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 Securities Exchange Act of 1934, as amended (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 SECs 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.
35
Managements
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, 2023 using the criteria established in Internal Control Integrated Framework (2013 Framework) issued by the Committee
of Sponsoring Organization of the Treadway Commission (COSO). Based on our evaluation using those criteria, our management
has concluded that, as of June 30, 2023, 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 quarter ended June 30, 2023, 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.
36
PART
III .
ITEM
10.
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The following table sets forth certain information
regarding our Board of Directors, our executive officers, and some of our key employees, as of August 9, 2023.
Name
Age
Director
Since
Position
Cuong
Do
57
2016
CEO
& President and Director
Joanne
Wendy Kim
68
—
CFO
Joseph
M. Palumbo, MD
63
—
Chief
Medical Officer
Jim
Lang
58
2016
Chairman of the Board
Michael
Sherman
64
2017
Director
Richard
J. Berman
81
2019
Director
Steve
Gorlin
86
2020
Director
Robert
Hariri, MD, PhD
64
2020
Director
Sigmund
Rogich
79
2020
Director
According to our Bylaws, the directors shall
be elected at the annual meeting of the stockholders and each director shall be elected to serve until his successor shall be elected
and shall qualify. A director need not be a stockholder. Directors shall not receive any stated salary for their services as directors
or as members of committees, but by resolution of the Board of Directors a fixed fee and expenses of attendance may be allowed for attendance
at each meeting. The Bylaws shall not be construed to preclude any director from serving the Company in any other capacity as an officer,
agent or otherwise, and receiving compensation therefor.
There are no familial relationships among
any of our directors or officers.
Biographical Information
Mr. Cuong Do , has served on
the Company’s Board of Directors since 2016 and effective April 27, 2021 was appointed the Company’s CEO and President. He
served as the President, Global Strategy Group, at Samsung from February 2015 to December 2020. Mr. Do helped set the strategic direction
for Samsung Group’s diverse business portfolio. He was previously the Chief Strategy Officer for Merck from October 2011 to March
2014, and Tyco Electronics from June 2009 to October 2011, and Lenovo from December 2007 to March 2009. Mr. Do is a former senior partner
at McKinsey & Company, where he spent 17 years and helped build the healthcare, high tech and corporate finance practices. He holds
a BA from Dartmouth College, and an MBA from the Tuck School of Business at Dartmouth.
We believe Mr. Do’s qualifications
to serve on our Board of Directors and as the CEO are primarily based on his decades of experience as an executive in the pharma, biotech,
and other high technology industries and his extensive experience in strategy, corporate finance practice and the development of companies
in all stages.
Ms. Joanne Wendy Kim has served
as the Company’s Chief Financial Officer since October 2018. Ms. Kim previously served as CFO for several companies throughout her
career, previously with Landmark Education Enterprises, and prior to that; other public entities in the entertainment and financial services
industry sectors. She provided interim CFO services to various organizations from 2016 to 2018. In her various roles, Ms. Kim oversaw
corporate finance and operational groups, closed eight acquisitions, secured bank financings, developed and implemented new business strategies,
managed risk and implemented new financial policies and procedures. As a CPA professional, she advised on accounting transactions, SEC
reporting matters and other regulatory matters to clients serving as a Director at BDO USA, LLP’s National Office SEC Department
and served on the U.S. desk in London for BDO LLP UK Firm in 2008-2016 and as a Senior Manager at KPMG in earlier part of her career.
She brings more than 35 years of accounting and finance experience to this position. Ms. Kim earned her BSA in accounting and finance
at California State University, Long Beach.
Wendy
Kims qualifications to serve as our Chief Financial Officer are primarily based on her 35 years of accounting and finance experience
both as a CFO and as a CPA in major global accounting and consultancy firms.
37
Dr.
Joseph M. Palumbo has served as our Chief Medical Officer since November 2021. Formerly he served as the CMO at Zynerba Pharmaceuticals
from July 2019 to October 2021, responsible for clinical operations, development, regulatory, and medical affairs. Prior to his time
at Zynerba, Dr. Palumbo held senior worldwide governance roles at Mitsubishi Tanabe Pharma in both the United States and Japan from April
2012 to June 2019, where he led medical science and translational research across multiple therapeutic areas, and guided successful
registrational programs for Radicava® (edaravone) for the treatment of Amyotrophic Lateral Sclerosis .
From April 2003 to March 2012, Dr. Palumbo was Global Head and Franchise Medical Leader for Psychiatry, and the Interim Head of
Global Neuroscience at Johnson & Johnson, where he led the medical teams who achieved successful global registrations for Risperdal®
(risperidone); Concerta® (methylphenidate HCL); and Invega® (paliperidone). He was Head of Psychiatry and Neurology at Pharmanet
for from April 2002 to April 2003. Dr Palumbo previously held industry positions in European Pharma with Sanofi-Synthelabo from April
1999 to April 2002, Biotech at Cephalon, from April 1997 to April 1998, and from July 1989 to April 2002, he held senior leadership and
hospital administration roles at prestigious academic research institutions including Yale, Cornell, and the University of Pennsylvania.
He holds a Bachelor of Arts at the University of Pennsylvania and received his Doctor of Medicine at the George Washington University
School of Medicine. He was a Biological Sciences Training Program Fellow of the National Institutes of Health and Chief Resident for
the Abraham Ribicoff Clinical Neuroscience Research Unit at Yale University. Dr Palumbo has received Board Certification in Psychiatry
and Addiction Psychiatry.
Dr.
Palumbos qualifications to serve as our Chief Medical Officer is based on the decades and depth of experiences in the roles he
has served in his medical profession and commercial experience in the healthcare industry and biopharma industries.
Mr.
Jim Lang has served as the Companys director since 2016 and as the Chairman of the Board since March 2023. He is currently
CEO of EVERSANA, the leading commercialization services company for the life sciences industry. In five years since he founded EVERSANA,
it is now over $1B in revenue, with >7000 employees across 40 global locations. He formerly served as the CEO of Decision Resources
Group (DRG), which he transformed into a leading healthcare data and analytics firm. Prior to that, Jim was CEO of IHS Cambridge Energy
Research Associates (IHS CERA), a recognized leader in energy industry subscription information products, and formerly the President
of Strategic Decisions Group (SDG), a leading global strategy consultancy. Mr. Lang holds a BS summa cum laude in electrical and computer
engineering from the University of New Hampshire and an MBA with Distinction from the Tuck School of Business. Jim Lang currently also
serves as a Director at OptimizeRX (OPRX), a Nasdaq listed Company.
Jim Lang’s qualifications to serve
on our Board of Directors are primarily based on his decades of experience as a strategy consultant, broad industry expertise, and senior-level
management experience running several healthcare and information technology companies.
Mr. Richard J. Berman has served
as the Company’s director since June 2019. Mr. Berman has over 35 years of venture capital, senior management, and merger &
acquisitions experience. He currently is a director of four public companies including; Cryoport Inc., Genius Group, Context Therapeutics,
and over the last decade served on the boards of six companies that reached a market capitalization over one billion including Cryoport,
Advaxis, EXIDE, Internet Commerce Corporation, Kapitus and Ontrak. From 1998-2000, he was employed by Internet Commerce Corporation (now
Easylink Services) as Chairman and CEO and was a director from 1998-2012. Previously, Mr. Berman was Senior Vice President of Bankers
Trust Company, where he started the M&A and Leveraged Buyout Departments; created the largest battery company in the world in the
1980’s by merging Prestolite, General Battery and Exide and advised on over $4 billion of M&A transactions (completed over 300
deals). He is a past Director of the Stern School of Business of NYU where he obtained his BS and MBA. He also has US and foreign law
degrees from Boston College and The Hague Academy of International Law, respectively.
We believe Richard J. Berman’s qualifications
to serve on our Board of Directors include his experience in the healthcare industry, and his current and past experience in numerous
private and publicly traded companies.
Mr. Steven Gorlin has served
as the Company’s director since June 2020. He has founded many biopharma companies including Hycor Biomedical, Theragenics, Medicis
Pharmaceutical, EntreMed, MRI Interventions, DARA BioSciences, MiMedx, Medivation (sold to Pfizer for $14 billion) and NantKwest. Mr.
Gorlin served for many years on the Business Advisory Council to the Johns Hopkins School of Medicine and on The Johns Hopkins BioMedical
Engineering Advisory Board. He is currently a member of the Research Institute Advisory Committee (RIAC) of Massachusetts General Hospital.
He started The Touch Foundation, a nonprofit organization for the blind, and was a principal contributor to Camp Kudzu for diabetic children.
Steve Gorlin’s qualifications to serve
on our Board of Directors are primarily based on his over 45 years of experience in founding and investing in several biopharma companies,
leading multiple NASDAQ AND NYSE companies to their success.
38
Dr. Robert Hariri MD, PhD ,
has served as the Company’s director since June 2020. Dr Hariri is the Chairman, founder, and CEO of Celularity, Inc., a leading
cellular therapeutics company. He was the founder and CEO of Anthrogenesis Corporation, and after its acquisition served as CEO of Celgene
Cellular Therapeutics. Dr. Hariri co-founded the genomic health intelligence company, Human Longevity, Inc. Dr. Hariri pioneered the use
of stem cells to treat a range of life-threatening human diseases. He is widely acknowledged for his discovery of pluripotent stem cells
and for assisting with discovering the physiological activities of tumor necrosis factor (TNF). He holds over 170 issued and pending patents.
Robert (Bob) Hariri’s qualifications
to serve on our Board of Directors are primarily based on his decades of founding and leading several companies in the cellular therapeutic
space, as well as pioneering in the use of stem cells to treat a range of life-threatening human diseases and discoveries in the physiological
activities of tumor necrosis factor. He has authored over 150 publications and garnered numerous awards for contributions to the fields
of biomedicine and aviation.
Mr. Sigmund (Sig) Rogich has
served as the Company’s director since June 2020. Sig is the CEO and President of The Rogich Communications Group and serves on
the Board of Keep Memory Alive, a philanthropic organization which raises awareness about brain disorders and Alzheimer’s disease. Keep
Memory Alive funds clinical trials to advance new treatments for patients with Alzheimer’s, Huntington’s and Parkinson’s
disease, as well as multiple sclerosis. Mr. Rogich was formerly the U.S. Ambassador to Iceland. He has served as a senior consultant
to Presidents Ronald Reagan and George H.W. Bush. Mr. Rogich serves on multiple boards of directors for charitable causes.
We believe Mr. Rogich’s qualifications
to serve on our Board of Directors are based on his experience in the Communications sector and philanthropic organization raising awareness
about brain disorders. His experience in service as a senior consultant to candidates of the highest office.
Mr. Michael Sherman JD has
served as the Company director since 2017. He retired from his position as a Managing Director at Barclays Plc in 2018, where he had worked
since 2008. Previously he was a Managing Director at Lehman Brothers, Inc. He has worked in investment banking for 30 years. Mr. Sherman
has significant experience in healthcare finance, most recently assisting on a $450 million convertible transaction for Neurocrine Biosciences.
He has worked on successful financial transactions for Teva Pharmaceutical Industries, Amgen Inc., Cubist Pharmaceuticals, Merck &
Co., and Cardinal Health, among other companies. After graduating from the University of Pennsylvania, Michael Sherman received his JD,
cum laude, from the Harvard Law School.
Michael Sherman’s qualifications to
serve on our Board of Directors are primarily based on his decades of finance industry experience and investment banking. Mr. Sherman
has significant experience in healthcare finance including having worked on successful financial transactions for several pharmaceutical
and healthcare focused companies.
Delinquent Section 16(a) Reports
Section 16(a) of the Securities Exchange
Act of 1934, as amended (Exchange Act), requires our directors and executive officers, and persons who own more than 10% of our outstanding
Common Stock, to file with the SEC, initial reports of ownership and reports of changes in ownership of our equity securities. Such persons
are required by SEC regulations to furnish us with copies of all such reports they file.
To our knowledge, based solely on a review
of the copies of such reports furnished to us regarding the filing of required reports, we believe that, except for the reports filed
by Clarence Ahlem (Form 4s filed on January 18, 2023 and February 22, 2023), Richard J. Berman (Form 4s filed on January 18, 2023, April
6, 2023 and June 15, 2023), Cuong Do (Form 4s filed on July 7, 2022, January 18, 2023, February 22, 2023 and June 26, 2023), Steve Gorlin
(Form 4 filed on January 18, 2023), Robert J. Hariri (Form 4 filed on January 18, 2023), Wendy Kim (Form 4s filed on January 8, 2023
and February 22, 2023), James Lang (Form 4 filed on January 18, 2023), Penelope Markham (Form 4s filed on January 18, 2023 and February
22, 2023), Joseph M Palumbo (Form 4s filed on January 18, 2023, February 22, 2023 and July 3, 2023), Terren Peizer (Form 3 filed on August
16, 2022 and Form 4s filed on August 26, 2022 and January 18, 2023), Christopher Reading (Form 4s filed on January 18, 2023 and February
22, 2023), Sigmund Rogich (Form 4 filed on January 18, 2023) and Michael Sherman (Form 4 filed on January 18, 2023), all Section 16(a)
reports applicable to our directors, executive officers and greater-than-ten-percent beneficial owners with respect to fiscal 2023 were
timely filed.
39
Independence of the Board of Directors
Our Common Stock is traded on the Nasdaq
Capital Market. The Board of Directors has determined that six of the seven members of the Board of Directors qualify as “independent,”
as defined by the listing standards of the Nasdaq. Consistent with these considerations, after review of all relevant transactions and
relationships between each director, or any of the director’s family members, and the Company, its senior management and its independent
auditors, the Board has determined further that Messrs. Lang, Sherman, Berman, Gorlin, Hariri and Rogich are independent under the listing
standards of Nasdaq. In making this determination, the Board of Directors considered that there were no new transactions or relationships
between its current independent directors and the Company, its senior management and its independent auditors since last making this determination.
2023 Meetings and Attendance
During fiscal year 2023, the Board held four
regular Board of Directors meetings and one special meeting of the Board of Directors, four Audit Committee meetings, six Compensation
Committee meetings and one Nominating and Corporate Governance Committee meeting. All Directors attended at least 75% or more of the aggregate
number of meetings of the Board and Board Committees on which they served.
Committees of the Board of Directors
Our Board of Directors has three standing
committees: an audit committee, a compensation committee and a nominating and corporate governance committee. Both our audit committee
and our compensation committee will be composed solely of independent directors. The audit committee is comprised solely of independent
directors, and the compensation committee and the nominating and corporate governance committee are comprised solely of independent directors.
Each committee operates under a charter approved by our Board of Directors and have the composition and responsibilities described below.
The charter of each committee is available on our website.
Audit Committee
We have established an audit committee of
the Board of Directors. The members of our audit committee are Richard Berman, Michael Sherman, Jim Lang and Sigmund Rogich each of whom
is an independent director within the meaning of the Nasdaq rules. Mr. Berman has served as chairman of the audit committee since October
2020 and qualifies as an “audit committee financial expert” as defined by Item 401(h)(2) of Regulation S-K.
We
have adopted an audit committee charter, detailing the principal functions of the audit committee, including:
● assisting
board oversight of (1) the integrity of our financial statements, (2) our compliance
with legal and regulatory requirements, (3) our independent auditors qualifications
and independence, and (4) the performance of our internal audit function and independent
auditors; the appointment, compensation, retention, replacement, and oversight of the work
of the independent auditors and any other independent registered public accounting firm engaged
by us;
● pre-approving
all audit and non-audit services to be provided by the independent auditors or any other
registered public accounting firm engaged by us, and establishing pre-approval policies and
procedures; reviewing and discussing with the independent auditors all relationships the
auditors have with us in order to evaluate their continued independence;
● setting
clear policies for audit partner rotation in compliance with applicable laws and regulations;
● obtaining
and reviewing a report, at least annually, from the independent auditors describing (1) the
independent auditors internal quality-control procedures and (2) any material issues
raised by the most recent internal quality-control review, or peer review, of the audit firm,
or by any inquiry or investigation by governmental or professional authorities, within the
preceding five years respecting one or more independent audits carried out by the firm and
any steps taken to deal with such issues;
● meeting
to review and discuss our annual audited financial statements and quarterly financial statements
with management and the independent auditor, including reviewing our specific disclosures
under Managements Discussion and Analysis of Financial Condition and Results
of Operations; reviewing and approving any related party transaction required to be
disclosed pursuant to Item 404 of Regulation S-K promulgated by the SEC prior to us entering
into such transaction; and
40
● reviewing
with management, the independent auditors, and our legal advisors, as appropriate, any legal,
regulatory or compliance matters, including any correspondence with regulators or government
agencies and any employee complaints or published reports that raise material issues regarding
our financial statements or accounting policies and any significant changes in accounting
standards or rules promulgated by the Financial Accounting Standards Board, the SEC or other
regulatory authorities.
Compensation
Committee
We have established a compensation committee
of the Board of Directors. The members of our Compensation Committee are Richard Berman, Michael Sherman and Steve Gorlin. Mr. Sherman
has served as chairman of the compensation committee since October 2020.
We
have adopted a compensation committee charter, which details the principal functions of the compensation committee, including:
● reviewing
and approving on an annual basis the corporate goals and objectives relevant to our Chief
Executive Officers compensation, evaluating our Chief Executive Officers performance
in light of such goals and objectives and determining and approving the remuneration (if
any) of our Chief Executive Officer based on such evaluation;
● reviewing
and making recommendations to our Board of Directors with respect to the compensation, and
any incentive-compensation and equity-based plans that are subject to board approval of all
of our other officers;
● reviewing
our executive compensation policies and plans;
● implementing
and administering our incentive compensation equity-based remuneration plans; assisting management
in complying with our proxy statement and annual report disclosure requirements;
● approving
all special perquisites, special cash payments and other special compensation and benefit
arrangements for our officers and employees; and
● producing
a report on executive compensation to be included in our annual proxy statement; and reviewing,
evaluating and recommending changes, if appropriate, to the remuneration for directors.
The
charter also provides that the compensation committee may, in its sole discretion, retain or obtain the advice of a compensation consultant,
independent legal counsel or other adviser and will be directly responsible for the appointment, compensation and oversight of the work
of any such adviser. However, before engaging or receiving advice from a compensation consultant, external legal counsel or any other
adviser, the compensation committee will consider the independence of each such adviser, including the factors required by Nasdaq and
the SEC.
Compensation
Committee Interlocks and Insider Participation
None
of our officers currently serves, or in the past year has served, as a member of the compensation committee of any entity that has one
or more officers serving on our Board of Directors.
Nominating
and Corporate Governance Committee
We
have established a nominating and corporate governance committee of the Board of Directors. The members of our nominating and corporate
governance committee are, Jim Lang, Michael Sherman and Robert Hariri. Mr. Lang has served as chair of the nominating and corporate governance
committee since August 2021.
We
have adopted a nominating and corporate governance committee charter, which details the purpose and responsibilities of the nominating
and corporate governance committee, including:
● identifying,
screening and reviewing individuals qualified to serve as directors, consistent with criteria
approved by the Board of Directors, and recommending to the Board of Directors candidates
for nomination for election at the annual meeting of stockholders or to fill vacancies on
the Board of Directors;
41
● developing
and recommending to the Board of Directors and overseeing implementation of our corporate
governance guidelines;
● coordinating
and overseeing the annual self-evaluation of the Board of Directors, its committees, individual
directors and management in the governance of the company; and
● reviewing
on a regular basis our overall corporate governance and recommending improvements as and
when necessary.
The
charter also provides that the nominating and corporate governance committee may, in its sole discretion, retain or obtain the advice
of, and terminate, any search firm to be used to identify director candidates, and will be directly responsible for approving the search
firms fees and other retention terms.
We
have not formally established any specific, minimum qualifications that must be met or skills that are necessary for directors to possess.
In general, in identifying and evaluating nominees for director, the Board of Directors considers educational background, diversity of
professional experience, knowledge of our business, integrity, professional reputation, independence, wisdom, and the ability to represent
the best interests of our stockholders. Prior to our initial business combination, holders of our public shares will not have the right
to recommend director candidates for nomination to our Board of Directors.
Set
forth below is information concerning the gender and demographic background of each of our current directors, as self-identified and
reported by each director. This information is being provided in accordance with Nasdaqs board diversity rules.
Board
Diversity Matrix (As of August 11, 2023)
Total
Number of Directors:
8
Did
Not
Non-
Disclose
Female
Male
Binary
Gender
Part
I: Gender Identity
Directors
0
7
0
0
Part
II: Demographic Background
African
American or Black
—
—
—
—
Alaskan
Native or Native American
—
—
—
—
Asian
—
1
—
—
Hispanic
or Latinx
—
—
—
—
Native
Hawaiian or Pacific Islander
—
—
—
—
White
—
3
—
—
Two
or More Races or Ethnicities
—
—
—
—
LGBTQ+
—
—
—
—
Did
Not Disclose Demographic Background
—
3
—
—
Code
of Ethics
We
have adopted a code of conduct and ethics meeting the requirements of Section 406 of the Sarbanes-Oxley Act of 2002. We believe our code
of conduct and ethics is reasonably designed to deter wrongdoing and promote honest and ethical conduct; provide full, fair, accurate,
timely and understandable disclosure in public reports; comply with applicable laws; ensure prompt internal reporting of violations;
and provide accountability for adherence to the provisions of the code of ethic. Our code of conduct and ethics is available on our website .
A
copy of our code of conduct and ethics is filed as an exhibit to this Form 10-K.
Anti-Hedging
Policy
We
have adopted an insider trading policy that includes a provision restricting trading of any interest or provision relating to the future
price of our securities, such as a put, call or short sale.
42
ITEM
11.
EXECUTIVE
COMPENSATION
Summary
Compensation Table
The
following table sets forth the total compensation paid during the last two fiscal years ended June 30, 2023 and 2022 to the following
executive officers of the Company, who are referred to as our named executive officers:
● Cuong
Do, our President and Chief Executive Officer
● Joanne
Wendy Kim, our Chief Financial Officer and Corporate Secretary
● Joseph
Palumbo, our Chief Medical Officer
Name and Principal
Position
Year
Salary
Bonus
Stock
Awards (1)
Option
Awards (1)
Non-Equity
Incentive Plan Compensation
Nonqualified
Deferred Compensation Earnings
All
Other Compensation
Total
Cuong
Do (2)
Chief
Executive Officer and President
2023
$ 618,000
$ 463,500
$ 734,668
$ 521,500
$ —
$ —
$ —
$ 2,337,668
2022
$ 300,000
$ 400,000
$ 210,439
$ 3,632,382
$ —
$ —
$ —
$ 4,542,821
Joanne
Wendy Kim (3)
Chief
Financial Officer, Treasurer and Corporate Secretary
2023
$ 246,750
$ 150,625
$ 242,499
$ 84,000
$ —
$ —
$ —
$ 723,874
2022
$ 235,000
$ 127,656
$ —
$ 582,343
$ —
$ —
$ —
$ 944,999
Joseph
Palumbo (4)
Chief
Medical officer
2022
$ 525,000
$ 197,000
$ 242,499
$ 126,000
$ —
$ —
$ —
$ 1,090,499
2022
$ 333,333
$ 239,167
$ —
$ 244,465
$ —
$ —
$ —
$ 816,965
(1)
The aggregate grant date fair value of such awards were computed in accordance with Financial Accounting Standards Board ASC Topic 718, Stock Compensation (ASC Topic 718), and do not take into account estimated forfeitures related to service-based vesting conditions, if any. The valuation assumptions used in calculating these values are discussed in Note 10 of our Notes to Financial Statements included in our Annual Report on Form 10-K for the year ended June 30, 2023. These amounts do not represent actual amounts paid or to be realized. Amounts shown are not necessarily indicative of values to be achieved, which may be more or less than the amounts shown as awards may subject to time-based vesting. The stock awards in form of RSUs and Stock Option Awards were awarded pursuant to the 2019 Omnibus Incentive Plan, (the “2019 Plan”).
(2)
Mr. Do’s salary from April 27, 2021 (date of his appointment as CEO) through December 31, 2021 was paid through RSUs. The aggregate grant date fair value of the award was $454,794 and the total 58,759 RSUs awarded allows Mr. Do to receive one shares of Common Stock for each RSU.
(3) Ms.
Kim served as the Chief Financial Officer and Corporate Secretary and Treasurer on a full
time basis effective July 1, 2021.
(4) Dr.
Palumbo joined the Company on November 1, 2021 and served as the Chief Medical Officer.
Employment
Agreements
All
employment arrangements are at will agreements.
43
Outstanding
Equity Awards at Fiscal Year-End
The
following table sets forth all outstanding equity awards held by our named executive officers as of June 30, 2023:
Options
Stock
Awards
Name
Grant
Date
Number
of securities underlying unexercised options exercisable
Number
of securities underlying unexercised options unexercisable
Equity
incentive plan awards: number of securities underlying unexercised unearned options
Option
exercise price
Option
expiration date
Number
of shares or units of stock that have not vested
Market
value of shares or units of stock that have to vested
Equity
incentive plan awards: number of unearned shares, units or other rights that have not vested
Equity
incentive plan awards: market or payout value of unearned shares, units or other right that have not vested
Cuong
Do, CEO
01-19-19
800
—
—
$ 3.75
01-19-24
—
—
—
$ —
01-19-20
800
—
—
$ 2.80
01-19-25
—
—
—
$ —
12-18-20
24,375
—
—
$ 13.91
12-18-25
—
—
—
$ —
08-20-21
387,400
—
357,600
$ 7.74
08-20-31
—
—
—
$ —
06-21-22
41,506
—
83,014
$ 1.69
06-21-32
—
—
83,014
$ 357,790
11-23-23
—
—
—
$ —
—
—
59,436
$ 256,169
06-29-23
—
—
175,000
$ 4.09
06-29-33
—
—
149,500
$ 644,345
Joanne
W. Kim, CFO
10-01-18
800
—
—
$ 8.75
10-01-23
—
—
—
$ —
10-01-19
800
—
—
$ 8.75
10-01-24
—
—
—
$ —
10-01-20
800
—
—
$ 9.54
10-01-25
—
—
—
$ —
08-20-21
40,726
—
83,441
$ 7.74
08-20-31
—
—
—
$ —
11-23-22
—
—
—
$ —
—
—
29,718
$ 128,085
06-07-23
5,000
—
15,000
$ 5.78
06-07-33
—
—
—
$ —
Joseph
M. Palumbo, CMO
02-01-22
24,833
—
99,334
$ 3.20
02-01-32
—
—
—
$ —
11-23-22
—
—
—
$ —
—
—
29,718
$ 128,085
06-07-23
7,500
—
22,500
$ 5.78
06-07-33
—
—
—
$ —
Named executive officers held stock options
to purchase a total of 1,371,729 shares of Common Stock as of June 30, 2023, with an aggregate grant date fair value of approximately
$5.4 million, the last of which vests in 2027. Stock options granted prior to August 20, 2021, vested on the grant date; the stock options
granted on August 20, 2021 vested 20% on the grant date, with the remaining stock options vesting in five equal annual installments beginning
on the first grant date anniversary; the stock options granted on June 7, 2023, vested 25% on the grant date, with the remaining stock
options vesting in four equal annual installments beginning on the first grant date anniversary; and the stock options and stock awards
in the form RSUs granted to the CEO on June 21, 2022 and June 29, 2023 vests in three equal annual installments beginning on the first
grant date anniversary. The RSU awarded on November 23, 2022 vested 25% on the grant date with the remaining RSU vesting in three equal
annual installments beginning on the first grant date anniversary. The total RSUs outstanding awarded to the named executive officers
totaled 351,386 with a market value totaling approximately $1.5 million as of June 30, 2023.
Potential Payments Upon Termination or Change
of Control
There are no arrangements with the named
executive officers or our equity incentive plan or individual award agreements thereunder providing for certain payments to our named
executive officers at or following or in connection with a termination of their employment or a change of control of the Company.
44
Director
Compensation
There
are no arrangements pursuant to which our directors are or will be compensated in the future for any services provided to the Company.
The
following table provides information regarding compensation that was earned or paid to the individuals who served as non-employee directors
during the year ended June 30, 2023. Except as set forth in the table, during the fiscal year 2023, directors did not earn nor receive
cash compensation or compensation in the form of stock awards, options awards or any other form.
Name
Stock awards (1)
Option awards(1)
Non-equity incentive plan compensation
Change in pension value and nonqualified deferred compensation
All other compensation
Total
Jim Lang
$ 266,697
—
$ —
$ —
$ —
$ 266,697
Michael Sherman
—
304,500
$ —
$ —
$ —
$ 304,500
Richard Berman
$ 266,697
—
$ —
$ —
$ —
$ 266,697
Steve Gorlin
$ 209,549
—
$ —
$ —
$ —
$ 209,549
Robert Hariri MD, Phd
$ 209,549
—
$ —
$ —
$ —
$ 209,549
Sigmund Rogich
$ —
223,300
$ —
$ —
$ —
$ 223,300
Terren Piezer (2)
$ —
263,900
$ —
$ —
$ —
$ 263,900
(1) The
aggregate grant date fair value of such awards were computed in accordance with Financial
Accounting Standards Board ASC Topic 718, Stock Compensation (ASC Topic 718), and do not
take into account estimated forfeitures related to service-based vesting conditions, if any.
The valuation assumptions used in calculating these values are discussed in Note 10 of our
Notes to Financial Statements included in our Annual Report on Form 10-K for the year ended
June 30, 2023. These amounts do not represent actual amounts paid or to be realized. Amounts
shown are not necessarily indicative of values to be achieved, which may be more or less
than the amounts shown as awards may subject to time-based vesting.
(2) Mr.
Piezer resigned from the Board of Directors effective March 2, 2023.
Our directors are eligible to participate
in our equity incentive plans, which are administered by our Compensation Committee under authority delegated by our Board of Directors.
The terms and conditions of the option grants to our non-employee directors under our equity incentive plans are and will be determined
in the discretion of our Compensation Committee, consistent with the terms of the applicable plan. The fiscal year 2023 annual compensation
granted to existing board members consisted of either an award of RSUs at one unit per share of Common Stock, a total of 155,636 RSU at
a grant date market value of $952,492 or stock options to purchase a total of 195,000 shares of commons stock with a grant date fair value
totaling $791,700. The former chairman of the Board of Directors, the chairman of the compensation committee and a member of the audit
committee received stock options to purchase 65,000, 75,000 and 55,000 shares of Common Stock, respectively. The chairmen of the audit
committee and the corporate governance and nominating committee each received 43,578 RSUs and the members of those committees each received
34,240 RSUs.
45
The
following tables sets forth the outstanding equity awards held by non-employee directors as of June 30, 2023:
Options
(1)
Stock
Awards (2)
Name
Grant
Date
Number
of securities underlying unexercised options exercisable
Number
of securities underlying unexercised options unexercisable
Equity
incentive plan awards: number of securities underlying unexercised unearned options
Option
exercise price
Option
expiration date
Number
of shares or units of stock that have not vested
Market
value of shares or units of stock that have to vested
Equity
incentive plan awards: number of unearned shares, units or other rights that have not vested
Equity
incentive plan awards: market or payout value of unearned shares, units or other right that have not vested
James
Lang
01-19-19
800
—
—
$ 3.13
01-19-24
—
—
—
$ —
01-19-20
800
—
—
$ 2.80
01-19-25
—
—
—
$ —
12-18-20
74,250
—
24,750
$ 13.91
12-18-25
—
—
—
$ —
04-05-22
63,950
—
63,950
$ 7.74
04-05-32
—
—
—
$ —
11-23-22
—
—
—
$ —
—
—
21,789
$ 93,911
Richard
J. Berman
01-19-20
800
—
—
$ 2.80
01-19-25
—
—
—
$ —
12-18-20
76,875
—
25,625
$ 13.91
12-18-25
—
—
—
$ —
04-05-22
64,525
—
64,525
$ 5.04
04-05-27
—
—
—
$ —
11-23-22
—
$ —
—
—
21,789
$ 93,911
Steve
Gorlin
12-18-20
72,225
—
24,075
$ 13.91
12-18-25
—
—
—
$ —
04-05-22
61,125
—
61,125
$ 5.04
04-05-27
11-23-22
—
—
—
$ —
—
—
17,120
$ 73,787
Robert
Hariri
12-18-20
71,925
—
23,975
$ 13.91
12-18-25
—
—
—
$ —
04-05-22
61,125
61,125
$ 5.04
04-05-27
—
—
—
$ —
11-23-22
—
—
—
$ —
17,120
$ 73,787
Sigmund
Rogich
12-18-20
72,975
—
24,325
$ 13.91
12-18-25
—
—
—
$ —
04-05-22
61,700
—
61,700
$ 5.04
04-05-27
—
—
—
$ —
11-23-22
27,500
—
27,500
$ 6.12
11-23-27
—
—
—
$ —
Michael
Sherman
10-13-18
800
—
—
$ 6.25
10-13-23
—
—
—
$ —
10-13-19
800
—
—
$ 7.13
10-13-24
—
—
—
$ —
10-13-20
800
—
—
$ 9.90
10-13-25
—
—
—
$ —
12-18-20
77,325
—
25,775
$ 13.91
12-18-25
—
—
—
$ —
04-05-22
65,075
—
65,075
$ 5.04
04-05-27
—
—
—
$ —
11-23-22
37,500
—
37,500
$ 6.12
11-23-27
—
—
—
$ —
(1)
There was a total of 1,483,300 stock options outstanding to directors as of June 30, 2023, with an aggregate grant date fair value of approximately $13.2 million, the last of which vest in 2027. Stock options granted on December 18, 2020 and April 5, 2022 vest 25% on grant date with the remaining stock options vesting in three annual equal installments beginning on the first grant date anniversary. Stock options granted on November 23, 2022 vest in four equal quarterly installments beginning February 9, 2023.
(2)
Equity awards granted the Board of Directors on November 23, 2022 were in the form of RSUs, one unit for one share of Common Stock, vest in four equal quarterly installments beginning February 9, 2023. There were 77,460 RSUs outstanding as of June 30, 2023, with an aggregate market value of approximately $335,000.
46
Long-Term
Incentive Plans and Awards
Other
than the options granted and RSU awards as described above, we do not currently have any long-term incentive plans that provide compensation
intended to serve as incentive for performance. Since prior to such grants, no individual grants or agreements regarding future payouts
under non-stock price-based plans had been made to any executive officer or any director or any employee or consultant since our inception,
no future payouts under non-stock price-based plans or agreements had been granted or entered into or exercised by our officer or director
or employees or consultants.
2019
Omnibus Equity Incentive Plan
On April 20, 2019, our Board of Directors
and our stockholders approved and adopted the 2019 Plan. The 2019 Plan allows us, under the direction of our Board of Directors or a committee
thereof, to make grants of stock options, restricted and unrestricted stock and other stock-based awards to employees, including our executive
officers, consultants and directors. The 2019 Plan allows for the issuance of up to 6,540,000 shares of common pursuant to new awards
granted under the 2019 Plan and as of June 30, 2023, there were 2,269,952 shares of Common Stock available for new awards granted under
the 2019 Plan.
Equity
Compensation Plan Information [1]
The
following table provides certain aggregate information with respect to all of the Companys equity compensation plans in effect
as of June 30, 2023:
(a)
(b)
(c)
Plan Category
Number of securities to be issued upon exercise of outstanding
options, warrants and rights
Weighted-average exercise price of outstanding options,
warrants and rights
Number of securities remaining available for future
issuance under equity compensation pans (excluding securities reflected in column (a))
Equity compensation plans approved by security holders
4,530,121
$ 6.71
2,269,952
Equity compensation not approved by security holders
—
$ —
—
Total
4,530,121
$ 6.71
2,269,952
PAY
VERSUS PERFORMANCE
As
required by Item 402(v) of Regulation S-K, we are providing the following information regarding the relationship between executive compensation
and our financial performance for each of the last two completed calendar years. In determining the “compensation actually paid”
to our named executive officers (“NEOs”), we are required to make various adjustments to amounts that have been previously
reported in the Summary Compensation Table in previous years, as the SEC’s valuation methods for this section differ from those
required in the Summary Compensation Table.
Pay
Versus Performance Table
The
table below summarizes compensation values both previously reported in our Summary Compensation Table, as well as the adjusted values
required in this section for fiscal years 2022 and 2023. Note that for our NEOs other than our principal executive officer (the “PEO”),
compensation is reported as an average.
47
Year
Summary
Compensation Table Total for PEO
($)(1)(2)
Compensation
Actually Paid to PEO
($)(1)(3)
Average
Summary Compensation Table Total for Non-PEO Named Executive Officers
($)(1)(4)
Average
Compensation Actually Paid to Non-PEO Named Executive Officers
($)(1)(5)
Value
of Initial Fixed $100 Investment Based on Total Shareholder Return
($)(6)
Net
Loss
($)(7)
(in
thousands)
2023
$2,337,668
$3,434,517
$1,185,289
$1,185,289
$25.43
$(50,256)
2022
$4,542,821
$916,050
$605,653
$605,653
$8.55
$(25,084)
(1) During fiscal years 2023 and 2022, the PEO was Cuong Do. During fiscal years 2023 and 2022, the non-PEO NEOs were Joanne W Kim and Joseph M Palumbo M.D.
(2) The
dollar amounts reported are the amounts of total compensation reported for Mr. Do and the
average total compensation reported for Non-PEO Named Executive Officers for the applicable
fiscal year in the “Total” column of the Summary Compensation Table (SCT).
(3) The
following table sets forth the adjustments made to the SCT total for each year represented
in the pay versus performance table to arrive at “compensation actually paid”
to our PEO, as computed in accordance with Item 402(v) of Regulation S-K:
2023
2022
SCT
Total for PEO
$2,337,668
$4,542,821
Less:
Amount reported under the “Stock Awards” column in the SCT
$(1,256,168)
$(3,842,821)
Add:
Fair value as of fiscal year-end of awards granted during the fiscal year that are outstanding and unvested as of the end of the
fiscal year
$2,770,583
$-
Add:
Change in fair value as of fiscal year-end, compared to prior fiscal year-end, of awards granted in any prior fiscal year that are
outstanding and unvested as of the end of the fiscal year
$(1,545,275)
$-
Add:
Fair value as of vest date of awards granted and vested in the fiscal year
$1,186,095
$1,153,260
Add:
Change in fair value as of vesting date, compared to prior fiscal year-end, of awards granted in any prior fiscal year for which
all vesting conditions were satisfied at fiscal year-end or during the fiscal year
$(58,386)
$(937,210)
Less:
Forfeitures during fiscal year equal to prior fiscal year-end value
$-
$-
Total
Adjustments
$1,096,849
$(3,626,771)
Compensation
Actually Paid to PEO
$3,434,517
$916,050
(4) The
following table sets forth the adjustments made to the SCT total for each year represented
in the pay versus performance table to arrive at “compensation actually paid”
to our PEO, as computed in accordance with Item 402(v) of Regulation S-K:
48
2023
2022
Average
SCT Total for Non-PEO NEOs
$907,186
$880,982
Less:
Amount reported under the “Stock Awards” column in the SCT
$(347,499)
$(413,404)
Add:
Fair value as of fiscal year-end of awards granted during the fiscal year that are outstanding and unvested as of the end of the
fiscal year
$551,399
$144,034
Add:
Fair value as of vest date of awards granted and vested in the fiscal year
$96,750
$135,839
Add: change in fair value as of vesting date, compared to prior fiscal year-end of awards granted in any prior fiscal year for which all vesting conditions were satisfied at fiscal year-end or during the fiscal year
$(22,548)
$(141,798)
Less: Forfeitures during fiscal year equal to prior fiscal year-end value
$-
$-
Total
Adjustments
$278,102
$(275,329)
Average
Compensation Actually Paid to Non-PEO NEOs
$1,185,289
$605,653
(5) The
amounts reported represent the measurement period value of an investment of $100 in our stock
on June 30, 2021 (the last trading day before the 2022 fiscal year), and then valued again
on each of June 30, 2022 (the last trading day of the 2022 fiscal year) and June 30, 2023
(the last trading day of the 2023 fiscal year), based on the closing price per share of the
Company’s common stock as of such dates and assuming the reinvestment of dividends.
(6) The
amounts reported represent net loss for the applicable fiscal year calculated in accordance
with generally accepted accounting principles in the United States.
49
Relationship
Between CAP Amounts and Performance Measures
The
following charts show graphically the relationships over the past two years of the CAP Amounts for the PEO and the Other NEOs as compared
to our (i) cumulative total shareholder return and (ii) net loss.
While
the Compensation Committee makes executive compensation decisions in consideration of a variety of factors, including corporate and individual
performance, the decisions of the Compensation Committee and Board of Directors in 2022 and 2023 were made independently of these disclosure
requirements.
50
ITEM
12.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Based solely upon information made available
to us, the following table sets forth information as of August 9, 2023 regarding the beneficial ownership of our Common Stock by:
● each
person known by us to be the beneficial owner of more than 5% of our outstanding shares of
Common Stock;
● each
of our named executive officers and directors; and
● all
our executive officers and directors as a group.
The percentage ownership information shown in
the table is based upon 36,765,035 shares of Common Stock outstanding as of August 9, 2023.
Beneficial
ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to the securities.
Except as otherwise indicated, each person or entity named in the table has sole voting and investment power with respect to all shares
of our capital shown as beneficially owned, subject to applicable community property laws.
In
computing the number and percentage of shares beneficially owned by a person as of a particular date, shares that may be acquired by
such person (for example, upon the exercise of options or warrants) within 60 days of such date are counted as outstanding, while these
shares are not counted as outstanding for computing the percentage ownership of any other person.
The
address of each holder listed below, except as otherwise indicated, is c/o BioVie Inc., 680 W Nye Lane, Suite 201, Carson City, Nevada
89703.
Name and Address of Beneficial Owner
Number of Common Shares of Beneficial Ownership
Percentage of Beneficial Ownership
Named
executive officers and directors:
James Lang (1)
170,570
*
Richard Berman (2)
110,738
*
Steve Gorlin (3)
178,468
*
Robert Hariri (4)
119,895
*
Sigmund Rogich (5)
145,075
*
Michael Sherman (6)
202,525
*
Cuong Do (7)
738,312
2.0 %
Joanne Wendy Kim (8)
80,397
*
Joseph Palumbo (9)
38,263
*
All directors and executive officers as a group (9)
1,784,243
4.8 %
5% Stockholders
Acuitas Group Holdings (10)
30,503,938
69.1 %
* Less than 1%
(1) Includes warrants
to purchase 17,333 shares of Common Stock and options to purchase 134,636 shares of Common Stock, all of which are exercisable
within 60 days of August 9, 2023.
(2) Includes options
to purchase 109,138 shares of Common Stock, all of which are exercisable within 60 days of August 9, 2023.
(3) Includes options
to purchase 102,788 shares of Common Stock, all of which are exercisable within 60 days of August 9, 2023. 50,000 shares of
common stock is held by Mr. Gorlin’s wife.
(4) Includes options to
purchase 102,775 shares of Common Stock, all of which are exercisable within 60 days of August 9, 2023.
(5) Includes options
to purchase 145,175 shares of Common Stock, all of which are exercisable within 60 days of August 9, 2023.
51
(6) Includes warrants
to purchase 13,333 shares of Common Stock and options to purchase 168,513 shares of Common Stock, all of which are exercisable
within 60 days of August 9, 2023. Common stock held of record by Sherman Children’s Trust Brian Krisber, Trustee. All shares
of common stock, warrants and options are deemed to be beneficially owned or controlled by Michael Sherman.
(7) Includes warrants to
purchase 70,666 shares of Common Stock and options to purchase 455,681 shares of Common Stock, all of which are exercisable within
60 days of August 9, 2023. 211,965 shares of Common Stock and warrants are held of record by Do & Rickles
Investments, LLC, a limited liability company 100% owned by Cuong Do and his wife, and as such, Mr. Do may be deemed to beneficially
own or control.
(8) Include options
to purchase shares 70,967of Common Stock, all of which are exercisable within 60 days of August 9, 2023.
(9) Includes options
to purchase 30,833 shares of Common Stock, all of which are exercisable within 60 days of August 9, 2023.
(10) Includes warrants
to purchase 7,272,728 shares of Common Stock and options to purchase 65,000 shares of Common Stock, all of which are exercisable
within 60 days of August 9, 2023. All shares held of record by Acuitas Group Holdings, LLC, a limited liability company 100%
owned by Terren Peizer, and as which Mr. Peizer may be deemed to beneficially own or control. Mr. Peizer disclaims beneficial
of any such securities.
52
ITEM
13.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The
following includes a summary of transactions since June 30, 2022, to which we have been a party in which the amount involved exceeded
or will exceed the lesser of (i) $120,000 and (ii) one percent (1%) of the average of our total assets at year-end for the prior two
fiscal years, and in which any of our directors, executive officers or beneficial owners of more than 5% of our capital stock or any
member of the immediate family of any of the foregoing persons had or will have a direct or indirect material interest.
On July 15, 2022, the Company, entered into
a Securities Purchase Agreement (the “Purchase Agreement”) with Acuitas, pursuant to which Acuitas agreed to purchase from
the Company, in a private placement (the “Private Placement”), (i) an aggregate of 3,636,364 shares of the Company’s
Class A Common Stock, par value $0.0001 per share at a price of $1.65 per share, and (ii) a warrant to purchase 7,272,728 shares of Common
Stock, at an exercise price of $1.82, with a term of exercise of five years; (collectively, the “Securities”). The aggregate
purchase price for the Securities sold in the Private Placement was $6 million. The Private Placement closed on August 15, 2022.
Review and Approval of Transactions with
Related Persons
Either the audit committee or the Board of
Directors approves all related party transactions. The procedure for the review, approval or ratification of related party transactions
involves discussing the proposed transaction with management, discussing the proposed transaction with the external auditors, reviewing
financial statements and related disclosures, and reviewing the details of major deals and transactions to ensure that they do not involve
related party transactions. Members of management have been informed and understand that they are to bring related party transactions
to the audit committee or the Board of Directors for pre-approval. These policies and procedures are evidenced in the audit committee
charter and our code of ethics.
53
ITEM
14.
PRINCIPAL
ACCOUNTANT FEES AND SERVICES
The
following table shows what the auditor billed for the audit and other services for the years ended June 30, 2023 and 2022.
2023
2022
Audit Fees
$ 317,772
$ 223,102
Audit - Related Fees
—
—
Tax Fees
—
—
All other Fees
—
—
Total
$ 317,772
$ 223,102
Audit
Fees —This category includes the audit of the Companys annual financial statements, review of financial statements included
in the Companys Form 10-Q Quarterly Reports and services that are normally provided by the independent auditors in connection
with engagements for those years.
Audit-Related
Fees —N/A
Tax
Fees —N/A
All Other
Fees —N/A
Policy
on Audit Committee Pre-Approval of Audit and Permissible Non-audit Services of Independent Public Accountant
Consistent
with SEC policies regarding auditor independence, the Audit Committee has responsibility for appointing, setting compensation and overseeing
the work of our independent registered public accounting firm. In recognition of this responsibility, the Audit Committee has established
a policy to pre-approve all audit and permissible non-audit services provided by our independent registered public accounting firm.
Prior
to engagement of an independent registered public accounting firm for the next years audit, management will submit an aggregate
of services expected to be rendered during that year for each of four categories of services to the Audit Committee for approval.
1. Audit
services include audit work performed in the preparation of financial statements,
as well as work that generally only an independent registered public accounting firm can
reasonably be expected to provide, including comfort letters, statutory audits, and attest
services and consultation regarding financial accounting and/or reporting standards.
2. Audit-Related
services are for assurance and related services that are traditionally performed
by an independent registered public accounting firm, including due diligence related to mergers
and acquisitions, employee benefit plan audits, and special procedures required to meet certain
regulatory requirements.
3. Tax
services include all services performed by an independent registered public accounting
firms tax personnel except those services specifically related to the audit of the
financial statements, and includes fees in the areas of tax compliance, tax planning, and
tax advice.
4. Other
Fees are those associated with services not captured in the other categories. The
Company generally does not request such services from our independent registered public accounting
firm.
Prior
to engagement, the Audit Committee pre-approves these services by category of service. The fees are budgeted and the Audit Committee
requires our independent registered public accounting firm and management to report actual fees versus the budget periodically throughout
the year by category of service. During the year, circumstances may arise when it may become necessary to engage our independent registered
public accounting firm for additional services not contemplated in the original pre-approval. In those instances, the Audit Committee
requires specific pre-approval before engaging our independent registered public accounting firm.
The
Audit Committee may delegate pre-approval authority to one or more of its members. The member to whom such authority is delegated must
report, for informational purposes only, any pre-approval decisions to the Audit Committee at its next scheduled meeting.
54
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).
4.1
Specimen Certificate representing shares of Class A Common Stock (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1 filed on April 26, 2019, File No. 333-231136).
4.2
Form of Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed on September 25, 2019).
4.3
Form of 10% OID Convertible Delayed Draw Debenture (incorporated by reference to Exhibit 4.1 the Company’s Current Report on Form 8-K filed on September 25, 2019).
4.4
Description of Securities (incorporated by reference to Exhibit 4.4 to the Company’s Annual Report on Form 10-K filed on August 30, 2021).
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).
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).
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).
55
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).
23.1
Consent of Independent Registered Public Accounting Firm - EisnerAmper LLP
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
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
56
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.
BIOVIE
INC.
By:
/s/ Cuong Do
Name:
Cuong
Do
Title:
Chief
Executive Officer
(Principal Executive Officer)
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities and
on the dates indicated.
Person
Capacity
Date
/s/
Cuong Do
Chief
Executive Officer
August
16, 2023
Cuong
Do
(Principal
Executive Officer)
/s/
Joanne Wendy Kim
Chief
Financial Officer
August
16, 2023
Joanne
Wendy Kim
(Principal
Financial Officer)
/s/
Jim Lang
Director
August
16, 2023
Jim
Lang
/s/
Michael Sherman
Director
August
16, 2023
Michael
Sherman
/s/
Richard J. Berman
Director
August
16, 2023
Richard
J. Berman
/s/
Steve Gorlin
Director
August
16, 2023
Steve
Gorlin
/s/
Robert Hariri
Director
August
16, 2023
Robert
Hariri
/s/
Sigmund Rogich
Director
August
16, 2023
Sigmund
Rogich
57
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
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, 2023 and 2022, 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, 2023 and 2022, and the results of its operations and its cash flows for each 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 in regard to these matters are also described in Note 2. The financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards
of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements
are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform,
an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal
control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
F- 2
Critical
Audit Matter
The critical audit matter communicated below is a
matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit
committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially
challenging, subjective, or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on
the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion
on the critical audit matter or on the accounts or disclosures to which it relates.
Research and development expenses and related accruals
As described in Note 3 to the accompanying financial
statements, research and development expenses consists primarily of costs associated with the preclinical and/or clinical trials of drug
candidates, compensation and other expenses for research and development, 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.
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 and accurate, their significance, their increase from the prior year, 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 expenses and the completeness
and accuracy of related accruals, reading the terms of the master service agreements and statements of work for significant vendors and
making selections of transactions to determine the adequacy of the support, their mathematical accuracy and their recording as research
and development expenses. We also made inquiries of management and reviewed subsequent payments of major research and development expenses
to ensure that accruals were complete as of June 30, 2023.
/s/
EisnerAmper LLP
We
have served as the Company’s auditor since 2019.
EISNERAMPER
LLP
Iselin,
New Jersey
August
16, 2023
F- 3
BioVie
Inc.
Balance
Sheets
June 30
June 30,
2023
2022
ASSETS
CURRENT ASSETS:
Cash and
cash equivalents
$ 19,460,883
$ 18,641,716
Investments in U.S.
Treasury Bills
14,477,726
—
Prepaids
and other assets
102,526
137,879
Total
current assets
34,041,135
18,779,595
Operating lease right-of-use
assets
80,789
118,254
Intangible assets,
net
637,095
866,472
Goodwill
345,711
345,711
Other assets, non-current
—
4,562
TOTAL
ASSETS
$ 35,104,730
$ 20,114,594
LIABILITIES AND
STOCKHOLDERS EQUITY
CURRENT LIABILITIES:
Accounts payable and
accrued expenses
$ 3,476,259
$ 2,442,804
Current portion of
other liabilities
48,385
1,304,925
Current portion of
operating lease liabilities
44,909
38,884
Current portion of
Note payable, net of financing cost, unearned premium and discount of $ 894,926 at June 30, 2023
9,105,074
—
Warrant liabilities
894,280
194,531
Embedded
derivative liability
925,762
188,030
Total
current liabilities
14,494,669
4,169,174
Other liabilities,
net of current portion
—
48,385
Operating lease liabilities,
net of current portion
42,505
87,414
Note
payable, net of current portion, financing cost, unearned premium and discount of $ 227,268 at June 30, 2023 and $ 2,861,314
at June 30, 2022
5,227,270
12,138,686
TOTAL
LIABILITIES
19,764,444
16,443,659
Commitments and contingencies
(Note 12)
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, 2023 and June 30, 2022, respectively; 36,451,829 shares issued of which 36,428,949
shares outstanding at June 30, 2023 and 24,984,083 issued and outstanding at June 30, 2022;
3,643
2,496
Additional paid in capital
316,385,759
254,638,329
Accumulated other comprehensive
income
176,591
Accumulated deficit
( 301,225,705 )
( 250,969,890 )
Treasury
stock
( 2 )
—
Total
stockholders equity
15,340,286
3,670,935
TOTAL
LIABILITIES AND STOCKHOLDERS EQUITY
$ 35,104,730
$ 20,114,594
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, 2023
June 30, 2022
OPERATING EXPENSES:
Amortization
$ 229,377
$ 229,377
Research and development expenses
33,299,503
17,258,341
Selling, general and administrative expenses
11,551,568
9,765,259
TOTAL OPERATING EXPENSES
45,080,448
27,252,977
LOSS FROM OPERATIONS
( 45,080,448 )
( 27,252,977 )
OTHER EXPENSE (INCOME):
Change in fair value of derivative liabilities
1,437,481
( 3,287,418 )
Interest expense
4,300,150
2,162,989
Interest income
( 562,264 )
( 44,080 )
TOTAL OTHER EXPENSE (INCOME), NET
5,175,367
( 1,168,509 )
NET LOSS
$ ( 50,255,815 )
$ ( 26,084,468 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ ( 50,255,815 )
$ ( 26,084,468 )
NET LOSS PER COMMON SHARE
- Basic
$ ( 1.55 )
$ ( 1.06 )
- Diluted
$ ( 1.55 )
$ ( 1.06 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
- Basic
32,483,489
24,662,557
- Diluted
32,483,489
24,662,557
NET LOSS
$ ( 50,255,815 )
$ ( 26,084,468 )
Other comprehensive income
Unrealized gain on investments for available-for-sale
176,591
Other comprehensive income
176,591
Comprehensive loss
$ ( 50,079,224 )
$ ( 26,084,468 )
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, 2023 and 2022
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, 2021
22,333,324
$ 2,232
$ 229,933,505
—
$ —
$ —
$ ( 224,885,422 )
$ 5,050,315
Stock
option-based compensation
—
—
5,807,871
—
—
—
—
5,807,871
Proceeds
from issuance of common stock, net costs of $2,224,992
2,592,000
259
18,510,750
—
—
—
—
18,511,009
Stock
based compensation – restricted stock
58,759
5
386,203
—
—
—
—
386,208
Net
loss
—
—
—
—
—
—
( 26,084,468 )
( 26,084,468 )
Balance,
June 30, 2022
24,984,083
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
215,175
21
1,780,028
( 22,880 )
( 2 )
—
—
1,780,047
Stock-based
compensation – issuance of common stock
50,000
5
372,495
—
—
—
—
372,500
—
Cashless
exercise of options
22,563
3
( 3 )
—
—
—
—
—
—
Cashless
exercise of warrants
3,590
—
—
—
—
—
—
—
—
Proceeds
from exercise of options
800
—
2,240
—
—
—
—
2,240
Proceeds
from issuance of common stock, net costs of $2,008,898
7,539,254
754
49,464,349
—
—
—
—
49,465,103
Proceeds
from issuance of common stock, net of costs of $94,160 – Related Party
3,636,364
364
5,905,476
—
—
—
—
5,905,840
Unrealized
gain on available-for-sale securities
—
—
—
—
—
176,591
—
176,591
Net
loss
—
—
—
—
—
—
( 50,255,815 )
( 50,255,815 )
Balance,
June 30, 2023
36,451,829
$ 3,643
$ 316,385,759
( 22,880 )
$ ( 2 )
$ 176,591
$ ( 301,225,705 )
$ 15,340,286
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, 2023
June 30, 2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 50,255,815 )
$ ( 26,084,468 )
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
1,780,047
386,208
Stock based compensation expense – stock options
4,222,845
5,807,871
Stock based compensation expense – stock issued
372,500
—
Amortization of financing costs
170,219
99,295
Accretion of unearned loan discount
1,601,445
934,177
Accretion of loan premium
421,994
165,278
Change in operating lease right-of-use assets
37,465
8,044
Change in fair value of derivative liabilities
1,437,481
( 3,287,418 )
Changes in operating assets and liabilities:
Prepaids and other assets
39,915
( 48,954 )
Accounts payable and accrued expenses
1,033,455
1,446,430
Operating lease liabilities
( 38,884 )
—
Other liabilities
( 1,304,925 )
1,353,310
Net cash used in operating activities
( 40,252,881 )
( 18,990,850 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of U.S. Treasury Bills
( 14,301,135 )
—
Net cash used in investing activities
( 14,301,135 )
—
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from issuance of common stock
49,465,103
18,511,009
Proceeds from note payable net of financing costs
—
14,609,915
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
55,373,183
33,120,924
Net increase in cash and cash equivalents
819,167
14,130,074
Cash and cash equivalents,
beginning of period
18,641,716
4,511,642
Cash and cash equivalents,
end of period
$ 19,460,883
$ 18,641,716
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for interest
$ 2,106,491
$ 964,241
SCHEDULE OF NON-CASH
FINANCING AND INVESTING ACTIVITIES:
Right of use assets
obtained in exchange for lease obligations
$ —
$ 130,039
Unrealized gain on
U.S. Treasury Bills
$ 176,591
$ —
The
accompanying notes are an integral part of the financial statements.
F- 7
BioVie
Inc.
Notes
to Financial Statements
For
the Years Ended June 30, 2023 and 2022
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), from a related party privately held clinical-stage
pharmaceutical company, in June 2021. The acquired assets included NE3107, a potentially selective inhibitor of inflammatory extracellular
single-regulated kinase(ERK) signaling that, based on animal studies and is believed to reduce neuroinflammation. NE3107
is a 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 Alzheimers Disease (AD) and Parkinsons Disease (PD), and NE3107 could,
if approved 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.
The
Company is conducting a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to
evaluate NE3107 in patients who have mild to moderate Alzheimers disease (NCT04669028). The Company is targeting primary completion
of this study in the fourth quarter of calendar year 2023.
The
Company completed its Phase 2 study assessing NE3107 in Parkinsons disease patients in the fourth quarter of calendar year 2022.
The NM201 study (NCT05083260) was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinsons
disease (PD) participants treated with carbidopa/levodopa and NE3107. The study was primarily designed to assess safety (general safety
in the patient population and potential for drug-drug interactions of NE3107 with levodopa); and secondary, to look for indications of
promotoric activity akin to promotoric activity and apparent enhancement of levodopa activity observed in preclinical models. Both the
safety and efficacy objectives of the study were met.
Neuroinflammation,
insulin resistance, and oxidative stress are common features in the major neurodegenerative diseases, including Alzheimers Disease
(AD), Parkinsons Disease (PD), frontotemporal lobar dementia, and Amyotrophic lateral sclerosis (ALS). NE3107 is
an orally bioavailable, blood-brain permeable, small molecule, with potential anti-inflammatory, insulin sensitizing, and ERK-binding
properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation. NE3107s potential to inhibit
neuroinflammation and insulin resistance forms the basis for the Companys work testing the molecule in AD and PD patients. NE3107
is patented in the United States, Australia, Canada, Europe and South Korea.
The Company’s Orphan Drug candidate BIV201
(continuous infusion terlipressin), with FDA Fast Track status, is being evaluated in a U.S. Phase 2b study (NCT04112199) for the treatment
of refractory ascites due to liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation. The study was closed before
full enrollment, without clinically meaningful adverse effects associated with BIV201 treatment. While the active agent is approved in
the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these
authorizations. Patients with refractory ascites suffer from frequent life-threatening complications, generate more than $5 billion in
annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months. The U.S. Food and Drug Administration (“FDA”)
has not approved any drug to treat refractory ascites.
The BIV201 development program was initiated by
LAT Pharma LLC (LAT Pharma). On April 11, 2016, the Company acquired LAT Pharma 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 and NanoAntibiotics, Inc., the Company is obligated
to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin), if approved, to be shared by the members
of LAT Pharma, PharmaIn Corporation and The Barrett Edge, Inc.
F- 8
BioVie
Inc.
Notes
to Financial Statements
For
the Years Ended June 30, 2023 and 2022
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, 2023 the Company had working capital of approximately $ 19.5 million, cash and cash equivalents and
US treasury bills totaling of approximately $ 33.9 million, stockholders’ equity of approximately $ 15.3 million, and an accumulated
deficit of approximately $ 301 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. Although our cash balance may possibly sustain operations over the next
12 months from the balance sheet date if measures are taken to delay planned expenditures in our research protocols and slow the progress
in the Company’s development of next phase clinical programs, the Company’s current planned operations to meet certain goals
and objectives, project cash flows to be depleted within that period of time.
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.
The Impact of COVID-19 pandemic created a widespread
labor shortage, including a shortage of medical professionals, and has impacted and may continue to impact the potential patient participation
in our studies, which may adversely impact our ability to continue or complete our clinical trials in the planned timeline.
Although
management continues to pursue the Companys 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 Companys 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
Companys 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 Companys 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 Companys
balance sheet and the amounts of expenses reported for each of the periods presented 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 leases and recoverability of intangible assets, 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.
F- 9
BioVie
Inc.
Notes
to Financial Statements
For
the Years Ended June 30, 2023 and 2022
3.
Significant
Accounting Policies (continued)
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, 2023, 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.
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 direct costs related to capital raise which will offset proceeds upon
the close.
Other
Assets, non-current
Other
assets consist of a security deposit for an office lease.
F- 10
BioVie
Inc.
Notes
to Financial Statements
For
the Years Ended June 30, 2023 and 2022
3.
Significant
Accounting Policies (continued)
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 Companys right to use an underlying asset for the lease term and lease liabilities
represent an obligation to make lease payments arising from the lease. 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 Companys 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, if necessary, 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 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, 2023 and 2022, 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, 2023 and 2022, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to
the net loss for the periods.
The
table below shows the number of outstanding stock options, warrants and restricted stock units as of June 30:
Schedule of Dilutive securities were excluded from the computation of diluted loss per share
June 30, 2023
June 30, 2022
Number of Shares
Number of Shares
Stock Options
3,952,864
3,398,764
Warrants
7,770,285
510,372
Restricted Stock Units
596,457
124,520
Total
12,319,606
4,033,656
F- 11
BioVie
Inc.
Notes
to Financial Statements
For
the Years Ended June 30, 2023 and 2022
3.
Significant
Accounting Policies (continued)
Stock-based
Compensation
The
Company has accounted for stock-based compensation under the provisions of FASB ASC 718 – Stock Compensation 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 employee 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 fair value of each stock option award is estimated
on the measurement date 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 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 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 Companys 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 Companys 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 no t recognize any goodwill impairments for the years ended June 30, 2023
and 2022.
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.
Recent
Accounting Pronouncements
The
Company considers the applicability and impact of all Accounting Standards Updates (ASUs). There were no recent
ASUs 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.” 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. In November 2019, the FASB issued No.
2019-10, Financial Instruments --Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842), which deferred
the effective date of ASU 2016-13 for Smaller Reporting Companies for fiscal years beginning after December 15, 2022, including interim
periods within those fiscal years. The Company does not expect a material impact from the adoption of ASU 2016-13 on the financial statements.
F- 12
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2023 and 2022
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 is 3 - 6 months
$ 14,301,136
$ 176,591
$ —
$ 14,477,726
$ 176,591
The Company purchased a total of approximately $ 46 million of U.S.
Treasury Bills during the year ended June 30, 2023. The U.S Treasury Bills that matured were approximately $ 18 million and none were
sold before maturity.
5.
Intangible
Assets
The
Companys 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, 2023 and 2022:
Schedule of intangible assets
June 30, 2023
June 30, 2022
Intellectual Property
$ 2,293,770
$ 2,293,770
Less Accumulated Amortization
( 1,656,675 )
( 1,427,298 )
Intellectual Property, Net
$ 637,095
$ 866,472
Amortization
expense amounted to $ 229,377 for each of the years ended June 30, 2023 and 2022, 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,
2024
$ 229,377
2025
229,377
2026
178,341
$ 637,095
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 Companys
majority stockholder, pursuant to which Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 3,636,364
shares of the Companys Common Stock, at a price of $1.65 per share (the PIPE Shares), and (ii) a warrant to purchase
7,272,728 shares of Common Stock (PIPE Warrant Shares), at an exercise price of $1.82, with a term of exercise of five
years. The warrant has a down round feature that reduces the exercise price of the warrant if the Company sells stock at a price lower
than the exercise price of the warrant. 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- 13
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2023 and 2022
6.
Related
Party Transactions (continued)
Asset
Acquisition with NeurMedix
On April 27, 2021, the Company entered into an
Asset Purchase Agreement (“APA”) with NeurMedix and Acuitas, which are related party affiliates, pursuant to which the Company
acquired certain assets from NeurMedix and assumed certain liabilities of NeurMedix. The acquired assets include, among others, certain
assets related to the drug candidates then being developed by NeurMedix, including NE3107. On June 10, 2021, and pursuant to the terms
of the APA, the Company issued to Acuitas (as NeurMedix’s assignee) 8,361,308 shares of the Company’s Common Stock and made
a cash payment to Acuitas of approximately $2.3 million. Since the transaction was between entities under common control, there were no
fair value adjustments of the purchased assets, and the historical cost basis of the purchased assets was zero. The total consideration
paid was expensed as in process research and development expense in the year ended June 30, 2021.
Subject to the terms and conditions of APA, as
amended on May 9, 2021, the Company may be obligated to deliver contingent stock consideration to NeurMedix (or its successor) consisting
of up to 18 million shares of the Company’s Common Stock, with 4.5 million shares issuable upon the achievement of each of the
four milestones related to certain clinical, regulatory and commercial milestones set forth in the APA, subject to a cap limiting the
issuance of shares if such issuance would result in the beneficial ownership of NeurMedix and its affiliates exceeding 87.5% of the
Company’s issued and outstanding Common Stock.
7.
Other
Liabilities
The
current portion of other liabilities at June 30, 2023 and June 30, 2022 were approximately $ 48,400 and $ 1.3 million, and included $ 48,400 and $ 580,614 ,
respectively, of a retention bonus payable for arrangements with certain employees. The payment terms of the total retention bonus arrangements
of $ 1,161,000 recognized in August 2021 provided for equal monthly installments over a 24-month period and began in August 2021.
8.
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 Companys 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, 2023 was 8.25 % . The Loan is secured
by a lien upon and security interest in all of the Companys assets, including intellectual property, subject to agreed exceptions.
The maturity date of the Loan is December 1, 2024.
The
Loan Agreement requires monthly interest-only payments during the first eighteen months of the term of the Loan. Following the interest-only
period, the Company will make equal monthly payments of principal, plus accrued interest, until the Loans 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 Loans 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.
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 Companys Common Stock at a conversion price of $6.98 per share.
On
the Closing Date, the Company issued to Avenue warrants to purchase 361,002 shares of Common Stock of the Company (the Avenue
Warrants) at an exercise price per share equal to $5.82. The Avenue Warrants are exercisable until November 30, 2026.
F- 14
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2023 and 2022
8.
Notes
Payable (continued)
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 $ 3.7 million, the total direct financing cost of approximately $ 390,000
and premium of $ 850,000 are recognized on an effective interest method over the term of the Loan. The adjusted effective interest rate
is 25%. The total interest expense of approximately $ 4.3 million for the year ended June 30, 2023, was recognized in the accompanying
statements of operations and comprehensive loss and included the interest only payments totaling approximately $ 2.1 million, the amortization of financing costs
of approximately $ 170,000 , unearned discount of approximately $ 1.6 million and the accretion of loan premium of approximately $ 422,000 .
The
total interest expense of approximately $ 2.2 million for the year ended June 30, 2022; was recognized in the accompanying statements
of operations and comprehensive loss and included the interest only payments totaling approximately $ 952,000 , the amortization of financing costs of approximately
$ 99,000 , unearned discount of approximately $934,000 and the accretion of loan premium totaled of approximately $ 165,000 .
As
of June 30, 2023, the remaining principal balance of $15 million under the Loan is payable in 18 monthly equal installments beginning
July 1, 2023; for a total of $10.0 million and $5.0 million in the fiscal years ended June 30, 2024 and 2025 respectively.
The
following is a summary of the Note Payable as of June 30, 2023 and June 30, 2022:
Current
portion of Notes Payable
Schedule of note payable
June 30, 2023
June 30, 2022
Current portion of Notes Payable
$ 10,000,000
$ —
Less debt financing costs
( 108,751 )
—
Less unearned discount
( 1,023,145 )
—
Plus accretion of loan premium
236,970
—
Current portion of Notes Payable, net of financing costs, unearned premiums and
discount
$ 9,105,074
$ —
Non-current
portion of Notes Payable
June 30, 2023
June 30, 2022
Notes Payable
$ 5,000,000
$ 15,000,000
Less debt financing costs
( 11,820 )
( 290,790 )
Less unearned discount
( 111,212 )
( 2,735,802 )
Plus accretion of loan premium
350,302
165,278
Notes Payable, net of the current portion financing costs, unearned premiums
and discount
$ 5,227,270
$ 12,138,686
Estimated
future amortization expense and accretion of premium is as follows:
Schedule of Estimated future amortization expense and accretion of premium
Unearned Discount
Debt Financing Costs
Loan accretion Premium
Year ending June 30,
2024
$ 1,023,145
$ 108,751
$ 236,970
2025
111,212
11,820
25,758
Total
$ 1,134,357
$ 120,571
$ 262,728
F- 15
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2023 and 2022
9.
Fair
Value Measurements
At
June 30, 2023 and 2022, 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, 2023
Level 1
Level 2
Level 3
Total
Derivative liability - Warrants
$ —
$ —
$ 894,280
$ 894,280
Derivative liability - Conversion option on notes payable
—
—
925,762
925,762
Total derivatives
$ —
$ —
$ 1,820,042
$ 1,820,042
Fair Value Measurements at
June 30, 2022
Level 1
Level 2
Level 3
Total
Derivative liability - Warrants
$ —
$ —
$ 194,531
$ 194,531
Derivative liability - Conversion option on note payable
—
—
188,030
188,030
Total derivatives
$ —
$ —
$ 382,561
$ 382,561
The
following table presents the activity for liabilities measured at fair value using unobservable inputs for the years ended June 30, 2023
and 2022:
Fair value, liabilities measured on recurring basis
Derivative liabilities - Warrants
Derivative liability - Conversion Option on Convertible Debenture
Balance at July 1, 2021
$ —
$ —
Additions to level 3 liabilities
1,456,513
2,213,466
Change in fair value of level 3 liability
( 1,261,982 )
( 2,025,436 )
Transfer in and/or out of Level 3
—
—
Balance at June 30, 2022
$ 194,531
$ 188,030
Additions to level 3 liabilities
—
—
Change in in fair value of level 3 liability
699,749
737,732
Transfer in and/or out of Level 3
—
—
Balance at June 30, 2023
$ 894,280
$ 925,762
The
fair values of derivative liabilities for the Avenue Warrants and conversion option at June 30, 2023 in the accompanying balance sheet,
were approximately $894,000 and approximately $926,000, respectively. The total change in the fair value of the derivative liabilities
totaled approximately $1.4 million and $3.3 million for the year ended June 30, 2023, and 2022, 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, 2023 included the closing stock price of $ 4.31 per share; for the Avenue Warrants, the exercise price of $ 5.82 , remaining term 3.4
year, risk free rate of 4.4 % and volatility of 92.0 % ; and for the embedded derivative liability of the conversion option, the conversion
price of $ 6.98 ; remaining term 1.4 years, risk free rate of 5.18 % and volatility of 92.0 % .
F- 16
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2023 and 2022
9.
Fair
Value Measurements (continued)
Derivative
liability – Avenue Warrants
The
Company accounts for stock purchase warrants as either equity instruments or derivative liabilities depending on the specific terms
of the warrant agreements. Under applicable accounting guidance, stock warrants that are precluded from being indexed to the
Companys own stock because of full-rachet and anti-dilution provisions or adjustments to the strike price due to an occurrence
of a future event are accounted for as derivative financial instruments. The Avenue Warrants were not considered to be indexed to
the Companys own stock, and accordingly, were recorded as a derivative liability at fair value in the accompany balance sheets at June 30, 2023 and 2022.
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 June 30, 2023.
The assumptions used for the fair value calculation at November 30, 2021 included: the closing stock price of $ 6.44 per share; the exercise
price of $ 5.82 ; 5 year term; a risk free rate of 1.14 % and volatility of 74.4 % .
Embedded
derivative liability – Conversion Option
The
embedded derivative liability represents the optional conversion feature of up to $5.0 million of the outstanding Loan, which meets the
definition of a derivative and requires bifurcation from the loan amount.
The
Black Scholes model was used to calculate the fair value of the embedded derivative to bifurcate the embedded derivative amount representing
the conversion option from the Loan amount funded. The assumption used for the fair value calculation at November 30, 2021 included:
the closing stock price of $ 6.44 per share; the conversion price of $ 6.98 ; 3 year term; risk free rate of 0.81 % and volatility of 76.85 % .
Financial
assets
As
of June 30, 2023, 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, 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
13,156,340
—
—
13,156,340
U.S. Treasury Bills due in 3 - 6 months
14,477,726
—
—
14,477,726
Total
$ 33,938,609
$ —
$ —
$ 33,938,609
Fair Value Measurements at
June 30, 2022
Level 1
Level 2
Level 3
Total
Cash
$ 18,641,716
$ —
$ —
$ 18,641,716
U.S. Treasury Bills due in 3 months or less
—
—
—
—
U.S. Treasury Bills due in 3 - 6 months
—
—
—
—
Total
$ 18,641,716
$ —
$ —
$ 18,641,716
F- 17
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2023 and 2022
10.
Equity
Transactions
Stock
Options
The
following table summarizes the activity relating to the Companys stock options for the years ended June 30, 2023 and 2022:
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, 2021
755,200
$ 4.34
4.4
$ 2,569,232
Granted
2,724,689
5.86
7.7
—
Options
Expired
( 8,000 )
29.17
—
Options
Forfeited
( 73,125 )
( 13.91 )
—
—
Outstanding
at June 30, 2022
3,398,764
7.42
5.5
—
Granted
714,667
5.90
8.6
38,610
Options
Expired
( 10,000 )
28.69
—
—
Options
Canceled
( 49,667 )
7.74
—
—
Options
Exercised
( 100,900 )
8.12
—
—
Outstanding
at June 30, 2023
3,952,864
$ 7.10
6.3
$ 1,067,966
Exercisable
at June 30, 2023
1,473,413
$ 7.68
5.4
$ 315,206
The
fair value of each option grant on the date of grant is estimated using the Black-Scholes option. The pricing model reflects the following
weighted-average assumptions for the years ended June 30, 2023 and 2022:
Schedule of assumptions used
June 30, 2023
June 30, 2022
Expected life of options (In years)
6
5
Expected volatility
81.65 %
76.47 %
Risk free interest rate
3.82 %
1.56 %
Dividend Yield
0 %
0 %
Expected
volatility is based on the historical volatilities of three comparable companies of the daily closing price of their respective Common
Stock and the expected life of options is based on historical data with respect to employee exercise periods. The Company accounts for
forfeitures as they are incurred.
The
Company recorded stock option-based compensation expense of approximately $ 4.2 million and $ 5.8 million for the years ended June 30,
2023 and 2022, respectively.
F- 18
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2023 and 2022
10.
Equity
Transactions (continued)
The
following is a summary of stock options outstanding and exercisable by exercise price as of June 30, 2023:
Schedule of summary of stock options outstanding and exercisable
Exercise
Price
Outstanding
Weighted
Average Contract Life
Exercisable
$ 1.69
124,520
4.0
41,507
$ 1.81
10,000
3.9
2,000
$ 1.98
72,000
3.9
16,000
$ 2.74
124,167
8.6
35,180
$ 2.80
5,600
1.6
5,600
$ 3.13
4,000
0.6
4,000
$ 3.20
248,167
8.6
79,834
$ 3.24
25,000
8.7
6,667
$ 4.09
175,500
10.0
—
$ 5.04
755,000
3.8
377,500
$ 5.21
10,000
9.4
—
$ 5.78
148,000
9.9
29,600
$ 6.12
195,000
4.4
97,500
$ 6.25
1,600
0.3
1,600
$ 7.36
124,167
9.8
—
$ 7.50
800
1.3
800
$ 7.74
1,241,668
8.1
447,000
$ 7.81
62,000
9.8
—
$ 8.75
1,600
0.8
1,600
$ 9.54
800
2.3
800
$ 9.90
800
2.3
800
$ 13.91
618,475
2.5
321,425
$ 42.09
4,000
2.6
4,000
3,952,864
1,473,413
Issuance
of Common Stock through exercise of Stock Options and Warrants
In December 2022, the Company issued 22,082 shares of Common Stock pursuant to a cashless exercise of stock options
to purchase 99,300 shares at an average exercise price of $ 7.64 .
In
November 2022, the Company issued 800 shares of Common Stock pursuant to a cash exercise of stock options to purchase 800 shares at an
average exercise price of $ 2.80 per share.
In
October 2022, the Company issued 3,590 shares of Common Stock pursuant to a cashless exercise of warrants to purchase 8,000 shares at
an average exercise price of $ 2.25 .
In
May 2023, the Company issued 481 shares of Common Stock pursuant to a cashless exercise of stock options to purchase 800 shares at an
average exercise price of $ 3.13 .
Issuance of common stock for cash
During the three months ended September 30, 2021,
the Company issued 2,592,000 of its Class A common stock at $8.00 per share in connection with its registered public offering of approximately
$ 18.5 million, net of issuance costs of approximately $ 2.2 million.
F- 19
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2023 and 2022
10.
Equity
Transactions (continued)
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, 2023, the Company sold 7,539,254 shares of common stock under the Sales Agreement for total net proceeds of $ 49.5
million after 3% commissions and expenses of approximately $ 2.0 million.
Issuance
of restricted stock units for services
On
August 20, 2021, the Company awarded 58,759 RSUs to the Companys President and CEO under
the Companys 2019 Omnibus Incentive Equity Plan (the 2019 Omnibus Plan) as his salary for the period from April
27, 2021, the date of his appointment, through December 31, 2021. The number of RSUs awarded was based on a prorated annual base salary
of $600,000 at a 10% discount to the grant date fair value of $ 7.74 per share of the Companys Common Stock. Each RSU awarded to
the CEO entitled him to receive one share of Common Stock upon vesting. A total of 15,339 RSUs (representing the pro rata portion of
the RSU award for the period from April 27, 2021 to June 30, 2021) vested at the grant date, 21,710 vested at September 30, 2021 and
the remaining 21,710 vested at December 31, 2021. Accordingly, the CEO was issued an aggregate of 58,759 shares of Common Stock over
the vesting period of the RSUs. The stock-based compensation expense related to these RSUs was $ 384,456 for the year ended June 30, 2022.
On
June 21, 2022, the Company awarded 124,520 RSUs to the President and CEO under the Companys 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 grant anniversary date. 41,506 RSUs vested in June 2023 at a fair value of $ 5.90 per share of the Companys Common
Stock. The stock-based compensation expense related to these RSUs was approximately $ 243,000 and $ 1,754 for the years ended June 30, 2023, and 2022, respectively.
On
November 23, 2022, the Company awarded 381,976 RSUs to certain employees and a consultant, with a grant date fair value of $ 6.12 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. For the year ended June 30, 2023, the stock-based compensation expense
related to these RSUs was $ 584,424 . On February 16, 2023, the Company delivered the vested portion of the RSUs and issued 72,612
shares of Common Stock net of 25 % withholding. 22,880 shares issued to employees were withheld in Treasury stock in exchange for payment
of withholding tax on behalf of the employees.
On
November 23, 2022, the Company issued equity awards for the Board of Directors annual compensation. Four directors received RSUs
to purchase a total of 155,636 shares of Common Stock at the grant date fair value of $ 6.12 per share, a total cost of $ 952,492 recognized
as stock compensation in the year ended June 30, 2023. Three directors received stock options to purchase 195,000 shares
of Common Stock at an exercise price of $ 6.12 per share, the grant date fair value. The total stock compensation cost of stock options
of $ 791,700 was recognized in the year ended June 30, 2023. The equity awards vest every three months beginning from the
last annual shareholders meeting on November 9, 2022, on February 9, 2023, May 9, 2023, August 9, 2023 and earlier of November
9, 2023 or the next annual shareholders meeting. While the agreements contain certain contractual vesting terms, there are circumstances
where the vesting can be accelerated that is not within the Companys control and as a result, for accounting purposes, the awards
are assumed to have been fully vested on the grant date, accordingly, the Company recognized the total compensation cost of $ 1,744,192
on November 23, 2022. On February 9, 2023, the Company delivered the vested portion and issued 39,088 shares of Common Stock. On May 9, 2023, the Company delivered the vested portion and issued 39,088 shares of Common Stock.
On
June 20, 2023, the Company awarded 149,500 RSUs to the President and CEO under the Companys 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 grant date anniversary.
Compensation expense related to vested RSUs for
the year ended June 30, 2023 was approximately $1.8 million.
The
following table summarizes vesting of restricted common stock:
Schedule of vesting of restricted common stock
Number of Shares
Weighted Average Grant Date Fair Value Per Share
Unvested at June 30, 2021
—
$ —
Granted
124,520
1.69
Unvested at June 30, 2022
124,520
1.69
Granted
687,112
5.89
Vested
( 215,175 )
5.27
Unvested at June 30, 2023
596,457
$ 5.24
F- 20
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2023 and 2022
10.
Equity
Transactions (continued)
Issuance
of Shares for Services
On
April 6, 2023, the Company awarded 50,000 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 $ 7.45 per share. The stock-based compensation expense related to this Common Stock
issuance was $ 372,500 .
Issuance
of Stock Options under the 2019 Omnibus Plan.
On
August 20, 2021, the Company granted stock options to purchase 1,365,835 shares of Common Stock to the executive management team. 20% of the shares underlying the options awarded vested on the grant date, and the remaining 80% will vest equally over a 5 -year
period, on the first, second, third, fourth and fifth anniversary of the grant date. The exercise price of the options is $ 7.74 per share,
the grant date fair value of the stock, and the options terminate on the earlier of the tenth anniversary of the grant date or the date
on which the options have been fully exercised.
On
April 5, 2022, the Company granted stock options to purchase 755,000 shares of Common Stock to the independent directors of the board
as compensation for services at an exercise price of $ 5.04
per share, the grant date fair value. 25 %
of the shares underlying the options awarded
vested on the grant date, and the remaining 75 %
vest ratably over three 3
years on the first, second, and third anniversary
of the grant date. The options terminate on the earlier of the fifth anniversary of the grant date or the date as of Xwhich the options
are fully exercised.
Pursuant
to a former employee Separation Agreement, dated April 11, 2022, the Company modified a former employees 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 on 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 74,500 options) to one year following
the Separation Date. The unvested portion of the 2021 Option Grant (totaling 49,667 options) was canceled. The modification was remeasured
as of July 8, 2022, and the incremental difference totaled $181,154, net credit, due to the original exercise price of $7.74 being greater
than the stock price of $1.80 on the remeasurement date, and accordingly was recognized on July 8, 2022.
On
June 21, 2022, the Company granted stock options to purchase 124,520
shares of Common Stock to the CEO. The options vest in three equal annual installments beginning on the first grant date anniversary. The exercise price is $ 1.69
per share, the grant date fair value, and the options terminate on the tenth anniversary of the grant date.
During
the fiscal year ended June 30, 2022, the Company granted stock options to purchase a total of 479,334 shares of Common Stock in connection
with compensation packages of seven new employees. The exercise prices were based on each of respective the grant date fair values with
vesting terms over a five years period and the options terminate on the earlier of tenth grant date anniversary or the date of which
the options are fully exercised.
On
June 7, 2023, the Company granted stock options to purchase 148,000 shares of Common Stock to the 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 $ 5.78 per share, the grant date fair value of the
stock, 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 286,167 share of Common Stock in connection
with compensation packages of three new employees. The exercise prices were as of each respective grant date fair value with vesting
terms over 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.
Forfeiture
of Stock Options
On
August 27, 2021, the Chief Executive Officer forfeited unvested stock options to purchase up to 73,125 shares of Common Stock that were
previously granted to him as compensation as an independent director of the Board of Directors.
F- 21
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2023 and 2022
10.
Equity
Transactions (continued)
Stock
Warrants
The
following table summarizes the warrants activity during the years ended June 30, 2023 and 2022:
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, 2021
158,761
$ 10.37
3.1
$ 1,765,437
Granted
361,002
5.82
5.0
—
Expired
( 9,391 )
12.29
—
—
Exercised
—
—
—
—
Outstanding and exercisable at June 30, 2022
510,372
$ 6.17
3.8
$ —
Granted
7,272,728
1.82
5.0
—
Expired
( 4,815 )
75.00
—
—
Exercised
( 8,000 )
2.25
—
—
Outstanding and exercisable at June 30, 2023
7,770,285
$ 2.06
4.0
$ 18,318,954
The
total warrants outstanding at June 30, 2023 expire in the following fiscal years ending June 30 as follows: 101,380 in 2025; 35,175 expire
in 2026; and 7,633,730 in 2027.
11.
Leases
Office
Leases
The
Company paid an annual rent of $2,200 for its headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 897603. The rental agreement
is for a one-year term and commenced on October 1, 2022.
On
February 26, 2022, the Companys San Diego office relocated to 5090 Shoreham Place, San Diego, CA 92122. The term for the new office
lease is 38 months and commenced on March 1, 2022. The monthly base rate of $4,175 began June 1, 2022, with annual increases of
three percent.
Total
operating lease expense of approximately $ 52,000 and $ 89,000 for the year ended June 30, 2023 and 2022, respectively; were included in
the accompanying statements of operations and comprehensive loss.
The
right-of-use asset, net and current and non current portion of the operating lease liabilities included in the accompany balance sheets
at June 30 follows:
Schedule of balance sheet information related to leases
June
30, 2023
June
30, 2022
Assets
Operating
lease, right-of-use asset, net
$ 80,789
$ 118,254
Liabilities
Current
portion of operating lease liabilities
$ 44,909
$ 38,884
Operating
lease liabilities, net of current portion
42,505
87,414
Total
operating lease liabilities
$ 87,414
$ 126,298
F- 22
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2023 and 2022
11.
Leases (continued)
At
June 30, 2023, 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, 2023
2024
$ 52,156
2025
44,636
Total
minimum lease payments
96,792
Less
amount representing interest
( 9,378 )
Present
value of future minimum lease payments
87,414
Less
current portion of operating lease liabilities
( 44,909 )
Operating
lease liabilities, net of current portion
$ 42,505
Total
cash paid for amounts included in the measurement of lease liabilities were $ 50,600 and $ 4,175 for the years ended June 30, 2023 and
2022, respectively.
The
weighted average remaining lease term and discount rate as of June 30, 2023, and 2022 were as follows:
Schedule of weighted average remaining lease term and discount rate
June
30, 2023
June
30, 2022
Weighted
average remaining lease term (Years)
Operating
leases
1.8
2.8
Weighted
average discount rate
Operating
leases
10.75 %
10.75 %
12.
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 U.S. patent no. 9,655,645
and any future foreign issuances, capped at a maximum of $200,000 per year.
13.
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 employees contributions to the 401K Plan., The Company
made contributions of approximately $ 171,900 and $ 121,000 , for the years ended June 30, 2023 and 2022, respectively.
F- 23
BioVie Inc.
Notes to Financial Statements
For the Years Ended June 30, 2023 and 2022
14.
Income
Taxes
Significant
components of the Companys deferred tax assets (liabilities) are as follows:
Schedule of deferred tax assets
June
30, 2023
June
30, 2022
Deferred
tax assets (liabilities):
Tax
loss carryforward
$ 4,018,817
$ 6,410,653
Intangible
assets
( 189,854 )
( 258,209 )
Stock
based compensation
1,788,862
1,845,836
R&D
capitalized
7,938,602
Valuation
Allowance
( 13,556,427 )
( 7,998,280 )
Net
deferred tax assets
$
$
At
June 30, 2023 and 2022, the Company has recorded a full valuation against its net deferred tax assets of approximately $ 13.6 million
and $ 8.0 million, respectively, since in the judgement of management, these assets are not more than likely than not to be realized.
The increase in the valuation allowance during the years ended June 30, 2023 and 2022 were approximately, $ 5.6 million and $ 6.0 million, respectively.
At
June 30, 2023, the Company had a Net Operating Loss (NOL) carryforward of approximately $ 168 million. NOLs 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, 2023 and 2022 is as follows:
Schedule of effective income tax rate reconciliation
2023
2022
Income tax expense at federal statutory rate
21 %
21 %
State taxes, net of federal benefit
9 %
9 %
Change in valuation allowance
( 30 )%
( 30 )%
Effective tax rate
—
—
15.
Subsequent
Events
Subsequent to June 30, 2023 the Company sold
336,089 shares of common stock for net proceeds of $ 1.6 million net of 3% commission and expenses totaling approximately $ 50,000 under
the Sales Agreement with the Agent.
F- 24
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.