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 Annual Report on 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.
44
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, 2024 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, 2024, 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, 2024, 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.
45
PART III.
ITEM 10.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item is
included in our 2024 Proxy Statement and is
incorporated herein by reference.
ITEM 11.
EXECUTIVE COMPENSATION
The information required by this item is
included in our 2024 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 2024 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 2024 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 2024 Proxy Statement and is
incorporated herein by reference.
46
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
Amended and Restated Bylaws of the Company, dated June 16, 2020 (incorporated by reference to Exhibit 3.5 to the Company’s Quarterly Report on Form 10-Q filed on November 10, 2021).
3.7
First Amendment to the Amended and Restated Bylaws of the Company, dated March 12, 2023 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on March 13, 2023).
3.8
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)
3.9
Termination of Amendment/Certificate (incorporated by reference to Exhibit 3.1 to the Company’s Current Report, as amended, on Form 8-K/A filed on August 6, 2024)
3.10
Certificate of Amendment (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)
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 Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on September 25, 2019).
4.4
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).
4.5
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).
4.6
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).
4.7
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 (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed on March 4, 2024).
10.1#
BioVie Inc. 2019 Omnibus Equity Incentive Plan (incorporated by reference to Appendix D to the Definitive Information Statement on Schedule 14C, filed on May 8, 2019).
47
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
Insider Trading Policy
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
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.
48
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: September 30, 2024
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
September 30, 2024
Cuong Do
(Principal Executive Officer)
/s/ Joanne Wendy Kim
Chief Financial Officer
September 30, 2024
Joanne Wendy Kim
(Principal Financial Officer)
/s/ Jim Lang
Director
September 30, 2024
Jim Lang
/s/ Michael Sherman
Director
September 30, 2024
Michael Sherman
/s/ Richard J. Berman
Director
September 30, 2024
Richard J. Berman
/s/ Robert Hariri
Director
September 30, 2024
Robert Hariri
/s/ Sigmund Rogich
Director
September 30, 2024
Sigmund Rogich
49
BioVie Inc.
Index to Financial Statements
Report of Independent Registered Public Accounting Firm – EisnerAmper LLP (PCAOB Number 274 )
F-2
Financial Statements:
Balance Sheets
F-4
Statements of Operations and Comprehensive Loss
F-5
Statements of Changes in Stockholders’ Equity
F-6
Statements of Cash Flows
F-7
Notes to Financial Statements
F-8
F- 1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Board of Directors and Stockholders of
BioVie, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of
BioVie, Inc. (the “Company”) as of June 30, 2024 and 2023, 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, 2024 and 2023, 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 and third-party facility 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.
F- 2
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 ensure that accruals were properly recorded as of June 30, 2024.
/s/ EisnerAmper LLP
We have served as the Company’s auditor since
2019.
EISNERAMPER LLP
Iselin , New Jersey
September 30, 2024
F- 3
BioVie Inc.
Balance Sheets
June
30,
June
30,
2024
2023
ASSETS
CURRENT
ASSETS:
Cash
and cash equivalents
$ 23,843,798
$ 19,460,883
Investments
in U.S. Treasury Bills (available-for-sale)
-
14,477,726
Prepaid
and other current assets
204,392
102,526
Total
current assets
24,048,190
34,041,135
Operating
lease right-of-use assets, net
406,726
80,789
Intangible
assets, net
407,718
637,095
Goodwill
345,711
345,711
TOTAL
ASSETS
$ 25,208,345
$ 35,104,730
LIABILITIES
AND STOCKHOLDERS' EQUITY
CURRENT
LIABILITIES:
Accounts
payable and accrued expenses
$ 3,586,912
$ 3,476,259
Other
current liabilities
-
48,385
Current
portion of operating lease liabilities
60,343
44,909
Current
portion of note payable, net of financing cost, unearned premium and discount of $ 701,210 at June 30, 2024 and $ 894,926 at June 30,
2023
5,701,210
9,105,074
Warrant
liability
3,771
894,280
Embedded
derivative liability
-
925,762
Total
current liabilities
9,352,236
14,494,669
Operating
lease liabilities, net of current portion
349,894
42,505
Note payable,
net of current portion, financing cost, unearned premium and discount of $ 0 and $ 227,268 at June 30, 2024 and June 30,
2023, respectively.
-
5,227,270
TOTAL
LIABILITIES
9,702,130
19,764,444
Commitments and contingencies
(Note 11)
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, 2024 and June 30, 2023, respectively; 6,216,398 shares issued of which 6,190,072
shares are outstanding at June 30, 2024; and 3,645,183 shares issued of which 3,642,895 shares outstanding at June 30, 2023
6,229
3,643
Additional
paid in capital
349,732,674
316,385,759
Accumulated
other comprehensive income
-
176,591
Accumulated
deficit
( 334,232,661 )
( 301,225,705 )
Treasury
stock
( 27 )
( 2 )
Total
stockholders' equity
15,506,215
15,340,286
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
$ 25,208,345
$ 35,104,730
The accompanying notes are an integral part of the
financial statements.
F- 4
BioVie Inc.
Statements of Operations and Comprehensive Loss
Year ended
Year ended
June 30, 2024
June 30, 2023
OPERATING EXPENSES:
Amortization of intangible assets
$ 229,377
$ 229,377
Research and development expenses
23,100,394
33,299,503
Selling, general and administrative expenses
8,849,814
11,551,568
TOTAL OPERATING EXPENSES
32,179,585
45,080,448
LOSS FROM OPERATIONS
( 32,179,585 )
( 45,080,448 )
OTHER (INCOME) EXPENSE:
Change in fair value of derivative liabilities
( 1,816,271 )
1,437,481
Interest expense
2,893,922
4,300,150
Interest income
( 1,136,703 )
( 562,264 )
TOTAL OTHER (INCOME) EXPENSE, NET
( 59,052 )
5,175,367
NET LOSS
$ ( 32,120,533 )
$ ( 50,255,815 )
Deemed dividend related to ratchet adjustment to warrants
886,423
-
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ ( 33,006,956 )
$ ( 50,255,815 )
NET LOSS PER COMMON SHARE
- Basic
$ ( 7.30 )
$ ( 15.47 )
- Diluted
$ ( 7.30 )
$ ( 15.47 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
- Basic
4,518,533
3,248,349
- Diluted
4,518,533
3,248,349
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ ( 33,006,956 )
$ ( 50,255,815 )
Other comprehensive (loss) income
Unrealized gain on available-for-sale investments
-
176,591
Reclassification of unrealized gains on available-for-sale investments upon settlement
( 176,591 )
-
Total other comprehensive (loss) income
( 176,591 )
176,591
Comprehensive loss
$ ( 33,183,547 )
$ ( 50,079,224 )
The accompanying notes are an integral part of the
financial statements.
F- 5
BioVie Inc.
Statements of Changes in Stockholders’ Equity
For the Years Ended June 30, 2024 and 2023
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, 2022
2,498,408
$ 2,496
$ 254,638,329
-
$ -
$ -
$ ( 250,969,890 )
3,670,935
Stock option-based compensation
-
-
4,222,845
-
-
-
-
4,222,845
Stock-based compensation - restricted stock units
21,518
21
1,780,028
( 2,288 )
( 2 )
-
-
1,780,047
Stock-based compensation - issuance of common stock for services rendered
5,000
5
372,495
-
-
-
-
372,500
-
Cashless exercise of options
2,256
3
( 3 )
-
-
-
-
-
-
Cashless exercise of warrants
359
-
-
-
-
-
-
-
-
Proceeds from exercise of options
80
-
2,240
-
-
-
-
2,240
Proceeds from issuance of common stock, net costs of $2,008,898
753,925
754
49,464,349
-
-
-
-
49,465,103
Proceeds from issuance of common stock, net of costs of $94,160
- Related Party
363,636
364
5,905,476
-
-
-
-
5,905,840
Unrealized gain on available-for-sale investments
-
-
-
-
-
176,591
-
176,591
Net loss
-
-
-
-
-
-
( 50,255,815 )
( 50,255,815 )
Balance, June 30, 2023
3,645,183
3,643
316,385,759
( 2,288 )
( 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
2,433,749
2,449
27,800,490
-
-
-
-
27,802,939
Issuance of common stock from vesting of restricted stock units
122,395
122
( 97 )
( 24,038 )
( 25 )
-
-
-
Stock-based compensation - issuance of common stock for services rendered
15,000
15
72,885
-
-
-
-
72,900
Deemed dividend for ratchet adjustment to warrants
-
-
886,423
-
-
-
( 886,423 )
-
Relcassification 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
71
-
-
-
-
-
-
-
Net Loss
-
-
-
-
-
-
( 32,120,533 )
( 32,120,533 )
Balance, June 30, 2024
6,216,398
$ 6,229
$ 349,732,674
( 26,326 )
$ ( 27 )
$ -
$ ( 334,232,661 )
$ 15,506,215
The accompanying notes are an integral part of the
financial statements.
F- 6
BioVie Inc.
Statements of Cash Flows
Year ended
Year ended
June 30, 2024
June 30, 2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 32,120,533 )
$ ( 50,255,815 )
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
1,763,450
1,780,047
Stock based compensation expense - stock options
2,823,764
4,222,845
Stock based compensation expense - stock issued
72,900
372,500
Amortization of financing costs
108,751
170,219
Accretion of unearned loan discount
1,023,145
1,601,445
Accretion of loan premium
236,970
421,994
Realized gain on maturity of available-for sale
( 223,865 )
-
Non-cash lease expense from right-of-use assets
49,346
37,465
Gain on termination of operating lease
( 5,215 )
-
Change in fair value of derivative liabilities
( 1,816,271 )
1,437,481
Changes in operating assets and liabilities:
Prepaid and other assets
( 101,866 )
39,915
Accounts payable and accrued expenses
110,653
1,033,455
Operating lease liabilities
( 47,245 )
( 38,884 )
Other current liabilities
( 48,385 )
( 1,304,925 )
Net cash used in operating activities
( 27,945,024 )
( 40,252,881 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from (purchases of) U.S. Treasury Bills (available-for-sale)
14,525,000
( 14,301,135 )
Net cash provided by (used in) investing activities
14,525,000
( 14,301,135 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from issuance of common stock
27,802,939
49,465,103
Payments of note payable
( 10,000,000 )
-
Proceeds from exercise of stock options
-
2,240
Net proceeds from issuance of common stock - Related Party
-
5,905,840
Net cash provided by financing activities
17,802,939
55,373,183
Net increase in cash and cash equivalents
4,382,915
819,167
Cash and cash equivalents, beginning of period
19,460,883
18,641,716
Cash and cash equivalents, end of period
$ 23,843,798
$ 19,460,883
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for interest
$ 1,525,056
$ 2,106,491
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING ACTIVITIES:
Right-of-use assets obtained in exchange for lease obligations
$ 432,192
$ -
Unrealized gain on U.S. Treasury Bills (available-for-sale)
$ -
$ 176,591
Reclassification of unrealized gains on U.S. Treasury Bills (available-for-sale investments) upon settlement
$ 176,591
$ -
Deemed dividend of ratchet adjustment to warrants
$ 886,423
$ -
The accompanying notes are an integral part of the
financial statements.
F- 7
BioVie Inc.
Notes to Financial Statements
1.
Background Information
BioVie Inc. (the “Company” or “we”
or “our”) is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including
neurological and neuro-degenerative disorders and liver disease.
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. 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 NE3107 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 and 1 million Americans suffering from PD.
Neurodengenerative Disease Program
In neurodegenerative disease, the Company’s
drug candidate NE3107 inhibits activation of inflammatory actions 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. NE3107 does not interfere with
their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation and insulin resistance are drivers
of AD and PD.
Alzheimer’s Disease (NCT05083260)
On November 29, 2023, the Company announced the analysis
of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate AD.
The study has 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 NE3107 orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally
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 has 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.
Parkinson’s Disease (NCT05083260)
The Phase 2 study of bezisterim (NE3107) for the treatment
of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study
in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state”
were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. This trial was launched with two design objectives:
1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions
of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric
activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met.
F- 8
1.
Background Information (continued)
Long COVID Program
In April 2024, the Company announced the grant of
a clinical trial award of up to $13.1 million from the DOD, awarded through the Peer Reviewed
Medical Research Program (“PRMRP”) of the Congressionally Directed Medical Research Programs (“CDMRP”). The award
can provide up to 2 years of non-dilutive funding for a Phase 2b clinical trial that will assess bezisterim (NE3107) for the treatment
of neurological symptoms that are associated with long COVID. The Company anticipates the trial to commence by early 2025.
Liver Disease Program
In liver disease, our investigational drug candidate
BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is
being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the
treatment of ascites due to chronic liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation.
In June 2021, the Company initiated a Phase 2 study
(NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment
cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites. The primary
endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared
to a pre-treatment period.
In March 2023, the Company announced enrollment was
paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid
during the 28 days after treatment initiation compared to the 28 days prior to treatment. The change in ascites volume was significantly
different from those patients receiving SOC treatment. Patients who completed the treatment with BIV201 experienced a 53% reduction in
ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment
period.
In June 2023, the Company requested and subsequently
received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites
due to chronic liver cirrhosis. The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment
of ascites due to chronic liver cirrhosis.
The BIV201 development program was initiated by LAT
Pharma LLC. On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program. The Company 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 our 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.
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, 2024, the Company had working capital of approximately $ 14.7 million, cash and cash equivalents of approximately
$ 23.8 million, stockholders’ equity of approximately $ 15.5 million, and an accumulated deficit of approximately $ 334.2 million.
The Company is in the pre-revenue stage and no revenues are expected in the foreseeable future. The Company’s future operations
are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure
additional financing as needed. Projected cash flows could be extended if further measures are taken to delay planned expenditures in
our research protocols and slow the progress in the Company’s development and launch of next phase clinical programs.
The future viability of the Company is largely dependent
upon its ability to raise additional capital to finance its operations. Management expects that future sources of funding may include
sales of equity, obtaining loans, or other strategic transactions.
F- 9
2.
Liquidity and Going Concern (continued)
Although management continues to pursue the Company’s
strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the
Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue
as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
3.
Significant Accounting Policies
Basis of Presentation
The Company’s financial statements have been
prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and include all adjustments
necessary for the fair presentation of the Company’s financial position for the periods presented.
Use of Estimates
The preparation of financial statements in conformity
with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying
notes. The Company bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the
circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of expenses reported
for each of the periods presented in the statements of operations and comprehensive loss are affected by estimates and assumptions, which
are used for, but not limited to, accounting for clinical accruals, share-based compensation, accounting for derivatives, 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, 2024, the Company had cash deposited
in certain financial institutions 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, in March
and April 2023, certain U.S. government banking regulators took steps to intervene in the operations of certain financial institutions
due to liquidity concerns, which caused general heightened uncertainties in financial markets. While these events have not had a material
direct impact on the Company’s operations, if further 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- 10
3.
Significant Accounting Policies (continued)
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 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 contract research and facility 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.
F- 11
3.
Significant Accounting Policies (continued)
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, 2024 and 2023, there was no such interest or penalty.
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,
2024 and 2023, 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, 2024
June 30, 2023
Number of Shares
Number of Shares
Stock Options
518,076
395,286
Warrants
1,932,029
777,029
Restricted Stock Units
40,291
59,646
Notes payable conversion option
71,633
71,633
Total
2,562,029
1,303,594
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. For non-employees, the Company
utilizes the graded vesting attribution method under which the entity treats each separately vesting portion (tranche) as a separate award
and recognizes compensation cost for each tranche over its separate vesting schedule. 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, 2024 and 2023.
F- 12
3.
Significant Accounting Policies (continued)
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, 2024 and 2023.
Reverse stock split up
The company effected a 1:10 reverse split of the issued and outstanding
shares of its Class A commons stock which was approved by the board of director after the approval obtained from shareholders at a special
meeting on July 29, 2024 which became effective on Nasdaq on August 6, 2024, 5 trading days after the shareholders’ approval was
obtained. All historical share and earnings per share amounts have been retroactively adjusted to reflect the split.
Recent Accounting Pronouncements
The Company considers the applicability and impact
of all Accounting Standards Updates (“ASU’s”). There were no recent ASU’s that are expected to have a material
impact on our balance sheets or statements of operations and comprehensive loss.
In June 2016, the Financial Accounting Standards Board
(“FASB”) issued ASU No. 2016-13, “Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on
Financial Instruments” (“ASU 2016-13”). This amendment replaces the incurred loss impairment methodology in current
GAAP with a methodology that reflects expected credit losses on instruments within its scope, including trade receivables. This update
is intended to provide financial statement users with more decision-useful information about the expected credit losses. The Company adopted
ASU 2016-13 effective July 1, 2023 and the adoption had an insignificant impact on the accompanying financial statements.
In November 2023, the FASB issued Accounting Standards Update (ASU) 2023-07, "Segment Reporting (Topic 280): Improvements to Reportable
Segment Disclosures," to enhance disclosures for significant segment expenses for all public entities required to report segment information
in accordance with ASC 280. The standard did not change the definition of a segment, the method for determining segments or the criteria
for aggregating operating segments into reportable segments. The amendments are effective for fiscal years beginning after December 15,
2023, and interim periods within fiscal years beginning after December 15, 2024. Retrospective adoption is required for all prior periods
presented in the financial statements. The adoption is not expected to have a material impact to our financial statements or disclosures.
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. We will adopt this standard on a prospective basis as allowed by the standard.
The adoption of this standard is not expected to have a material impact on our financial statements.
F- 13
4. Investments in U.S. Treasury Bills available-for-sale
The following is a summary of the U.S. Treasury Bills
held at June 30, 2023:
Schedule of U.S. treasury bills held
Amortized
Cost Basis
Gross
Unrealized Gain
Gross
Unrealized loss
Fair
Value
Total
Accumulated Other Comprehensive Income
U.S. Treasury
Bills due in 3 - 6 months
$ 14,301,136
$ 176,591
$ —
$ 14,477,726
$ 176,591
During the fiscal year ended June 30, 2023, the Company
purchased a total of approximately $ 46 million of U.S. Treasury Bills. All outstanding investments in U.S. Treasury Bills available-for-sale
held at June 30, 2023 matured during the three months ended September 30, 2023 and were settled, resulting in a realized gain of $ 223,865
recorded as a component of interest income on the accompanying statement of operations and comprehensive loss.
5.
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, 2024 and 2023:
Schedule of intangible assets
June 30, 2024
June 30, 2023
Intellectual Property
$ 2,293,770
$ 2,293,770
Less: Accumulated Amortization
( 1,886,052 )
( 1,656,675 )
Intellectual Property, Net
$ 407,718
$ 637,095
Amortization expense amounted to $ 229,377 for each
of the years ended June 30, 2024 and 2023, respectively. The Company amortizes intellectual property over the expected original useful
lives of 10 years.
Estimated future amortization expense is as follows:
Schedule of future amortization expense
Year ending June 30,
2025
$ 229,377
2026
178,341
Finite lived intangible assets, net
$ 407,718
6.
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 363,636 shares of the Company’s Common
Stock, at a price of $16.50 per share (the “PIPE Shares”), and (ii) a warrant to purchase 727,273 shares of Common Stock (“PIPE
Warrant Shares”), at an exercise price of $18.20, with a term of exercise of five years. The down round feature reduced the exercise
price of the PIPE Warrant Shares to $10.00 per share on March 6, 2024 in connection with the offering further described in Note 9 as the
Company sold stock at a price lower than its initial exercise price. The Company calculated the difference in fair value of the PIPE Warrant
Shares between the stated exercise price and the reduced exercise price and recorded $ 886,423 as a deemed dividend. The fair value of
the PIPE Warrant Shares were estimated using the Black Scholes Method with the following inputs, the stock price of $ 10.65 , exercise price
of $ 18.20 and $ 10.00 , remaining term of 3.5 years, risk free rate of 4.4 % and volatility of 95.0 % .
On August 15, 2022, the Company received net proceeds of approximately
$5.9 million, net of costs of approximately $94,000, and entered into an amended and restated registration agreement with Acuitas, which
amended and restated that certain registration rights agreement, dated as of June 10, 2021, by and between the Company and Acuitas (the
“Existing Registration Rights Agreement”), to amend the definition of “Registrable Securities” in the Existing
Registration Rights Agreement to include the PIPE Shares and the PIPE Warrant Shares as Registrable Securities thereunder.
F- 14
7.
Notes Payable
On November 30, 2021 (the “Closing
Date”), the Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and
Promissory Notes (together, the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (“AVOPI”) and
Avenue Venture Opportunities Fund II, L.P. (“AVOPII,” and together with AVOPI, “Avenue”) for growth capital
loans in an aggregate commitment amount of up to $20 million (the “Loan”). On the Closing Date, $15 million of the Loan
was funded (“Tranche 1”). The Loan provided for an additional $5 million to be available to the Company on or prior to
September 15, 2022, subject to the Company’s achievement of certain milestones with respect to certain of its ongoing clinical
trials, which were not achieved. The Loan bears 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 prime rate at June 30, 2024 was 8.50 % .
The Loan is secured by a lien upon and security interest in all of the Company’s assets, including intellectual property,
subject to agreed exceptions. The maturity date of the Loan is December 1, 2024.
The Loan Agreement required monthly interest-only
payments during the first eighteen months of the term of the Loan. Following the interest-only period, on July 1, 2023, the Company pays
equal monthly payments of principal, plus accrued interest, until the Loan’s maturity date when all remaining principal and accrued
interest is due. If the Company prepays the Loan, it will be required to pay (a) a prepayment fee in an amount equal to 3.0% of the principal
amount of the Loan that is prepaid during the interest-only period; and (b) a prepayment fee in an amount equal to 1.0% of the principal
amount of the Loan that is prepaid after the interest-only period. At the Loan’s maturity date, or on the date of the prepayment
of the Loan, the Company will be obligated to pay a final payment equal to 4.25% of the Loan commitment amount, the sum of Tranche 1 and
Tranche 2, which amounts to $850,000 (the “Loan Premium”).
The Loan Agreement includes 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 $69.80 per share (the “Conversion Option”).
On the Closing Date, the Company issued to Avenue
warrants to purchase 36,101 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share equal
to $58.20. 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, approximately $ 1.4 million, to the fair value of the
Avenue Warrants, and approximately $ 2.2 million 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
are being amortized using the effective interest method over the term of the Loan. The adjusted effective interest rate is 27%.
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 .
Total interest expense for the year ended June 30,
2023 was approximately $ 4.3 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 $ 2.1 million, amortization of financing costs of approximately
$ 170,000 , amortization of the unearned discount of $1.6 million, and the accretion of the Loan Premium of approximately $ 422,000 .
As of June 30, 2024, the remaining principal balance
of $ 5.0 million under the Loan is payable in 6 monthly equal installments. For the year ended June 30, 2024, the Company paid back $ 10
million, of the original loan of $15 million.
F- 15
7.
Notes Payable (continued)
The following is a summary of the Notes Payable as of June 30, 2024 and
2023:
Current portion of Notes Payable
Schedule of note payable
June 30, 2024
June 30, 2023
Current portion of Notes Payable
$ 5,000,000
$ 10,000,000
Less: debt financing costs
( 11,820 )
( 108,751 )
Less: unearned discount
( 111,212 )
( 1,023,145 )
Plus: accretion of Loan Premium
824,242
236,970
Current portion of Notes Payable, net of financing costs, unearned premium and discount
$ 5,701,210
$ 9,105,074
Non-current portion of Notes Payable
June 30, 2024
June 30, 2023
Notes Payable
$ -
$ 5,000,000
Less: debt financing costs
-
( 11,820 )
Less: unearned discount
-
( 111,212 )
Plus: accretion of Loan Premium
-
350,302
Notes Payable, net of the current portion financing costs, unearned premium and discount
$ -
$ 5,227,270
Estimated future amortization expense and accretion of Loan Premium is
as follows:
Schedule of estimated future amortization expense and accretion of premium
Unearned Discount
Debt Financing Costs
Loan Premium
Year ending June 30,
2025
$ 111,212
$ 11,820
$ 25,758
Total
$ 111,212
$ 11,820
$ 25,758
F- 16
8.
Fair Value Measurements
At June 30, 2024 and 2023, the estimated fair value of derivative liabilities
measured on a recurring basis are as follows:
Schedule of derivative liabilities at fair value
Fair Value Measurements at
June 30, 2024
Level 1
Level 2
Level 3
Total
Derivative liability - Warrants
$ -
$ -
$ 3,771
$ 3,771
Derivative liability - Conversion Option
-
-
-
-
Total derivative liabilities
$ -
$ -
$ 3,771
$ 3,771
Fair Value Measurements at
June 30, 2023
Level 1
Level 2
Level 3
Total
Derivative liability - Warrants
$ -
$ -
$ 894,280
$ 894,280
Derivative liability - Conversion option
-
-
925,762
925,762
Total derivative liabilities
$ -
$ -
$ 1,820,042
$ 1,820,042
The following table presents the activity for level 3 liabilities measured
at fair value using unobservable inputs for the years ended June 30, 2024 and 2023:
Fair value, liabilities measured on recurring basis
Derivative liability - Warrants
Derivative liability - Conversion Option
Balance at June 30, 2022
$ 194,531
$ 188,030
Additions to level 3 liabilities
-
-
Change in in fair value of level 3 liabilities
699,749
737,732
Transfer in and/or out of level 3
-
-
Balance at June 30, 2023
$ 894,280
$ 925,762
Additions to level 3 liabilities
-
-
Change in 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
$ -
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 approximately
zero, respectively. The total change in the fair value of the derivative liabilities totaled approximately $(1.8) million and $1.4 million
for the years ended June 30, 2024, and 2023, 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 derivative liabilities at June 30, 2024 included
the closing stock price of $ 4.00 per share; for the Avenue Warrants, the exercise price of $ 58.20 , remaining term 2.4 year, risk free
rate of 4.6 % and volatility of 82.0 % ; and for the Conversion Option, the conversion price of $ 69.80 ; remaining term of 5 months, risk
free rate of 5.38 % and volatility of 91.0 % .
Derivative liability – Avenue Warrants
The Avenue Warrants were not considered to be indexed
to the Company’s own stock, and accordingly, were recorded as a derivative liability at fair value in the accompanying balance sheets
at June 30, 2024 and 2023.
The Black Scholes model was used to calculate the
fair value of the warrant derivative to bifurcate the warrant derivative amount from the Avenue Loan amount funded. The Avenue Warrants
are recorded at their fair values at the date of issuance and remeasured at each subsequent reporting period end date.
F- 17
8.
Fair Value Measurements (continued)
Embedded derivative liability – Conversion
Option
The Conversion Option is accounted for as an embedded
derivative liability and required bifurcation from the Loan amount. The Black Scholes model was used to calculate the fair value of the
Conversion Option to bifurcate it from the Loan.
Financial assets
As of June 30, 2024, investments in U.S. Treasury Bills were valued through
use of quoted prices and are classified as Level 1. The following table presents information about our assets that are measured at fair
value on a recurring basis using the above input categories.
Measured at fair value on a recurring basis
Fair Value Measurements at
June 30, 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
Fair Value Measurements at
June 30, 2023
Level 1
Level 2
Level 3
Total
Cash
$ 6,304,543
$ -
$ -
$ 6,304,543
U.S. Treasury Bills due in 3 months or less at purchase
13,156,340
-
-
13,156,340
U.S. Treasury Bills due in 3 - 6 months at purchase
14,477,726
-
-
14,477,726
Total
$ 33,938,609
$ -
$ -
$ 33,938,609
9.
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 333,749 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, 2023, the Company sold 753,925
shares of common stock under the Sales Agreement for total net proceeds of approximately $ 49.5 million after 3 % commissions and expenses
of approximately $ 2.0 million.
On March 6, 2024, the Company closed a best efforts
public offering (the “Offering”) of 1,500,000 shares (the “Shares”) of its common stock, par value $ 0.001 per
share (the “Common Stock”), pre-funded warrants (the “Pre-funded Warrants”) to purchase 600,000 shares of Common
Stock, and warrants to purchase up to 1,050,000 shares of Common Stock (the “Common Warrants”) at a combined public offering
price of $ 10.00 per Share, or Pre-funded Warrant, and the associated Common Warrant. The Common
Warrants have an exercise price of $15.00 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 105,000 shares
of Common Stock exercisable at a per share price of $12.50, 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 600,000 shares of Common Stock were issued during the year ended June 30, 2024.
F- 18
9.
Equity Transactions (continued)
Issuance of common stock for services
On April 6, 2023, the Company awarded 5,000 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 $ 74.50 per share. The stock-based compensation expense related to this Common Stock issuance was $ 372,500 .
On May 10, 2024, the Company awarded 15,000 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 $ 4.86 per share. The stock-based compensation expense related to this Common Stock issuance was $ 72,900 .
Stock Options
The following table summarizes the activity relating to the Company’s
stock options for the years ended June 30, 2024 and 2023:
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, 2022
339,876
$ 74.20
5.5
$ -
Granted
71,467
59.00
8.6
38,610
Options Expired
( 1,000 )
286.90
-
-
Options Canceled
( 4,967 )
77.40
Options Exercised
( 10,090 )
81.20
-
-
Outstanding at June 30, 2023
395,286
71.00
6.3
1,067,966
Granted
155,242
11.70
9.8
-
Options Expired
( 640 )
46.09
-
-
Options Canceled
( 31,812 )
57.19
-
-
Outstanding at June 30, 2024
518,076
$ 54.11
6.1
$ -
Exercisable at June 30, 2024
296,934
$ 66.65
4.9
$ -
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, 2024
June 30, 2023
Expected life of options (in years)
6
6
Expected volatility
86.28 %
81.65 %
Risk free interest rate
4.40 %
3.82 %
Dividend Yield
0 %
0 %
The Company recorded stock based compensation expense
relating to the vesting of stock options of approximately $ 2.8 million and $ 4.2 million for the years ended June 30, 2024 and 2023, respectively.
Issuance and modification of restricted stock units and options:
On June 21, 2022, the Company awarded 12,452 restricted
stock units (“RSUs”) to the President and CEO under the Company’s 2019 Omnibus Plan. Each RSU awarded to the CEO entitles
him to receive one share of Common Stock upon vesting. The RSUs vest in three equal annual installments beginning on the first anniversary
grant date. 4,151 and 4,151 RSUs vested in June 2023 and 2024, respectively.
On November 23, 2022, the Company awarded 38,198 RSUs
to certain employees and a consultant, with a grant date fair value of $ 61.20 per share. 25% of these RSUs vested on the grant date and
the remaining RSUs vest in three equal installments over three years beginning on the first anniversary of the grant date. During the
year ended June 30, 2023, 9,550 of these RSUs vested, of which 2,288 shares were withheld in Treasury stock in exchange for payment of
withholding tax on behalf of the employees.
F- 19
9.
Equity Transactions (continued)
On November 23, 2022, the Company issued equity awards
for the board of directors’ annual compensation. Four directors received 15,564 RSUs with a grant date fair value of $ 61.20 per
share. In addition, three directors received stock options to purchase 19,500 shares of common stock at an exercise price of $ 61.20 per
share with a grant date fair value of $40.60 per share. The equity awards vest quarterly on February 23, 2023, May 23, 2023, August 23,
2023 and earlier of November 23, 2023 or the next annual shareholders’ meeting. During the year ended June 30, 2024, 7,746 of these
RSUs vested. These RSUs and options contain certain contractual vesting terms where the vesting can be accelerated outside the Company’s
control and as a result, for accounting purposes, are assumed to have been fully vested on the grant date, and accordingly, the Company
recognized the total compensation cost of $ 1,744,192 on November 23, 2022.
On November 9, 2023, the Company issued equity awards
for the board of directors’ annual compensation. Four directors received 18,270 RSUs with a grant date fair value of $ 30.10 per
share. In addition, two directors received stock options to purchase 18,325 shares of common stock at an exercise price of $ 30.10 per
share with a grant date fair value of $18.30 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, 4,568 of these RSUs
vested.
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 5,623 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 $15.40 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, 1,030 vesting RSUs were accelerated
as of the Separation date. The modified RSUs were remeasured based on the stock price of $15.40 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.
In connection with the separation, the Company canceled
18,396 unvested stock options and 1,030 unvested RSUs. Additionally, the Company canceled an additional 13,416 unvested stock options
for employees that voluntarily left the company.
In June 2023, the Company issued 14,950 RSUs with
a grant date fair value of $ 41.10 per share to the President and CEO under the Company’s 2019 Omnibus Plan. The RSUs vest in three
equal annual installments beginning on the first anniversary grant date. 4,983 RSUs vested in June 2024.
In June 2024, the Company issued 85,800 RSUs to employees,
with a grant date fair value of $ 4.74 per share. The RSUs vested on the grant date. The Company delivered the vested portion of the RSU’s
and issued 85,800 shares of Common Stock, of which 21,450 shares were withheld in Treasury stock in exchange for payment of withholding
tax on behalf of the employees.
The following table summarizes vesting of restricted
stock units:
Schedule of vesting of restricted common stock
Number of Shares
Weighted Average Grant Date Fair Value Per Share
Unvested at June 30, 2022
12,452
$ 16.90
Granted
68,711
58.87
Vested
( 21,518 )
52.70
Unvested at June 30, 2023
59,646
$ 52.40
Issued
104,070
9.16
Vested
( 122,395 )
16.94
Canceled
( 1,030 )
61.20
Unvested at June 30, 2024
40,291
$ 44.59
F- 20
9.
Equity Transactions (continued)
The total stock-based compensation expense from restricted
stock units for the year ended June 30, 2024 and 2023 was approximately $ 1.8 million and $ 1.8 million, respectively.
Issuance of Common Stock through exercise of Stock Options and Warrants
In December 2022, the Company issued 2,209 shares
of Common Stock pursuant to a cashless exercise of stock options to purchase 9,930 shares at an average exercise price of $ 76.40 .
In November 2022, the Company issued 80 shares of
Common Stock pursuant to a cash exercise of stock options to purchase 80 shares at an average exercise price of $ 28.00 per share.
In October 2022, the Company issued 359 shares of
Common Stock pursuant to a cashless exercise of warrants to purchase 800 shares at an average exercise price of $ 22.50 .
In May 2023, the Company issued 48 shares of Common
Stock pursuant to a cashless exercise of stock options to purchase 80 shares at an average exercise price of $ 31.30 .
Issuance of Stock Options under the 2019 Omnibus Plan.
Pursuant to a former employee’s Separation Agreement,
dated April 11, 2022, the Company modified their stock option award granted on August 20, 2021, pursuant to the 2019 Omnibus Plan (“2021
Options Grant”). Pursuant to the terms of the Separation Agreement, effective July 8, 2022 (the “Separation Date”),
the Company accelerated the vesting of options scheduled to vest on the first and second anniversary of the grant date as deemed vested
(“Accelerated Options”) and after giving effect to the Accelerated Options, extended the exercise period of the total vested
outstanding and unexercised options (totaling 7,450 options) to one year following the Separation Date. The unvested portion of the 2021
Option Grant (totaling 4,967 options) was canceled. The modification was remeasured as of July 8, 2022, and the incremental difference
in fair value resulted in a net credit to stock based compensation expense of $181,154, due to the original exercise price of $77.40 being
greater than the stock price of $18.00 on the remeasurement date, and accordingly was recognized on July 8, 2022.
On June 7, 2023, the Company granted stock options
to purchase 14,800 shares of Common Stock to certain employees. 20 % of the shares underlying the options awarded vested on the grant date,
and the remaining 80 % will vest in four equal annual installments beginning, on the first grant date anniversary. The exercise price of
the options is $ 57.80 per share, the grant date fair value and the options terminate on the earlier of the tenth grant date anniversary
or the date of which the options are fully exercised.
During the fiscal year ended June 30, 2023, the Company
granted stock options to purchase a total of 28,617 shares of Common Stock in connection with compensation packages of three new employees.
The exercise prices were set at the grant date fair value with vesting terms over a five year period and the options terminate on the
earlier of tenth grant date anniversary or the date of which the options are fully exercised.
On October 3, 2023, the Company granted stock options
to purchase 21,117 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 $ 34.10 , 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 115,800 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 $ 4.70 , 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.
F- 21
9.
Equity Transactions (continued)
Stock Warrants
The following table summarizes the warrants activity during the years ended
June 30, 2024 and 2023:
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, 2022
51,037
$ 61.70
3.8
$ -
Granted
727,273
18.20
5.0
-
Expired
( 482 )
750.00
-
-
Exercised
( 800 )
22.50
-
-
Outstanding and exercisable at June 30, 2023
777,029
20.60
4.0
18,318,954
Granted
1,755,000
13.14
5.0
-
Exercised
( 600,000 )
10.00
-
-
Outstanding and exercisable at June 30, 2024
1,932,029
$ 14.03
4.0
$ -
Of the above warrants outstanding at June 30, 2024,
10,138 expire in the fiscal year ending June 30, 2025, 3,518 expire in the fiscal year ending June 30, 2026, 763,373 expire in the fiscal
year ending June 30, 2027 and 1,155,000 expire in the fiscal year ending June 30, 2029.
10. Leases
Office Leases
The Company pays an annual rent of $2,200 for its
headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 89703. The rental agreement was for a one-year term, commenced on October
1, 2022 and has been subsequently renewed for another year 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 $9,685,
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.
Total operating lease expense for the years ended
June 30, 2024 and 2023 of approximately $ 78,000 and $ 52,000 , 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:
F- 22
10.
Leases (continued)
Schedule of deferred tax assets
June 30, 2024
June 30, 2023
Assets
Operating lease, right-of-use asset, net
$ 406,726
$ 80,789
Liabilities
Current portion of operating lease liability
$ 60,343
$ 44,909
Operating lease liability, net of current portion
349,894
42,505
Total operating lease liability
$ 410,237
$ 87,414
At June 30, 2024, 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,
2025
$ 117,915
2026
122,042
2027
126,313
2028
130,734
2029
77,796
Total minimum lease payments
574,800
Less amount representing interest
( 164,563 )
Present value of future minimum lease payments
410,237
Less current portion of operating lease liability
( 60,343 )
Operating lease liability, net of current portion
$ 349,894
Total cash paid for amounts included in the measurement of lease liabilities
were $ 83,910 and $ 50,600 for the years ended June 30, 2024 and 2023, respectively.
The weighted average remaining lease term and discount
rate as of June 30, 2024 and 2023 were as follows:
Schedule of weighted average remaining lease term and discount rate
June 30, 2024
June 30, 2023
Weighted average remaining lease term (Years)
Operating lease
4.6
1.8
Weighted average discount rate
Operating lease
15.00 %
10.75 %
F- 23
11.
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
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.
The Company believes the lawsuit is without merit
and intends to defend the case vigorously. At this early stage of the proceedings, the Company is unable to make any prediction regarding
the outcome of the litigation. No adjustment or accruals have been reflected in the accompanying financial statements.
12.
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 $ 153,200 and $ 171,900 ,
for the years ended June 30, 2024 and 2023, respectively.
F- 24
13.
Income Taxes
Significant components of the Company’s deferred tax assets (liabilities)
are as follows:
Schedule of deferred tax assets
June 30, 2024
June 30, 2023
Deferred tax assets (liabilities):
Tax loss carryforward
$ 51,429,074
$ 48,080,664
Intangible assets
( 114,161 )
( 189,854 )
Stock based compensation
5,860,272
4,575,852
R&D capitalized
12,467,969
8,171,276
Valuation Allowance
( 69,643,154 )
( 60,637,938 )
Net deferred tax assets
$ -
$ -
At June 30, 2024 and 2023, the Company has recorded a full valuation
against its net deferred tax assets of approximately $ 69.6 million
and $ 60.6 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, 2024 was approximately $ 9.0 million.
At June 30, 2024, the Company had a Net Operating
Loss (“NOL”) carryforward of approximately $ 184 million. NOL’s generated prior to 2018 have expiration dates ranging
from 2032 to 2037 .
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, 2024
and 2023 is as follows:
Schedule of effective income tax rate reconciliation
2024
2023
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
-
-
14.
Subsequent Events
On September 25, 2024, the Company closed a best
efforts public offering (the “September 2024 Offering”) of 1,360,800
shares of its common stock, par value $ 0.0001
per share, pre-funded warrants (the “September Pre-funded Warrants”) to purchase 600,000
shares of Common Stock, and warrants to purchase up to 1,960,800
shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $ 1.53
per Share, or September Pre-funded Warrant, and the associated September Common Warrant. The September Common
Warrants have an exercise price of $ 1.53
per share and are 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 were approximately $ 3.0
million, before deducting placement agent fees and offering expenses of approximately $ 560,000 .
Additionally, upon closing the Company issued the placement agent warrants (“September Placement Agent’s
Warrants”) to purchase 98,040
shares of Common Stock exercisable at a per share price of $ 1.91 ,
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- 25
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.