Item 9A. Controls and Procedures
ITEM
9A. CONTROLS AND PROCEDURES.
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Securities Exchange
Act of 1934 filings are recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms,
and that such information is accumulated and communicated to our management, including our Chief Executive Officer (Principal Executive
Officer) and Chief Financial Officer (Principal Financial Officer), as appropriate, to allow timely decisions regarding required disclosure.
In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, as ours are designed
to do, and management was necessarily required to apply its judgment in evaluating the cost-benefit relationship of possible controls
and procedures.
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our
disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31,
2022 (the “Evaluation Date”). Based on such evaluation, those officers have concluded that, as of the Evaluation Date, our
disclosure controls and procedures were effective
67
Report
of Management on Internal Control over Financial Reporting
We
are responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial
reporting is defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act, as a process designed by, or under the supervision of our
principal executive and principal financial officers and effected by our board of directors, management and other personnel 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 and includes those policies and procedures that:
● pertain
to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and disposition of our assets;
● provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally
accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorization of our management
and directors; and
● provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could
have a material effect on the financial statements.
Our
management, including the CEO and CFO, conducted an evaluation, pursuant to Rule 13a-15(c) promulgated under the Exchange Act, of the
effectiveness, as of the end of the period covered by this Annual Report, of its internal control over financial reporting using the
criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control - Integrated Framework
(2013). Based on the results of this evaluation, management concluded that our internal control over financial reporting was effective
as of December 31, 2022.
Changes
in Internal Control Over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2022 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
During
the year ended December 31, 2022, we implemented certain internal control procedures to address the previously identified material weaknesses
related to our control environment, risk assessment and monitoring.
ITEM
9B. OTHER INFORMATION.
None.
ITEM
9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
Not
applicable.
68
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
Directors
and Executive Officers
The
following table contains information with respect to our directors and executive officers. To the best of our knowledge, none of our
directors or executive officers have an arrangement or understanding with any other person pursuant to which he or she was selected as
a director or officer. Our executive officers are appointed by and serve at the pleasure of the Board of Directors.
Name
Age
Position
Amir Reichman
47
Chief Executive Officer and Director
Tamar Ben-Yedidia
59
Chief Scientist
Uri Ben-Or
52
Chief Financial Officer
Elad Mark
41
Chief Operating Officer
Mark Germain
73
Chairman of the Board of Directors
Jay Green (3)
51
Director
George H. Lowell
77
Director
Morris Laster (1) (2)
58
Director
Yael
Margolin (1) (2) (3)
70
Director
Samuel Moed
60
Director
Adi Raviv (1) (2)
67
Director
Avner Rotman
79
Director
(1) Member
of the Audit Committee.
(2) Member of the Compensation Committee.
(3) Member of the Nominating and Governance Committee
The
following noteworthy experience, qualifications, attributes and skills for each executive officer and Board member, led to our conclusion
that the person should serve as a director in light of our business and structure:
Mr.
Amir Reichman became full-time CEO of the Company on March 2, 2021 after sharing CEO duties during a transition period beginning
on January 21, 2021. Mr. Reichman served as Head of Global Vaccines Engineering Core Technologies and Asset Management at GSK Vaccines
(“GSK”) in Belgium from December 2017 until March 2021. Prior to this, Mr. Reichman served as Senior Director of Vaccines
Supply Chain for GSK from September 2015 to November 2017. Prior to GSK, Mr. Reichman held various leadership roles of increasing responsibility
in the Global Vaccines Value Chain Management organization of Novartis Vaccines and Diagnostics Ltd. (“Novartis”) in Holly
Springs, NC from 2011 to 2015 when until Novartis Vaccines was acquired by GSK. In 2003, Mr. Reichman’s academic research contributed
to the founding of NeuroDerm Ltd. (“NeuroDerm”), an Israeli company that developed a drug device combination product aimed
at transdermal drug delivery for the treatment of Parkinson’s NeuroDerm was acquired by Mitsubishi Tanabe Pharma Corporation in
2017 for $1.1 billion. Mr. Reichman served as NeuroDerm’s first employee and Senior Scientist until his departure for an MBA at
the Wharton school in 2009. Mr. Reichman earned an M.Sc. in Biotechnology Engineering from the Ben-Gurion University of the Negev in
Be’er Sheva, Israel and an MBA in Finance and Health Care Management from the Wharton School of the University of Pennsylvania
in Philadelphia, PA.
69
Dr.
Tamar Ben-Yedidia has served as our Chief Scientist since 2004 and is responsible for the pre-clinical and clinical development and
trials of the Company. Dr. Ben-Yedidia began her career at Biotechnology General (Israel) Ltd., BTG (Rehovot), where she was employed
as lab manager from 1991 to 1994. Dr. Ben-Yedidia joined the Department of Immunology at the Weizmann Institute of Science from 1994
- 2004. Dr. Ben-Yedidia was involved in two European Consortium projects related to the evaluation of different approaches for vaccination,
has been invited to address conferences worldwide and is published in various scientific journals. Dr. Ben-Yedidia received her Ph.D.
in immunology from the Weizmann Institute after completion of her doctoral thesis titled “A Peptide-Based Vaccine Against Influenza.”
Mr.
Uri Ben-Or , CPA, MBA, has served as our Chief Financial Officer since 2007. In January, 2007, Mr. Ben-Or founded CFO Direct, in which
he has served as the chief executive officer and through which he provides his services to our company. Mr. Ben-Or has over 20 years
of experience and significant expertise in corporate finance, accounting, M&A transactions and IPOs, and has served as CFO with life
science companies traded on the TASE, on Nasdaq and over the counter. Mr. Ben-Or holds a B.Aegree in Business from the College of Administration,
and a M.B.A degree from the Bar Ilan University and is a certified public accountant in Israel.
Mr. Elad Mark joined
the Company in 2018 as Site Head and has served as Chief Operating Officer since September 2019. As COO he oversees BiondVax’s manufacturing
facility and scale up and technology transfer activities, including potential future CMO’s. Prior to joining BiondVax, Mr. Mark
served for more than three years at Novartis as TPM (Technical Process Manager) and Area Lead Process for a large-scale biological facility
establishment in Singapore, a $800 million investment in a biologics facility focused on drug substance manufacturing based on cell culture
technology, which was designed to support both clinical and commercial production of potential new products that include monoclonal antibodies
for use in helping patients with autoimmune, respiratory and oncology disorders. Before that Mr. Mark served as the Head of the Engineering
Department in Biopharmax Group, a company which focuses on EPCM (Engineering, Procurement, Construction and Management) in the pharmaceutical
field. Mr. Mark is a principal bioprocess engineer with over 15 consecutive years of biotechnology engineering experience with diverse
project stages including feasibility study, conceptual and detail design, commissioning, qualification and process validation. Mr. Mark
holds a B.Sc. in Engineering from the Afeka Academic College of Engineering in Tel Aviv and an MBA from the Open University of Israel.
Mr.
Mark Germain joined the board in 2018 and has served as the Chairman of our board of directors since 2019. Mr. Germain has been involved
as a founder, director, chairman of the board of, and/or investor in, over twenty companies in the biotech field and assisted many of
them in arranging corporate partnerships, acquiring technology, entering into mergers and acquisitions, and executing financings and
going public transactions. He graduated from New York University School of Law in 1975, Order of the Coif, and was a partner in a New
York law firm practicing corporate and securities law before leaving in 1986. Since then, and until he entered the biotech field in 1991,
he served in senior executive capacities, including as president of a public company that was sold in 1991. In addition to being a director
of BiondVax, Mr. Germain is a Managing Director at The Aentib Group, a boutique merchant bank, and served as a director on the board
of Pluristem Therapeutics from 2007 through June, 2022, including time as Co-Chairman and lead independent director. He is also a co-founder
and director of a number of private companies in and outside the biotech field.
70
Mr.
Jay Green CPA, CA, MAcc, joined the board in 2022. He is currently the Chief Financial Officer of a privately held, Canadian-based
healthcare services company, a role that he has held since January 2022. Prior to this, he completed a 19-year career with GSK across
several progressive leadership positions in GSK’s three businesses of consumer healthcare, pharmaceuticals, and vaccines, as well
as corporate development. He also led GSK’s global enterprise resource planning (ERP) program, one of the largest IT-enabled business
transformation programs in the company’s history. Mr. Green recently served from 2014 to 2020 as Senior Vice President, Finance
and CFO of GSK’s global vaccines business. Since 2020, Mr. Green has served in an advisory role to Gavi for COVAX, an international
initiative to support equitable distribution of COVID-19 vaccines. He is a Chartered Professional Accountant who holds a Master of Accounting
from the University of Waterloo, Ontario, Canada.
Prof.
George H. Lowell, M.D. has served as a member of our board of directors since 2008. He is also since 2019 a member of the Board of
Directors and Chief Scientific Officer (CSO) of Healables Ltd., a private Israeli digital health start-up company. Prior to joining our
company, Prof. Lowell served as CSO for BioDefense at GlaxoSmithkline Biologicals (2006-7) which acquired ID Biomedical Corp. (IDB) and
CSO of IDB (2001-6) which acquired Intellivax Intl. Prof. Lowell served as founding CEO, President and CSO of the vaccine R&D companies
he founded, Intellivax, Inc. in Baltimore and Intellivax Intl. Inc. in Montreal from 1995 until 2001. From 1974, Prof. Lowell served
on active duty in the US Army Medical R&D Command (USAMRDC), retiring in 1994 with the rank of Colonel. During this period he served
as consultant in pediatric infectious diseases at The Walter Reed Army Medical Center and director of his laboratories at The Walter
Reed Army Institute of Research in Washington, D.C. From 1989-1991 COL Lowell served as Medical Liaison Officer attached to the US Embassy
in Israel representing the USAMRDC to the IDF Medical Corps Research Unit. Prof. Lowell has held a number of academic posts, including
Visiting Scientist at the Weizmann Institute of Science (Israel) and Visiting Professor, Hebrew University-Hadassah Medical Center (Israel).
Prof. Lowell holds a B.A. from Yeshiva University, and an M.D. from the Albert Einstein College of Medicine of Yeshiva University. Prof.
Lowell performed three years of post-doctoral training in pediatrics and pediatric infectious diseases and immunology at NYU-Bellevue
Medical Center, and The Mount Sinai Medical Center, NY, NY. We believe that Prof. Lowell is qualified to serve on our board of directors
based on his extensive experience and knowledge in the field of health care and years of executive leadership in the biomedical industry.
Dr.
Morris Laster has served as a member of our board of directors since November 2017. Dr. Laster is a healthcare executive and entrepreneur
with 30 years of experience in the biopharmaceutical industry. His expertise lies in the identification, development, management and
financing of advanced biomedical drugs and technologies. Dr. Laster is currently the CEO of Clil Medical Ltd., a biomedical consultancy
company, a position he has held since 2010. Since 2013, he is a Medical Venture Partner at OurCrowd, where he has led over 40 investments
and represents OurCrowd on the board of directors of Oncohost, HiL Applied Medical, MigVax, Sweetch and DreaMed Diabetes. Dr. Laster
has founded seven companies that have gone public in the U.S., UK or Israel. Previously, he was the founding CEO of BioLineRx Ltd. (TASE:BLRX)
from 2003 to 2009. In addition, he was the chairman and CEO of Keryx Biopharmaceuticals (NASDAQ:KERX) from 1997 to 2002. Dr. Laster began
his career as a VP of medical venture capital at Paramount Capital in NYC. Dr. Laster received his MD from Downstate Medical Center,
Brooklyn, NY in 1990 and a BS in Biology from SUNY Albany.
Dr.
Yael Margolin has more than 35 years of experience as senior manager, CEO and board member in venture capital and in the pharmaceutical
and biotech industries, leading strategic and business planning, financing, team building, product development and corporate partnerships.
From 2005 to 2019, Dr. Margolin served as President, Chief Executive Officer and director of Gamida Cell Ltd., a clinical stage biopharmaceutical
company, leading the company from preclinical development through phase 3 international registration studies. Prior to that, Dr. Margolin
was Vice President of Denali Ventures LLC, a venture capital firm focused on healthcare, and a program manager at Teva Pharmaceuticals.
Dr. Margolin holds a bachelor of science in biology and a master of science Cum Laude from the department of microbiology, both from
Tel Aviv University in Israel, a Ph.D. from the department of membrane research at the Weitzman Institute of Science in Rehovot, Israel
and was a post-doctoral associate at the Yale University School of Medicine.
71
Mr.
Samuel Moed is a healthcare executive with over 35 years of experience. Mr. Moed was for seven years Head of Corporate Strategy at
Bristol Myers Squibb (“BMS”), a global biopharma company, until his retirement in 2020. Prior to that role, Mr. Moed was
Head of Strategy Worldwide Pharma, President of US Pharma and President of the WW Consumer Healthcare Business at BMS. In addition to
BiondVax, Mr. Moed serves on the board of Mediwound Ltd., a company that develops, manufactures and commercializes bio-therapeutic solutions
for tissue repair and regeneration, is a Venture Partner at aMoon, a HealthTech and Life Sciences investment fund with BiondVax’s
former controlling shareholder Mr. Marius Nacht as the anchor investor, and advises companies in the healthcare arena. Mr. Moed received
his BA in history from Columbia University in New York City in 1985.
Mr.
Adi Raviv is a senior financial executive with a career spanning over 35 years. Mr. Raviv founded HTI Associates LLC in 1996 and
since then has served as its managing member. In addition, since April 2016 he has been a Principal at Capacity Funding LLC, a company
providing working capital solutions to small businesses. Prior to that, Mr. Raviv served in a chief financial officer position in two
other companies that provide similar types of funding alternatives from 2009 to 2016. Mr. Raviv has extensive capital markets, cash management,
corporate finance, investment banking, investor relations, restructuring, tax and treasury, and transactional experience along with knowledge
of the private equity and venture capital arenas. Mr. Raviv co-founded THCG, Inc., a publicly traded technology merchant banking and
consulting company (where he was also CFO), and has been involved with companies in challenging startup, growth, and turnaround environments.
He was also an investment banker at Lehman Brothers, Oscar Gruss and Hambros for over a dozen years. Mr. Raviv has served on the boards
of directors of many private and several public companies, as well as various non-profit entities. He received a bachelor’s degree
in International Relations with honors from the Hebrew University of Jerusalem and an MBA, with honors, from Columbia University in New
York City.
Professor
Avner Rotman has been a member of our board of directors since 2005 and served as the Chairman until 2019. Prof. Rotman founded Rodar
Technologies Ltd. in 2000 and served as its Chief Executive Officer and Chairman of the Board until 2019. Prof. Rotman also founded Bio-Dar
Ltd. in 1984, and served as its President and CEO from 1985 until 2000. Prof. Rotman was also the chairman of the I-Tech incubator at
Kyriat Weizmann. Prof. Rotman is the Founder and Chairman of the Foundation of Cardiovascular Research in Israel. Prof. Rotman holds
a PhD in chemistry from the Weizmann Institute of Science, Israel, and an M.Sc and B.Sc in chemistry from the Hebrew University of Jerusalem,
Israel. We believe that Prof. Rotman is qualified to serve on our board of directors based on his extensive experience and knowledge
in the field of biotechnology and as an executive officer and director of multiple biotechnology companies.
Our
Scientific Advisory Board
The
following table sets forth certain biographical information with respect to our Scientific Advisory Board members:
Professor
Ruth Arnon , the head of our Scientific Advisory Board, is the inventor of the new synthetic influenza vaccine and head of BiondVax’s
Scientific Advisory Board. Formerly Vice-President of the Weizmann Institute of Science (1988-1997), Professor Arnon is an internationally
acclaimed immunologist. Along with Prof. Michael Sela, she conceptualized and developed Copaxone®, a drug for the treatment of multiple
sclerosis which was approved by the FDA and is presently marketed worldwide. Prior to her appointment as Vice-President of the Weismann
Institute, Prof. Arnon served as Head of the Department of Chemical Immunology and as Dean of the Faculty of Biology. From 1985 to 1994,
Prof. Arnon was Director of the Weisman Institute’s McArthur Center for Molecular Biology of Tropical Diseases. Prof. Arnon has
made significant contributions in the fields of vaccine development, cancer research and to the study of parasitic diseases. She has
served as President of the European Federation of Immunological Societies, and as Secretary-General of the International Union of Immunological
Societies. Dr. Arnon is the recipient of numerous international and Israeli awards including the prestigious Israel Prize. Prof. Arnon
was also the Advisor for Science to the President of Israel. She is a member of the Israel Academy of Sciences, where she served as President
from 2010-2015. Prof. Arnon is the incumbent of the Paul Ehrlich Chair in Immunochemistry at the Weizmann Institute.
72
Prof.
Michel Revel , has M.D. and Ph.D. degrees. Born in 1938 in France, he joined the Weizmann Institute of Science, Rehovot, Israel in
1968, where he has been a full professor since 1973, heading for several periods the Departments of Virology and of Molecular Genetics.
He has been an emeritus professor since 2010. Prof. Revel is best known for his work on the mechanism of action of interferon and the
cloning of the genes for human interferon beta (IFN-β) and interleukin-6 (IL-6). He developed the first efficient genetic engineering
production of a protein (IFN-b) in animal cells (CHO cells). He was Chief Scientist of InterPharm (Serono group), which produced the
recombinant IFN-b (Rebif), a leading drug for treatment of multiple sclerosis, now 20 years in the market and sold in 90 countries by
Merck Kga. Since 2010, Prof. Revel is co-founder and Chief Scientist of Kadimastem, an Israeli company producing human tissues by differentiation
of pluripotent stem cells (ESC). The first product of Kadimastem, AstroRx, has recently been approved for clinical trial in Amyotrophic
Lateral Sclerosis (ALS). Kadimastem also develops ESC-derived islet-like cells for the treatment of diabetes. Prof. Revel has received
the Israel Prize for Medicine in 1999 and the Emet Prize in 2004. He was elected at the Israel National Academy of Science and Humanities
in 2005. He served as chairman of the National Biotechnology Committee of Israel (1999-2002).
Professor
Dr. Matthias Dobbelstein has served as Director of the Institute of Molecular Oncology at the University Medical Center Göttingen
(UMG), Germany since 2005 and is also an Associate Member of the Max Planck Institute for Multidisciplinary Sciences (MPI-NAT). He received
his training as a physician at the University of Munich (LMU) and performed research as a virologist and cancer biologist at Princeton
University (USA), the University of Marburg (Germany) and the University of Southern Denmark.
Professor
Dobbelstein’s research interests focus on principles of infections and cancer, including the application of anti-cancer drugs as
antivirals, as well as alpaca-derived NanoAbs (nanosized antibodies also known as nanobodies and VHH antibodies) as therapeutics. His
collaboration with Professor Dr. Dirk Görlich at MPI-NAT as highlighted in their 2021 EMBO Journal article titled “Neutralization
of SARS-CoV-2 by highly potent, hyperthermostable, and mutation-tolerant nanobodies” forms the scientific basis of BiondVax’s
exclusive license for development and commercialization of an innovative, self-administered, inhaled NanoAb for the treatment of COVID-19.
As recently reported, a preclinical trial of the inhaled anti-COVID-19 NanoAbs demonstrated significantly milder illness and faster recovery
in comparison to infected hamsters treated with inhaled placebo. In addition, Professor Dobbelstein, together with Professor Görlich,
is collaborating with BiondVax under a five-year strategic research agreement for the discovery, characterization and cloning of additional
NanoAbs for the treatment of autoimmune diseases such as psoriasis, psoriatic arthritis, asthma and macular degeneration.
Prof.
George H. Lowell, M.D. , a member of our board of directors, also serves on our Scientific Advisory Board. Biographical information
regarding Prof. Lowell appears above.
Family
Relationships.
There
are no family relationships between any of our directors or executive officers.
Section
16(a) Beneficial Ownership Reporting Compliance
Section
16(a) of the Exchange Act requires the Company’s executive officers and directors, and persons who own more than 10% of a registered
class of our equity securities, to file reports with the SEC relating to their share ownership and changes in such ownership. As a former
foreign private issuer, our executive officers, directors and greater than 10% shareholders were not subject to the Section 16(a) filing
requirements during the fiscal year ended December 31, 2022.
Code
of Ethics
The
Company currently maintains a Code of Ethics which applies to all directors, officers, and employees. A copy of our Code of Ethics can
be found on our website at www.biondvax.com.
73
Board
Composition and Director Independence
Our
board of directors consists of nine members. The directors will serve until our next annual meeting and until their successors are duly
elected and qualified. The Company defines “independent” as that term is defined in Rule 5605(a)(2) of the NASDAQ listing
standards.
In making the determination of whether a member of the board is independent,
our board considers, among other things, transactions and relationships between each director and his immediate family and the Company,
including those reported under the caption “ Certain Relationships and Related Transactions ”. The purpose of this review
is to determine whether any such relationships or transactions are material and, therefore, inconsistent with a determination that the
directors are independent. On the basis of such review and its understanding of such relationships and transactions, our board affirmatively
determined that Morris Laster, Yael Margolin, Adi Raviv, Jay Green, Avner Rotman and George H. Lowell are qualified as independent and
that they have no material relationship with us that might interfere with his or her exercise of independent judgment.
Board
Committees
Our board of directors has established an audit committee, a compensation
committee, and a nominating and governance committee. Each of the board committees has the composition and responsibilities described
below. Members will serve on these committees until their resignation or until otherwise determined by our Board of Directors.
Audit
Committee
Our
audit committee consists of Mr. Adi Raviv, Dr. Yael Margolin and Dr. Morris Laster. Mr. Adi Raviv serves as the chairman of the audit
committee.
Under
the NASDAQ Capital Market corporate governance rules, we are required to maintain an audit committee consisting of at least three independent
directors, each of whom is financially literate and one of whom has accounting or related financial management expertise.
All
members of our audit committee meet the requirements for financial literacy under the applicable rules and regulations of the SEC and
the NASDAQ Capital Market corporate governance rules. Our board of directors has affirmatively determined that Mr. Adi Raviv is an audit
committee financial expert as defined by the SEC rules and has the requisite financial experience as defined by the NASDAQ Capital Market
corporate governance rules.
Each
of the members of the audit committee are deemed “independent” as such term is defined in Rule 10A-3(b)(1) under the Exchange
Act, which is different from the general test for independence of board and committee members.
Our
board of directors adopted an audit committee charter effective upon the listing of the ADSs and warrants on the NASDAQ Capital Market
that set forth the responsibilities of the audit committee consistent with the rules of the SEC and the listing rules of the NASDAQ Capital
Market, as well as the requirements for such committee under the Companies Law, including the following:
●
oversight
of our independent registered public accounting firm and recommending the engagement, compensation or termination of engagement of
our independent registered public accounting firm to the board of directors in accordance with Israeli law;
●
recommending
the engagement or termination of the person filling the office of our internal auditor; and
●
recommending
the terms of audit and non-audit services provided by the independent registered public accounting firm for pre-approval by our board
of directors.
Our
audit committee provides assistance to our board of directors in fulfilling its legal and fiduciary obligations in matters involving
our accounting, auditing, financial reporting, internal control and legal compliance functions by pre-approving the services performed
by our independent accountants and reviewing their reports regarding our accounting practices and systems of internal control over financial
reporting. Our audit committee also oversees the audit efforts of our independent accountants and takes those actions that it deems necessary
to satisfy itself that the accountants are independent of management.
74
Compensation
Committee
Our
compensation committee currently consists of Mr. Adi Raviv, Dr. Yael Margolin and Dr. Morris Laster. Dr. Yael Margolin serves as the
Chairman of the Compensation committee. The duties of the compensation committee include the recommendation to the company’s board
of directors of a policy regarding the terms of engagement of office holders, to which we refer as a compensation policy. That policy
must be adopted by the company’s board of directors, after considering the recommendations of the compensation committee, and will
need to be brought for approval by the company’s shareholders, which approval requires a special approval for Compensation.
Under
the Companies Law, the board of directors of a public company must appoint a compensation committee and adopt a compensation policy.
Nominating and Governance Committee
Our nominating and governance
committee currently consists of Mr. Jay Green and Dr. Yael Margolin. Mr. Jay Green serves as the Chairman of the nominating and governance
committee. The duties of the nominating and governance committee include identifying individuals qualified to become members of the Board
and recommending to the Board the nominees for election to the Board at the next annual general meeting of shareholders, reviewing the
Board committee structure and recommending to the Board for its approval directors to serve as members of each committee and reviewing
and reassessing the adequacy of the Company’s corporate governance guidelines.
Israeli
Corporate Governance Requirements
Companies
incorporated under the laws of the State of Israel whose shares are publicly traded, including companies with shares listed on the Nasdaq
Capital Market, are considered public companies under Israeli law and are required to comply with various corporate governance requirements
under Israeli law relating to such matters as external directors, the audit committee, the compensation committee and an internal auditor.
These requirements are in addition to the corporate governance requirements imposed by the listing rules of the Nasdaq Capital Market
and other applicable provisions of U.S. securities laws.
Pursuant
to regulations enacted under the Israeli Companies Law, the board of directors of a public company whose shares are listed on certain
non-Israeli stock exchanges, including Nasdaq, that do not have a controlling shareholder (as such term is defined in the Israeli Companies
Law), may, subject to certain conditions, elect to “opt-out” of the requirements of the Israeli Companies Law regarding the
election of external directors and to the composition of the audit committee and compensation committee, provided that the company complies
with the requirements as to director independence and audit committee and compensation committee composition applicable to companies
that are incorporated in the jurisdiction in which its stock exchange is located. In March 2023, our board of directors elected to opt-out
of the Israeli Companies Law requirements to appoint external directors and related Israeli Companies Law rules concerning the composition
of the audit committee and compensation committee.
The
foregoing exemptions will continue to be available to us so long as: (i) we do not have a “controlling shareholder” (as such
term is defined under the Israeli Companies Law), (ii) our shares are traded on a U.S. stock exchange, including Nasdaq, and (iii) we
comply with the Nasdaq rules applicable to domestic U.S. companies. If in the future we were to have a controlling shareholder, we would
again be required to comply with the requirements relating to external directors and composition of the audit committee and compensation
committee.
Under
the Israeli Companies Law, the term “controlling shareholder” means a shareholder with the ability to direct the activities
of the company, other than by virtue of being an office holder. A shareholder is presumed to be a controlling shareholder if the shareholder
holds 50% or more of the voting rights in a company or has the right to appoint the majority of the directors of the company or its general
manager. For the purpose of approving transactions with controlling shareholders, the term “controlling shareholder” also
includes any shareholder that holds 25% or more of the voting rights of the company if no other shareholder holds more than 50% of the
voting rights in the company
Compensation
Policy
The
Compensation Policy must be based on certain considerations, must include certain provisions and needs to reference certain matters as
set forth in the Companies Law. The Compensation Policy must be approved by the company’s board of directors after considering
the recommendations of the compensation committee. In addition, the Compensation Policy needs to be approved by the company’s shareholders
by a simple majority, provided that (i) such majority includes a majority of the votes cast by the shareholders who are not controlling
shareholders and who do not have a personal interest in the matter, present and voting (abstentions are disregarded) or (ii) the votes
cast by shareholders who are not controlling shareholders and who do not have a personal interest in the matter who were present and
voted against the Compensation Policy, constitute two percent or less of the voting power of the company. Such majority determined in
accordance with clause (i) or (ii) is hereinafter referred to as the Compensation Majority.
75
To
the extent a Compensation Policy is not approved by shareholders at a duly convened shareholders meeting, the board of directors of a
company may override the resolution of the shareholders following a re-discussion of the matter by the board of directors and the compensation
committee and for specified reasons, and after determining that despite the rejection by the shareholders, the adoption of the Compensation
Policy is for the benefit of the company.
A
Compensation Policy that is for a period of more than three years must be approved in accordance with the above procedure every three
years.
Notwithstanding
the above, the amendment of existing terms of office and employment of office holders (other than directors or controlling shareholders
and their relatives, who serve as office holders) requires the approval of only the compensation committee, if such committee determines
that the amendment is not material in relation to its existing terms.
Pursuant
to the Companies Law and following the recommendation of our compensation committee, our board of directors approved our compensation
policy, and our shareholders, in turn, approved the Compensation Policy at our annual general meeting of shareholders that was held on
December 27, 2021.
The
Compensation Policy must serve as the basis for decisions concerning the financial terms of employment or engagement of office holders,
including exculpation, insurance, indemnification or any monetary payment or obligation of payment in respect of employment or engagement.
The Compensation Policy must relate to certain factors, including advancement of the Company’s objectives, the Company’s
business plan and its long-term strategy, and creation of appropriate incentives for office holders. It must also consider, among other
things, the Company’s risk management, size and the nature of its operations. The Compensation Policy must furthermore consider
the following additional factors:
●
the
knowledge, skills, expertise and accomplishments of the relevant office holder;
●
the
office holder’s roles and responsibilities and prior compensation agreements with him or her;
●
the
ratio between the cost of the terms of employment of an office holder and the cost of the compensation of the other employees of
the company, including those employed through manpower companies, in particular the ratio between such cost and the average and median
compensation of the other employees of the company, as well as the impact such disparities may have on the work relationships in
the company;
●
the
possibility of reducing variable compensation, if any, at the discretion of the board of directors; and the possibility of setting
a limit on the exercise value of non-cash variable equity-based compensation; and
●
as
to severance compensation, if any, the period of service of the office holder, the terms of his or her compensation during such service
period, the company’s performance during that period of service, the person’s contribution towards the company’s
achievement of its goals and the maximization of its profits, and the circumstances under which the person is leaving the company.
76
The
Compensation Policy must also include:
●
a
link between variable compensation and long-term performance and measurable criteria;
●
the
relationship between variable and fixed compensation, and the ceiling for the value of variable compensation;
●
the
conditions under which an office holder would be required to repay compensation paid to him or her if it was later shown that the data
upon which such compensation was based was inaccurate and was required to be restated in the company’s financial statements;
●
the
minimum holding or vesting period for variable, equity-based compensation; and
●
maximum
limits for severance compensation.
The
compensation committee is responsible for (a) recommending the compensation policy to a company’s board of directors for its approval
(and subsequent approval by its shareholders) and (b) duties related to the compensation policy and to the compensation of a company’s
office holders as well as functions previously fulfilled by a company’s audit committee with respect to matters related to approval
of the terms of engagement of office holders, including:
●
recommending
whether a compensation policy should continue in effect, if the then-current policy has a term of greater than three years (approval
of either a new compensation policy or the continuation of an existing compensation policy must in any case occur every three years);
●
recommending
to the board of directors periodic updates to the compensation policy;
●
assessing
implementation of the compensation policy; and
●
determining
whether the compensation terms of the chief executive officer of the company need not be brought to approval of the shareholders.
Our
compensation committee’s responsibilities include:
●
reviewing
and recommending overall compensation policies with respect to our Chief Executive Officers and other executive officers;
●
reviewing
and approving corporate goals and objectives relevant to the compensation of our Chief Executive Officers and other executive officers
including evaluating their performance in light of such goals and objectives;
●
reviewing
and approving the granting of options and other incentive awards; and
●
reviewing,
evaluating and making recommendations regarding the compensation and benefits for our non-employee directors.
Internal
Auditor
Under
the Companies Law, the board of directors of an Israeli public company must appoint an internal auditor in accordance with the recommendation
of the audit committee. An internal auditor may not be:
●
a
person (or a relative of a person) who holds more than 5% of the company’s outstanding shares or voting rights;
●
a
person (or a relative of a person) who has the power to appoint a director or the general manager of the company;
●
an
office holder (including a director) of the company (or a relative thereof); or
●
a
member of the company’s independent accounting firm, or anyone on his or her behalf.
77
●
The
role of the internal auditor is to examine, among other things, our compliance with applicable law and orderly business procedures.
The audit committee is required to oversee the activities and to assess the performance of the internal auditor as well as to review
the internal auditor’s work plan. On October 22, 2014, we appointed Mr. Gewirtz Yisrael as our internal auditor. Mr. Gewirtz
Yisrael is a certified internal auditor and a partner at Fahn Kanne & Co. Grant Thornton Israel, a certified public accounting
firm in Israel.
●
The
board of directors shall determine the direct supervisor of the internal auditor. The internal auditor is required to submit his
findings to the audit committee, unless specified otherwise by the board of directors.
Exculpation,
Insurance and Indemnification of Directors and Officers
Under
the Companies Law, a company may not exculpate an office holder from liability for a breach of the duty of loyalty. An Israeli company
may exculpate an office holder in advance from liability to the company, in whole or in part, for damages caused to the company as a
result of a breach of duty of care but only if a provision authorizing such exculpation is included in its articles of association. Our
articles of association include such a provision. The company may not exculpate in advance a director from liability arising out of a
prohibited dividend or distribution to shareholders.
Under
the Companies Law, a company may indemnify an office holder in respect of the following liabilities and expenses incurred for acts performed
by him or her as an office holder, either pursuant to an undertaking made in advance of an event or following an event, provided its
articles of association include a provision authorizing such indemnification:
●
financial
liability imposed on him or her in favor of another person pursuant to a judgment, including a settlement or arbitrator’s award
approved by a court. However, if an undertaking to indemnify an office holder with respect to such liability is provided in advance,
then such an undertaking must be limited to events which, in the opinion of the board of directors, can be reasonably foreseen based
on the company’s activities when the undertaking to indemnify is given, and to an amount or according to criteria determined
by the board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned foreseen events
and amount or criteria;
●
reasonable
litigation expenses, including attorneys’ fees, incurred by the office holder (i) as
a result of an investigation or proceeding instituted against him or her by an authority
authorized to conduct such investigation or proceeding, provided that (A) no indictment was
filed against such office holder as a result of such investigation or proceeding; and (B)
no financial liability, such as a criminal penalty, was imposed upon him or her as a substitute
for the criminal proceeding as a result of such investigation or proceeding or, if such financial
liability was imposed, it was imposed with respect to an offense that does not require proof
of criminal intent; and (ii) in connection with a monetary sanction; and
●
reasonable
litigation expenses, including attorneys’ fees, incurred by the office holder or imposed by a court in proceedings instituted
against him or her by the company, on its behalf, or by a third party, or in connection with criminal proceedings in which the office
holder was acquitted, or as a result of a conviction for an offense that does not require proof of criminal intent.
78
Under
the Companies Law and the Israeli Securities Law 5728-1968 (the “Israeli Securities Law”), a company may insure an office
holder against the following liabilities incurred for acts performed by him or her as an office holder if and to the extent provided
in the company’s articles of association:
●
a
breach of the duty of loyalty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe
that the act would not harm the company;
●
a
breach of duty of care to the company or to a third party, to the extent such a breach arises out of the negligent conduct of the
office holder; and
●
a
financial liability imposed on the office holder in favor of a third party.
Under
our articles of association, we may insure an office holder against the aforementioned liabilities as well as the following liabilities:
●
a
breach of duty of care to the company or to a third party.
●
any
other action against which we are permitted by law to insure an office holder;
●
expenses
incurred and/or paid by the office holder in connection with an administrative enforcement procedure under any applicable law including
the Efficiency of Enforcement Procedures in the Securities Authority Law (legislation amendments), 5771-2011 and the Israeli Securities
Law, which we refer to as an Administrative Enforcement Procedure, and including reasonable litigation expenses and attorney fees; and
●
a
financial liability in favor or a victim of a felony pursuant to Section 52ND of the Israeli Securities Law.
Under
the Companies Law, a company may not indemnify, exculpate or insure an office holder against any of the following:
●
a
breach of the duty of loyalty, except for indemnification and insurance for a breach of the duty of loyalty to the company to the
extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company;
●
a
breach of duty of care committed intentionally or recklessly, excluding a breach arising solely out of the negligent conduct of the office
holder;
●
an
act or omission committed with intent to derive illegal personal benefit; or
●
a
fine, civil fine, administrative fine or ransom or levied against the office holder.
Under
the Companies Law, exculpation, indemnification and insurance of office holders in a public company must be approved by the compensation
committee and the board of directors and, with respect to certain office holders or under certain circumstances, also by the shareholders.
Our
articles of association permit us to exculpate, indemnify and insure our office holders to the fullest extent permitted or to be permitted
by the Companies Law and the Israeli Securities Law, including expenses incurred and/or paid by the office holder in connection with
an Administrative Enforcement Procedure.
We
have entered into agreements with each of our directors and executive officers exculpating them, to the fullest extent permitted by law
and our articles of association, and undertaking to indemnify them to the fullest extent permitted by law and our articles of association.
This indemnification is limited to events determined as foreseeable by the board of directors based on our activities, and to an amount
or according to criteria determined by the board of directors as reasonable under the circumstances.
The
maximum indemnification amount set forth in such agreements is limited to an amount which shall not exceed 25% of our net assets based
on our most recently audited or reviewed financial statements prior to actual payment of the indemnification amount. Such maximum amount
is in addition to any amount paid (if paid) under insurance and/or by a third-party pursuant to an indemnification arrangement
79
In
the opinion of the SEC, indemnification of directors and office holders for liabilities arising under the Securities Act of 1933, however,
is against public policy and therefore unenforceable.
We
have obtained directors’ and officers’ liability insurance for the benefit of our office holders and intend to continue to
maintain such coverage and pay all premiums thereunder to the fullest extent permitted by the Companies Law. In addition, we entered
into agreements with each of our office holders undertaking to indemnify them to the fullest extent permitted by the Companies Law, including
with respect to liabilities resulting from the initial public offering in the U.S., to the extent that these liabilities are not covered
by insurance.
Involvement
in Certain Legal Proceedings.
To the best of our knowledge, none of our directors
or executive officers has, during the past ten years:
●
been
convicted in a criminal proceeding or been subject to a pending criminal proceeding (excluding traffic violations and other minor
offenses);
●
had
any bankruptcy petition filed by or against the business or property of the person, or of any partnership, corporation or business
association of which he was a general partner or executive officer, either at the time of the bankruptcy filing or within two years
prior to that time;
●
been
subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction
or federal or state authority, permanently or temporarily enjoining, barring, suspending or otherwise limiting, his involvement in
any type of business, securities, futures, commodities, investment, banking, savings and loan, or insurance activities, or to be
associated with persons engaged in any such activity;
●
been
found by a court of competent jurisdiction in a civil action or by the Securities and Exchange Commission or the Commodity Futures
Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended,
or vacated;
●
been
the subject of, or a party to, any federal or state judicial or administrative order, judgment, decree, or finding, not subsequently
reversed, suspended or vacated (not including any settlement of a civil proceeding among private litigants), relating to an alleged
violation of any federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions
or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution,
civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or any law or regulation prohibiting
mail or wire fraud or fraud in connection with any business entity; or
●
been
the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization
(as defined in Section 3(a)(26) of the Exchange Act), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange
Act), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons
associated with a member.
Except
as set forth in our discussion below in “Certain Relationships and Related Transactions,” none of our directors or executive
officers has been involved in any transactions with us or any of our directors, executive officers, affiliates or associates which are
required to be disclosed pursuant to the rules and regulations of the Commission.
80
ITEM
11. EXECUTIVE COMPENSATION
EXECUTIVE
OFFICER COMPENSATION TABLE
The
following summary compensation table sets forth all compensation awarded to, earned by, or paid to the named executive officers paid
by us during the years ended December 31, 2022 and 2021.
Stock
All Other
Total
Name and Position(s)
Year
Salary ($ )
Bonus ($)
Awards
($) (1)
Compensation ($) (2)
Compensation ($)
Amir Reichman
2022
$ 368,257
$ 182,012
$ 545,538
$ 12,228
$ 1,108,035
Chief Executive Officer and Director
2021
$ 426,904
$ 250,267
$ 572,347
$ 8,682
$ 1,258,200
Tamar Ben-Yedidia
2022
$ 257,225
$ 41,773
$ 48,814
$ 15,926
$ 636,738
Chief Scientist
2021
$ 233,457
$ 39,855
$ 85,852
$ 19,293
$ 378,457
-
Elad Mark
2022
$ 233,736
$ 39,216
$ 13,098
$ 4,064
$ 290,114
Chief Operating Officer
2021
$ 202,361
$ 37,511
$ 24,437
$ 21,543
$ 285,852
(1) Represents the grant date fair value of the RSU awards calculated for
book purposes in accordance with GAAP. These are non-cash amounts and do not represent actual amounts paid or to be realized. This is
a calculation performed for accounting purposes even though recipients may never realize any value from their awards. These RSUs are subject
to vesting and limitations on resales. For further information see Note 2 to the financial statements.
(2) All
other compensation consists of a car allowance.
Employment
Agreements and Change-in-Control Provisions
Mr.
Germain Service Agreement
We
are party to a services agreement with Mr. Germain, pursuant to which he receives a monthly payment of $12,500. Pursuant to this agreement,
in May 2019, Mr. Germain was granted an option to purchase 13,071 ADSs at an exercise price of $79.80 per ADS. 25% of the options vested
upon approval by shareholders, and the remainder vested in equal increments on each anniversary of the grant date and became fully vested
on April 30, 2022. In May 2021, Mr. Germain was granted an option to purchase 16,000 ADSs at an exercise price of $69.50 per ADS, The
options vest in equal monthly installments during a period of four (4) years commencing one (1) month following April 6, 2021 and become
fully vested on April 6, 2025. The agreement, as amended to date, expires in May 2025 and provides that either party may terminate the
agreement upon 90 days’ written notice. In addition, in May 2022 we granted Mr. Germain a cash payment of $90,000, and in March
2023, our compensation committee and board of directors approved a cash payment of $37,500, subject to shareholder approval.
81
Mr.
Reichman Employment Agreement
Pursuant
to his employment agreement entered into with us on January 20, 2021, Mr. Reichman is entitled to an annual gross salary of USD 350,000.
During the transition period between January 20, 2021, the date the agreement was signed, and March 2, 2021, Mr. Reichman was entitled
to a pro-rated portion of this amount equal to 20% of his monthly salary.
The
agreement also provides that Mr. Reichman was entitled to a one-time signing bonus at the gross lump sum amount of USD 50,000 and is
eligible to receive an annual cash bonus of a gross amount equal to three to six monthly salaries to the extent Mr. Reichman meets annual
objectives that shall be approved by the board of directors and by shareholders. It is currently contemplated that the annual bonus would
be (i) four monthly salaries for meeting a set of baseline annual objectives, and (ii) three monthly salaries in the case of underperforming
compared to such annual objectives, provided the Employee meets the baseline objectives set by the board of directors. Under extraordinary
circumstances reflecting performance by Mr. Reichman significantly above all such annual objectives, the board of directors may, in its
sole discretion, consider an additional cash bonus of not more than an additional three monthly salaries (up to nine monthly salaries
in total). The bonus amounts and annual objectives shall be subject to the terms of the Company’s Compensation Policy from time
to time.
Furthermore,
under the agreement Mr. Reichman is entitled to receive 60,000 restricted share units (the “RSUs”) under the Company’s
2018 Israeli Share Option Plan, which will vest over a period of five years, 20% to vest each year starting on January 20, 2021 (the
“Commencement Date”), and would become fully vested, in accordance with the terms of the grant, on January 20, 2026. The
ADSs underlying the RSUs may not be sold by Mr. Reichman during the term of his employment except that, commencing on the third anniversary
of the Commencement Date, sales may be made pursuant to a Rule 10b5-1 plan, with the number of RSUs sold during any one year period not
exceeding five percent of the vested RSUs held by Mr. Reichman at the time of such sales (the “Resale Limits”). If Mr. Reichman’s
employment agreement is terminated by the Company for no cause prior to the fifth anniversary of the Commencement Date, the Resale Limits
shall terminate. If Mr. Reichman’s employment agreement is terminated by Mr. Reichman or terminated by the Company for cause prior
to the fifth anniversary of the Commencement Date, the Resale Limits shall continue until the earlier of (i) one year after such termination,
or (ii) the fifth anniversary of the Commencement Date. The RSUs would be subject to accelerated vesting in the event of a change of
control.
For
these purposes, a “change of control” means the first to occur of (i) a sale of all or substantially all of the assets of
the Company; (ii) a merger, consolidation, or like transaction of the Company with or into another company; provided, that in the case
of either clauses (i) or (ii) the Company’s stockholders of record immediately prior to such transaction will, immediately after
such transaction, hold less than fifty percent (50%) of the voting power of the surviving or acquiring entity, and provided further that
a change of control shall not include (x) any consolidation, merger or reorganization effected to change the domicile of the Company
or (y) any transaction or series of transactions effected principally for bona fide equity financing purposes in which cash is received
by the Company or any successor or indebtedness of the Company is cancelled or converted or a combination thereof; (iii) the acquisition
by any person, entity or group not directly or indirectly affiliated with Angels Investments in Hi Tech Ltd. (“Angels”) of
more than 50% of the voting power of the Company, in a single or series of related transactions; and (iv) when a person, entity or group
not directly or indirectly affiliated with Angels becomes a shareholder that has “control,” as defined in the Israeli Companies
Law, 1999.
The
Company will provide Mr. Reichman other benefits, such as a company car, vacation, sick days, contribution towards work disability insurance,
monthly contributions equal to 7.5% of monthly salary to an Education Fund (“Keren Hishtalmut”, a short-term savings plan
available in Israel which is tax free to the employee up to a cap determined by law) and a manager’s insurance policy or a pension fund
and other benefits and perquisites similar to those of other officers of the Company.
Each
of Mr. Reichman and the Company may terminate Mr. Reichman’s employment by prior written notice of 60 days. In the event of termination
by the Company without cause, the Company will pay Mr. Reichman nine monthly salaries, which includes amounts accrued in a pension insurance
policy and amounts required by Israeli law.
82
In
May 2022, we granted Mr. Reichman an annual bonus for the year 2021 of $250,266. In March 2023, we granted Mr. Reichman an annual cash
bonus for the year 2022 of $182,000, equal to 50% of his annual base compensation) and, subject to shareholder approval, and
a grant of 78,125 RSUs that vest in three years.
Dr.
Ben-Yedidia Employment Agreement
Pursuant
to her employment agreement entered into with us on March 15, 2005, as amended to date, Dr. Ben-Yedidia is employed on a full-time basis
and is currently entitled to a monthly salary of NIS 49,000 plus Company car (approximately $13,500) which also includes monthly contributions
equal to 7.5% of her monthly salary to an Education Fund and a manager’s insurance policy and other benefits and perquisites similar
to those of other officers of the Company. In addition, we provide Dr. Ben-Yedidia with a leased company car and a mobile phone. Dr.
Ben-Yedidia is entitled to 22 annual paid vacation days.
Dr.
Ben-Yedidia’s employment agreement may be terminated by either us or Dr. Ben-Yedidia upon 120 days’ prior written notice
or by us immediately for cause (i.e., termination due to embezzlement of our funds, or the material breach of the terms and conditions
of the employment agreement, or if Dr. Ben-Yedidia is involved in an act which constitutes a breach of trust between her and us or constitutes
a severe breach of discipline, or conduct causing grave injury to us any, monetarily or otherwise, or Dr. Ben-Yedidia’s inability
to carry out her duties for a period exceeding 120 consecutive days, provided that her resumption of duties for a period of less than
15 consecutive days shall not be deemed to have broken the continuity of the aforementioned 120 days). Under her employment agreement,
Dr. Ben-Yedidia received options to purchase 25,000 ordinary shares, which were later exchanged for 7,850 RSUs.
In
addition, in February 2012 our board of directors approved the grant of the following conditioned bonus to Tamar Ben-Yedidia: in the
event that we duly enter into one or more material agreement(s) (i.e. an agreement or a series of agreements, pertaining to a transaction
with us (or any other entity designated by us for the transaction by us) in connection with the sale of all or substantially all of our
assets or a commercialization of one of our products in the field of business, with aggregate proceeds received resultant of such agreement
are no less than a sum of $10 million) with any third party during the term of Dr. Ben-Yedidia’s engagement with us or during a
period of three years commencing on the date of the termination of the employment agreement by us, Dr. Ben-Yedidia shall be entitled
to receive a one-time bonus per material agreement equal to 1.25% of the proceeds received by us as a result of the material agreement.
In May 2022, Dr. Ben-Yedidia was granted a 2021 bonus of NIS 140,250 (approximately $43,800), an amount equal to three months’
salary. For the year 2022, Dr. Ben-Yedidia was granted a performance-based incentive package of NIS 147,000 (approximately $42,000),
an amount equal to 25% of her annual compensation, and a grant of 20,082 RSUs vesting in three years.
Mr.
Mark Employment Agreement
Pursuant
to his employment agreement entered into with us on September 5, 2018. He is currently entitled to a monthly salary of NIS 46,000 (approximately
$13,000), which also includes monthly contributions equal to 7.5% of his monthly salary to an Education Fund and a manager’s insurance
policy and other benefits and perquisites similar to those of other officers of the Company. In addition, we provide Mr. Mark with a
leased company car and a mobile phone. Mr. Mark is entitled to 16 annual paid vacation days.
Mr.
Mark’s employment agreement may be terminated by either us or Mr. Mark upon 60 days’ prior written notice or by us immediately
for cause (i.e., termination due to embezzlement of our funds, or the material breach of the terms and conditions of the employment agreement,
or if Mr. Mark is involved in an act which constitutes a breach of trust between his and us or constitutes a severe breach of discipline,
or conduct causing grave injury to us any, monetarily or otherwise, or Mr. Mark’s inability to carry out his duties for a period
exceeding 120 consecutive days, provided that his resumption of duties for a period of less than 15 consecutive days shall not be deemed
to have broken the continuity of the aforementioned 120 days). For the year 2022, Mr. Mark was granted a performance-based incentive
package of 138,000 NIS (approximately $39,000), an amount equal to 25% of his annual compensation, and 18,852 RSUs vesting in three years.
83
Outstanding
Equity Awards at Fiscal Year End
The
following table sets forth information regarding equity awards that were made in the option plan to employees and directors: December
31, 2022:
Option Awards(1)
Stock Awards
Name
Number of Securities Underlying Unexercised Options, Exercisable
Number of Securities Underlying Unexercised Options, Not Exercisable
Option Exercise Price
Option Expiration Date
Number of ADS Units of Stock That Have Not Vested (1)
Market Value of ADS Units of Stock That Have Not Vested (2)
Amir Reichman
-
-
-
-
48,000
142,080
Tamar Ben-Yedidia
-
-
-
-
7,850
23,236
Elad Mark
-
-
-
-
4,430
13,113
(1) Vests
in accordance with the following schedule: Mr. Reichman – 12,000
RSUs vest per year over the next four years; Dr. Ben Yedidia – 750 RSUs will vest in September 2024, 3,350 RSUs will vest in October
2024, and 3,750 RSUs will vest in March 2025; and Mr. Mark – 900 RSUs will vest in October 2024 and 3,530 RSUs will vest in March
2025.
(2) Based
on the $2.96 closing price of our ADSs on December 30, 2022, as reported by Nasdaq.
Director
Compensation
The following Director Compensation
Table sets forth the compensation of our directors for the fiscal year ending on December 31, 2022. Each of our non-management directors
receives a cash retainer, meeting participation fees, and equity awards, as detailed below.
Fees Earned
or Paid in
Stock
Option
Cash
Awards
Awards
Total
Name
($)
($)(1)
($)(1)
($)
Mark Germain
123,858
-
212,811
336,669
Jay Green
41,981
3,883
26,493
72,358
George H. Lowell
40,604
5,000
22,757
68,361
Morris Laster
51,030
5,000
22,757
78,787
Yael Margolin
51,030
5,000
30,986
87,016
Samuel Moed
43,528
-
449,621
493,149
Adi Raviv
53,954
6,226
32,012
92,192
Avner Rotman
40,604
5,000
30,986
76,590
(1) Represents the grant date fair value of the RSU and option awards
calculated for book purposes in accordance with GAAP. These are non-cash amounts and do not represent actual amounts paid or to be
realized. This is a calculation performed for accounting purposes even though recipients may never realize any value from their
awards. RSUs are subject to vesting and limitations on resale. Options were granted at an exercise price at least equal to market
value during the 30 trading days or 30 calendar days prior to approval of the grant by the Board or shareholders, as the case may
be. Options are subject to vesting and other limitations on sales. For further information see Note 2 to the financial
statements.
The following table sets forth the range of exercise
prices of the options held by directors and the market value of the vested RSU awards held by directors as of December 31, 2022:
Market Value
of Vested
Name
Option
Exercise Price
($)
RSUs At
December 31,
2022
($) (a)
Mark Germain
69.5 - 85.8
-
Jay Green
29.36
(b)
George H. Lowell
69.50 - 7.76
(b)
Morris Laster
69.50 - 79.76
(b)
Yael Margolin
69.50 - 72.8
(b)
Samuel Moed
69.50 - 72.8
0
Adi Raviv
69.50 - 80.76
(b)
Avner Rotman
69.50 - 72.8
(b)
Amir Reichman
-
35,520
(a) Based on the closing price of the ADSs on December 31, 2022,
$2.96.
(b) Less than $1,000.
84
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
The
following table sets forth certain information as of March 15, 2023 concerning the beneficial ownership of ADSs: (i) each director and
director nominee, (ii) each Named Executive Officer in the Summary Compensation Table under “Executive Compensation” above,
(iii) all executive officers and directors as a group, and (iv) each person (including any “group” as that term is used in
Section 13(d)(3) of the Exchange Act) known by us to be the beneficial owner of 5% or more of our ADSs. The address for each of the persons
below who are beneficial owners of 5% or more of our ADSs is our corporate address at BiondVax Pharmaceuticals Ltd., Jerusalem BioPark,
2nd floor, Hadassah Ein Kerem Campus, Jerusalem, Israel. The information with respect to beneficial ownership of ADSs by our major shareholders
is given based on information reported in such shareholder’s Schedule 13G or Schedule 13D, except where more updated information
was provided to us by the shareholders.
Beneficial
ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to ADSs. ADSs issuable
under share options or other conversion rights that were exercisable within 60 days after March 31, 2023, are deemed outstanding for
the purpose of computing the percentage ownership of the person holding the options or other conversion rights but are not deemed outstanding
for the purpose of computing the percentage ownership of any other person. The percentage of ADSs beneficially owned is based on 3,284,058
ADSs outstanding as of March 31, 2023.
Except
as indicated by the footnotes below, we believe, based on the information furnished to us, that the persons and entities named in the
table below have sole voting and investment power with respect to all ADSs that they beneficially own.
None
of our shareholders has different voting rights from other shareholders. To the best of our knowledge, we are not owned or controlled,
directly or indirectly, by another corporation or by any foreign government. We are not aware of any arrangement that may, at a subsequent
date, result in a change of control of our company.
Except
as otherwise indicated in the footnotes to this table, we believe the persons named in this table have sole voting and investment power
with respect to all the ordinary shares indicated.
85
Percent of
ADSs
Class %
Directors and Executive Officers
Avner Rotman (1)
4,314
*
George H. Lowell (2)
4,854
*
Uri Ben-Or
-
*
Tamar Ben-Yedidia
-
*
Elad Mark
-
*
Mark Germain (3)
21,738
*
Morris Laster (4)
3,966
*
Adi Raviv (5)
3,966
*
Yael Margolin (6)
3,966
*
Sam Moed (7)
7,267
*
Amir Reichman (8)
12,000
*
Jay Green (9)
1,417
*
All executive officers and directors as a group (12 people)
63,488
*
5% Shareholders
Angels Investments in Hi Tech Ltd.
427,404
12.77 %
Daniel Stone
298,150
8.91 %
Sabby Volatility Warrant Master Fund, Ltd (10)
228,329
6.83 %
* Less
than 1%.
(1) Consists
of 514 ADSs, options to purchase 3,606 ADSs and 194 ADSs issuable upon settlement of vested RSUs. The ADS options are comprised of options
to purchase (i) 1800 ADSs at an exercise price per ADS of $72.8 that expire in March 2030 and (ii) 1,806 ADSs at an exercise price per
ADS of $69.5 that expire in April 2031.
(2) Consists
of 1,054 ADSs, options to purchase 3,606 ADSs and 194 ADSs issuable upon settlement of vested RSUs. The options are comprised of options
to purchase (i) 1,800 ADSs at an exercise price per ADS of $79.60 that expire in March 2030 and (ii) 3,806 ADSs at an exercise price
per ADS of $69.50 that expire in April 2031.
(3) Consists
of options to purchase 21,738 ADSs. The options are comprised of ADS options to purchase (i)13,071 ADSs at an exercise price per ADS
of $85.80 that expire in May 2029 and (ii) 8,667 ADSs at an exercise price per ADS of $69.50 that expire in April 2031.
(4) Consists
of 167 ADSs, options to purchase 3,606 ADSs and 194 ADSs issuable upon settlement of vested RSUs. The options are comprised of
options to purchase (i) 1,800ADS at an exercise price per ADS of $79.76 that expire in March 2030 and (ii) 1,806 shares at an exercise
price per ADS of $69.5 that expire in April 2031.
(5) Consists
of 167 ADSs, options to purchase 3,606 ADSs and 194 ADSs issuable upon settlement of vested RSUs. The options are comprised of options
to purchase (i) 1,800 ADSs at an exercise price per ADS of $80.76 that expire in March 2030 and (ii) 1,806 ADSs at an exercise price
per ADS of $69.50 that expire in April 2031.
(6) Consists
of 167 ADSs, options to purchase 3,606 ADSs and 194 ADSs issuable upon settlement of vested RSUs. The options are comprised of options
to purchase (i) 1,800 ADSs at an exercise price per ADS of $80.76 that expire in March 2030 and (ii) 1,806 ADSs at an exercise price
per ADS of $69.50 that expire in April 2031.
(7) Consists
of options to purchase 7,267 ADSs. The options are comprised of options to purchase (i) 1,800 ADSs at an exercise price per ADS of $72.80
that expire in March 2030 and (ii) 5,467 ADSs at an exercise price per ADS of $69.50 that expire in August 2030.
86
(8) Consists
of 12,000 ADSs issuable upon settlement of vested RSUs.
(9) Consists
of options to purchase 1,181 ADS at an exercise price per ADS of $29.36 per ADS that expire in December 2031 and 236 ADSs issuable upon
settlement of vested RSUs.
(10)
Sabby
Management, LLC is the investment manager of Sabby Volatility Warrant Master Fund, Ltd. and
shares voting and investment power with respect to these shares in this capacity. As manager
of Sabby Management, LLC, Hal Mintz also shares voting and investment power on behalf of
Sabby Volatility Warrant Master Fund, Ltd. The address of the Sabby Volatility Warrant Master
Fund, Ltd. is c/o c/o Ogier Fiduciary Services (Cayman) Limited, 89 Nexus Way, Camana Bay,
Grand Cayman KY1-9007, Cayman Islands. Each of Sabby Management, LLC and Hal Mintz disclaims
beneficial ownership over the securities listed except to the extent of their pecuniary interest
therein.
Includes
ADSs exercisable upon exercise of warrants to acquire ADSs. The terms of the warrants preclude a holder thereof from exercising such
holder’s warrant, if after giving effect to the issuance of ordinary shares upon such exercise, the holder (together with the
holder’s affiliates and any other persons acting as a group together with the holder or any of the holder’s affiliates)
would beneficially own in excess of 9.99% of the number of ordinary shares outstanding immediately after giving effect to the issuance
of ordinary shares issuable upon such exercise subject to certain exceptions.
Changes
in Control
We
are not aware of any arrangements that may result in “changes in control” as that term is defined by the provisions of Item
403(c) of Regulation S-K.
Equity
Compensation Plan Information
2005
Israeli Share Option Plan
The
2005 Israeli Share Option Plan (the “2005 Plan”) permits grants of options to employees, directors, consultants, service
providers and other entities which the board shall decide their services are considered valuable to the Company. Options granted under
the 2005 Plan are subject to applicable vesting schedules and generally expire 10 years from the grant date.
Upon
the termination of a recipient’s engagement with us for any reason other than death, disability or for cause, all unvested options
allocated shall automatically expire and all vested options allocated will automatically expire 90 days after the termination unless
expired earlier due to their term. If the recipient’s engagement was terminated for cause (as defined in the 2005 Plan), the recipient’s
right to exercise any unexercised options, awarded and allocated in favor of such recipient, whether vested or not, will immediately
cease and expire as of the date of such termination. If the recipient dies or is disabled, any vested but unexercised options will automatically
expire 12 months from the termination of the engagement, unless expired earlier due to their term.
In
the event that options allocated under the 2005 Plan expire or otherwise terminate in accordance with the provisions of the 2005 Plan,
such expired or terminated options will become available for future grant awards and allocations under the 2005 Plan. In the event of
(i) the sale of all or substantially all of our assets; (ii) a sale (including an exchange) of all or substantially all of our share
capital; or (iii) a merger, acquisition or reorganization of the Company with or into another corporation, then, subject to obtaining
the applicable approvals of the Israeli tax authorities, unexercised options then outstanding shall be assumed or substituted for an
appropriate number of shares of the successor company subject to certain adjustments as determined by the board of directors in its sole
discretion. Subject to certain conditions, the board shall also have the power to provide for immediate acceleration in a recipient’s
option agreement in the event of such a transaction.
As of March 31, 2023, the Company had outstanding grants under the
2005 Option Plan to acquire 7,933,400 ordinary shares.
87
2018
Israeli Share Option Plan
The
2018 Israeli Share Option Plan (the “2018 Plan”) permits the granting of options, restricted share units or allotment of
shares or other equity-based awards to employees, directors, consultants, service providers and other entities which the board shall
decide their services are considered valuable to the Company, under similar terms and conditions to the 2005 Plan.
Options
granted under the 2018 Plan are subject to applicable vesting schedules and generally expire 10 years from the grant date.
Upon
the termination of a recipient’s engagement with us for any reason other than death, disability or for cause, all unvested options
allocated shall automatically expire and all vested options allocated will automatically expire 90 days after the termination, unless
expired earlier due to their term, or unless expiration is extended beyond termination under certain circumstance for a period not to
exceed the term of the options, such as was recently approved by shareholders in connection with option grants to directors. If the recipient’s
engagement was terminated for cause (as defined in the 2018 Plan), the recipient’s right to exercise any unexercised options, awarded
and allocated in favor of such recipient, whether vested or not, will immediately cease and expire as of the date of such termination.
If the recipient dies or is disabled, any vested but unexercised options will automatically expire 12 months from the termination of
the engagement, unless expired earlier due to their term.
In
the event that options allocated under the 2018 Plan expire or otherwise terminate in accordance with the provisions of the 2018 Plan,
such expired or terminated options will become available for future grant awards and allocations under the 2018 Plan.
Restricted
share units granted under the 2018 Plan are subject to applicable vesting schedules, and the Board may condition the grant or vesting
of restricted share units upon the attainment of specified performance targets or such other factors as the Board may determine, in its
sole discretion.
In
the event of (i) the sale of all or substantially all of our assets; (ii) a sale (including an exchange) of all or substantially all
of our share capital; or (iii) a merger, acquisition or reorganization of the Company with or into another corporation, then, subject
to obtaining the applicable approvals of the Israeli tax authorities, unexercised awards then outstanding shall be assumed or substituted
for an appropriate number of shares of the successor company subject to certain adjustments as determined by the board of directors in
its sole discretion. Subject to certain conditions, the board shall also have the power to provide for immediate acceleration in a recipient’s
award agreement in the event of such a transaction.
The
Company has reserved an unlimited amount of the issued and outstanding capital of the Company available for issuance under the 2018 Plan.
As
of March 31, 2023, the Company had awarded grants under the Option Plan to acquire 63,398,080 ordinary shares.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS; AND DIRECTOR INDEPENDENCE.
a. Related
parties consist of nine directors (including the CEO) serving on the Company’s board of directors and three key officers.
b. Transactions
with related parties:
For information regarding transactions with our officers:
please
see Item 11 Executive Compensation - Employment Agreements and Change-in-Control Provisions.
88
c. Balances
with related parties:
Payables
Key management personnel:
December 31, 2021
721
December 31, 2022
531
d. Transactions
with related parties:
Research and
development
Marketing, general
and administrative
Key management personnel:
2021
463
4,197
2022
521
2,500
ITEM
14. PRINCIPAL ACCOUNTING FEES AND SERVICES
Kost
Forer Gabbay & Kasierer, a member of Ernst & Young Global, served as our independent registered public accountants for the years
ended December 31, 2022 and 2021.
Audit
Fees
For
the Company’s fiscal years ended December 31, 2022 and 2021, we were billed approximately $126,000 and $65,000, respectively, for
professional services rendered by our independent auditors for the audit and review of our financial statements.
Audit-Related
Fees
For
the Company’s fiscal years ended December 31, 2022 and 2021, there were $49,000 and $9,000 for professional services rendered by
our independent auditors for tax compliance, tax advice, and tax planning.
All
Other Fees
For
the Company’s fiscal years ended December 31, 2022 and 2021, we were billed approximately $50,000 and $67,500, respectively, for
professional services rendered by our independent auditors related to the Registration Statement on Form F-1 and amendments thereto filed
with the SEC in those years.
Pre-Approval
Policies
All
of the above services and fees were reviewed and approved by the entire Board. No services were performed before or without approval.
89
PART
IV
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
Exhibit
No.
Exhibit
Description
3.1#
Articles of Association of BiondVax Pharmaceuticals Ltd.,
4.1#
Description of Securities
4.2
Form of Pre-Funded Warrant, (incorporated by reference to Exhibit 4.16 to the Registration Statement on Form F-1/A filed with the SEC on December 14, 2022).
4.3
Form
of Exchangeable Warrant, (incorporated by reference to the Registration Statement on Form F-1/A filed with the SEC on December 14,
2022).
4.4
Form
of Non-Exchangeable Warrant, (incorporated by reference to the Registration Statement on Form F-1/A filed with the SEC on December
14, 2022).
10.1
Form of Deposit Agreement between BiondVax Pharmaceuticals Ltd., The Bank of New York Mellon as Depositary, and owners and holders from time to time of ADSs issued thereunder, (incorporated by reference to Exhibit 4.1 to the Registration Statement on Form F-1 filed with the SEC on April 6, 2015).
10.2**
2005 Share Incentive Plan, (incorporated by reference to Exhibit 4.1 to the Annual Report on Form 20-F filed with the SEC on June 12, 2020).
10.3**
2018 Share Incentive Plan, (incorporated by reference to Exhibit 4.2 to the Annual Report on Form 20-F filed with the. SEC on June 12, 2020).
10.4**
Compensation Policy, (incorporated by reference to Appendix B to the Exhibit 99.1 to the Form 6-K filed with the SEC on November 22, 2021).
10.5**
Employment Agreement, dated January 20, 2021, between BiondVax Pharmaceuticals Ltd. And Mr. Amir Reichman, (incorporated by reference to Exhibit 4.4 to the Annual Report on Form 20-F filed with the SEC on March 28, 2022).
10.6**
Employment Agreement dated March 15, 2005, between BiondVax Pharmaceuticals Ltd. and Dr. Tamar Ben-Yedidia, (incorporated by reference to Exhibit 10.6 to the Registration Statement on Form F-1 filed with the SEC on December 29, 2014).
10.7**
Addendum to Employment Agreement dated April 1, 2012, between BiondVax Pharmaceuticals Ltd. and Dr. Tamar-Ben Yedidia, (incorporated by reference to Exhibit 10.11 to the Registration Statement on Form F-1 filed with the SEC on December 29, 2014).
10.8**#
Addendum to Employment Agreement dated May 28, 2015, between BiondVax Pharmaceuticals Ltd. and Dr. Tamar-Ben Yedidia.
10.9**#
Addendum to Employment Agreement dated April 1, 2012, between BiondVax Pharmaceuticals Ltd. and Dr. Tamar-Ben Yedidia
10.10**#
Employment Agreement dated September 5, 2018, between BiondVax Pharmaceuticals Ltd. and Elad Mark.
10.11
Form of Indemnification Letter (unofficial English translation from Hebrew original), (incorporated by reference to Exhibit 10.9 to the Registration Statement on Form F-1 filed with the SEC on December 29, 2014).
10.12
Form of Indemnification and Exculpation Agreement, (incorporated by reference to Exhibit 10.18 to the Registration Statement on Form F-1 filed with the SEC on April 6, 2015).
10.13
Finance Contract between BiondVax Pharmaceuticals Ltd. and the European Investment Bank, (incorporated by reference to Exhibit 99.2 to Form 6-K filed with the SEC on June 19, 2017).
10.14
Amendment No. 1, dated January 11, 2021, to Finance Contract dated June 19, 2017, by and between BiondVax Pharmaceuticals Ltd. and the European Investment Bank, (incorporated by reference to Exhibit 4.16 to the Annual Report on Form 20-F filed with the SEC on May 13, 2021).
10.15
Lease Agreement dated July 10, 2017 between BiondVax Pharmaceuticals Ltd. and Unihad BioPark Ltd., (incorporated by reference to Exhibit 4.19 to the Form 20-F filed with the SEC on April 30, 2018).
10.16
Services Agreement between BiondVax Pharmaceuticals Ltd. and Mark Germain, (incorporated by reference to Appendix C to the Form 6-K filed with the SEC on April 23, 2019).
10.17+
License Agreement, dated December 11, 2021, between BiondVax Pharmaceuticals Ltd. and Max-Planck-Innovation GmbH, (incorporated by reference to Exhibit 4.16 to the Annual Report on Form 20-F filed with the SEC on March 28, 2022).
10.18+
Accompanying Research Collaboration Agreement, dated December 11, 2021, between BiondVax Pharmaceuticals Ltd., Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V and Georg-August-Universität Göttingen Stiftung Öffentlichen Rechts Universitätsmedizin Göttingen, (incorporated by reference to Exhibit 4.17 to the Annual Report on Form 20-F filed with the SEC on March 28, 2022).
90
10.19+
Research Collaboration Agreement, dated March 23, 2022, between BiondVax Pharmaceuticals Ltd., Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V and Georg-August-Universität Göttingen Stiftung Öffentlichen Rechts Universitätsmedizin Göttingen, (incorporated by reference to Exhibit 4.18 to the Annual Report on Form 20-F filed with the SEC on March 28, 2022).
10.20+
Form of License Agreement between BiondVax Pharmaceuticals Ltd., Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V and Georg-August-Universität Göttingen Stiftung Öffentlichen Rechts Universitätsmedizin Göttingen (incorporated by reference to Exhibit 4.19 to the Annual Report on Form 20-F filed with the SEC on March 28, 2022).
10.21#
Amendment
Agreement dated August 9, 2022, to Finance Contract dated June 19, 2017 and as amended from time to time, by and between BiondVax Pharmaceuticals
Ltd. and the European Investment Bank,
14.1#
Code of Conduct
23.1#
Consent of Kost Forer Gabbay & Kasierer, Certified Public Accountant (Isr.), a member of Ernst & Young Global, independent registered public accounting firm for the Registrant
31.1#
Certification of Principal Executive Officer of BiondVax Pharamaceuticals Ltd. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2#
Certification of Principal Financial and Accounting Officer of BiondVax Pharamaceuticals Ltd. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1##
Certification of Principal Executive Officer of BiondVax Pharamaceuticals Ltd. pursuant to Section 906 of the Sarbanes-Oxley act of 2002
32.2##
Certification of Principal Financial and Accounting Officer of BiondVax Pharamaceuticals Ltd. pursuant to Section 906 of the Sarbanes-Oxley act of 2002
101.INS#
Inline
XBRL Instance Document.
101.SCH#
Inline
XBRL Taxonomy Extension Schema Linkbase Document.
101.CAL#
Inline
XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF#
Inline
XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB#
Inline
XBRL Taxonomy Extension Label Linkbase Document.
101.PRE#
Inline
XBRL Taxonomy Extension Presentation Linkbase Document.
104#
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
#
Filed
herewith.
##
In
accordance with SEC Release 33-8238, Exhibits 32.1 and 32.2 are being furnished and not deemed
filed for purposes of Section 18 of the Exchange Act.
**
Indicates
a management contract or compensatory plan or arrangement.
+
Certain
confidential portions of this exhibit have been redacted from the publicly filed document because such portions are (i) not material
and (ii) would be competitively harmful if publicly disclosed.
91
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
Date: April 17, 2023
BiondVax Pharmaceuticals Ltd.
By:
/s/ Amir Reichman
Amir Reichman
Chief Executive Officer
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacity and on the dates indicated.
Name
Capacity
Date
/s/ Amir Reichman
Chief Executive Officer and Director
April 17, 2023
Amir Reichman
(Principal Executive Officer)
/s/ Uri Ben-Or
Chief Financial Officer
April 17, 2023
Uri Ben-Or
(Principal Financial Officer and Principal Accounting Officer)
/s/ Mark Germain
Chairman of the Board of Directors
April 17, 2023
Mark Germain
/s/ Jay Green
Director
April 17, 2023
Jay Green
/s/ George H. Lowell
Director
April 17, 2023
George H. Lowell
/s/ Morris Laster
Director
April 17, 2023
Morris Laster
/s/ Yael Margolin
Director
April 17, 2023
Yael Margolin
/s/ Samuel Moed
Director
April 17, 2023
Samuel Moed
/s/ Adi Raviv
Director
April 17, 2023
Adi Raviv
/s/ Avner Rotman
Director
April 17, 2023
Avner Rotman
92
BIONDVAX
PHARMACEUTICALS LTD.
AUDITED
FINANCIAL STATEMENTS
December
31, 2022 and 2021
BIONDVAX
PHARMACEUTICALS LTD.
Index
to the Financial Statements
(Audited)
Page
Report of Independent Registered Public Accounting Firm PCAOB ID: 1281 F-2
Balance Sheets F-3 – F-4
Statements of Operations F-5
Statements of Comprehensive Loss F-6
Statements of Changes in Shareholders’ Equity F-7
Statements of Cash Flows F-8 – F-9
Notes to Financial Statements F-10 – F-29
-
- - - - - - - - - - - - -
F- 1
Kost
Forer Gabbay & Kasierer
144 Menachem Begin Road, Building A
Tel-Aviv 6492102, Israel
Tel:
+972-3-6232525
Fax: +972-3-5622555
ey.com
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Shareholders and the Board of Directors of
BIONDVAX
PHARMACEUTICALS LTD.
Opinion
on the Financial Statements
We have audited the accompanying balance sheets
of Biondvax Pharmaceuticals Ltd. (the Company) as of December 31, 2022 and 2021, the related statements of operations, comprehensive
loss, changes in shareholders’ equity and cash flows for each of the two years in the period ended December 31, 2022 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 December 31, 2022 and 2021, and the results of its operations
and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with U.S. generally accepted accounting
principles.
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 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 include examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits
provide a reasonable basis for our opinion.
Critical Audit Matters
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 account or disclosure to which it relates.
Liquidity and Capital Resources
Description of the Matter
As discussed in Note 1 to the financial statements,
the Company has incurred losses, and has not yet started recognizing revenues from sales. As of December 31, 2022, the Company's cash
position (cash and cash equivalents) totaled $14,075. In the year ended December 31, 2022, the Company had an operating loss of $5,796
and negative cash flows from operating activities of $7,265 million. The Company's operations are dependent on its existing working capital
resources and additional sources of capital and financing. This dependency will continue until the Company will be able to completely
finance its operations by generating revenue from its products and to raise funds (through public or private securities offerings, debt
financings, government funding or grants, or other sources) to support the ongoing advancement of its clinical trials and corporate activities.
Also, the Company’s board of directors approved a cost saving plan, to be implemented if and as required, to allow the Company to
continue its operations and meet its cash obligations. The Company and the board of directors believe that its existing financial resources
and its operating plans, including the effects of the costs saving plan, will be adequate to satisfy its expected liquidity requirements
for a period of at least twelve months from the end of the filing date.
Liquidity and Capital Resources are a critical audit
matter due to the subjective judgments and various assumptions required by management concerning the level and timing of cash receipts
and cash outlays for operating expenses and capital expenditures, including a cost saving plan and to conclude the Company would have
sufficient liquidity to sustain itself for at least a year beyond the date of the issuance of the financial statements. This in turn led
to a high degree of auditor subjectivity and judgment to evaluate the audit evidence supporting the liquidity conclusions. Additionally,
the relevance of management’s liquidity conclusions to the users of the financial statements also impacted our assessment of these
circumstances as a critical audit matter.
How We Addressed the Matter in Our Audit
Addressing the matter involved performing procedures
and evaluating audit evidence in connection with our overall opinion on the financial statements. Our audit procedures to evaluate the
significant judgments and assumptions made by management included, among others, inquiries with management, testing the reasonableness
of the forecasted operating expenses compared to historic amounts and the underlying management assumptions, including the assumptions
used for the saving plan, reconsidering certain prior management forecasted amounts to evaluate whether those forecasted amounts approximated
the ultimate actual results. This was performed in consideration of management’s ability to put forth reasonable estimates and evaluating
the adequacy of the Company’s disclosure of these circumstances in the financial statements. Additionally, these procedures included
evaluating the sufficiency of the company's liquidity disclosure included in the notes to the financial statements.
/s/ KOST FORER GABBAY & KASIERER
A Member of Ernst & Young Global
We have served as the Company’s auditor since 2005.
Tel-Aviv, Israel
April 17, 2023
F- 2
BIONDVAX PHARMACEUTICALS
LTD.
BALANCE
SHEETS
U.S.
dollars in thousands (except share and per share data)
December 31,
2022
2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 14,075
$ 17,374
Restricted cash
140
143
Prepaid expenses and other receivables
155
326
Total current assets
14,370
17,843
NON-CURRENT ASSETS:
Property, plant and equipment, net
11,245
12,386
Operating lease right-of-use assets
1,452
1,807
Total non-current assets
12,697
14,193
Total assets
$ 27,067
$ 32,036
The
accompanying notes are an integral part of the financial statements.
F- 3
BIONDVAX PHARMACEUTICALS LTD.
BALANCE
SHEETS
U.S.
dollars in thousands (except share and per share data)
December 31,
2022
2021
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$ 716
$ 999
Operating lease liabilities
382
375
Other payables
1,240
1,070
Total current liabilities
2,338
2,444
NON-CURRENT LIABILITIES:
Warrants liability
5,329
-
Loan from others
20,082
27,164
Non-current operating lease liabilities
1,078
1,446
Total non-current liabilities
26,489
28,610
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY (DEFICIT):
Ordinary shares of no par value: Authorized: 20,000,000,000 shares at December 31, 2022 and 1,800,000,000 at December 31, 2021; Issued and outstanding 989,290,784 shares at December 31, 2022 and 739,048,544 shares at December 31, 2021
-
-
Additional paid-in capital
116,082
113,076
Accumulated deficit
( 115,835 )
( 110,039 )
Accumulated other comprehensive loss
( 2,007 )
( 2,055 )
Total shareholders’ equity (deficit)
( 1,760 )
982
Total liabilities and shareholders’ equity
$ 27,067
$ 32,036
The
accompanying notes are an integral part of the financial statements.
F- 4
BIONDVAX PHARMACEUTICALS
LTD.
STATEMENTS
OF OPERATIONS
U.S.
dollars in thousands (except share and per share data)
Year
ended
December 31,
2022
2021
Research and development.
$ 5,765
$ 3,249
Marketing, general and administrative
5,296
7,625
Other income
-
( 12 )
Total operating loss
11,061
10,862
Financial income, net
( 5,265 )
( 2,656 )
Net loss
$ 5,796
$ 8,206
Net loss per share attributable to ordinary shareholders, basic and diluted
( 0.01 )
( 0.02 )
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted
754,076,407
564,575,967
The
accompanying notes are an integral part of the financial statements.
F- 5
BIONDVAX
PHARMACEUTICALS LTD.
STATEMENTS
OF COMPREHENSIVE LOSS
U.S.
dollars in thousands (except share and per share data)
Year
ended
December
31,
2022
2021
Net loss
$ 5,796
$ 8,206
Other comprehensive income:
Foreign currency translation adjustments
( 48 )
( 39 )
Total comprehensive loss
$ 5,748
$ 8,167
The
accompanying notes are an integral part of the financial statements.
F- 6
BIONDVAX
PHARMACEUTICALS LTD.
STATEMENTS
OF CHANGES IN SHAREHOLDERS’ EQUITY
U.S.
dollars in thousands (except share and per share data)
Ordinary shares
Additional
Accumulated
Total
Number
Amount
paid-in capital
comprehensive loss
Accumulated
deficit
shareholders’
equity
Balance as of December 31, 2020
461,285,824
$ -
$ 88,889
$ ( 2,094 )
$ ( 101,833 )
$ ( 15,038 )
Issuance of shares, net of issuance costs of $ 424
277,762,720
-
21,430
-
-
21,430
Share-based compensation
-
-
2,757
-
-
2,757
Other comprehensive income
-
-
-
39
-
39
Net loss
-
-
-
-
( 8,206 )
( 8,206 )
Balance as of December 31, 2021
739,048,544
-
113,076
( 2,055 )
( 110,039 )
982
Issuance of shares, net of issuance costs of $ 129
168,104,520
-
1,154
-
-
1,154
Exercise of warrants
75,060,000
-
250
-
-
250
Share-based compensation
7,077,720
1,602
-
-
1,602
Other comprehensive income
-
-
-
48
-
48
Net loss
-
-
-
-
( 5,796 )
( 5,796 )
Balance as of December 31, 2022
989,290,784
$ -
$ 116,082
$ ( 2,007 )
$ ( 115,835 )
$ ( 1,760 )
The
accompanying notes are an integral part of the financial statements.
F- 7
BIONDVAX
PHARMACEUTICALS LTD.
STATEMENTS
OF CASH FLOWS
U.S.
dollars in thousands (except share and per share data)
Year ended
December 31,
2022
2021
Cash flows from operating activities:
Net loss
$ ( 5,796 )
$ ( 8,206 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property, plant and equipment
562
471
Expense of in-process research and development
209
-
Financial income related to loan from others
( 4,113 )
( 3,152 )
Share-based compensation
1,602
2,757
Decrease in other receivables
140
59
Changes in operating lease right-of-use assets
153
148
Increase (decrease) in trade payables
( 175 )
3
Changes in operating lease liabilities
( 156 )
( 150 )
Increase in other payables
309
644
Net cash used in operating activities
( 7,265 )
( 7,426 )
Cash flows from investing activities:
Purchase of property, plant and equipment
( 836 )
( 139 )
Net cash used in investing activities
$ ( 836 )
$ ( 139 )
The
accompanying notes are an integral part of the financial statements.
F- 8
BIONDVAX
PHARMACEUTICALS LTD.
STATEMENTS
OF CASH FLOWS
U.S.
dollars in thousands (except share and per share data)
Year ended
December 31
2022
2021
Cash flows from financing activities:
Proceed from issuance of warrants
$ 5,844
$ -
Proceeds from issuance of shares, net
932
21,430
Net cash provided by financing activities
6,776
21,430
Effect of exchange rate changes on cash, cash equivalents and restricted cash
( 1,977 )
575
Increase (decrease) in cash, cash equivalents and restricted cash
( 3,302 )
14,440
Cash, cash equivalents and restricted cash at beginning of year
17,517
3,077
Cash, cash equivalents and restricted cash at end of year
$ 14,215
$ 17,517
Supplementary disclosure of cash flows activities:
(1) Cash paid during the year for:
Interest
$ 916
$ -
(2) Non-cash transactions:
Exercise of warrants liability to equity
$ 250
$ -
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents
$ 14,075
$ 17,374
Restricted cash
140
143
Cash, cash equivalents and restricted cash
$ 14,215
$ 17,517
The
accompanying notes are an integral part of the financial statements.
F- 9
BIONDVAX
PHARMACEUTICALS LTD.
NOTES
TO FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
1:- GENERAL
a. BIONDVAX
PHARMACEUTICALS LTD.(the “Company”), is focused on developing and ultimately
commercializing products for prevention and treatment of infectious diseases and related
illnesses. The Company was incorporated on July 21, 2003 in Israel, and started its activity
on March 31, 2005. The Company’s principal executive offices and main laboratory are
located at Jerusalem, Israel.
b. On December 22, 2021, the Company signed an exclusive, worldwide,
license agreement with the Max Planck Society (“MPG”), the parent organization of the Max Planck Institute for Multidisciplinary
Sciences, and the University Medical Center Göttingen (“UMG”), both in Germany, for the development and commercialization
of an innovative Covid-19 NanoAb therapy and an accompanying research collaboration agreement with MPG and UPG in support of the abovementioned development of a COVID-19 NanoAb. The agreements became effective January 1, 2022 and provide for an upfront payment, development and sales milestones and royalties based on sales and sharing of sublicense revenues.
c. On March 23, 2022, the Company executed an additional research
collaboration agreement (RCA) with MPG and UMG covering discovery, selection and characterization of NanoAbs for several other disease
indications with large and growing markets that leverage their unique and strong binding affinity, stability at high temperatures, and
potential for more effective and convenient routes of administration. These targets are the basis for validated and currently marketed
monoclonal antibodies, including for conditions such as psoriasis, asthma, macular degeneration, and psoriatic arthritis. According to
the contract, BiondVax will have an exclusive option for exclusive license agreement for the development and commercialization of each
of the NanoAbs covered by the agreement with MPG and UMG.
d. As of December 31, 2022, the Company's cash position (cash
and cash equivalents) totaled $ 14,075 . In the year ended December 31, 2022, the Company had an operating loss of $ 5,796 and negative
cash flows from operating activities of $ 7,265 million. The Company’s current operating budget includes various assumptions concerning
the level and timing of cash receipts and cash outlays for operating expenses and capital expenditures, including a cost saving plan.
The Company is planning to finance its operations from its existing working capital resources and additional sources of capital and financing.
However, there is no assurance that additional capital and/or financing will be available to the Company, and even if available, whether
it will be on terms acceptable to the Company or in amounts required. Accordingly, the Company’s board of directors approved a
cost saving plan, to be implemented if and as required, in whole or in part, at its discretion, to allow the Company to continue its
operations and meet its cash obligations. The cost saving plan consists of cutting expenditures by means of further efficiencies and
synergies, which include mainly the following steps: reduction in headcount and postponing or cancelling capital expenditures that would
not be required for the implementation of the revised business plan. Nevertheless, the Company and the board of directors believe that
its existing financial resources and its operating plans, including the effects of the costs saving plan, will be adequate to satisfy
its expected liquidity requirements for a period of at least twelve months from the end of the filing date.
F- 10
BIONDVAX
PHARMACEUTICALS LTD.
NOTES
TO FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES
a. Basis of presentation of the financial statements:
The
Company’s financial statements have been prepared in accordance with United States generally accepted accounting principles (U.S.
GAAP) as set forth in the Financial Accounting Standards Board (the FASB) Accounting Standards Codification (ASC).
Prior to 2022, the Company prepared
its financial statements in accordance with International Financial Reporting Standards (IFRS), as issued by the International Accounting
Standards Board (IASB), as permitted in the United States based on the Company’s qualification as a “foreign private issuer”
under the rules and regulations of the U.S Securities and Exchange Commission (the SEC). In connection with the loss of the Company's
status as a foreign private issuer effective on January 1, 2023, the Company, as a domestic filer, prepared its financial statements in
accordance with U.S. GAAP.
b. Use of estimates:
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that
affect the amounts reported in the financial statements and accompanying notes. The Company’s management believes that the estimates,
judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and
assumptions can affect the reported amounts of assets and liabilities at the dates of the financial statements, and the reported amount
of expenses during the reporting periods. Actual results could differ from those estimates.
c. Functional and reporting currency:
The functional currency is the currency
that best reflects the economic environment in which the Company operates and conducts their transactions. Most of the Company’s
costs are incurred in NIS. The Company’s management believes that the functional currency of the Company is the NIS.
Accordingly,
monetary accounts maintained in currencies other than the NIS are remeasured into NIS in accordance with ASC No. 830 “Foreign Currency
Matters”. All transaction gains and losses of the remeasured monetary balance sheet items are reflected in the statements of operations
as financing income or expenses as appropriate.
Due to the loss
of the Company's status as a foreign private issuer effective on January 1, 2023, the Company, as a domestic filer, changed its reporting
currency from NIS to U.S. dollar. The change in reporting currency was applied retrospectively. Financial statements for all periods presented
have been recast into U.S. dollars.
In applying the
change in reporting currency, all assets and liabilities of the Company’s operations were translated from their NIS functional
currency into U.S. dollars using the exchange rates in effect on the balance sheet date, and shareholders’ equity were translated
at the historical rates. Opening shareholders’ equity at August 1, 2018 has been translated at the historic rate on that date and
any other movements in shareholders’ equity during the period from August 1, 2018 to December 31, 2022 were translated using the
appropriate historical rates at the date of the respective transaction. All other revenues, expenses and cash flows were translated at
the average rates during the reporting periods presented. The resulting translation adjustments are reported under comprehensive income
as a separate component of shareholders’ equity.
F- 11
BIONDVAX
PHARMACEUTICALS LTD.
NOTES
TO FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
d. Comprehensive income:
The Company accounts for comprehensive
income in accordance with ASC 220, "Comprehensive Income". Comprehensive income generally represents all changes in shareholders'
equity during the period except those resulting from investments by, or distributions to, shareholders.
e. Cash equivalents:
Cash equivalents
are short-term highly liquid deposits that are readily convertible to cash with original maturities of three months or less, at the date
acquired.
f. Restricted cash:
Restricted cash are deposits with
original maturities of three months or less and are used as security for the Company’s credit cards. Restricted cash amounted to
$ 140 and $ 143 as of December 31, 2022 and 2021, respectively.
g. Property, plant and equipment:
Property, plant
and equipment are measured at cost, including directly attributable costs, less accumulated depreciation, accumulated impairment losses
and any related investment grants, excluding day-to-day servicing expenses.
Depreciation is
calculated on a straight-line basis over the useful life of the assets at annual rates as follows:
%
Laboratory equipment
10 - 15
Office, furniture and equipment
6 - 33
Computers and Cars
33
Leasehold improvements
(* )
Manufacturing plant in process
(** )
(*) Leasehold improvements are depreciated on a straight-line
basis over the shorter of the lease term or the expected life of the improvement.
(**) As of December 31, 2022, the manufacturing plant is under
validation process and therefore is not yet ready for production. Depreciation of the manufacturing plant will commence upon completion
of the validation process.
F- 12
BIONDVAX
PHARMACEUTICALS LTD.
NOTES
TO FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
2: - SIGNIFICANT ACCOUNTING POLICIES (Cont.)
h. Impairment of long-lived assets:
The Company’s
long-lived assets are reviewed for impairment in accordance with ASC No. 360 “Property, Plant and Equipment,” whenever events
or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If indicators of impairment exist and
the undiscounted future cash flows that the assets are expected to generate are less than the carrying value of the assets, the Company
reduces the carrying amount of the assets through an impairment charge, to their estimated fair values. During the years ended December
31, 2022 and 2021, no impairment indicators have been identified.
i. Government grants:
The Company received
royalty-bearing grants from the Israel Innovation Authority ("IIA") for approved research and development projects and, in return,
undertook to pay royalties amounting to 3 %- 5 % on the revenues derived from sales of products or services developed in whole or in part
using these grants. These grants are recognized at the time the Company is entitled to such grants on the basis of the costs incurred
as provided by the relevant agreement and included as a deduction from research and development expenses. The Company recognized the amounts
of grants received in research and development as a reduction from research and development expenses. For the years ended December 31,
2022 and 2021, no funds were received from the IIA
j. Research and development expenses:
Research and development expenses
net of grants , are recognized in the statements of operations when incurred. Research and development
expenses consist of personnel costs (including salaries, benefits and share-based compensation), materials, consulting fees and payments
to subcontractors, costs associated with obtaining regulatory approvals, and executing pre-clinical and clinical studies. In addition,
research and development expenses include overhead allocations consisting of various administrative and facilities related costs. The
Company charges research and development expenses as incurred.
k. Acquired In-Process Research and Development:
In an asset acquisition, the initial costs of rights to in-process
research and development projects acquired are expensed as R&D in the statements of operations, unless the in-process research and
development has an alternative future use. In a business combination, the fair value of in-process research and development is capitalized
as an indefinite-lived intangible asset, regardless of whether the in-process research and development asset has an alternative future
use.
F- 13
BIONDVAX
PHARMACEUTICALS LTD.
NOTES
TO FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
2: - SIGNIFICANT ACCOUNTING POLICIES (Cont.)
In accordance
with the agreement with MPG disclosed in note 1b, the Company issued 150,000 ADSs at no cost to MPG as an upfront payment for the license.
The ADSs are restricted for a period of three years. The Company evaluated the fair value of the license at $ 209 . The fair value was calculated
by an independent valuation, at a discount rate of 31 % based on the following assumptions:
Stock price
1.48
variance
150 %
Risk free interest
1 %
The fair value
of the license in the amount of $ 209 was recorded as expense in the statement of operating income for the year ended 2022.
l. Share-based compensation:
The Company accounts
for share-based compensation in accordance with ASC No. 718, “Compensation - Stock Compensation”, which requires companies
to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The value of the award is
recognized as an expense over the requisite service periods, which is the vesting period of the respective award, on a straight-line basis
when the only condition to vesting is continued service.
The Company has
selected the binominal option-pricing model as the most appropriate fair value method for its option awards. The Binomial model takes
into account variables such as volatility, dividend yield rate, and risk-free interest rate and also allows for the use of dynamic assumptions
and considers the contractual term of the option, and the probability that the option will be exercised prior to the end of its contractual
life. The fair value of restricted shares is based on the closing market value of the underlying shares at the date of grant. The Company
estimates the forfeitures at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those
estimates. Estimated forfeitures are based on actual historical pre-vesting forfeitures.
Stock-based compensation
cost is measured at the grant date, based on the fair value of the award. The Company recognizes compensation expense for the value of
its awards, which have graded vesting, on a straight-line basis when the only condition to vesting is continued service.
F- 14
BIONDVAX
PHARMACEUTICALS LTD.
NOTES
TO FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
2: - SIGNIFICANT ACCOUNTING POLICIES (Cont.)
m. Severance pay and retirement plans:
The
majority of the Company’s employees who are Israeli citizens have subscribed to Section 14 of Israel’s Severance Pay
Law, 5723-1963 (the “Severance Pay Law”). Pursuant to Section 14 of the Severance Pay Law, employees covered by this
section are entitled to monthly deposits at a rate of 8.33 % of their monthly salary, made on their behalf by the Company. Payments made
to employees in accordance with this section release the Company from any future severance liabilities with respect to such employees.
Neither severance pay liability nor severance pay fund under Section 14 of the Severance Pay Law is recorded on the Company’s balance
sheets.
Severance
expense for the years ended December 31, 2022 and 2021, amounted to $ 288 and $ 177 , respectively.
n. Fair value of financial instruments:
The
accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value, and expands
disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer
a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes
a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:
Level 1: Quoted prices (unadjusted)
in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority
to Level 1 inputs.
Level 2: Observable inputs that are
based on inputs not quoted on active markets but corroborated by market data.
Level 3: Unobservable inputs are used
when little or no market data are available.
The carrying amounts of cash and cash
equivalents, restricted cash, prepaid expenses and other receivables, trade payables and other current payables approximate their fair
value due to the short-term maturity of such instruments.
F- 15
BIONDVAX
PHARMACEUTICALS LTD.
NOTES
TO FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
2: - SIGNIFICANT ACCOUNTING POLICIES (Cont.)
o. Leases:
The Company accounts for leases according
to ASC 842, “Leases”. The Company determines if an arrangement is a lease and the classification of that lease at inception.
The Company elected the practical expedient for lease agreements with a term of twelve months or less and does not recognize right-of-use
(“ROU”) assets and lease liabilities in respect of those agreements. The Company also elected the practical expedient to not
separate lease and non-lease components for its leases.
An ROU asset represents the right
to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising
from the lease agreement. An ROU asset is measured based on the discounted present value of the remaining lease payments, plus any initial
direct costs incurred and prepaid lease payments, excluding lease incentives. The lease liability is measured at lease commencement date
based on the discounted present value of the remaining lease payments. The implicit rate within the operating leases is generally not
determinable, therefore the Company uses the Incremental Borrowing Rate (“IBR”) based on the information available at commencement
date in determining the present value of lease payments. The Company’s IBR is estimated to approximate the interest rate for collateralized
borrowing with similar terms and payments and in economic environments where the leased asset is located. Certain leases include options
to extend the lease. An option to extend the lease is considered in connection with determining the ROU asset and lease liability when
it is reasonably certain that the Company will exercise that option. An option to terminate is considered unless it is reasonably certain
that the Company will not exercise the option.
Payments under the Company’s
lease arrangements are primarily fixed however, certain lease agreements contain variable payments, which are expensed as incurred and
not included in the operating lease right-of-use assets and liabilities.
p. Contingencies:
The Company is currently involved
in various commitment and contingent liabilities. The Company reviews the status of each matter and assesses its potential financial exposure.
If the potential loss from any claim or legal proceeding is considered probable and the amount can be reasonably estimated, the Company
accrues a liability for the estimated loss (see Note 8).
F- 16
BIONDVAX
PHARMACEUTICALS LTD.
NOTES
TO FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
q. Income taxes:
The Company accounts for income taxes
in accordance with ASC 740, “Income Taxes”, which prescribes the use of the liability method whereby deferred tax asset
and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities
and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company
provides a valuation allowance, to reduce deferred tax assets to their estimated realizable value, if needed.
ASC 740 offers
a two-step approach for recognizing and measuring a liability for uncertain tax positions. The first step is to evaluate the
tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more
likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any
related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than 50 % likely
to be realized upon ultimate settlement. As of December 31, 2022, and 2021 no liability for unrecognized tax benefits was recorded as
a result of ASC 740.
r. Basic and diluted net loss per share:
The Company’s basic net loss
per share is calculated by dividing net loss attributable to ordinary shareholders by the weighted-average number of shares of ordinary
shares outstanding for the period, without consideration of potentially dilutive securities. Diluted net loss per share is the same as
basic net loss per share in periods when the effects of potentially dilutive ordinary shares are anti-dilutive.
s. Warrants:
The
Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s
specific terms and applicable authoritative guidance. The assessment considers whether the warrants are freestanding financial instruments,
meet the definition of a liability under ASC 480, and meet all of the requirements for equity classification, including whether the warrants
are indexed to the Company’s own common stock. Warrants that determined to be classified as equity, are recorded as a component
of additional paid-in capital. Warrants that determined to be classified as liabilities are recorded at their initial fair value on the
date of issuance and remeasured to fair value at each balance sheet date thereafter. Changes in the estimated fair value of the warrants
are recognized in Financial expenses, net in the statements of operations.
F- 17
BIONDVAX
PHARMACEUTICALS LTD.
NOTES
TO FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
2:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)
t. Recently adopted accounting pronouncements:
In November 2021, the FASB issued
ASU 2021-10, “Government Assistance (Topic 832): Disclosure by Business Entities about Government Assistance.” The new standard
improves the transparency of government assistance received by most business entities by requiring the disclosure of: (1) the types of
government assistance received; (2) the accounting for such assistance; and (3) the effect of the assistance on a business entity's financial
statements. This guidance is effective for financial statements issued for annual periods beginning after December 15, 2021. The adoption
of this ASU did not have a significant impact on the Company’s financial statements and disclosures.
u. Recently issued accounting pronouncements, not yet adopted:
In June 2016,
the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments
(“ASU 2016-13”). ASU 2016-13 requires the measurement of all expected credit losses for financial assets held at the reporting
date based on historical experience, current conditions, and reasonable and supportable forecasts. ASU 2016-13 requires enhanced qualitative
and quantitative disclosures to help investors and other financial statement users better understand significant estimates and judgments
used in estimating credit losses, as well as the credit quality and underwriting standards of an organization’s portfolio. ASU 2016-13
is effective for fiscal years beginning after December 15, 2022, and interim periods within those fiscal years. The Company has evaluated
that the adoption of this ASU will not have a significant impact on the Company’s financial statements and disclosures.
NOTE 3:-
PREPAID EXPENSES AND OTHER RECEIVABLES
December 31,
2022
2021
Government authorities
$ 110
$ 98
Prepaid expenses and other
45
228
$ 155
$ 326
F- 18
BIONDVAX
PHARMACEUTICALS LTD.
NOTES
TO FINANCIAL STATEMENTS
U.S.
dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE 4:-
FAIR VALUE MEASUREMENTS
In accordance with ASC No. 820,
the Company measures warrants liability at fair value classified within Level 2 as the valuation inputs are based on quoted prices and
market observable data of similar instruments
The following table
presents assets measured at fair value on a recurring basis as of December 31, 2022 and 2021:
December 31,
2022
2021
Fair value measurement using
input Level 2
Non-current liabilities:
Warrants liability
$ 5,329
$ -
Total liabilities
$ 5,329
$ -
NOTE
5:- PROPERTY, PLANT AND EQUIPMENT, NET
The composition
of property, plant and equipment is as follows:
December 31,
2022
2021
Cost:
Laboratory equipment
$ 1,588
$ 887
Computers and Cars
289
294
Office, furniture and equipment
43
45
Leasehold improvements
3,915
4,430
Manufacturing plant in process
7,831
8,861
13,666
14,517
Less - accumulated depreciation
( 2,421 )
( 2,131 )
Property and equipment, net
$ 11,245
$ 12,386
Depreciation expenses amounted to $ 562 and $ 471 for the years ended
December 31, 2022 and 2021, respectively.
F- 19
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
6:- LEASES
The Company has several operating lease agreements that include leases
of offices and cars that are used to maintain the Company’s ongoing operation. The leases of the offices and cars are for
a period of 10 and 3 years, respectively. Some of these lease agreements include extension options. The Company does not include
in the lease term the exercise of extension options unless it is reasonably certain at lease commencement that the extension options
will be exercised.
Supplemental
balance sheet information related to operating leases is as follows:
Year ended
December 31,
2022
2021
Office
Weighted average remaining lease term (in years)
5
6
Weighted average discount rate
8 %
8 %
Cars
Weighted average remaining lease term (in years)
1.7
2
Weighted average discount rate
18 %- 23 %
18 %
Minimum
lease payments for the Company’s right of use assets over the remaining lease periods as of December 31, 2022, are as follows:
Office
Cars
2023
$ 322
$ 74
2024
322
44
2025
322
12
2026
322
-
Thereafter
322
-
Total undiscounted lease payments
1,610
130
Less - adjustment to discounted lease payments
( 260 )
( 20 )
Present value of lease liabilities
$ 1,350
$ 110
NOTE
7:- OTHER PAYABLES
December 31,
2022
2021
Employees and payroll accruals
$ 484
$ 709
Accrued expenses
756
361
$ 1,240
$ 1,070
F- 20
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
8:- CONTINGENT LIABILITIES AND COMMITMENTS
Since 2006, the Company received approximately
$ 5,830 in grants from the Israeli Innovation Authority (IIA), formerly known as the Office of the Chief Scientist. The grants were for
research and development of M-001.
In return to those grants, the Company
undertook to pay royalties amounting to 3 %- 5 % on the revenues derived from sales of products or services developed in whole or in part
using these grants. The maximum aggregate royalties paid generally cannot exceed 100 % of the grants received by the Company, plus annual
interest generally equal to the 12-month LIBOR applicable to dollar deposits, as published on the first business day of each calendar
year. The maximum royalty amounts payable by the Company as of December 31, 2022 is approximately $ 5,830 which represents the
total gross amount of grants actually received by the Company from the IIA including accrued interest. As of December 31, 2022, the
Company had not paid any royalties to the IIA.
In light of the Phase 3 clinical trial
results (see also Note 9.c below), the Company does not currently expect any future revenues from M-001 and therefore do not currently
expect to make any royalty payments to the IIA and the Company does not record a liability for amounts received from IIA until the related
revenues are recognized. In the event of failure of a project that was partly financed by the IIA, the Company will not be obligated
to pay any royalties or repay the amounts received.
The Company also subject to various other restrictions pursuant to
the grant, including limitations on transferring IP developed with grant funds. In light of the Company’s new strategy, it does
not expect these restrictions to be material to its ongoing operations.
NOTE
9:- LOAN FROM OTHERS.
a. On June 19, 2017, the Company entered into a Finance Contract with the European Investment bank (EIB)
for a total amount of approximately $22,422 (€ 20,000 ) and up to 50% of the Company's expected cost of developing and marketing
the Company’s product candidate, M-001. In addition, as a repayment features, EIB was entitled to receive the higher between 3%
of any M-001 sales revenues for a period of ten years, or realizing a cash-on-cash multiple of 2.8 times
During 2018, the Company received
approximately $ 23,599 (€ 20,000 ) in two tranches of approximately $ 7,080 (€ 6,000 ) and the third tranche of approximately
$ 9,439 (€ 8,000 ).
On October 7, 2019, the Company received the remaining approximately $ 4,390 (€ 4,000 ).
In the event the Company elects to
prepay the EIB financing, or in the event the EIB shall demand prepayment following certain events, including a change of control, senior
management changes or merger events, the Company shall be required to pay EIB the principal amount of the tranches already paid, or the
Prepayment Amount, plus the greater of:
(i) the amount, as determined by EIB required in order for the EIB to realize an internal rate of return on
the relevant amount prepaid of 20 %; and
(ii) the Prepayment Amount.
The Finance Contract also stipulates
that in the event the EIB demands prepayment of the loan due to any prepayment event to non-EIB lenders, the Company shall be obligated
to pay the Prepayment Amount plus an additional reduced amount. In addition, and as consideration for the EIB financing, the EIB shall
be entitled to 3 % of any annual M-001 sales revenues.
F- 21
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
9:- LOAN FROM OTHERS (Cont.)
b. On April 22, 2019, the Committee of EIB Bank agreed to expand the 2017 financing agreement to the Company
by an additional approximately $4,502 (€ 4,000) to a total of approximately $27,013 (€ 4,000). An amendment to that effect was
signed in June 2019 (the "Amendment"). Those funds were received in October 2019 and will be used in support of the ongoing
pivotal, clinical efficacy, Phase 3 trial of BiondVax’s M-001 Universal Flu Vaccine candidate in Europe.
According to the Amendment, as repayment features, EIB is entitled
to receive the higher between 3% of any M-001 sales revenues for a period of twelve years or realizing a cash-on-cash multiple of 2.8
times
c. On October 23, 2020, the Company announced Phase 3 clinical trial results of the M-001 universal vaccine
product. The results did not demonstrate a statistically significant difference between the vaccinated group and the placebo group in
reduction of flu illness and severity. Therefore, the study failed to meet both the primary and secondary efficacy endpoints. However,
the study’s primary safety endpoint was met.
As a result of the Phase 3 clinical
trial failure, Company's management estimates that there will be no future revenues from the M-001 product. Therefore, most likely, there
will be no future royalty payments to EIB.
Under the Finance Contract, the EIB
may accelerate all loans extended thereunder if an event of default has occurred, which includes, amongst other things, an event of default
arising from the occurrence of a material adverse change, defined as any event or change of condition, which in the opinion of the EIB,
has a material adverse effect on: our ability to perform our obligations under the Finance Documents; our business, operations, property,
condition (financial or otherwise) or prospects; or the rights or remedies of the EIB under the Finance Contract, amongst other things.
If the EIB determines that an event of default has occurred, it could accelerate the amounts outstanding under the Finance Contract, making
those amounts immediately due and payable.
In accordance with the EIB loan agreement,
and due to the above, the Company was required to pay EIB the principal amount of the tranches already loaned by the EIB to the Company,
within five years of the date of each tranche of the loan. On December 31, 2020, the Company re-evaluated the loan in the sum of $ 29,443 .
As a result, the Company recorded an amount of $ 6,162 as revaluation income of the EIB loan.
F- 22
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE 9:- LOAN FROM
OTHERS (Cont.)
On January 26, 2021, the EIB notified the Company that they welcome the Company’s efforts
to secure future equity financing in an amount not less than $ 2,000 in order to enable the Company to pursue new business opportunities,
strengthen the Company balance sheet and invest in growth. Thus, within that context, the EIB wrote in their letter that they will not
consider the failure of the Company’s pivotal phase 3 trial for M-001 to meet the primary and secondary efficacy endpoints as a
trigger for prepayment of a loan extended under the Finance Contract. However, EIB cautioned the Company that their letter is not a consent,
agreement, amendment or waiver in respect of the terms of the Finance Contract, reserving any other right or remedy the EIB may have now
or subsequently.
d. On August 9, 2022, the Company signed a loan restructuring agreement with the European Investment Bank
(EIB) for the new terms of its outstanding approximately $ 24,554 (€ 24,000 ) loan to the Company. The new terms include:
1. An extension of the maturity dates from 2023 (approximately $20,462) and 2024 (approximately $4,092) until
December 31, 2027.
2. Interest on the Loan will begin to accrue starting January 1, 2022, at an annual rate of 7%. The interest
payments will be deferred until the new maturity date and will be added to the principal balance at the end of each year during the loan
period.
3. An amount of $ 900 (approximately € 880) were paid by BiondVax on August 15, 2022, shortly after
the execution of the relevant amendment letter with the EIB and was applied to reduce the outstanding loan. Going forward 10% of any capital
raises until maturity will be used to further repay the Loan principal including any outstanding accrued interest.
4. If the Company sales exceed approximately $5,332 (€ 5,000), 3% of the revenues will be paid to the
EIB as royalties until the EIB receives (from the Loan repayment, inter alia the interest and the royalties) the higher of (i) a total
of 2.8 times the original approximately $25,596 (€ 24,000) principal (as provided in the original Loan agreement) and (ii) 20% IRR
on the principal.
5. In case the Company decides to discharge all liabilities under the finance contract, inter alia payments
of the variable remuneration, the Company would need to repay to the EIB an indemnity amount in addition to the Loan principal and the
accrued interest. The indemnity amount will be calculated such that the EIB receives an additional payment equal to the greater of (i)
the prepayment amount (i.e. twice the prepayment amount in the aggregate) and (ii) the amount required to realize 20% IRR on the prepayment
amount at the time of prepayment.
F- 23
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE 9:- LOAN FROM
OTHERS (Cont.)
The Company recorded the cash received
in each tranche and a corresponding liability to repay the cash. The Company evaluates the estimated cash flows from the EIB loan at each
reporting period. When the estimated cash flows change from the estimates used as of the date on which the EIB loan was issued, the EIB
loan's carrying amount is adjusted to an amount equal to the present value of the estimated remaining future payments, discounted by using
the original effective interest rate. The adjustment to the carrying amount is recognized in earnings as an adjustment to interest expenses,
in the period in which the change in estimate occurred.
As a result of the loan restructure,
the Company recorded an amount of $ 7,168 under finance income. Interest expense related to the EIB loan were to $ 87
As of December 31, 2022, the outstanding principal amount related to
the EIB loan in nominal terms is $ 25,596 .
NOTE
10:- SHAREHOLDERS’ EQUITY
a. Rights
attached to shares:
An
Ordinary share confers upon its holder(s) a right to vote at the general meeting, a right to participate in distribution of dividends,
and a right to participate in the distribution of surplus assets upon liquidation of the Company.
b. On
February 2, 2021, the Company closed an underwritten offering in which it sold 2,434,783 ADSs at a public offering price of $ 4.95 per
ADS. On February 10, 2021, Aegis Capital Corp., the sole bookrunning manager for the underwritten offering, fully exercised its over-allotment
option to purchase an additional 365,217 ADSs, bringing total gross proceeds to the Company from the offering including exercise of the
over-allotment option of approximately $ 13,800 . The Company received a net amount of $ 12,480 after deduction of issuance expenses of $ 360 .
c. An
amendment to the Company’s Articles of Association increasing the registered share capital of the Company by an additional 1,100,000,000
Ordinary Shares (the equivalent of 27,500,000 ADSs) such that the total registered share capital of the Company would consist of 1,800,000,000
Ordinary Shares, no par value (the equivalent of 45,000,000 ADSs).
d. On December 27, 2021, the Company closed an underwritten offering in which it sold 3,813,560 ADSs at a public offering price of $ 2.36 per ADS. On December 27, 2021, Aegis Capital Corp., the sole bookrunning manager for the underwritten offering, fully exercised its over-allotment option to purchase an additional 330, 508 ADSs, bringing total gross proceeds to the Company from the offering including exercise of the over-allotment option of approximately $ 9,780 . The Company received a net sum of $ 8,956 (after deduction of issuance expenses of $ 63 .
e. On
November 10, 2022, the Company announced that it plans to affect a ratio change of the Company’s American Depositary Shares (ADSs)
to its non-traded ordinary shares from the current ratio of one (1) ADS representing forty (40) ordinary shares to a new ratio of one
(1) ADS representing four hundred (400) ordinary shares. The ratio change will have the same effect as a reverse split of the existing
ADSs of one (1) new ADS for every ten (10) old ADSs. The effective date for the ratio change was November 25, 2022.
F- 24
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
10:- SHAREHOLDERS’ EQUITY (Cont.)
f. On
December 13 2022, an amendment to the Company’s Articles of Association increasing the registered share capital of the Company by an
additional 18,200,000,000 Ordinary Shares (the equivalent of 45,500,000 ADSs) such that the total registered share capital of the Company
would consist of 20,000,000,000 Ordinary Shares, no par value (the equivalent of 50,000,000 ADSs).
g. On December 20, 2022, the Company closed an underwritten public offering with gross proceeds to the Company of $ 8,000,000 , before deducting
underwriting discounts and other expenses payable by the Company. The offering consisted of 1,600,000 units and pre-funded units. Each
unit consisted of one American Depositary Share (“ADS”) and two warrants, each to purchase one ADS, and each pre-funded unit
consists of one pre-funded warrant to purchase one ADS and two warrants each to purchase one ADS. One of the warrants will expire three
years from the date of issuance, and the other warrant will expire one year from the date of issuance and may be exercised for half an
ADS on or prior to six (6) months following the original issuance for no additional consideration. Each ADS (or pre-funded warrant) was
sold together with two warrants at a combined purchase price of $ 5.00 per unit (or $ 4.99 per pre-funded unit after reducing $ 0.01 attributable
to the exercise price of the pre-funded warrants). Each ADS represents 400 of our ordinary shares, no par value per share. The Company
received a net sum of $ 7,231 after deduction of underwriter discount and issuance expenses of $ 769 . The warrants were classified as liabilities,
initially and subsequently measured at fair value through earnings pursuant to ASC 480 as the warrants are not considered indexed to the
Company's own shares.
NOTE
11:- SHARE-BASED COMPENSATION
a. Option
plans:
Options
granted under the Company’s 2005 Israeli Share Option Plan (“Plan”) were exercisable in accordance with the terms of the Plan,
within 10 years from the date of grant, against payment of an exercise price. The options generally vest over a period of three
or four years.
In
March 2018, the Company’s Board of Directors approved the adoption of the Company’s 2018 Israeli Share Option Plan (“2018 Plan”)
for the grant of options and restricted shares (“RSU”) to employees, directors and service providers. The options are exercisable
within 10 years from the date of grant, against payment of the exercise price, in accordance with the terms of the 2018 Plan. The options
generally vest over a period of three or four years.
Option
grants:
Expected
volatility was calculated based upon the Company’s historical share price and historical volatilities of similar entities in
the related sector index. The expected term of the options granted is derived from output of the option valuation model and
represents the period of time that options granted are expected to be outstanding. The risk-free interest rate is based on
the yield from U.S. treasury bonds with an equivalent term. The Company has historically not paid dividends and has no foreseeable
plans to pay dividends.
F- 25
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
11:- SHARE-BASED COMPENSATION (Cont.)
The
following table lists the inputs to the binomial option-pricing model used for the fair value measurement of equity-settled share options
for the above Options Plans for the years 2022 and 2021:
December 31,
2022
2021
Dividend yield
0 %
0 %
Expected volatility of the share prices
84 %
110 %
Risk-free interest rate
2.1 %
1.7 %
Expected term (in years)
10
10
Based
on the above inputs, the fair value of the ADS options was determined to be $ 0.157 , $ 0.281 and $ 0.384 per 3ADS option at the grant date.
b. The
following table summarizes the number of options granted to employees under the Option Plans for the year ended December 31, 2022 and
related information:
Number of options
Weighted
average
exercise
price
Weighted average remaining contractual term
(in years)
Aggregate
intrinsic value
Balance as of December 31, 2021
28,889,600
$ 1.57
16.3
$ 85
Granted
1,000,000
0.29
9
( *
Expired
( 970,000 )
0.01
5.69
( *
Balance as of December 31, 2022
28,919,600
0.8
7.07
12
Exercisable as of December 31, 2022
21,084,680
$ 0.8
6.9
$ 5
As
of December 31, 2022, there are $ 890 of total unrecognized costs related to share-based compensation that is expected to be recognized
over a period of up to four years .
*) Less than 1 thousand USD
F- 26
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
11:- SHARE-BASED COMPENSATION (Cont.)
c. The
following table summarizes information about the Company’s outstanding and exercisable options granted to employees as of December 31,
2022:
Exercise price
Options outstanding as of
December 31, 2022
Weighted average remaining
contractual
term
( years)
Options exercisable as of December 31,
2022
Weighted average remaining
contractual term
(years)
$ 0.007 – 0.452
28,919,600
7.07
21,084,680
6.9
28,919,600
21,084,680
d. A
summary of restricted shares activity for the year ended December 31, 2022 is as follows:
Number of restricted shares
Weighted average grant date fair value
Balance as of December 31, 2021
$ 60,490
3.92
Granted
49,357
9.92
Vested
( 278 )
9.76
Forfeited
( 1,801 )
13.7
Balance as of December 31, 2022
107,768
6.49
e. The
total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the years ended December 31,
2022 and 2021 is comprised as follows:
Year ended
December 31,
2022
2021
Research and development expenses
$ 100
$ 323
Marketing, general and administrative expenses
1,502
2,434
Total share-based compensation
$ 1,602
$ 2,757
F- 27
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
12:- TAXES ON INCOME
a. Corporate
tax rates
Taxable
income of the Israeli parent is subject to the Israeli corporate tax at the rate of 23 % in 2022 and 2021.
b. Net
operating losses carryforward:
The Company has
net operating losses for tax purposes as of December 31, 2022 totaling approximately $ 95,734 , respectively, which may be carried
forward and offset against taxable income in the future for an indefinite period.
c. Final tax assessments:
The Company’s
tax assessments through the 2016 tax year are considered final.
d. Deferred taxes:
Deferred income
taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting
purposes and the amounts used for income tax purposes.
Significant
components of the Company’s deferred tax assets and liabilities are as follows:
Year ended
December 31,
2022
2021
Deferred tax assets:
Net operating loss carry forward
$ 21,683
$ 19,571
Temporary differences mainly relating to Research and Development
336
840
Lease liabilities
336
419
Deferred tax asset before valuation allowance
22,355
20,830
Deferred tax liabilities:
Right-of-use assets
( 334 )
( 416 )
Deferred tax liabilities before valuation allowance
( 334 )
( 416 )
Valuation allowance
( 22,021 )
( 20,414 )
Deferred tax asset, net
$ -
$ -
e. Reconciliation of the theoretical tax expense to the actual
tax expense:
F- 28
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data and unless otherwise indicated)
NOTE
12:- TAXES ON INCOME (Cont.)
The main reconciling
item between the statutory tax rate of the Company and the effective tax rate is the recognition of valuation allowance in respect of
deferred taxes relating to accumulated net operating losses carried forward due to the uncertainty of the realization of such deferred
taxes.
NOTE
13:- BASIC AND DILUTED NET LOSS PER SHARE
a. Basic net loss per ordinary share is computed by dividing
net loss for each reporting period by the weighted-average number of ordinary shares outstanding during each year. Diluted net loss per
ordinary share is computed by dividing net loss for each reporting period by the weighted average number of ordinary shares outstanding
during the period, plus dilutive potential ordinary shares considered outstanding during the period, in accordance with ASC No. 260-10
“Earnings Per Share”. The Company experienced a loss in the year ended December 31, 2022; hence all potentially dilutive
ordinary shares were excluded due to their anti-dilutive effect.
Details
of the number of shares and loss used in the computation of net loss per share:
Year ended December 31,
2022
2021
Weighted number of shares
Net loss attributable to equity holders of the Company
Weighted number of shares
Net loss attributable to equity holders of the Company
For the computation of basic and diluted loss
754,076,407
5,796
564,575,967
8,206
b. The following items have been excluded from the diluted weighted
average number of shares outstanding because they are anti – diluted:
Year ended
December 31,
2022
2021
Share Options
28,919,600
28,889,600
Restricted share units
43,107,200
24,196,000
warrants
292,940,000
-
NOTE
14:- FINANCIAL INCOME, NET
Year ended
December 31,
2022
2021
Income:
Exchange differences, net
$ 1,524
$ -
Remeasurement of warrants liabilities
711
-
Finance income in respect of loans from others
8,130
3,152
10,365
3,152
Expenses:
Exchange differences, net
-
487
Finance expenses in respect of loans from others
4,886
-
Bank commissions and other financial expenses
21
9
5,100
496
Total financial income, net
$ 5,265
$ 2,656
NOTE 15
- SUBSEQUENT EVENTS
a. On February, 2023, $ 725 thousand was paid to the EIB as part of the loan restructure agreement.
b. On March 8, 2023, the board of directors approved the grant of an aggregate of 203,732 RSUs, each vesting
in three years, to officers and employees of the company. The grant of 78,125 RSUs to our chief executive officer is subject to
shareholder approval.
F-29