 30, 2025 and 2024 was approximately $ 1.2 million and $ 1.8 million, respectively.
F- 19
Stock Warrants
The following table summarizes the warrants activity during the years
ended June 30, 2025 and 2024:
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, 2023
77,703
$ 206.00
4.0
$ 18,318,954 .00
Granted
175,500
131.40
5.0
-
Exercised
( 60,000 )
100.00
-
-
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
$ -
The table below shows the expiration of the warrants
outstanding as of June 30, 2025:
Schedule of warrants outstanding
Number of Warrants
Expiring June 30,
-
2026
360
2027
3,610
2028
72,728
2029
115,509
2030
767,891
Total outstanding warrants
960,098
9.
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 1 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 212, San Diego, CA 92122 which commenced on March 1, 2022, was for a term of 38 months with a base monthly rate
of $4,300, and annual increases of three percent. In February 2024, the Company amended the lease agreement which allowed the Company
to vacate the then current space and move to a larger space at Suite 206. The current monthly base rate for the new office space is $ 10,024 ,
with an annual increase of four percent. The term for the new office lease is 60 months and commenced on February 12, 2024. The lease
that was in place for the 5090 Shoreham Place Suite 212 office was effectively extinguished upon the commencement of the new office space
lease on February 12, 2024, resulting in the write off of the corresponding remaining right-of-use asset and operating lease liability
of $ 56,909 and $ 62,124 , respectively, and a gain to selling, general and administrative expenses of $ 5,215 for the year ended June 30,
2024.
F- 20
Total operating lease expense for the years ended
June 30, 2025 and 2024 of approximately $ 127,000 and $ 78,000 , respectively, were included in the accompanying statements of operations
and comprehensive loss as a component of selling, general and administrative expenses.
The right-of-use asset, net and current and non-current
portion of the operating lease liabilities included in the accompanying balance sheets are as follows:
Schedule of deferred tax assets
June 30, 2025
June 30, 2024
Assets
Operating lease right-of-use asset, net
$ 339,653
$ 406,726
Liabilities
Current portion of operating lease liability
$ 74,464
$ 60,343
Operating lease liability, net of current portion
275,430
349,894
Total operating lease liability
$ 349,894
$ 410,237
At June 30, 2025, 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 June 30
2026
$ 122,042
2027
126,313
2028
130,734
2029
77,796
Total minimum lease payments
456,885
Less amount representing interest
( 106,991 )
Present value of future minimum lease payments
349,894
Total cash paid for amounts included in the measurement of lease liabilities
were $ 117,915 and $ 83,910 for the years ended June 30, 2025 and 2024, respectively.
The weighted average remaining lease term and
discount rate as of June 30, 2025 and 2024 were as follows:
Schedule of weighted average remaining lease term and discount rate
June 30, 2025
June 30, 2024
Weighted average remaining lease term (Years)
Operating lease
3.6
4.6
Weighted average discount rate
Operating lease
15.00 %
15.00 %
F- 21
10.
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 is obligated to pay a low
single digit royalty on net sales of all terlipressin products covered by US patent no. 9,655,645 and any future foreign issuances, capped
at a maximum of $200,000 per year.
Shareholder class action complaint and shareholder derivative complaints
On January 19, 2024, a purported shareholder 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, 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 that motion was fully briefed as of December 5, 2024. On March 27, 2025,
the court denied the defendants’ motion to dismiss, and the parties are now engaged in the early stages of fact discovery .
On December 30, 2024, a shareholder derivative
lawsuit was filed in the United States District Court for the District of Nevada by putative stockholder Andrew Hulm, allegedly on behalf
of the Company, that piggy-backs on the securities class action also pending in that court. The derivative complaint names certain current
and former officers and directors as defendants, and generally alleges that they breached their fiduciary duties by causing or failing
to prevent the securities violations alleged in the securities class action. The derivative complaint also alleges claims for unjust enrichment,
waste of corporate assets, gross mismanagement, and abuse of control as against all defendants. On March 18, 2025, the court ordered the
Hulm derivative lawsuit stayed, pending resolution of the motion to dismiss the securities class action described above.
On April 28, 2025, a second shareholder derivative
lawsuit was filed in the United States District Court for the District of Nevada by putative stockholder William Settel, allegedly on
behalf of the Company, that likewise piggy-backs on the securities class action. The Settel derivative complaint alleges essentially the
same claims as the Hulm derivative action against the same defendants based on the same alleged conduct.
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.
11.
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 $ 152,400
and $ 153,200 , for the years ended June 30, 2025 and 2024, respectively.
F- 22
12.
Income Taxes
Significant components of the Company’s deferred tax assets (liabilities)
are as follows:
Schedule of deferred tax assets
June 30, 2025
June 30, 2024
Deferred tax assets (liabilities):
Tax loss carryforward
$ 58,323,950
$ 51,429,074
Intangible assets
( 49,935 )
( 114,161 )
Stock based compensation
6,531,784
5,860,272
R&D capitalized
10,134,322
12,467,969
Valuation Allowance
( 74,940,121 )
( 69,643,154 )
Net deferred tax assets
$ -
$ -
At June 30, 2025 and 2024, the Company has recorded a full valuation
against its net deferred tax assets of approximately $ 74.9 million and $ 69.6 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, 2025 was
approximately $ 5.3 million.
At June 30, 2025, the Company had a Net Operating
Loss (“NOL”) carryforward of approximately $ 208 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.
The Company has no current tax expense due to its net losses and a
full valuation allowance.
Reconciliation of the differences between income
tax benefit computed at the federal and state statutory tax rates and the provision for income tax benefit for the years ended June 30,
2025 and 2024 is as follows:
Schedule of effective income tax rate reconciliation
2025
2024
Income tax expense at federal statutory rate
21 %
21 %
State taxes, net of federal benefit
7 %
7 %
Change in valuation allowance
( 28 %)
( 28 %)
Effective tax rate
-
-
On July 4, 2025, the U.S. enacted the One Big Beautiful Bill Act (the
“Act”), which contains a broad range of tax reform provisions affecting businesses. The Company is currently evaluating
the full effects of the Act and does not anticipate a material impact on the financial statements.
13.
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 expenses
for the years ended June 30, 2025 and 2024:
Schedule of segment reporting information
For the Year Ended
For the Year Ended
June 30, 2025
June 30, 2024
Clinical studies
$ 3,660,000
$ 11,081,000
Clinical teams
4,479,000
8,873,000
Chemistry, manufacturing and controls
834,000
2,066,000
Other research and development expenses
294,000
1,081,000
Selling, general and administrative expenses
8,570,000
8,850,000
Amortization of intangible assets
229,000
229,000
Other income, net
( 524,000 )
( 59,000 )
Net loss
$ ( 17,542,000 )
$ ( 32,121,000 )
F- 23
14.
Subsequent Events
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 $ 10.4 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 $1.999 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.
F- 24