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Vascular Biogenics Ltd.

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FY2022 Annual Report · Vascular Biogenics Ltd.
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
 
 
 
Form
10-K
 
 
 
(Mark One)
 
☒
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For
the fiscal year ended December 31, 2022
or
 
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For
the transition period from _____ to ____.
 
Commission
file number 001-36581
 
 
 
Vascular
Biogenics Ltd.
(Exact
name of registrant as specified in its charter)
 
 
 
Israel
 
Not
applicable
(State
or other jurisdiction of
incorporation
or organization)
 
(I.R.S.
Employer
Identification
No.)
 
 
 
8
HaSatat St.
Modi’in,
Israel
 
7178106
(Address
of principal executive offices)
 
(Zip
Code)
 
Registrant’s
telephone number, including area code +972-8-9935000
 
Securities
registered pursuant to Section 12(b) of the Act:
 
Title
of each class
 
Trading
Symbol(s)
 
Name
of each exchange on which registered
Ordinary
Shares, par value NIS 0.01 per share
 
VBLT
 
The Nasdaq
Capital Market
 
Securities
registered pursuant to Section 12(b) of the Act: None
 
 
 
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
 
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
 
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
 
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of
this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
 
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See
the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
 
Large
accelerated filer
☐ 
Accelerated
filer
☐
Non-accelerated
filer
☒ 
Smaller
reporting company
☒
 
 
 
Emerging
growth company
☐
 
If
 an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
 with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting
under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
 
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of
an error to previously issued financial statements. ☐
 
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s
executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
 
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
 
 
 
As
of June 30, 2022, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market
value of the registrant’s ordinary shares held by non-
affiliates of the registrant, based on the closing price of the ordinary
shares on the Nasdaq Global Market was approximately $93.8 million.
 
The
number of registrant’s ordinary shares outstanding as of March 13, 2023 was 69,750,117.
 
 
 

 

 
 
TABLE
OF CONTENTS
 
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
1
SUMMARY OF RISK FACTORS
2
PART I
 
3
Item
1.
Business
3
Item
1A.
Risk Factors
22
Item
1B.
Unresolved Staff Comments
50
Item
2.
Properties
50
Item
3.
Legal Proceedings
50
Item
4.
Mine Safety Disclosures
50
PART II
 
51
Item
5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
51
Item
6.
[Reserved]
51
Item
7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
52
Item
7A.
Quantitative and Qualitative Disclosures About Market Risk
58
Item
8.
Financial Statements and Supplementary Data
59
Item
9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
59
Item
9A.
Controls and Procedures
59
Item
9B.
Other Information
59
Item
9C.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
59
PART III
 
60
Item
10.
Directors, Executive Officers and Corporate Governance
60
Item
11.
Executive Compensation
63
Item
12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
68
Item
13.
Certain Relationships and Related Transactions, and Director Independence
70
Item
14.
Principal Accounting Fees and Services
73
PART IV
 
74
Item
15.
Exhibits and Financial Statement Schedules
74
Item
16.
Form 10-K Summary
74
SIGNATURES
75
 
i

 
 
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
 
This
Annual Report contains forward-looking statements that relate to future events or our future financial performance, which express the
current beliefs and expectations of our
management. Such statements involve a number of known and unknown risks, uncertainties and other
factors that could cause our actual future results, performance or achievements
to differ materially from any future results, performance
or achievements expressed or implied by such forward-looking statements. Forward-looking statements include all statements
that are not
historical facts and can be identified by words such as, but not limited to, “believe,” “expect,” “anticipate,”
“estimate,” “intend,” “plan,” “targets,” “likely,” “will,”
“would,”
“could,” and similar expressions or phrases. We have based these forward-looking statements largely on our management’s
current expectations and future events and
financial trends that we believe may affect our financial condition, results of operations,
business strategy and financial needs. Forward-looking statements include, but are not limited
to, express or implied statements about:
 
 
●
the
completion of the proposed merger, or the Merger, with Notable Labs, Inc. or Notable;
 
●
implementation
of our organizational streamlining and workforce reduction and anticipated savings therefrom;
 
●
our
cash runway;
 
●
exploration of additional strategic transactions to further maximize shareholder
value, including benefits from the sale of our rights to lease the Modi’in manufacturing facility
and certain related assets;
 
●
receipt of additional grant funding from the European Innovation Council,
or EIC, accelerator program;
 
●
effects
of discontinuation of the OVAL trial and ofra-vec program in all indications;
 
●
the initiation, timing, progress and results of our preclinical and clinical
activities, including the first-in-human Phase 1 trial for VB-601 and our research and development
program, if at all;
 
●
our
expectations about the availability and timing of data from any clinical trial;
 
●
our
ability to advance product candidates into, and successfully complete, clinical trials;
 
●
our
plans for future clinical trials;
 
●
our
ability to manufacture our product candidate in sufficient quantities for clinical trials and, if appropriate, commercialization;
 
●
the
timing or likelihood of regulatory filings and approvals, including data required to file for regulatory approval;
 
●
the
commercialization of our product candidate, if approved;
 
●
potential
advantages of our product candidate;
 
●
the
pricing and reimbursement of our product candidate, if approved;
 
●
our
ability to develop and commercialize additional product candidates based on our platform technology;
 
●
our
business strategy;
 
●
the
implementation of our business model, strategic plans for our business, product candidate and technology;
 
●
the
scope and duration of protection we are able to establish and maintain for intellectual property rights covering our product candidate
and technology;
 
●
estimates
of our expenses, future revenues, capital requirements and our needs for additional financing;
 
●
our
ability to establish and maintain collaborations and the benefits of such collaborations;
 
●
our
ability to maintain our level of grant funding or obtain additional grant or other non-dilutive sources of funding;
 
●
developments
relating to our competitors and our industry; and
 
●
other
risks and uncertainties, including those listed under the caption “Risk Factors.”
 
All
forward-looking statements involve risks, assumptions and uncertainties. You should not rely upon forward-looking statements as
predictors of future events. The occurrence of the
events described, and the achievement of the expected results, depend on many
events, some or all of which are not predictable or within our control. Actual results may differ
materially from expected results.
See “Item 1A. Risk Factors,” “Item 7. Management’s Discussion and Analysis of Financial Condition and
Results of Operations” and elsewhere in
this Annual Report for a more complete discussion of these risks, assumptions and
uncertainties and for other risks and uncertainties. These risks, assumptions and uncertainties are
not necessarily all of the
important factors that could cause actual results to differ materially from those expressed in any of our forward-looking
statements. Other unknown or
unpredictable factors also could harm our results.
 
All
of the forward-looking statements we have included in this Annual Report are based on information available to us on the date of this
Annual Report. We undertake no obligation,
and specifically decline any obligation, to update publicly or revise any forward-looking
statements, whether as a result of new information, future events or otherwise. In light of these
risks, uncertainties and assumptions,
the forward-looking events discussed in this Annual Report might not occur.
 
1

 
 
SUMMARY
OF RISK FACTORS
 
Investing
in our common shares involves a high degree of risk. You should carefully consider the risks summarized below and other risks that we
face, a detailed discussion of which
can be found under “Item 1A. Risk Factors” below, together with other information in
this annual report on Form 10-K and our other filings with the Securities and Exchange
Commission, or SEC. This summary list of risks
is not exhaustive of the factors that may affect any of our forward-looking statements and our business and financial results. If any
of
these risks actually occur, our business, financial condition and financial performance would likely be materially adversely affected.
In such case, the trading price of our common
shares would likely decline and you may lose part or all of your investment. Below is a
summary of some of the principal risks we face:
 
●
There
is no assurance that the proposed Merger will be completed in a timely manner or at all.
If the proposed Merger is not consummated, our business could suffer
materially and our stock
price could decline.
●
If
the proposed Merger is not completed, we may be unsuccessful in completing an alternative
transaction on terms that are as favorable as the terms of the proposed Merger
with Notable,
or at all, and we may otherwise be unable to continue to operate our business. Our board
of directors may decide to pursue a dissolution and liquidation of our
company. In such an
event, the amount of cash available for distribution to our shareholders will depend heavily
on the timing of such liquidation as well as the amount of
cash that will need to be reserved
for commitments and contingent liabilities.
●
The
issuance of our ordinary shares to Notable stockholders in the proposed merger will substantially
dilute the voting power of our current shareholders.
●
We
are exploring strategic alternatives to enhance shareholder value, including the proposed merger with Notable, transactions
involving VB-601 and the recently completed
sale of our Modi’in facility rights. We may not be successful in consummating such
transactions or they may not deliver the value to our shareholders that we anticipate.
●
Historically,
we have been highly dependent on the success of ofra-vec in oncology applications. The Phase
3 OVAL clinical trial evaluating ofra-vec in ovarian cancer has
been discontinued after not
meeting statistical significance in progression-free survival, or PFS, or overall survival,
or OS, and we have ceased further development of ofra-
vec in all indications. Such failure
and discontinued internal development of ofra-vec has resulted in, and may result in future,
workplace reduction measures, decrease
anticipated near-term revenues and profitability,
may cause reputational harm and result in a wind down of our operations.
●
We
are not in compliance with the Nasdaq’s minimum bid price requirement and if we fail
to regain compliance with Nasdaq’s continued listing requirements (or if the merger
is completed and the combined company does not meet Nasdaq’s initial listing requirements),
our ordinary shares could be delisted, which could adversely affect the liquidity
of our
ordinary shares and our ability to raise additional capital or enter into strategic transactions.
●
We
have undergone a significant workforce reduction to reduce operating expenses and extend
our cash runway, but such efforts may not yield the anticipated benefits, which
could have
a material effect on our operations.
●
We
have incurred significant losses since our inception and anticipate that we will continue
to incur significant losses for the foreseeable future.
●
We
have never generated any revenue from product sales and may never be profitable.
●
We
may need to raise additional funding, which may not be available on acceptable terms, or
at all. Failure to obtain this necessary capital when needed may force us to delay,
limit
or terminate our product development efforts or other operations (or could impact our ability
to complete the proposed merger or the equity split in the proposed merger).
●
We
have received and may continue to receive Israeli or other governmental grants to assist
in the funding of our research and development activities. If we lose our funding
from these
research and development grants and do not receive new grants, we may encounter difficulties
in the funding of future research and development projects and
implementing technological
improvements, which would harm our operating results.
●
We
may not receive the full €2.5 million grant from the Horizon Europe EIC Accelerator
Program, which funding is subject to a lengthy process prior to receipt and which we
may
not successfully achieve, particularly in light of our decision to terminate the ofra-vec
program and pursue the merger with Notable.
●
We
are highly dependent on our technology in general, and we cannot be certain that our product
candidate VB-601 will receive regulatory approval or be commercialized or
that we will be
able to realize any value from VB-601. Any failure to successfully develop, obtain regulatory
approval for and commercialize any current or future product
candidates, independently or
in cooperation with a third party collaborator, or the experience of significant delays in
doing so, would compromise our ability to generate
revenue and become profitable.
●
Our
product candidate VB-601 is based on novel technology and is in very early stages of development,
which makes it difficult to predict the time and cost of development
and potential regulatory
approval.
●
We
may find it difficult to enroll patients in future clinical trials, and patients could discontinue
their participation in our clinical trials, which could delay or prevent clinical
trials
of our product candidate.
●
We
may encounter substantial delays in our clinical trials or we may fail to demonstrate safety
and efficacy to the satisfaction of applicable regulatory authorities.
●
The
results from our future clinical trials may not be sufficiently robust to support the submission
for marketing approval for our product candidate. Before we submit our
product candidates
for marketing approval, the U.S. Food and Drug Administration, or FDA, and the European Medicines
Agency, or EMA, may require us to conduct
additional clinical trials, or evaluate subjects
for an additional follow-up period.
●
Legislative
and regulatory activity may exert downward pressure on potential pricing and reimbursement
for our product candidate, if approved, that could materially affect
the opportunity to commercialize.
●
We
expect to rely on third parties to conduct some or all aspects of our product manufacturing,
protocol development, research and preclinical and clinical testing, and these
third parties
may not perform satisfactorily.
●
We
intend to rely on third-party manufacturers to produce commercial quantities of any of our
product candidates that receive regulatory approval, but we have not entered
into binding
 agreements with any such manufacturers to support commercialization. Additionally, these
 manufacturers do not have experience producing our product
candidate at commercial levels
and may not pass regulatory inspections or achieve the necessary regulatory approvals or
 produce our product candidate at the quality,
quantities, locations and timing needed to
support commercialization.
●
Our
future success depends on our ability to retain key employees, consultants, and advisors
and to attract, retain and motivate qualified personnel.
●
Pandemics
or other global emergencies could have an adverse impact on our developmental programs and
our financial condition.
●
The
market price of our ordinary shares may be highly volatile, and you may not be able to resell
your shares at the purchase price.
●
As
of January 1, 2023, we lost our foreign private issuer status, and we are required to comply
with (1) the Exchange Act’s domestic reporting regime and (2) accepted
governance practices
associated with U.S. domestic issuers in accordance with various SEC and Nasdaq rules, which
will likely cause us to incur significant legal, accounting
and other expenses. We also now
qualify as a “smaller reporting company” and intend to use the scaled disclosures
 available to such companies, which may make an
investment in our company less attractive
to some investors.
 
2

 
 
PART
I
 
Item 1. BUSINESS
 
Overview
 
We
are a biopharmaceutical company that has historically focused on developing targeted therapies for immune-inflammatory diseases and cancer.
Our goal has been to provide
differentiated targeted therapeutics to address the underlying cause of diseases where treatment options
are limited.
 
Our
 sole product candidate, VB-601, is a targeted antibody for immune-inflammatory applications that has shown disease-modifying activity
 across multiple preclinical models
including multiple sclerosis, rheumatoid arthritis and inflammatory bowel disease. VB-601 was developed
using our monocyte targeting technology, or MTT, and is designed to
specifically inhibit monocyte migration. In October 2022, we submitted
an application to the Israel Ministry of Health and institutional review board for a first-in-human Phase 1 trial
evaluating VB-601 in
healthy volunteers. Production of cGMP grade material of VB-601 for the Phase 1 trial was completed using a third party vendor, and the
procedures required for
study launch are being finalized. Initiation of this trial is subject to the progress and outcome of our corporate
strategic process, and we may look to monetize this asset rather than
continue development internally.
 
Prior
to July 2022, our lead candidate was ofra-vec (VB-111), a custom designed therapeutic candidate comprised of a viral vector, promoter,
and therapeutic gene. In July 2022, we
announced top-line results from the Phase 3 OVAL clinical trial. The trial did not meet the primary
endpoints of achieving a statistically significant improvement in progression-free
survival (PFS), or overall survival (OS) and we discontinued
the trial. We have conducted a strategic review of the ofra-vec program and have ceased further development of ofra-vec
in all indications.
 
In
August 2022, we announced a process to explore strategic alternatives to enhance shareholder value and engaged Chardan Capital Markets,
LLC, or Chardan, as our exclusive
financial advisor to assist in this process. Potential strategic options to be explored or evaluated
as part of the process included, but were not limited to merger, reverse merger, other
business combination, sale of assets, licensing,
or other strategic transactions.
 
In
 August 2022, we also announced an organizational streamlining designed to reduce operating expenses and preserve capital as we explored
 strategic options to maximize
shareholder value. As a result, and to date, have we reduced our workforce by approximately 84% of our
full-time employees. As part of the organizational streamlining, Dr. Ron
Cohen, Dr. Bennett Shapiro and Ms. Alison Finger resigned from
our board of directors, effective August 1, 2022, reducing the number of members of our board of directors from nine
to six.
 
Recent
Developments
 
Proposed
Merger with Notable Labs, Inc.
 
On
February 22, 2023, we entered into an Agreement and Plan of Merger, or the Merger Agreement, with Notable and Vibrant Merger Sub, Inc.,
a Delaware corporation and our direct,
wholly-owned subsidiary, or Merger Sub, pursuant to which, and subject to the satisfaction or
waiver of the conditions set forth in the Merger Agreement, Notable will be merged with
and into Merger Sub (which transaction we refer
to throughout this Annual Report on Form 10-K as the Merger) at the effective time of the Merger, or the Effective Time, with Notable
continuing after the Merger as the surviving corporation and our wholly-owned subsidiary. The Merger is intended to qualify as a tax-free
reorganization for U.S. federal income tax
purposes.
 
At
the Effective Time, each outstanding share of Notable capital stock will be converted into the right to receive our ordinary shares,
as set forth in the Merger Agreement. Under the
exchange ratio formula in the Merger Agreement, immediately following the Effective Time,
the former Notable securityholders are expected to own approximately 76% of our
ordinary shares on a fully diluted basis and subject
to adjustment and our securityholders of VBL as of immediately prior to the Effective Time are expected to own approximately 24%
of our
ordinary shares on a fully diluted basis and subject to adjustment. Under certain circumstances further described in the Merger Agreement,
the ownership percentages may be
adjusted upward or downward based on the level of our net cash at the closing of the Merger, and the
terms and net proceeds of Notable’s pre-merger financing. There can be no
assurances as to our level of net cash between the signing
of the Merger Agreement and the closing of the Merger.
 
The
Merger Agreement contains a customary “no-shop” provision under which neither we nor Notable is permitted to (i) solicit
any alternative acquisition proposals, (ii) furnish any
non-public information to any person in connection with or in response to any
alternative acquisition proposal, (iii) engage in any negotiations or discussions with any person with
respect to any alternative acquisition
proposal, (iv) approve, endorse or recommend any alternative acquisition proposal, or (v) execute or enter into any agreement relating
to any
alternative acquisition proposal. The “no-shop” provision is subject to certain exceptions that permit the board of
directors of either party to comply with its fiduciary duties, which,
under certain circumstances, would enable us or Notable to provide
 information to, and enter into discussions or negotiations with, third parties in response to any alternative
acquisition proposals.
 
The
Merger Agreement contains customary representations, warranties and covenants made by Notable and our company, including representations
relating to obtaining the requisite
approvals of the securityholders of Notable and our company, agreements relating to indemnification
of directors and officers, and covenants relating to Notable’s and our conduct our
respective businesses between the date of signing
the Merger Agreement and the Effective Time.
 
3

 
 
The
Merger Agreement provides each of our company and Notable with specified termination rights, and further provides that, upon termination
of the Merger Agreement under
specified circumstances, the terminating party may be required to pay the other party a termination fee
of $2,500,000. In addition, in connection with certain terminations of the Merger
Agreement, we may be required to pay Notable’s
out-of-pocket fees and expenses up to $500,000, or Notable may be required to pay our out-of-pocket fees and expenses up to
$500,000.
 
The
Merger Agreement provides that, immediately following the Effective Time, the board of directors of the combined company will consist
of up to seven directors, with one
director designated by us. Upon the closing of the transaction, the combined company will be led by
Notable’s chief executive officer and executive management team. In connection
with the Merger, we will seek to amend our articles
of incorporation to: (i) effect an increase of our registered share capital and/or effect a reverse split of our ordinary shares at a
ratio
to be determined; (ii) change our name to “Notable Labs, Ltd.”; and (iii) make other such changes as mutually agreeable
to our company and Notable.
 
Our
and Notable’s obligations to consummate the Merger are subject to the satisfaction or waiver of customary closing conditions, including,
among others, obtaining the requisite
approval of our shareholders, obtaining the requisite approval of Notable’s stockholders,
proceeds of Notable’s pre-closing financing, net of certain specified expenses, not being less
than $5,000,000 and our net cash
not being less than $15,000,000.
 
In
 connection with the execution of the Merger Agreement, we and Notable entered into shareholder support agreements with our current directors
 and executive officers who
collectively beneficially own or control an aggregate of approximately 2% of our outstanding ordinary shares.
These shareholder support agreements provide that, among other things,
each of the shareholders has agreed to vote or cause to be voted
all of its ordinary shares beneficially owned by such shareholder in favor of the issuance of our ordinary shares in the
Merger at the
VBL shareholder meeting to be held in connection with the Merger.
 
Although
we have entered into the Merger Agreement and intend to consummate the proposed Merger, there is no assurance that we will be able to
successfully consummate the
proposed Merger on a timely basis, or at all. If, for any reason, the proposed Merger is not completed, we
will reconsider our strategic alternatives and could pursue one or more of the
following courses of action:
 
 
●
Pursue
potential collaborative, partnering or other strategic arrangements for our assets, including a sale or other divestiture of our
assets, such as VB-601; or in-licensing
additional programs and assets to develop internally.
 
●
Pursue
another strategic transaction like the proposed Merger. Our board of directors may elect to pursue an alternative strategy, one of
which may be a strategic transaction
similar to the proposed Merger.
 
●
Dissolve
and liquidate our assets. If, for any reason, the proposed Merger is not consummated and we are unable to identify and complete an
alternative strategic transaction
like the Merger or potential collaborative, partnering or other strategic arrangements for our
 assets, or to continue to operate our business due to our inability to raise
additional funding, we may be required to dissolve and
liquidate our assets. In such case, we would be required to pay all of our debts and contractual obligations, and to set
aside certain
reserves for potential future claims, and there can be no assurances as to the amount or timing of available cash left to distribute
to our shareholders after paying
our debts and other obligations and setting aside funds for reserves.
 
Sale
of Assets in the Modi’in Facility
 
On
February 15, 2023, we entered into an Asset Purchase Agreement, or the Purchase Agreement, providing for the sale of our rights to
lease the Modi’in manufacturing facility, along
with certain tangible assets and equipment located therein for $7.1 million.
We intend to use the proceeds from the asset sale to meet the $15.0 million minimum net cash closing
condition provided in the
Merger Agreement and are disposing of such rights in contemplation of the Merger (although completion of such asset sale is not a
condition to the Merger).
There can be no guarantee that we will have sufficient funds to satisfy the minimum net cash closing
required pursuant to the Merger Agreement. We completed the asset sale on
March 9, 2023. We have retained the right to use a
portion of the space for a nominal fee until May 31, 2023.
 
4

 
 
Platform
Technology
 
Monocyte
Targeting Technology
 
Our
monocyte targeting technology, or MTT, is based on the internal discovery of a novel target, MOSPD2. This novel target, which we call
the “mono-walk” receptor, is selectively
expressed on the surface of monocytes and controls their ability to migrate (or
“walk” to) inflamed tissues. Monocytes are an important cell implicated in the chronicity of disease in
inflammatory indications
and previous attempts by others to specifically target this cell type and prevent its migration to sites of inflammation have been unsuccessful.
We believe that
our approach can address this gap in being able to optimally address chronic inflammation and we are utilizing antibody
technology to specifically inhibit this target with high potency.
 
VB-601
Program- MTT Candidate
 
Our
current MTT candidate, VB-601, is an investigational proprietary monoclonal antibody that binds the MOSPD2 surface protein, which we
call the “mono-walk” receptor, and is
engineered to specifically prevent monocytes from exiting the blood stream and traveling
to inflamed tissues. Monocytes are one of the key cells types in inflammation and particularly
implicated in being responsible for the
chronicity of disease. VB-601 is designed to offer a novel and differentiated approach in the landscape of current anti-inflammatory
agents, most
of which target pro-inflammatory molecules and work through T and B lymphocytes but are not targeted to the monocyte cells.
 
We
have conducted various in-vivo pharmacology studies that demonstrate VB-601’s potential activity against a broad range of
prevalent chronic inflammatory indications:
 
 
 
5

 
 
We
have also performed ex-vivo proof-of-concept studies demonstrating the ability of VB-601 to inhibit migration of monocytes isolated
from blood samples of patients with a broad
range of prevalent chronic inflammatory indications:
 
 
 
 
Based
 on our preclinical in-vivo and human ex-vivo data, we believe VB-601 has potential utility in a wide range of immune-inflammatory
 diseases, such as multiple sclerosis
(relapsing-remitting (RRMS) and progressive (PMS)), rheumatoid arthritis (RA), psoriatic arthritis
 (PsA), non-alcoholic steatohepatitis (NASH), inflammatory bowel disease
(including Crohn’s disease (CD) and ulcerative colitis
(UC)) and other immune-inflammatory diseases.
 
6

 
 
We
 had a successful pre-IND meeting with the FDA regarding our development plan and have since completed IND-enabling toxicology studies
 that demonstrated a favorable
tolerability profile that supports moving VB-601 into the clinic. Additionally, in October 2022, we submitted
an application to the Israel Ministry of Health and institutional review
board for a first-in-human Phase 1 trial evaluating VB-601 in
healthy volunteers. We used a third-party vendor for cGMP grade material of VB-601 for the Phase 1 clinical trial and are
currently finalizing
the procedures required to initiate this Phase 1 clinical trial. Initiation of this clinical trial is subject to the progress and outcome
of the proposed Merger and we
continue to explore strategic transactions to monetize this asset, which could result in ceasing internal
development altogether.
 
Our
Strategy
 
In
August 2022, we announced a process to explore strategic alternatives to enhance shareholder value and engaged Chardan as our exclusive
financial advisor to assist in this process.
Potential strategic options explored or evaluated as part of the process included, but were
not limited to merger, reverse merger, other business combination, sale of assets, licensing, or
other strategic transactions. As a result
of this process, we entered into the Merger Agreement and recently closed the sale of our lease and certain related assets in our Modi’in
facility.
 
While
our current focus is on completing the Merger to maximize value for our shareholders, we will also continue to explore options for our
product candidate, VB-601. We do not
anticipate further development of this asset if the Merger is completed given the shift in strategic
focus if the Merger is successful. However, there is no guarantee that we will be
successful in identifying any strategic transaction
for VB-601 or that we will be able to monetize or further develop this asset.
 
Competition
 
Inflammation
is a defensive reaction involving the immune system. However, chronic inflammation can cause tissue damage and remodeling, which may
cause the body’s immune
system to attack its own organs. There are various chronic inflammatory diseases, including multiple sclerosis,
rheumatoid arthritis, lupus, ulcerative colitis, Crohn’s disease, among
others. Many of these diseases are insufficiently managed
by existing treatments that provide mostly symptomatic relief. Certain therapies that target T or B lymphocytes can offer new
possibilities
for some of the patients, yet there is still an huge unmet need.
 
Unlike
existing therapies, VB-601 is designed to target monocytes, a key component in chronic inflammation that is currently lacking therapeutic
options. We believe VB-601 offers
differentiated technology, based on VBL’s newly discovered biology - blocking the ability of
monocytes to reach inflamed tissues via MOSPD2. While there are numerous drug
candidates in development for inflammatory indications,
to the best of our knowledge, no other drug candidate are designed to target MOSPD2.
 
Governmental
Regulation
 
The
FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among
other things, the research, development, testing,
manufacture, quality control, import, export, safety, effectiveness, labeling, packaging,
storage, distribution, recordkeeping, approval, advertising, promotion, marketing, post-approval
monitoring and post-approval reporting
 of biologics. We, along with our vendors, contract research organizations, or CROs, clinical investigators and contract development and
manufacturing organizations, or CDMOs, will be required to navigate the various preclinical, clinical, manufacturing and commercial approval
 requirements of the governing
regulatory agencies of the countries in which we wish to conduct studies or seek approval of our product
candidates. The process of obtaining regulatory approvals of drugs and
biologics and ensuring subsequent compliance with appropriate
federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial
resources.
 
In
the United States, the FDA regulates biologics under the Federal Food, Drug, and Cosmetic Act, or FD&C Act, and biologics under the
FD&C Act and the Public Health Service
Act, or PHSA, as amended, and their implementing regulations. Biologics are also subject to
other federal, state and local statutes and regulations. If we fail to comply with applicable
FDA or other requirements at any time with
respect to product development, clinical testing, approval or any other regulatory requirements relating to product manufacture, processing,
handling, storage, quality control, safety, marketing, advertising, promotion, packaging, labeling, export, import, distribution, or
sale, we may become subject to administrative or
judicial sanctions or other legal consequences. These sanctions or consequences could
include, among other things, the FDA’s refusal to approve pending applications, issuance of
clinical holds for ongoing studies,
 suspension or revocation of approved applications, warning or untitled letters, product withdrawals or recalls, product seizures, relabeling
 or
repackaging, total or partial suspensions of manufacturing or distribution, injunctions, fines, civil penalties or criminal prosecution.
 
7

 
 
Our
product candidate must be approved for therapeutic indications by the FDA before it may be marketed in the United States. For biologic
product candidates regulated under the
FD&C Act and PHSA, FDA must approve a BLA. The process generally involves the following:
 
●
completion
of extensive preclinical studies in accordance with applicable regulations, including studies
conducted in accordance with good laboratory practice, or GLP,
requirements;
●
completion
of the manufacture, under current good manufacturing practice, or cGMP requirements, of the
drug substance and drug product that the sponsor intends to use in
human clinical trials
along with required analytical and stability testing;
●
submission
to the FDA of an investigational new drug application, or IND, which must become effective
before clinical trials may begin and must be updated annually and
when certain changes are
made;
●
approval
by an institutional review board, or IRB, or independent ethics committee at each clinical
trial site before each trial may be initiated;
●
performance
of adequate and well-controlled clinical trials in accordance with applicable IND regulations,
good clinical practice, or GCP, requirements and other clinical trial-
related regulations
to establish the safety and efficacy of the investigational product for each proposed indication;
●
preparation
and submission to the FDA of a BLA;
●
a
determination by the FDA within 60 days of its receipt of a BLA to file the application for
review;
●
satisfactory
completion of one or more FDA pre-license inspections of the manufacturing facility or facilities
where the product will be produced to assess compliance with
cGMP requirements to assure
that the facilities, methods and controls are adequate to preserve the biological product’s
identity, strength, quality and purity;
●
satisfactory
completion of FDA audit of the clinical trial sites that generated the data in support of
the BLA;
●
payment
of user fees for FDA review of the BLA, unless a waiver applies; and
●
FDA
review and approval of the BLA, including, where applicable, consideration of the views of
any FDA advisory committee, prior to any commercial marketing or sale of
the product in the
United States.
 
Preclinical
Studies and Clinical Trials for Biologics
 
Before
 testing any biologic in humans, the product candidate must undergo rigorous preclinical testing. Preclinical studies include laboratory
 evaluations of product chemistry,
formulation and stability, as well as in vitro and animal studies to assess safety and in some
cases to establish the rationale for therapeutic use. The conduct of preclinical studies is
subject to federal and state regulation and
requirements, including GLP requirements for safety/toxicology studies. The results of the preclinical studies, together with manufacturing
information and analytical data, must be submitted to the FDA as part of an IND.
 
An
IND is a request for authorization from the FDA to administer an investigational product to humans and must become effective before clinical
trials may begin. The central focus of
an IND submission is on the general investigational plan and the protocol(s) for clinical studies.
The IND also includes the results of animal and in vitro studies assessing the
toxicology, pharmacokinetics, pharmacology, and
pharmacodynamic characteristics of the product; chemistry, manufacturing, and controls, or CMC, information; and any available
human
data or literature to support the use of the investigational product. Some long-term preclinical testing may continue after the IND is
submitted. The IND automatically becomes
effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises
concerns or questions about the conduct of the clinical trial, including concerns that
human research subjects will be exposed to unreasonable
health risks, and imposes a full or partial clinical hold. FDA must notify the sponsor of the grounds for the hold and any
identified
deficiencies must be resolved before the clinical trial can begin. Submission of an IND may result in the FDA not allowing clinical trials
to commence or not allowing
clinical trials to commence on the terms originally specified in the IND. A clinical hold can also be imposed
 once a trial has already begun, thereby halting the trial until the
deficiencies articulated by FDA are corrected.
 
The
clinical stage of development involves the administration of the product candidate to healthy volunteers or patients under the supervision
of qualified investigators, who generally
are physicians not employed by or under the trial sponsor’s control, in accordance with
GCP requirements, which include the requirements that all research subjects provide their
informed consent for their participation in
any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial,
dosing
procedures, subject selection and exclusion criteria and the parameters and criteria to be used in monitoring safety and evaluating
effectiveness. Each protocol, and any subsequent
amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore,
each clinical trial must be reviewed and approved by an IRB for each institution at which
the clinical trial will be conducted to ensure
that the risks to individuals participating in the clinical trials are minimized and are reasonable compared to the anticipated benefits.
The
IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative
and must monitor the clinical trial until completed.
The FDA, the IRB, or the sponsor may suspend or discontinue a clinical trial at
any time on various grounds, including a finding that the subjects are being exposed to an unacceptable
health risk. Additionally, some
clinical trials are overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as a data and
safety monitoring
committee, or DSMC. This group provides authorization for whether or not a trial may move forward at designated intervals
based on access to certain data from the trial. There also
are requirements governing the reporting of ongoing clinical trials and completed
clinical trials to public registries. Information about clinical trials, including results for clinical trials
other than Phase 1 investigations,
 must be submitted within specific timeframes for publication on www.ClinicalTrials.gov, a clinical trials database maintained by the
 National
Institutes of Health.
 
A
sponsor who wishes to conduct a clinical trial outside of the United States may, but need not, obtain FDA authorization to conduct the
clinical trial under an IND. If a foreign clinical
trial is not conducted under an IND, FDA will nevertheless accept the results of the
study in support of an NDA if the study was conducted in accordance with GCP requirements, and
the FDA is able to validate the data through
an onsite inspection if deemed necessary.
 
8

 
 
Clinical
trials to evaluate therapeutic indications to support a BLA for marketing approval are typically conducted in three sequential phases,
which may overlap.
 
●
Phase
1—Phase 1 clinical trials involve initial introduction of the investigational product
in a limited population of healthy human volunteers or patients with the target
disease or
condition. These studies are typically designed to test the safety, dosage tolerance, absorption,
metabolism, distribution and excretion of the investigational product
in humans, the side
effects associated with increasing doses, and, if possible, to gain early evidence of effectiveness.
 
 
 
●
Phase
2—Phase 2 clinical trials typically involve administration of the investigational
product to a limited patient population with a specified disease or condition to evaluate
the product’s potential efficacy, to determine the optimal dosages and dosing schedule
and to identify possible adverse side effects and safety risks.
 
 
 
●
Phase
3—Phase 3 clinical trials typically involve administration of the investigational
product to an expanded patient population to further evaluate dosage, to provide
statistically
significant evidence of clinical efficacy and to further test for safety, generally at multiple
geographically dispersed clinical trial sites. These clinical trials are
intended to establish
the overall risk/benefit ratio of the investigational product and to provide an adequate
basis for product approval and physician labeling. Generally, two
adequate and well-controlled
Phase 3 trials are required by the FDA for approval of a BLA.
 
Post-approval
 trials, sometimes referred to as Phase 4 clinical trials or post-marketing studies, may be conducted after initial marketing approval.
These trials are used to gain
additional experience from the treatment of patients in the intended therapeutic indication and are commonly
intended to generate additional safety data regarding use of the product in
a clinical setting. In certain instances, the FDA may mandate
the performance of Phase 4 clinical trials as a condition of a BLA approval.
 
Progress
reports detailing the results of the clinical trials, among other information, must be submitted at least annually to the FDA. Written
IND safety reports must be submitted to the
FDA and the investigators fifteen days after the trial sponsor determines the information
qualifies for reporting for serious and unexpected suspected adverse events, findings from
other studies or animal or in vitro
testing that suggest a significant risk for human volunteers and any clinically important increase in the rate of a serious suspected
adverse reaction
over that listed in the protocol or investigator brochure. The sponsor must also notify the FDA of any unexpected fatal
or life-threatening suspected adverse reaction as soon as possible
but in no case later than seven calendar days after the sponsor’s
initial receipt of the information.
 
Concurrent
with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry
and physical characteristics of
the product candidate and finalize a process for manufacturing the drug product in commercial quantities
in accordance with cGMP requirements. The manufacturing process must be
capable of consistently producing quality batches of the product
candidate and manufacturers must develop, among other things, methods for testing the identity, strength, quality and
purity of the final
drug product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate
that the product candidate does
not undergo unacceptable deterioration over its shelf life.
 
U.S.
Marketing Approval for Biologics
 
Assuming
successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailed
information relating to the product’s CMC
and proposed labeling, among other things, are submitted to the FDA as part of a BLA.
A BLA is a request for approval to market a new biologic for one or more specified indications
and must contain proof of the biologic’s
safety, purity and potency for the requested indications. The marketing application is required to include both negative and ambiguous
results
of preclinical studies and clinical trials, as well as positive findings, together with detailed information relating to the
product’s CMC, and proposed labeling, among other things. Data
may come from company-sponsored clinical trials intended to test
the safety and efficacy of a product’s use or from a number of alternative sources, including studies initiated by
investigators.
To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety, purity and potency
of the investigational biologic, to
the satisfaction of the FDA. The FDA must approve a BLA before a biologic may be marketed in the
United States.
 
The
FDA reviews all submitted BLAs to ensure they are sufficiently complete to permit substantive review before it accepts them for filing
and may request additional information
rather than accepting the BLA for filing. The FDA must make a decision on accepting a BLA for
filing within 60 days of receipt, and such decision could include a refusal to file by
the FDA. Once the submission is accepted for filing,
the FDA begins an in-depth substantive review of the BLA. The FDA reviews a BLA to determine, among other things, whether
the product
is safe and effective for the indications sought and whether the facility in which it is manufactured, processed, packaged or held meets
standards designed, including cGMP
requirements, designed to assure and preserve the product’s continued identity, strength, quality
and purity. Under the goals and polices agreed to by the FDA under the Prescription
Drug User Fee Act, or PDUFA, the FDA targets ten
months, from the filing date, in which to complete its initial review of a new molecular entity BLA and respond to the applicant,
and
six months from the filing date of a new molecular entity BLA for priority review. The FDA does not always meet its PDUFA goal dates
for standard or priority BLAs, and the
review process is often extended by FDA requests for additional information or clarification.
 
9

 
 
Further,
under PDUFA, as amended, each BLA must be accompanied by a substantial user fee. The FDA adjusts the PDUFA user fees on an annual basis.
Fee waivers or reductions are
available in certain circumstances, including a waiver of the application fee for the first application
filed by a small business. Additionally, no user fees are assessed on BLAs for
products designated as orphan drugs, unless the product
also includes a non-orphan indication.
 
The
FDA also may require submission of a Risk Evaluation and Mitigation Strategy, or REMS, if it believes that a risk evaluation and mitigation
strategy is necessary to ensure that the
benefits of the biologic outweigh its risks. A REMS can include use of risk evaluation and mitigation
strategies like medication guides, physician communication plans, assessment
plans, and/or elements to assure safe use, such as restricted
distribution methods, patient registries, special monitoring or other risk-minimization tools.
 
The
FDA may refer an application for a novel biologic to an advisory committee. An advisory committee is a panel of independent experts,
including clinicians and other scientific
experts, which reviews, evaluates and provides a recommendation as to whether the application
 should be approved and under what conditions. The FDA is not bound by the
recommendations of an advisory committee, but it considers
such recommendations carefully when making decisions.
 
Before
approving a BLA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve
an application unless it determines that
the manufacturing processes and facilities are in compliance with cGMP requirements and are
adequate to assure consistent production of the product within required specifications.
Additionally, before approving a BLA, the FDA
may inspect one or more clinical trial sites to assure compliance with GCP and other requirements and the integrity of the clinical data
submitted to the FDA.
 
After
evaluating the BLA and all related information, including the advisory committee recommendation, if any, and inspection reports regarding
the manufacturing facilities and
clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete response letter.
A complete response letter indicates that the review cycle of the application is
complete and the application is not ready for approval.
A complete response letter generally contains a statement of specific conditions that must be met in order to secure final
approval of
the BLA, except that where the FDA determines that the data supporting the application are inadequate to support approval, the FDA may
issue the complete response
letter without first conducting required inspections, testing submitted product lots, and/or reviewing proposed
labeling. In issuing the complete response letter, the FDA may require
additional clinical or preclinical testing or recommend other
actions, such as requests for additional information or clarification, that the applicant might take in order for the FDA to
reconsider
the application. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy
the regulatory criteria for approval.
If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically
issue an approval letter. An approval letter authorizes commercial marketing of the
product with specific prescribing information for
specific indications.
 
Even
if the FDA approves a product, depending on the specific risk(s) to be addressed it may limit the approved indications for use of the
product, require that contraindications,
warnings or precautions be included in the product labeling, require that post-approval studies,
including Phase 4 clinical trials, be conducted to further assess a product’s safety after
approval, require testing and surveillance
programs to monitor the product after commercialization, or impose other conditions, including distribution and use restrictions or other
risk
management mechanisms under a REMS, which can materially affect the potential market and profitability of the product. The FDA may
prevent or limit further marketing of a
product based on the results of post-marketing studies or surveillance programs. After approval,
some types of changes to the approved product, such as adding new indications,
manufacturing changes, and additional labeling claims,
are subject to further testing requirements and FDA review and approval.
 
Orphan
Drug Designation and Exclusivity
 
Under
the Orphan Drug Act, the FDA may grant orphan drug designation to a biologic intended to treat a rare disease or condition, which is
a disease or condition with either a patient
population of fewer than 200,000 individuals in the United States, or a patient population
greater than 200,000 individuals in the United States when there is no reasonable expectation
that the cost of developing and making
the product available in the United States for the disease or condition will be recovered from sales of the product. Orphan drug designation
must
be requested before submitting a BLA. After the FDA grants orphan drug designation, the generic identity of the therapeutic agent
and its potential orphan use are disclosed publicly by
the FDA. Orphan drug designation does not convey any advantage in or shorten the
duration of the regulatory review and approval process, though companies developing orphan
products are eligible for certain incentives,
including tax credits for qualified clinical testing and waiver of application fees.
 
If
a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it has
such designation, the product is entitled to a
seven-year period of marketing exclusivity during which the FDA may not approve any other
applications to market the same therapeutic agent for the same indication, except in
limited circumstances, such as a subsequent product’s
showing of clinical superiority over the product with orphan exclusivity or where the original applicant cannot produce sufficient
quantities
of product. Competitors, however, may receive approval of different therapeutic agents for the indication for which the orphan product
has exclusivity or obtain approval for
the same therapeutic agent for a different indication than that for which the orphan product has
exclusivity. Orphan product exclusivity could block the approval of one of our products
for seven years if a competitor obtains approval
for the same therapeutic agent for the same indication before we do, unless we are able to demonstrate that our product is clinically
superior. If an orphan designated product receives marketing approval for an indication broader than what is designated, it may not be
entitled to orphan exclusivity. Further, orphan
drug exclusive marketing rights in the United States may be lost if the FDA later determines
that the request for designation was materially defective or the manufacturer of the
approved product is unable to assure sufficient
quantities of the product to meet the needs of patients with the rare disease or condition.
 
10

 
 
Expedited
Development and Review Programs for Biologics
 
The
FDA maintains several programs intended to facilitate and expedite development and review of new biologics to address unmet medical needs
in the treatment of serious or life-
threatening diseases or conditions. These programs include fast track designation, breakthrough therapy
designation, priority review and accelerated approval, and the purpose of these
programs is to either expedite the development or review
of important new biologics to get them to patients more quickly than standard FDA review timelines typically permit.
 
A
new biologic is eligible for fast track designation if it is intended to treat a serious or life-threatening disease or condition and
demonstrates the potential to address unmet medical
needs for such disease or condition. Fast track designation applies to the combination
of the product candidate and the specific indication for which it is being studied. Fast track
designation provides increased opportunities
for sponsor interactions with the FDA during clinical development, in addition to the potential for rolling review once a marketing
application
is submitted. Rolling review means that the FDA may review portions of the marketing application before the sponsor submits the complete
application.
 
In
addition, a new biologic may be eligible for breakthrough therapy designation if it is intended to treat a serious or life-threatening
disease or condition and preliminary clinical
evidence indicates that the biologic, alone or in combination with one or more other drugs
or biologics, may demonstrate substantial improvement over existing therapies on one or
more clinically significant endpoints, such as
substantial treatment effects observed early in clinical development. Breakthrough therapy designation provides all the features of fast
track designation in addition to intensive guidance on an efficient product development program beginning as early as Phase 1, and FDA
organizational commitment to expedited
development, including involvement of senior managers and experienced review staff in a cross-disciplinary
review, where appropriate.
 
Any
product submitted to the FDA for approval, including a product with fast track or breakthrough therapy designation, may also be eligible
for additional FDA programs intended to
expedite the review and approval process, including priority review designation and accelerated
approval. A biologic is eligible for priority review, once a BLA is submitted, if the
product that is the subject of the marketing application
has the potential to provide a significant improvement in safety or effectiveness in the treatment, diagnosis or prevention of a
serious
disease or condition. Under priority review, the FDA’s goal date to take action on the marketing application is six months compared
to ten months for a standard review.
Products may be eligible for accelerated approval if they can be shown to have an effect on a surrogate
endpoint that is reasonably likely to predict clinical benefit, or an effect on a
clinical endpoint that can be measured earlier than
an effect on irreversible morbidity or mortality, which is reasonably likely to predict an effect on irreversible morbidity or mortality
or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative
treatments.
 
Accelerated
approval is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, adequate and well-controlled additional
post-approval confirmatory studies to
verify and describe the product’s clinical benefit and, under the Food and Drug Omnibus Reform
Act, or FDORA, the FDA is now permitted to require, as appropriate, that such trials
be underway prior to approval or within a specific
time period after accelerated approval is granted. Additionally, under FDORA, the FDA has increased authority for expedited
procedures
to withdraw approval of a product or an indication approved under accelerated approval if, for example, the confirmatory trial fails
to verify the predicted clinical benefit of
the product. In addition, for products being considered for accelerated approval, the FDA
 generally requires, unless otherwise informed by the Agency, that all advertising and
promotional materials intended for dissemination
or publication within 120 days of marketing approval be submitted to the agency for review during the pre-approval review period.
After
the 120-day period has passed, all advertising and promotional materials must be submitted at least 30 days prior to the intended time
of initial dissemination or publication.
 
Even
if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for
qualification or the time period for FDA
review or approval may not be shortened. Furthermore, fast track designation, breakthrough therapy
designation, priority review and accelerated approval do not change the scientific
or medical standards for approval or the quality of
evidence necessary to support approval, though they may expedite the development or review process.
 
Pediatric
Information and Pediatric Exclusivity
 
Under
the Pediatric Research Equity Act, or PREA, as amended, certain BLAs and certain BLA supplements must contain data that can be used to
assess the safety and efficacy of the
product candidate for the claimed indications in all relevant pediatric subpopulations and to support
dosing and administration for each pediatric subpopulation for which the product is
safe and effective. The FDA may grant deferrals for
submission of pediatric data or full or partial waivers. The FD&C Act requires that a sponsor who is planning to submit a
marketing
application for a product candidate that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new
route of administration submit an
initial Pediatric Study Plan, or PSP, within 60 days of an end-of-Phase 2 meeting or, if there is no
such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3
study. The initial PSP must include an outline
of the pediatric study or studies that the sponsor plans to conduct, including study objectives and design, age groups, relevant endpoints
and statistical approach, or a justification for not including such detailed information, and any request for a deferral of pediatric
 assessments or a full or partial waiver of the
requirement to provide data from pediatric studies along with supporting information.
 The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit
amendments to an agreed-upon initial PSP at any time
if changes to the pediatric plan need to be considered based on data collected from preclinical studies, early phase clinical trials
and/or other clinical development programs. Unless otherwise required by regulation, PREA does not apply to a biologic for an indication
for which orphan drug designation has been
granted.
 
11

 
 
A
drug or biologic can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months
to existing exclusivity periods and patent terms.
This six-month exclusivity, which runs from the end of other exclusivity protection
or patent term, may be granted based on the voluntary completion of a pediatric study in accordance
with an FDA-issued “Written
Request” for such a study.
 
U.S.
Post-Approval Requirements for Biologics
 
Biologics
 manufactured or distributed pursuant to FDA approvals are subject to continuing regulation by the FDA, including, among other things,
 requirements relating to
recordkeeping, periodic reporting, product sampling and distribution, reporting of adverse experiences with
the product, complying with promotion and advertising requirements,
which include restrictions on promoting products for unapproved uses
 or patient populations (known as “off-label use”) and limitations on industry-sponsored scientific and
educational activities.
Although physicians may prescribe approved products for off-label uses, manufacturers may not market or promote such uses. The FDA and
other agencies
actively enforce the laws and regulations prohibiting the promotion of off-label uses, including not only by company employees
but also by agents of the company or those speaking on
the company’s behalf, and a company that is found to have improperly promoted
off-label uses may be subject to significant liability, including investigation by federal and state
authorities. Failure to comply with
these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil
and criminal
penalties, including liabilities under the False Claims Act where products are obtain reimbursement under federal health
care programs. Promotional materials for approved biologics
must be submitted to the FDA in conjunction with their first use or first
publication. Further, if there are any modifications to the biologic, including changes in indications, labeling or
manufacturing processes
or facilities, the applicant may be required to submit and obtain FDA approval of a new BLA or BLA supplement, which may require the
development of
additional data or preclinical studies and clinical trials.
 
The
FDA may impose a number of post-approval requirements as a condition of approval of a BLA. For example, the FDA may require post-market
testing, including Phase 4 clinical
trials, and surveillance to further assess and monitor the product’s safety and effectiveness
after commercialization. In addition, manufacturers and their subcontractors involved in the
manufacture and distribution of approved
biologics are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced
inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMPs, which impose
certain procedural and documentation
requirements on sponsors and their CMOs. Changes to the manufacturing process are strictly regulated,
and, depending on the significance of the change, may require prior FDA
approval before being implemented. FDA regulations also require
investigation and correction of any deviations from cGMP and impose reporting requirements upon us and any third
party manufacturers
 that a sponsor may use. Manufacturers and manufacturers’ facilities are also required to comply with applicable product tracking
 and tracing requirements.
Accordingly, manufacturers must continue to expend time money and effort in the area of production and quality
control to maintain compliance with cGMP and other aspects of
regulatory compliance. Failure to comply with statutory and regulatory
 requirements may subject a manufacturer to possible legal or regulatory action, such as warning letters,
suspension of manufacturing,
product seizures, injunctions, civil penalties or criminal prosecution. There is also a continuing, annual program user fee for any marketed
product.
 
The
FDA may withdraw approval of a product if compliance with regulatory requirements and standards is not maintained or if problems occur
after the product reaches the market.
Later discovery of previously unknown problems with a product, including adverse events of unanticipated
severity or frequency, or with manufacturing processes, or failure to comply
with regulatory requirements, may result in revisions to
the approved labeling to add new safety information, requirements for post-market studies or clinical trials to assess new safety
risks,
or imposition of distribution or other restrictions under a REMS. Other potential consequences include, among other things:
 
●
restrictions
on the marketing or manufacturing of the product, complete withdrawal of the product from
the market or product recalls;
●
the
issuance of safety alerts, Dear Healthcare Provider letters, press releases or other communications
containing warnings or other safety information about the product;
●
fines,
warning letters or holds on post-approval clinical trials;
●
refusal
of the FDA to approve applications or supplements to approved applications, or suspension
or revocation of product approvals;
●
product
seizure or detention, or refusal to permit the import or export of products;
●
injunctions
or the imposition of civil or criminal penalties; and
●
consent
decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;
or
●
mandated
modification of promotional materials and labeling and issuance of corrective information.
 
12

 
 
United
States Patent Term Restoration
 
Depending
upon the timing, duration and specifics of FDA approval of our product candidate, one of our United States patents may be eligible for
limited patent term extension under
the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman
Amendments. The Hatch-Waxman Amendments permit restoration
of the patent term of up to five years as compensation for patent term lost
during the FDA regulatory review process. Patent term restoration, however, cannot extend the remaining
term of a patent beyond a total
of 14 years from the product’s approval date and only those claims covering such approved product, a method for using it or a method
for manufacturing
it may be extended. The patent term restoration period is generally one-half the time between the effective date of
an IND and the submission date of a BLA plus the time between the
submission date of aa BLA and the approval of that application, except
that the review period is reduced by any time during which the applicant failed to exercise due diligence. Only
one patent applicable
to an approved biologic is eligible for the extension and the application for the extension must be submitted prior to the expiration
of the patent. The U.S. Patent
and Trademark Office, or U.S. PTO, in consultation with the FDA, reviews and approves the application
for any patent term extension or restoration. In the future, we may apply for
restoration of patent term for our currently owned or licensed
patents to add patent life beyond a patent’s current expiration date, depending on the expected length of the clinical trials
and
other factors involved in the filing of the relevant BLA.
 
Biosimilars
and Exclusivity
 
The
Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2012, collectively the
ACA, includes a subtitle called the
Biologics Price Competition and Innovation Act, or BPCIA, which created an abbreviated approval pathway
for biological products that are biosimilar to or interchangeable with an
FDA-licensed reference biological product. The FDA has issued
several guidance documents outlining an approach for the review and approval of biosimilars in the United States.
Biosimilarity, which
requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety,
purity, and potency, can be
shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability requires
that a product is biosimilar to the reference product and the product must
demonstrate that it can be expected to produce the same clinical
results as the reference product in any given patient and, for products that are administered multiple times to an
individual, the biologic
and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or
risks of diminished
efficacy relative to exclusive use of the reference biologic.
 
Under
the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the
reference product was first licensed by the FDA.
In addition, the approval of a biosimilar product may not be made effective by the
FDA until 12 years from the date on which the reference product was first licensed. During this 12-
year period of exclusivity,
another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing
product containing that
applicant’s own preclinical data and data from adequate and well-controlled clinical trials to
demonstrate the safety, purity and potency of its product. The BPCIA also created certain
exclusivity periods for biosimilars
approved as interchangeable products. The FDA may approve multiple “first” interchangeable products so long as they are
all approved on the same
first day of marketing. This exclusivity period, which may be shared amongst multiple first interchangeable
products, lasts until the earlier of: (1) one year after the first commercial
marketing of the first interchangeable product; (2) 18
months after resolution of a patent infringement suit instituted under 42 U.S.C. § 262(l)(6) against the applicant that
submitted the
application for the first interchangeable product, based on a final court decision regarding all of the patents in the
litigation or dismissal of the litigation with or without prejudice; (3)
42 months after approval of the first interchangeable
product, if a patent infringement suit instituted under 42 U.S.C. § 262(l)(6) against the applicant that submitted the
application for
the first interchangeable product is still ongoing; or (4) 18 months after approval of the first interchangeable
 product if the applicant that submitted the application for the first
interchangeable product has not been sued under 42 U.S.C.
 § 262(l)(6). Products deemed “interchangeable” by the FDA may be readily substituted by pharmacies, and such
substitution is governed by state pharmacy law.
 
Other
Regulatory Matters
 
Following
 product approval, where applicable, the manufacturing, sales, promotion and other activities around product candidates and/or commercialization
 are also subject to
regulation by numerous regulatory authorities in the United States in addition to the FDA. Regulatory agencies with
authority over product candidates may include, and are not limited
to, the Centers for Medicare & Medicaid Services, other divisions
 of the U.S. Department of Health and Human Services, the Department of Justice, the Drug Enforcement
Administration, the Consumer Product
Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency
and state and local governments and governmental agencies.
 
If
any products that we may develop are made available to authorized users of the Federal Supply Schedule of the General Services Administration,
additional laws and requirements
apply. Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention
Packaging Act. Manufacturing, labeling, packaging, distribution, sales,
promotion and other activities also are potentially subject to
federal and state consumer protection and unfair competition laws, among other requirements to which we may be subject.
 
The
distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive recordkeeping, licensing,
storage and security requirements
intended to prevent the unauthorized sale of pharmaceutical products.
 
13

 
 
The
failure to comply with any of these laws or regulatory requirements may subject firms to legal or regulatory action. Depending on the
circumstances, failure to meet applicable
regulatory requirements can result in criminal prosecution, fines or other penalties, injunctions,
exclusion from federal healthcare programs, requests for recall, seizure of products,
total or partial suspension of production, denial
or withdrawal of product approvals, relabeling or repackaging, or refusal to allow a firm to enter into supply contracts, including
government
contracts. Any claim or action against us for violation of these laws, even if we successfully defend against it, could cause us to incur
significant legal expenses and divert
our management’s attention from the operation of our business. Prohibitions or restrictions
on marketing, sales or withdrawal of future products marketed by us could materially affect
our business in an adverse way.
 
Changes
in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example:
(i) changes to our manufacturing
arrangements; (ii) additions or modifications to product labeling or packaging; (iii) the recall or
discontinuation of our products; or (iv) additional recordkeeping requirements. If any
such changes were to be imposed, they could adversely
affect the operation of our business.
 
Other
Healthcare Laws
 
If
we obtain regulatory approval of our products, we may be subject to various federal and state laws targeting fraud, waste, and abuse
in the healthcare industry. These laws may
impact, among other things, our proposed sales, marketing, and education programs. In addition,
we may be subject to patient privacy regulation by both the federal government and
the states in which we conduct our business. The U.S.
laws that may affect our ability to operate include:
 
●
the
U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly
and willfully soliciting, receiving, offering or paying remuneration,
directly or indirectly,
to induce, or in return for, either the referral of an individual, or the purchase or recommendation
of an item or service for which payment may be made
under a federal healthcare program, such
as the Medicare and Medicaid programs. In addition, the government may assert that a claim
including items or services resulting
from a violation of the federal Anti-Kickback Statute
constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act
or federal civil money penalties
statute (as discussed below);
●
U.S.
federal civil and criminal false claims laws and civil monetary penalty laws, including the
federal False Claims Act, which impose criminal and civil penalties against
individuals or
entities for knowingly presenting, or causing to be presented, to the federal government,
including the Medicare and Medicaid programs, claims for payment
that are false or fraudulent,
making a false statement to avoid, decrease or conceal an obligation to pay money to the
 federal government, or knowingly concealing or
knowingly and improperly avoiding or decreasing
such an obligation;
●
the
U.S. federal Health Insurance Portability and Accountability Act of 1996, or HIPAA and its
implementing regulations, which created new federal criminal statutes that
prohibit executing
a scheme to defraud any healthcare benefit program and prohibit knowingly and willfully falsifying,
concealing or covering up a material fact or making
any materially false statements in connection
with the delivery of or payment for healthcare benefits, items or services;
●
HIPAA,
as amended by the Health Information Technology for Economic and Clinical Health Act of 2009,
or HITECH, and their respective implementing regulations, which
impose certain obligations,
including mandatory contractual terms, on covered healthcare providers, health plans, and
healthcare clearinghouses, as well as their business
associates, with respect to safeguarding
the privacy, security and transmission of individually identifiable health information;
●
the
U.S. federal Physician Payments Sunshine Act which requires certain manufacturers of drugs,
devices, biologics, and medical supplies for which payment is available
under Medicare, Medicaid,
or the Children’s Health Insurance Program, with specific exceptions, to report annually
 to the Centers for Medicare & Medicaid Services
information related to payments or transfers
of value made to physicians (currently defined to include doctors, dentists, optometrists,
podiatrists and chiropractors), physician
assistants, nurse practitioners, clinical nurse
 specialists, certified registered nurse anesthetists and teaching hospitals, as well as information
 regarding ownership and
investment interests held by the physicians described above and their
immediate family members;
●
federal
government price reporting laws, which require us to calculate and report complex pricing
metrics in an accurate and timely manner to government programs;
●
federal
consumer protection and unfair competition laws, which broadly regulate marketplace activities
and activities that potentially harm consumers; and
●
analogous
state and laws and regulations in other jurisdictions, such as state anti-kickback and false
claims laws, which may apply to sales or marketing arrangements and
claims involving healthcare
items or services reimbursed by non-governmental third-party payers, including private insurers,
and state and laws in other jurisdiction governing
the privacy and security of health information
in certain circumstances, many of which differ from each other in significant ways and often
are not preempted by HIPAA, thus
complicating compliance efforts.
 
Many
U.S. states have adopted laws similar to the federal Anti-Kickback Statute and False Claims Act, and may apply to our business practices,
including, but not limited to, research,
distribution, sales or marketing arrangements and claims involving healthcare items or services
reimbursed by non-governmental payers, including private insurers. In addition, some
states have passed laws that require pharmaceutical
 companies to comply with the April 2003 Office of Inspector General Compliance Program Guidance for Pharmaceutical
Manufacturers and/or
the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals. Several states also
impose other marketing
restrictions or require pharmaceutical companies to make marketing or price disclosures to the state and require
the registration of pharmaceutical sales representatives.
 
14

 
 
At
 the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product
 pricing, including price or patient
reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure
and transparency measures, and, in some cases, designed to encourage
importation from other countries and bulk purchasing.
 
Because
of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, in the event we obtain regulatory
approval for any one of our products,
it is possible that some of our business activities could be subject to challenge and found to
violate one or more of such laws, regulations, and guidance. Law enforcement authorities
are increasingly focused on enforcing fraud
and abuse laws, and it is possible that some of our practices may be challenged under these laws. Violations of these laws can subject
us to
administrative, civil and criminal penalties, damages, fines, disgorgement, the exclusion from participation in federal and state
 healthcare programs, individual imprisonment,
reputational harm, and the curtailment or restructuring of our operations, as well as additional
 reporting obligations and oversight if we become subject to a corporate integrity
agreement or other agreement to resolve allegations
of non-compliance with these laws. Efforts to ensure that our current and future business arrangements with third parties, and our
business
generally, will comply with applicable healthcare laws and regulations will involve substantial costs.
 
Insurance
Coverage and Reimbursement
 
Significant
uncertainty exists as to the coverage and reimbursement status of any drug products for which we may obtain regulatory approval. In the
United States, sales of any
products for which we may receive regulatory approval for commercial sale will depend in part on the availability
of coverage and reimbursement from third-party payers. Third-party
payers include government programs such as Medicare and Medicaid,
managed care providers, private health insurers, and other organizations. The process for determining whether a
payer will provide coverage
for a drug product may be separate from the process for setting the reimbursement rate that the payer will pay for the drug product.
In the United States,
the principal decisions about reimbursement for new medicines are typically made by CMS, an agency within HHS.
CMS decides whether and to what extent a new medicine will be
covered and reimbursed under Medicare and private payers tend to follow
CMS to a substantial degree. Third-party payers may limit coverage to specific drug products on an approved
list, or formulary, which
might not include all of the FDA-approved drugs for a particular indication. Moreover, a payer’s decision to provide coverage for
a drug product does not
imply that an adequate reimbursement rate will be approved. Adequate third-party reimbursement may not be available
to enable us to maintain price levels sufficient to realize an
appropriate return on our investment in product development. Third-party
payers are increasingly challenging the price and examining the medical necessity and cost- effectiveness of
medical products and services,
in addition to their safety and efficacy. In order to obtain coverage and reimbursement for any product that might be approved for sale,
we may need to
conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of any
 products, in addition to the costs required to obtain
regulatory approvals. Factors payers consider in determining reimbursement are
based on whether the product is:
 
●
a
covered benefit under its health plan;
●
safe,
effective and medically necessary;
●
appropriate
for the specific patient;
●
cost-effective;
and
●
neither
experimental nor investigational.
 
Our
product candidates may not be considered medically necessary or cost-effective. If third-party payers do not consider a product to be
cost-effective compared to other available
therapies, they may not cover the product after approval as a benefit under their plans or,
if they do, the level of payment may not be sufficient to allow a company to sell its products at
a profit.
 
The
U.S. government and state legislatures have shown significant interest in implementing cost containment programs to limit the growth
of government-paid health care costs,
including price controls, restrictions on reimbursement and requirements for substitution of generic
products for branded prescription drugs. For example, the ACA contains provisions
that may reduce the profitability of drug products,
including, for example, increased rebates for drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid
managed
care plans, mandatory discounts for certain Medicare Part D beneficiaries, and annual fees based on pharmaceutical companies’ share
of sales to federal health care programs.
At the state level, legislatures have increasingly passed legislation and implemented regulations
 designed to control pharmaceutical product pricing, including price or patient
reimbursement constraints, discounts, restrictions on
certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage
importation
from other countries and bulk purchasing. Adoption of government controls and measures, and tightening of restrictive policies in jurisdictions
with existing controls and
measures, could limit payments for pharmaceuticals.
 
The
marketability of any products for which we receive regulatory approval for commercial sale may suffer if the government and third-party
payers fail to provide adequate coverage
and reimbursement. In addition, an increasing emphasis on cost containment measures in the United
States has increased and we expect will continue to increase the pressure on
pharmaceutical pricing. Coverage policies and third-party
reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or
more products
for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
 
15

 
 
Current
and Future Healthcare Reform Legislation
 
The
United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system
that could prevent or delay marketing
approval of our product candidates, restrict or regulate post-approval activities and affect our
ability to profitably sell any product for which we obtain marketing approval. Changes in
regulations, statutes or the interpretation
of existing regulations could impact our business in the future by requiring, for example: (i) changes to our manufacturing arrangements;
(ii)
additions or modifications to product labeling; (iii) the recall or discontinuation of our products; or (iv) additional record-keeping
requirements.
 
In
March 2010, the ACA was enacted, which includes measures that have or will significantly change the way health care is financed by both
U.S. governmental and private insurers.
Among the provisions of the ACA of greatest importance to the pharmaceutical industry are the
following:
 
●
The
Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and have
in effect a national rebate agreement with the Secretary of the Department
of HHS as a condition
for states to receive federal matching funds for the manufacturer’s outpatient drugs
furnished to Medicaid patients. The ACA made several changes to
the Medicaid Drug Rebate
Program, including increasing pharmaceutical manufacturers’ rebate liability by raising
the minimum basic Medicaid rebate on most branded
prescription drugs from 15.1% of average
manufacturer price, or AMP, to 23.1% of average manufacturer price, or AMP, and adding a
new rebate calculation for “line
extensions” (i.e., new formulations, such as
extended release formulations) of solid oral dosage forms of branded products, as well as
potentially impacting their rebate
liability by modifying the statutory definition of AMP.
The ACA also expanded the universe of Medicaid utilization subject to drug rebates by requiring
pharmaceutical
manufacturers to pay rebates on Medicaid managed care utilization and by expanding
the population potentially eligible for Medicaid drug benefits. In addition, the ACA
provides
for the public availability of retail survey prices and certain weighted average AMPs under
the Medicaid program.
●
In
order for a pharmaceutical product to receive federal reimbursement under the Medicare Part
B and Medicaid programs or to be sold directly to U.S. government agencies,
the manufacturer
must extend discounts to entities eligible to participate in the 340B drug pricing program.
The required 340B discount on a given product is calculated based
on the AMP and Medicaid
rebate amounts reported by the manufacturer. The ACA expanded the types of entities eligible
to receive discounted 340B pricing, although, under
the current state of the law, with the
exception of children’s hospitals, these newly eligible entities will not be eligible
to receive discounted 340B pricing on orphan drugs
when used for the orphan indication. In
addition, as 340B drug pricing is determined based on AMP and Medicaid rebate data, the revisions
to the Medicaid rebate formula
and AMP definition described above could cause the required
340B discount to increase.
●
Expansion
of the eligibility criteria for Medicaid programs by, among other things, allowing states
to offer Medicaid coverage to additional individuals and by adding new
mandatory eligibility
categories for certain individuals with income at or below 133% of the Federal Poverty Level,
thereby potentially increasing manufacturers’ Medicaid
rebate liability.
●
The
ACA imposed a requirement on manufacturers of branded drugs to provide a 70% discount off
the negotiated price of branded drugs dispensed to Medicare Part D
patients in the coverage
gap (increased from 50% pursuant to the Bipartisan Budget Act of 2018, effective as of 2019).
●
The
ACA imposed an annual, nondeductible fee on any entity that manufactures or imports certain
branded prescription drugs, apportioned among these entities according to
their market share
in certain government healthcare programs, although this fee would not apply to sales of
certain products approved exclusively for orphan indications.
●
A
 Patient-Centered Outcomes Research Institute was established pursuant to the ACA to oversee,
 identify priorities in, and conduct comparative clinical effectiveness
research, along with
funding for such research. The research conducted by the Patient-Centered Outcomes Research
Institute may affect the market for certain pharmaceutical
products.
●
The
ACA established the Center for Medicare and Medicaid Innovation within CMS, which is charged
with testing new, innovative payment and service delivery models.
 
Since
its enactment, there have been judicial, Congressional and executive challenges to certain aspects of the ACA. On June 17, 2021, the
U.S. Supreme Court dismissed the most
recent judicial challenge to the ACA brought by several states without specifically ruling on the
constitutionality of the ACA. Prior to the Supreme Court’s decision, President Biden
issued an executive order to initiate a special
enrollment period from February 15, 2021 through August 15, 2021 for purposes of obtaining health insurance coverage through the ACA
marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules
that limit access to healthcare, including
among others, reexamining Medicaid demonstration projects and waiver programs that include
work requirements, and policies that create unnecessary barriers to obtaining access to
health insurance coverage through Medicaid or
the ACA. It is unclear how other healthcare reform measures of the Biden administration or other efforts, if any, to challenge, repeal
or
replace the ACA will impact our business.
 
16

 
 
In
addition, other legislative and regulatory changes have been proposed and adopted in the United States since the ACA was enacted:
 
●
On
August 2, 2011, the U.S. Budget Control Act of 2011, among other things, included aggregate
reductions of Medicare payments to providers of 2% per fiscal year. These
reductions went
into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute,
 will remain in effect through 2030, with the exception of a
temporary suspension from May
1, 2020 through March 31, 2022 due to the COVID-19 pandemic. Following the temporary suspension,
a 1% payment reduction will occur
beginning April 1, 2022 through June 30, 2022, and the
2% payment reduction will resume on July 1, 2022.
●
On
January 2, 2013, the U.S. American Taxpayer Relief Act of 2012 was signed into law, which,
among other things, further reduced Medicare payments to several types of
providers.
●
On
April 13, 2017, CMS published a final rule that gives states greater flexibility in setting
benchmarks for insurers in the individual and small group marketplaces, which
may have the
effect of relaxing the essential health benefits required under the ACA for plans sold through
such marketplaces.
●
On
May 30, 2018, the Right to Try Act, was signed into law. The law, among other things, provides
a federal framework for certain patients to access certain investigational
new drug or biological
products that have completed a Phase 1 clinical trial and that are undergoing investigation
for FDA approval. Under certain circumstances, eligible
patients can seek treatment without
enrolling in clinical trials and without obtaining FDA permission under the FDA expanded
access program. There is no obligation for a
pharmaceutical manufacturer to make its products
available to eligible patients as a result of the Right to Try Act.
●
On May
23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using
step therapy for Part B drugs beginning January 1, 2020.
●
On
December 20, 2019, former President Trump signed into law the Further Consolidated Appropriations
Act (H.R. 1865), which repealed the Cadillac tax, the health
insurance provider tax, and
the medical device excise tax. It is impossible to determine whether similar taxes could
be instated in the future.
 
Additionally,
 there has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices. Specifically,
 there has been heightened
governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which
has resulted in several U.S. Congressional inquiries and proposed and
enacted federal and state legislation designed to, among other
things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, and review the
relationship between
pricing and manufacturer patient programs. At a federal level, President Biden signed an Executive Order on July 9, 2021 affirming the
administration’s policy to
(i) support legislative reforms that would lower the prices of prescription drug and biologics, including
by allowing Medicare to negotiate drug prices, by imposing inflation caps, and,
by supporting the development and market entry of lower-cost
generic drugs and biosimilars; and (ii) support the enactment of a public health insurance option. Among other things,
the Executive
Order also directs HHS to provide a report on actions to combat excessive pricing of prescription drugs, enhance the domestic drug supply
chain, reduce the price that the
Federal government pays for drugs, and address price gouging in the industry; and directs the FDA to
 work with states and Indian Tribes that propose to develop section 804
Importation Programs in accordance with the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003, and the FDA’s implementing regulations. FDA released such
implementing regulations
on September 24, 2020, which went into effect on November 30, 2020, providing guidance for states to build and submit importation plans
for drugs from
Canada. On September 25, 2020, CMS stated drugs imported by states under this rule will not be eligible for federal rebates
under Section 1927 of the Social Security Act and
manufacturers would not report these drugs for “best price” or Average
Manufacturer Price purposes. Since these drugs are not considered covered outpatient drugs, CMS further stated
it will not publish a
National Average Drug Acquisition Cost for these drugs. If implemented, importation of drugs from Canada may materially and adversely
affect the price we
receive for any of our product candidates. Further, on November 20, 2020 CMS issued an Interim Final Rule implementing
the Most Favored Nation, or MFN, Model under which
Medicare Part B reimbursement rates would have been calculated for certain drugs
and biologicals based on the lowest price drug manufacturers receive in Organization for Economic
Cooperation and Development countries
 with a similar gross domestic product per capita. However, on December 29, 2021 CMS rescinded the Most Favored Nations rule.
Additionally,
on November 30, 2020, HHS published a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers
to plan sponsors under Part
D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The
rule also creates a new safe harbor for price reductions reflected at the point-
of-sale, as well as a safe harbor for certain fixed fee
arrangements between pharmacy benefit managers and manufacturers. Pursuant to court order, the removal and addition of the
aforementioned
safe harbors were delayed and recent legislation imposed a moratorium on implementation of the rule until January 1, 2026. Although a
number of these and other
proposed measures may require authorization through additional legislation to become effective, and the Biden
administration may reverse or otherwise change these measures, both
the Biden administration and Congress have indicated that they will
continue to seek new legislative measures to control drug costs.
 
We
expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that
the U.S. Federal Government will pay for
healthcare drugs and services, which could result in reduced demand for our drug candidates
or additional pricing pressures.
 
Other
U.S. Environmental, Health and Safety Laws and Regulations
 
We
may be subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and
the handling, use, storage, treatment and
disposal of hazardous materials and wastes. From time to time and in the future, our operations
may involve the use of hazardous and flammable materials, including chemicals and
biological materials, and may also produce hazardous
 waste products. Even if we contract with third parties for the disposal of these materials and waste products, we cannot
completely eliminate
the risk of contamination or injury resulting from these materials. In the event of contamination or injury resulting from the use or
disposal of our hazardous
materials, we could be held liable for any resulting damages, and any liability could exceed our resources.
We also could incur significant costs associated with civil or criminal fines
and penalties for failure to comply with such laws and
regulations.
 
17

 
 
We
maintain workers’ compensation insurance to cover us for costs and expenses that we may incur due to injuries to our employees,
but this insurance may not provide adequate
coverage against potential liabilities. However, we do not maintain insurance for environmental
liability or toxic tort claims that may be asserted against us.
 
In
addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.
Current or future environmental laws and
regulations may impair our research, development or production efforts. In addition, failure
to comply with these laws and regulations may result in substantial fines, penalties or other
sanctions.
 
Government
Regulation of Biologics Outside of the United States
 
In
addition to regulations in the United States, we will be subject to a variety of regulations in other jurisdictions governing, among
other things, clinical trials and any commercial
sales and distribution of our products. The cost of establishing a regulatory compliance
system for numerous varying jurisdictions can be very significant. Although many of the issues
discussed above with respect to the United
States apply similarly in the context of the European Union and in other jurisdictions, the approval process varies between countries
and
jurisdictions and can involve additional product testing and additional administrative review periods. The time required to obtain
approval in other countries and jurisdictions might
differ from and be longer than that required to obtain FDA approval. Regulatory approval
in one country or jurisdiction does not ensure regulatory approval in another, but a failure or
delay in obtaining regulatory approval
in one country or jurisdiction may negatively impact the regulatory process in others.
 
Whether
or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in foreign countries
prior to the commencement of clinical
trials or marketing of the product in those countries. Certain countries outside of the United
States have a similar process that requires the submission of a clinical trial application
much like the IND prior to the commencement
of human clinical trials. In the European Union, on January 31, 2022, the new Clinical Trials Regulation (EU) No 536/2014 became
directly
applicable in all the European Union Member States and simplifies and streamlines the approval of clinical trials in the European Union.
The transitory provisions of the new
Regulation provide that ongoing clinical trials authorized under the previous EU Clinical Trials
Directive can remain under the Directive, or they can transition to the Regulation. By
January 31, 2025, all ongoing clinical trials
must have transitioned to the new Regulation. The main characteristics of the regulation include: a streamlined application procedure
via a
single entry point, the “Clinical Trials Information System”, a single set of documents to be prepared and submitted
for the application; and a harmonized procedure for the assessment
of applications for clinical trials. Strict deadlines have also been
established for the assessment of clinical trial applications. To obtain regulatory approval of a medicinal product under
European Union
regulatory systems, we must submit a marketing authorization application. The application required in the European Union is similar to
a BLA in the United States,
with the exception of, among other things, country-specific document requirements. The European Union also
provides opportunities for market exclusivity. For example, in the
European Union, upon receiving marketing authorization, new chemical
entities generally receive eight years of data exclusivity and an additional two years of market exclusivity. If
granted, data exclusivity
prevents generic or biosimilar applicants from referencing the innovator’s preclinical and clinical trial data contained in the
dossier of the reference product
when applying for a generic or biosimilar marketing authorization in the European Union, for a period
of eight years from the date on which the reference product was first authorized
in the European Union. During the additional two-year
period of market exclusivity, a generic or biosimilar marketing authorization can be submitted, and the innovator’s data may be
referenced, but no generic or biosimilar product can be marketed until the expiration of the market exclusivity. The innovator may obtain
an additional one year of market exclusivity if
the innovator obtains an additional authorization during the initial eight year period
for one or more new indications that demonstrate significant clinical benefit over existing therapies.
However, there is no guarantee
that a product will be considered by the European Union’s regulatory authorities to be a new chemical entity, and products may
not qualify for data
exclusivity. The same exclusivity periods are available for new biologics.
 
Orphan
medicinal products in the European Union are eligible for 10-year market exclusivity. A “similar medicinal product” is defined
as a medicinal product containing a similar
active substance or substances as contained in an authorized orphan medicinal product, and
which is intended for the same therapeutic indication. This 10-year market exclusivity may
be reduced to six years if, at the end of
the fifth year, it is established that the product no longer meets the criteria for orphan designation, for example, if the product is
sufficiently
profitable not to justify maintenance of market exclusivity. During the period of market exclusivity, a marketing authorization
may only be granted to a “similar medicinal product” for
the same indication at any time if:
 
●
the
second applicant can establish that its product, although similar, is safer, more effective
or otherwise clinically superior to the authorized product;
●
the
marketing authorization holder for the authorized orphan product consents to a second orphan
medicinal product application; or
●
the
marketing authorization holder for the authorized orphan product cannot supply enough orphan
medicinal product.
 
18

 
 
The
European Union adopted the new Clinical Trials Regulation (EU) No 536/2014 in April 2014, which replaced the Clinical Trials Directive
2001/20/EC on January 31, 2022. The
transitory provisions of the new Regulation offer sponsors the possibility to choose between the
requirements of the previous Directive and the new Regulation if the request for
authorization of a clinical trial is submitted in the
year after the new Regulation became applicable. If the sponsor chooses to submit under the Directive, the clinical trial continues to
be governed by the previous Directive until three years after the new Regulation became applicable. If a clinical trial continues for
more than three years after the Regulation became
applicable, the new Regulation will at that time begin to apply to the clinical trial.
The new Regulation overhauls the system of approvals for clinical trials in the European Union.
Specifically, it is directly applicable
 in all Member States (meaning that no national implementing legislation in each Member State is required), and aims at simplifying and
streamlining the approval of clinical trials in the European Union. The main characteristics of the new Regulation include: a streamlined
application procedure via a single-entry point
through the Clinical Trials Information System; a single set of documents to be prepared
and submitted for the application as well as simplified reporting procedures for clinical trial
sponsors; and a harmonized procedure
 for the assessment of applications for clinical trials, which is divided in two parts (Part I contains scientific and medicinal product
documentation and Part II contains the national and patient-level documentation). Part I is assessed by a coordinated review by the competent
authorities of all European Union
Member States in which an application for authorization of a clinical trial has been submitted (Concerned
Member States) of a draft report prepared by a Reference Member State. Part
II is assessed separately by each Concerned Member State.
Strict deadlines have also been established for the assessment of clinical trial applications.
 
The
requirements and process governing the conduct of clinical trials, product approval or licensing, pricing and reimbursement vary from
country to country. In all cases, the clinical
trials are conducted in accordance with GCP, the applicable regulatory requirements and
the ethical principles that have their origin in the Declaration of Helsinki.
 
To
obtain regulatory approval of a medicinal product under European Union regulatory systems, we must submit a marketing authorization application.
The application required in the
European Union is similar to a BLA in the United States, with the exception of, among other things, country-specific
 document requirements. Marketing approvals in multiple
European Union Member States may be obtained through a centralized, mutual recognition
or decentralized procedure. The centralized procedure results in the grant of a single
marketing authorization that is valid throughout
the European Union Member States, as well as the additional Member States of the European Economic Area (Norway, Iceland and
Liechtenstein).
 
Pursuant
to Regulation (EC) No. 726/2004, as amended, the centralized procedure is mandatory for certain products, including those developed by
means of specified biotechnological
processes, advanced therapy medicinal products (gene-therapy, somatic-cell therapy, and tissue-engineered
products), products for human use containing a new active substance for
which the therapeutic indication is the treatment of specified
diseases, including AIDS, HIV, cancer, diabetes, neurodegenerative disorders, auto-immune diseases and other immune
dysfunctions and
viral diseases, as well as products designated as orphan medicinal products. The Committee for Medicinal Products for Human Use, or CHMP,
of the EMA also has
the discretion to permit other products to use the centralized procedure if it considers them sufficiently innovative
or they contain a new active substance or they may be of benefit to
public health at the European Union level.
 
Under
the centralized procedure in the European Union, the maximum timeframe for the evaluation of a marketing authorization application by
the EMA is 210 days, excluding clock
stops, when additional written or oral information is to be provided by the applicant in response
to questions asked by the CHMP. Clock stops may extend the timeframe of evaluation
of a marketing authorization application considerably
beyond 210 days. Where the CHMP gives a positive opinion, it provides the opinion together with supporting documentation to
the European
Commission, who makes the final decision to grant a marketing authorization, which is issued within 67 days of receipt of the EMA’s
recommendation. Accelerated
evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be
of major interest from the point of view of public health and in particular
from the viewpoint of therapeutic innovation. If the CHMP
accepts such request, the time limit of 210 days will be reduced to 150 days, excluding clock stops, but it is possible that the
CHMP
can revert to the standard time limit for the centralized procedure if it considers that it is no longer appropriate to conduct an accelerated
assessment.
 
Now
that the UK (which comprises Great Britain and Northern Ireland) has left the European Union, Great Britain will no longer be covered
by centralized marketing authorizations
(under the Northern Ireland Protocol, centralized marketing authorizations will continue to be
recognized in Northern Ireland). All medicinal products with a current centralized
marketing authorization were automatically converted
to Great Britain marketing authorizations on January 1, 2021. For a period of two years from January 1, 2021, the Medicines and
Healthcare
products Regulatory Agency the United Kingdom’s medicines regulator, may rely on a decision taken by the European Commission on
the approval of a new marketing
authorization in the centralized procedure, in order to more quickly grant a new Great Britain marketing
authorization. A separate application will, however, still be required.
 
The
 European Union also provides opportunities for market exclusivity. For example, in the European Union, upon receiving marketing authorization,
 new chemical innovative
medicinal products generally receive eight years of data exclusivity and an additional two years of market exclusivity.
If granted, data exclusivity prevents applicants for authorization
of generics or biosimilars of these innovative products in the European
Union from referencing the innovator’s preclinical and clinical trial data when applying for a generic or
biosimilar marketing
authorization in the European Union, during a period of eight years from the date on which the reference product was first authorized
in the European Union.
During the additional two-year period of market exclusivity, a generic marketing authorization can be submitted,
and the innovator’s data may be referenced, but no generic product
can be marketed until the expiration of the market exclusivity.
 The innovator may obtain an additional one year of market exclusivity if the innovator obtains an additional
authorization during the
initial eight year period for one or more new indications that demonstrate significant clinical benefit over currently approved therapies.
Even if a product is
considered to be an innovative medicinal product so that the innovator gains the prescribed period of data exclusivity,
another company may market another version of the product if
such company obtained a marketing authorization based on a marketing authorization
application with a completely independent data package of pharmaceutical tests, preclinical tests
and clinical trials. However, there
is no guarantee that a product will be considered by the European Union’s regulatory authorities to be a new chemical entity, and
products may not
qualify for data exclusivity. Similar exclusivity periods are available for new biologics.
 
19

 
 
A
product can be designated as an orphan medicinal product by the European Commission if its sponsor can establish: that (1) the product
is intended for the diagnosis, prevention or
treatment of a life-threatening or chronically debilitating condition; (2) either (a) such
 condition affects no more than five in 10,000 persons in the European Union when the
application is made, or (b) it is unlikely that
the product, without the benefits derived from orphan status, would generate sufficient return in the European Union to justify the
necessary
investment in its development; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of such condition authorized
for marketing in the European
Union or, if such method exists, the product will be of significant benefit to those affected by that condition.
Orphan medicinal products are eligible for financial incentives such as
reduction of fees or fee waivers. The application for orphan
designation must be submitted before the application for marketing authorization. The applicant will receive a fee reduction
for the
marketing authorization application if the orphan designation has been granted, but not if the designation is still pending at the time
the marketing authorization is submitted.
Orphan designation does not convey any advantage in, or shorten the duration of, the regulatory
review and approval process.
 
The
aforementioned European Union rules are generally applicable in the European Economic Area, which consists of the European Union Member
States, plus Norway, Liechtenstein
and Iceland.
 
On
June 23, 2016, the electorate in the United Kingdom voted in favor of leaving the European Union, commonly referred to as Brexit, and
the UK formally left the European Union
on January 31, 2020. There was a transition period during which European Union pharmaceutical
laws continued to apply to the United Kingdom, which expired on December 31,
2020. However, the European Union and the United Kingdom
have concluded a trade and cooperation agreement, or TCA, which was provisionally applicable since January 1, 2021
and has been formally
applicable since May 1, 2021. The TCA includes specific provisions concerning pharmaceuticals, which include the mutual recognition of
GMP, inspections of
manufacturing facilities for medicinal products and GMP documents issued, but does not foresee wholesale mutual recognition
 of United Kingdom and European Union
pharmaceutical regulations. At present, Great Britain has implemented European Union legislation
on the marketing, promotion and sale of medicinal products through the Human
Medicines Regulations 2012 (as amended) (under the Northern
Ireland Protocol, the European Union regulatory framework will continue to apply in Northern Ireland). The regulatory
regime in Great
Britain therefore broadly aligns with current European Union regulations, however it is possible that these regimes will diverge in future
now that Great Britain’s
regulatory system is independent from the European Union and the TCA does not provide for mutual recognition
of United Kingdom and European Union pharmaceutical legislation.
 
If
we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal
of regulatory approvals, product
recalls, seizure of products, operating restrictions and criminal prosecution.
 
Intellectual
Property
 
Our
success depends, at least in part, on our ability to protect our proprietary technology and intellectual property, and to operate without
infringing or violating the proprietary rights
of others. We rely on a combination of patent, trademark, trade secret and copyright laws,
 know-how, intellectual property licenses and other contractual rights, including
confidentiality and invention assignment agreements
to protect our intellectual property rights.
 
See
“Item 1A. Risk Factors—Risks Related to Our Intellectual Property” for additional discussion on our intellectual property
and associated risks.
 
Patents
 
As
of February 28, 2023, we have more than 148 granted patents and 28 applications pending worldwide for our former oncology
program and VTS platform technology. We also have
33 granted patents and 22 applications pending worldwide for
our VB-601 program and the MTT.
 
Trademarks
 
We
rely on trade names, trademarks and service marks to protect our name brands. Our trademarks and registered trademarks in several countries
include the following: “VTS,” “VBL
THERAPEUTICS,” “VASCULAR TARGETING SYSTEM VTS,” “VBL,”
 “V VBL THERAPEUTICS & Design,” “VASCULAR BIOGENICS,” “V & Design,” “GLOBE &
Design,”
“OVAL & Design” “VENHIBO,” “VENHEBO,” and “
(“VBL
Logo”)”.
 
Trade
Secrets and Confidential Information
 
In
addition to patented technology, we rely on our unpatented proprietary technology, trade secrets, processes and know-how. We rely on,
among other things, confidentiality and
invention assignment agreements to protect our proprietary know-how and other intellectual property
that may not be patentable, or that we believe is best protected by means that do
not require public disclosure. For example, we require
our employees to execute confidentiality agreements in connection with their employment relationships with us, and to disclose
and assign
to us inventions conceived in connection with their services to us. However, there can be no assurance that these agreements will be
enforceable or that they will provide us
with adequate protection.
 
20

 
 
We
may be unable to obtain, maintain and protect the intellectual property rights necessary to conduct our business, and may be subject
to claims that we infringe or otherwise violate
the intellectual property rights of others, which could materially harm our business.
 
Sales
and Marketing
 
We
have not yet established sales, marketing or product distribution operations because our product candidate, VB-601, is an early-stage
asset.
 
Manufacturing
 
We
rely on third-party manufacturers to manufacture supplies for our product candidate, VB-601. We also contract with additional third parties
for the formulating, labeling, packaging,
storage and distribution of the final drug product.
 
In
 October 2017, we announced the opening of a 20,000 sq. ft. new gene therapy manufacturing plant in Modi’in, Israel, which was
 planned to be the commercial facility for
production of our former lead product candidate, ofra-vec. Following the discontinuation
of the OVAL trial and ofra-vec program in all indications, we sought to monetize this facility
and in February 2023 entered into an
 agreement providing for the sale of our rights in this facility for $7.1 million, which transaction closed in March 2023. See
 “—Recent
Developments— Sale of Assets in the Modi’in Facility” above.
 
Human
Capital Resources
 
As
of March 1, 2023, we had seven employees, mostly within general and administrative positions, to support our corporate strategic
process and research and development. All of our
employees are located in Israel with the exception of one employee in the United
States, and three of our employees have either M.D.s or Ph.D.s. None of our employees currently
work under any collective bargaining
agreements. We have experienced significant employee turnover due to the reduction in force after the results of the OVAL study and
termination
of the ofra-vec program and sale of our rights in the Modi’in facility and pursuit of the proposed Merger and
 exploration of alternatives to monetize VB-601. This additional
uncertainty has resulted in further employee resignations. We
believe our employee relations with the remaining employees are good and we have provided additional severance
considerations to
retain such employees. See “Item 11. Executive Compensation” for additional information regarding these
additional retention benefits.
 
Israeli
labor laws govern the length of the workday, minimum wages for employees, procedures for hiring and dismissing employees, determination
of severance pay, annual leave,
sick days, advance notice of termination of employment, equal opportunity and anti- discrimination laws
and other conditions of employment. Subject to specified exceptions, Israeli
law generally requires severance pay upon the retirement,
death or dismissal of an employee, and requires us and our employees to make payments to the National Insurance Institute,
which is similar
to the U.S. Social Security Administration. Our employees have defined benefit pension plans that comply with the applicable Israeli
legal requirements.
 
Corporate
Information
 
The
legal name of our company is Vascular Biogenics Ltd., and we conduct business under the name VBL Therapeutics. We were incorporated in
Israel on January 31, 2000 as a
company limited by shares under the name Medicard Ltd. In February 2002, we changed our name to Vascular
Biogenics Ltd. Our registered and principal office is located 8 HaSatat
St., Modi’in, Israel 7178106 and our telephone number is
972-8-9935000. We also have a wholly owned U.S. subsidiary, VBL Inc., with an office located at 1 Blue Hill Plaza, Suite
1509, Pearl
River, NY 10965. Our internet website address is www.vblrx.com. The information contained on, or that can be accessed through, our website
is not a part of this Annual
Report on Form 10-K.
 
21

 
 
Item
1A. RISK FACTORS
 
In
February 2023, we entered into a Merger Agreement with Notable, pursuant to which, subject to the approval of our shareholders and the
satisfaction or waiver of the conditions set
forth in the Merger Agreement, if completed as proposed (which could be as early as the
second quarter of 2023), Notable’s stockholders would own a majority of the post-transaction
entity, its management team would replace
our management team, Notable’s business would become our business, and its financial statements would become our financial statements
under appliable accounting rules (e.g., Notable would be the “accounting acquiror” even though we would be the legal acquiror).
Additional information regarding the proposed
Merger including risk factors related to Notable will be found in VBL’s registration
statement on Form S-4 when filed with the U.S. Securities and Exchange Commission. You should
consider carefully the risks and uncertainties
described below, together with all of the other information in this Annual Report, including the financial statements and the related
notes
included elsewhere in this Annual Report and “Item 7. Management’s Discussion and Analysis of Financial Condition and
 Results of Operations.” The risks and uncertainties
described below are not the only ones we face. Additional risks and uncertainties
that we are unaware of, or that we currently believe are not material, may also become important
factors that adversely affect our business.
If any of the following risks actually occurs, our business, financial condition, results of operations, and future prospects could be
materially
and adversely affected.
 
Risks
Related to the Proposed Merger
 
There
is no assurance that the proposed Merger will be completed in a timely manner or at all. If the proposed Merger is not consummated, our
business could suffer
materially and our stock price could decline.
 
The closing of the proposed Merger is subject to the satisfaction or waiver
of a number of closing conditions, as described above, including the required approvals by our shareholders
and Notable’s stockholders
and other customary closing conditions. See “—The proposed Merger is subject to approval of the Merger Agreement by our
shareholders and the Notable
stockholders. Failure to obtain these approvals would prevent the closing of the Merger” and “—If
the conditions to the Merger are not met, the Merger will not occur” below. If the
conditions are not satisfied or waived, the
proposed Merger may be materially delayed or abandoned. If the proposed Merger is not consummated, our ongoing business may be
adversely
affected and, without realizing any of the benefits of having consummated the proposed Merger, we will be subject to a number of risks,
including the following:
 
●
we
have incurred and expect to continue to incur significant expenses related to the proposed
Merger even if the Merger is not consummated;
●
we
could be obligated to pay Notable a termination fee equal to $2,500,000 and/or cover Notable’s reasonable out-of-pocket
 expenses up to $500,000 under certain
circumstances set forth in the Merger Agreement;
●
the
market price of our ordinary shares may decline to the extent that the current market price
reflects a market assumption that the proposed Merger will be completed;
●
we
may not be able to meet the Nasdaq continued listing standards, which may lead to delisting
procedures by Nasdaq; and
●
matters
relating to the proposed Merger have required and will continue to require substantial commitments
 of time and resources by our remaining management and
employees, which could otherwise have
been devoted to other opportunities that may have been beneficial to us.
 
We
also could be subject to litigation related to any failure to consummate the proposed Merger or to perform our obligations under the
Merger Agreement. If the proposed Merger is
not consummated, these risks may materialize and may adversely affect our business, financial
condition and the market price of our ordinary shares.
 
If
the proposed Merger is not completed, we may be unsuccessful in completing an alternative transaction on terms that are as favorable
as the terms of the proposed
Merger with Notable, or at all, and we may otherwise be unable to continue to operate our business. Our
 board of directors may decide to pursue a dissolution and
liquidation of VBL. In such an event, the amount of cash available for distribution
to our shareholders will depend heavily on the timing of such liquidation as well as the
amount of cash that will need to be reserved
for commitments and contingent liabilities.
 
While
we have entered into the Merger Agreement with Notable, the closing of the proposed Merger may be delayed or may not occur at all and
there can be no assurance that the
proposed Merger will deliver the anticipated benefits we expect or enhance shareholder value. If we
are unable to consummate the proposed Merger, our board of directors may elect to
pursue an alternative strategy, one of which may be
a strategic transaction similar to the proposed Merger. Attempting to complete an alternative transaction like the proposed Merger
will
be costly and time consuming, and we can make no assurances that such an alternative transaction would occur at all. Alternatively, our
board of directors may elect to continue
our operations to advance the preclinical and clinical development of our program, which would
require that we obtain additional funding, and to resume our efforts to seek potential
collaborative, partnering or other strategic arrangements
for our program, including a sale or other divestiture of our program assets, or our board of directors could instead decide to
pursue
a dissolution and liquidation of our company. In such an event, the amount of cash available for distribution to our shareholders will
depend heavily on the timing of such
decision, and subject to the provisions of the Israeli Companies Law 5759-1999, or the Companies
Law, and with the passage of time the amount of cash available for distribution will
be reduced as we continue to fund our operations.
In addition, if our board of directors were to approve and recommend, and our shareholders were to approve, a voluntary liquidation
of
our company, our board of directors would be required under Israeli corporate law to declare that following examination of the company’s
state of affairs, the company will be able
to pay its outstanding debts within twelve months from the date on which the voluntary liquidation
commences, prior to making any distributions in liquidation to our shareholders.
Our commitments and contingent liabilities may include
severance obligations, regulatory and preclinical obligations, and fees and expenses related to the proposed Merger. As a result
of this
requirement, a portion of our assets may need to be reserved pending the resolution of such obligations. In addition, we may be subject
to litigation or other claims related to a
dissolution and liquidation. If a dissolution and liquidation were pursued, our board of directors,
in consultation with its advisors, would need to evaluate these matters and make a
determination about a reasonable amount to reserve.
Accordingly, holders of our ordinary shares could lose all or a significant portion of their investment in the event of a liquidation,
dissolution or winding up of the company.
 
22

 
 
The
issuance of our ordinary shares to Notable stockholders in the proposed Merger will substantially dilute the voting power of our current
shareholders.
 
If
the proposed Merger is completed, each outstanding share of Notable capital stock will be converted into the right to receive a number
of our ordinary shares equal to the exchange
ratio determined pursuant to the Merger Agreement. Immediately following the Merger, the
 former Notable equity holders immediately before the Merger are expected to own
approximately 76.0% of our ordinary shares, and our equity
holders immediately before the Merger are expected to own approximately 24.0% of our ordinary shares, each on a fully
diluted basis as
provided in the Merger Agreement and subject to certain assumptions. Accordingly, the issuance of our ordinary shares to Notable stockholders
in the Merger will
reduce significantly the relative voting power of each ordinary share held by our current shareholders. Consequently,
our shareholders as a group will have significantly less influence
over the management and policies of the combined company after the
Merger than prior to the Merger. These estimates are based on the anticipated exchange ratio and are subject to
adjustment as provided
in the Merger Agreement. See also “—The exchange ratio set forth in the Merger Agreement is not adjustable based on the
market price of our ordinary shares,
so the merger consideration at the closing of the Merger may have a greater or lesser value than
at the time the Merger Agreement was signed” below.
 
The
proposed Merger is subject to approval of the Merger Agreement by our shareholders and the Notable stockholders. Failure to obtain these
approvals would prevent
the closing of the Merger.
 
Before
the proposed Merger can be completed, our shareholders and the stockholders of Notable must approve the Merger Agreement. Failure to
obtain the required stockholder
approvals may result in a material delay in, or the abandonment of, the Merger. Any delay in completing
the proposed Merger may materially adversely affect the timing and benefits
that are expected to be achieved from the proposed Merger.
 
The
Merger may be completed even though certain events occur prior to the closing that materially and adversely affect our company or Notable.
 
The
Merger Agreement provides that either we or Notable can refuse to complete the proposed Merger if there is a material adverse change
affecting the other party between February
22, 2023, the date of the Merger Agreement, and the closing of the Merger that is continuing.
However, certain types of changes do not permit either party to refuse to complete the
proposed Merger, even if such change could be
said to have a material adverse effect on our company or Notable, including:
 
●
any
effect resulting from the announcement or pendency of the proposed Merger or any related
transactions;
●
the
taking of any action, or the failure to take any action, by either us or Notable required
to comply with the terms of the Merger Agreement, and with respect to us, the taking
of any
action expressly permitted under Section 5.1(b) of the disclosure schedule appended to the
Merger Agreement;
●
any
natural disaster or epidemics, pandemics or other force majeure events, or any act or threat
of terrorism or war, any armed hostilities or terrorist activities (including any
escalation
or general worsening of any of the foregoing) anywhere in the world or any governmental or
other response or reaction to any of the foregoing;
●
any
change in U.S. generally accepted accounting principles or any change in applicable laws,
rules, or regulations or the compliance with or interpretation thereof;
●
general
economic or political conditions or conditions generally affecting the industries in which
we or Notable, as applicable, operate;
●
with
respect to Notable, any change in the cash position of Notable that results from operations
in the ordinary course of its normal operations and consistent with its past
practices;
●
with
respect to our company, any change in our stock price or trading volume excluding any underlying
effect that may have caused such change;
●
with
respect to our company, the suspension of trading in or delisting of our ordinary shares
on Nasdaq; and
●
with
respect to our company, the sale or winding down of our business as conducted prior to the
date of the Merger Agreement and our operations, and the sale, license or
other disposition
of all of our assets, technology and intellectual property as they existed at any time prior
to the date of the Merger Agreement.
 
If
adverse changes occur and we and Notable still complete the Merger, the market price of the combined organization’s ordinary shares
may suffer. This in turn may reduce the value
of the Merger to the equityholders of our company, Notable or both.
 
23

 
 
Some
of our and Notable’s officers and directors have interests in the proposed Merger that are different from the respective securityholders,
and that may influence them to
support or approve the Merger without regard to the interests of the respective securityholders.
 
Certain
officers and directors of our company and of Notable participate in arrangements that provide them with interests in the proposed Merger
that are different from the interests of
the respective securityholders, including, among others, the continued service as an officer
or director of the combined organization, severance benefits, the acceleration of option
vesting, continued indemnification and the potential
ability to sell an increased number of ordinary shares of the combined organization in accordance with Rule 144 under the
Securities
Act of 1933, as amended.
 
For
example, we have entered into certain employment and severance benefits agreements with certain of our executive officers that may result
in the receipt by such executive officers
of cash severance payments and other benefits in the event of a covered termination of employment
of each executive officer’s employment. The closing of the Merger will also result
in the acceleration of vesting of options to
purchase ordinary shares and restricted stock units, or RSUs, held by our executive officers and directors, whether or not there is a
covered
termination of such officer’s employment. In addition, and for example, certain of Notable’s directors and executive
officers have options, subject to vesting, to purchase shares of
Notable’s capital stock that, at the closing of the Merger, will
be converted into and become options to purchase our ordinary shares, certain of Notable’s directors and executive
officers are
expected to become directors and executive officers of our company upon the closing of the Merger, and all of Notable’s directors
and executive officers are entitled to
certain indemnification and liability insurance coverage pursuant to the terms of the Merger Agreement.
These interests, among others, may influence our officers and directors and
those of Notable to support or approve the proposed Merger.
 
The
market price of our ordinary shares following the Merger may decline as a result of the Merger.
 
The
market price of our ordinary shares may decline as a result of the Merger for a number of reasons including if:
 
●
investors
react negatively to the prospects of the combined organization’s product candidates,
business and financial condition following the Merger;
●
the
effect of the Merger on the combined organization’s business and prospects is not consistent
with the expectations of financial or industry analysts; or
●
the
combined organization does not achieve the perceived benefits of the Merger as rapidly or
to the extent anticipated by financial or industry analysts.
 
Our
equityholders will have a reduced ownership and voting interest in, and will exercise less influence over the management of, the combined
organization following the
closing of the Merger as compared to their current ownership and voting interest.
 
After
the completion of the Merger, the current securityholders of our company and Notable will own a smaller percentage of the combined company
than their ownership in their
respective companies prior to the Merger. Immediately after the Merger, it is currently estimated that
Notable equityholders will own approximately 76.0% of the ordinary shares of the
combined company, and our equityholders, whose ordinary
shares will remain outstanding after the Merger, will own approximately 24.0% of the Vibrant Ordinary Shares (as defined
in the Merger
Agreement) subject to certain assumptions. These estimates are based on the anticipated exchange ratio and are subject to adjustment
 as provided in the Merger
Agreement. See also “—The exchange ratio set forth in the Merger
Agreement is not adjustable based on the market price of our ordinary shares, so the merger consideration at the
closing of the Merger
may have a greater or lesser value than at the time the Merger Agreement was signed” below.
 
In
addition, the up to seven member board of directors of the combined company will initially include one individual with prior affiliations with our company. Consequently, our
securityholders and those of Notable will
be able to exercise less influence over the management and policies of the combined organization following the closing of the Merger
than
they currently exercise over the management and policies of their respective companies.
 
Our
shareholders and Notable stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience
in connection with the
Merger.
 
If
the combined company is unable to realize the strategic and financial benefits currently anticipated from the proposed Merger, our shareholders
and Notable’s stockholders will have
experienced substantial dilution of their ownership interests in their respective companies
 without receiving the expected commensurate benefit, or only receiving part of the
commensurate benefit to the extent the combined company
is able to realize only part of the expected strategic and financial benefits currently anticipated from the proposed Merger.
 
24

 
 
The
combined company will need to raise additional capital by issuing securities or debt or through licensing or other strategic arrangements,
which may cause dilution to
the combined company’s shareholders or restrict the combined company’s operations or impact its
proprietary rights.
 
The
combined company may be required to raise additional funds sooner than currently planned. In this regard, the exchange ratio may be impacted
by cash levels of the respective
companies at the closing of the Merger. The Merger Agreement conditions the completion of the Merger
 upon us holding a minimum amount of cash greater than or equal to
$15,000,000 at the effective time of the Merger. The Merger Agreement
does not condition the completion of the Merger upon Notable holding a minimum amount of cash at the
effective time of the Merger. If
either or both of our company or Notable hold less cash at the time of the closing Merger than the parties currently expect, the combined
company will
need to raise additional capital sooner than expected. Additional financing may not be available to the combined company
when it needs it or may not be available on favorable terms.
To the extent that the combined company raises additional capital by issuing
 equity securities, such an issuance may cause significant dilution to the combined company’s
shareholders’ ownership and
the terms of any new equity securities may have preferences over the combined company’s ordinary shares. Any debt financing the
combined company
enters into may involve covenants that restrict its operations. These restrictive covenants may include limitations
on additional borrowing and specific restrictions on the use of the
combined company’s assets, as well as prohibitions on its ability
to create liens, pay dividends, redeem its stock or make investments. In addition, if the combined company raises
additional funds through
licensing, partnering or other strategic arrangements, it may be necessary to relinquish rights to some of the combined company’s
technologies or product
candidates and proprietary rights, or grant licenses on terms that are not favorable to the combined company.
 
During
the pendency of the proposed Merger, we and Notable may not be able to enter into a business combination with another party at a favorable
price because of
restrictions in the Merger Agreement, which could adversely affect our respective businesses.
 
Covenants
in the Merger Agreement impede our ability and that of Notable to make acquisitions, subject to certain exceptions relating to fiduciary
duties, as set forth below, or to
complete other transactions that are not in the ordinary course of business pending completion of the
proposed Merger. As a result, if the Merger is not completed, the parties may be at
a disadvantage to their competitors during such period.
In addition, while the Merger Agreement is in effect, each party is generally prohibited from soliciting, initiating, encouraging
or
entering into certain extraordinary transactions, such as a merger, sale of assets, or other business combination outside the ordinary
course of business with any third party, subject to
certain exceptions relating to fiduciary duties. Any such transactions could be favorable
to such party’s stockholders.
 
Certain
provisions of the Merger Agreement may discourage third parties from submitting alternative takeover proposals, including proposals that
may be superior to the
arrangements contemplated by the Merger Agreement.
 
The
terms of the Merger Agreement prohibit each of us and Notable from soliciting alternative takeover proposals or cooperating with persons
making unsolicited takeover proposals,
except in limited circumstances when such party’s board of directors determines in good
faith that an unsolicited bona fide alternative takeover proposal is more favorable, from a
financial point of view, to either our shareholders
or Notable’s stockholders, as applicable, than the terms of the Merger and is not subject to any financing conditions (or, if financing
is
required, such financing is then fully committed to the third party). With respect to us, our board of directors must also determine
in good faith that the failure to enter into such
alternative takeover proposal would reasonably be expected to be inconsistent with
its fiduciary obligations, and we are required to pay a termination fee of $2,500,000.
 
The
exchange ratio set forth in the Merger Agreement is not adjustable based on the market price of our ordinary shares, so the merger consideration
at the closing of the
Merger may have a greater or lesser value than at the time the Merger Agreement was signed.
 
The
Merger Agreement has set the exchange ratio for the Notable capital stock, and the exchange ratio is based on the outstanding
capital stock of Notable and our outstanding
ordinary shares, in each case immediately prior to the closing of the Merger. Applying
 the exchange ratio formula in the Merger Agreement, the former Notable equityholders
immediately before the Merger are expected to
 own approximately 76.0% of the combined company’s outstanding ordinary shares immediately following the Merger, and our
equityholders immediately before the Merger are expected to own approximately 24.0% of the combined company’s outstanding
ordinary shares, each on a fully diluted basis as
provided in the Merger Agreement. Under certain circumstances further described in
 the Merger Agreement, however, these ownership percentages may be adjusted upward or
downward based on cash levels of the respective
companies at the closing of the Merger and the terms and net proceeds of Notable’s pre-merger financing, and as a result, either our
shareholders or the Notable stockholders could own less of the combined company than expected.
 
Any
changes in the market price of our ordinary shares before the completion of the Merger will not affect the number of ordinary shares
issuable to Notable’s stockholders pursuant to
the Merger Agreement. Therefore, if before the completion of the Merger the market
price of our ordinary shares declines from the market price on the date of the Merger Agreement,
then Notable’s stockholders could
receive merger consideration with substantially lower value than the value of such merger consideration on the date of the Merger Agreement.
Similarly, if before the completion of the Merger the market price of our ordinary shares increases from the market price of our ordinary
shares on the date of the Merger Agreement,
then Notable’s stockholders could receive merger consideration with substantially greater
value than the value of such merger consideration on the date of the Merger Agreement. The
Merger Agreement does not include a price-based
termination right. Because the exchange ratio does not adjust as a result of changes in the market price of our ordinary shares, for
each one percentage point change in the market price of our ordinary shares, there is a corresponding one percentage point rise or decline,
respectively, in the value of the total merger
consideration payable to Notable’s stockholders pursuant to the Merger Agreement.
 
25

 
 
Because
the lack of a public market for Notable’s capital stock makes it difficult to evaluate the value of Notable’s capital stock,
the stockholders of Notable may receive our
ordinary shares in the Merger that have a value that is less than, or greater than, the fair
market value of Notable’s capital stock.
 
The
outstanding capital stock of Notable is privately held and is not traded in any public market. The lack of a public market makes it extremely
difficult to determine the fair market
value of Notable. Because the percentage of our ordinary shares to be issued to Notable’s
stockholders was determined based on negotiations between the parties, it is possible that the
value of our ordinary shares to be received
by Notable’s stockholders will be less than the fair market value of Notable, or we may pay more than the aggregate fair market
value for
Notable.
 
If
the conditions to the Merger are not met, the Merger will not occur.
 
Even
if the Merger is approved by our shareholders and Notable stockholders, specified conditions must be satisfied or waived to complete
the Merger. We cannot assure you that all of
the conditions will be satisfied or waived. If the conditions are not satisfied or waived,
the Merger will not occur or will be delayed, and we and Notable each may lose some or all of
the intended benefits of the proposed Merger.
 
Litigation
relating to the proposed Merger could require us or Notable to incur significant costs and suffer management distraction, and could delay
or enjoin the proposed
Merger.
 
We
and Notable could be subject to demands or litigation related to the proposed Merger, whether or not the Merger is consummated. Such
actions may create uncertainty relating to
the Merger, or delay or enjoin the Merger. Litigation is often expensive and diverts management’s
attention and resources, which could adversely affect our or Notable’s business.
 
Risks
Related to Our Financial Condition and Capital Requirements
 
We
have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable
future.
 
We
are an early clinical-stage biotechnology company, and we have not yet generated any regular revenue streams. We have incurred losses
in each year since our inception in 2000,
including net losses of $32.3 million and $29.9 million for the years ended December 31, 2022
and 2021, respectively. As of December 31, 2022, we had an accumulated deficit of
$294.4 million.
 
Historically,
we have devoted most of our financial resources to research and development, including our clinical and preclinical development
activities. To date, we have financed our
operations primarily through the sale of equity securities and convertible debt and, to a
lesser extent, through grants from governmental agencies. The amount of our future net losses
will depend, in part, on the rate of
our future expenditures and our ability to obtain funding through equity or debt financings, strategic collaborations or additional
grants. We have
never completed a pivotal clinical trial for any of our product candidates. Ofra-vec, our former product candidate
did not meet the primary endpoint in our Phase 3 OVAL trial and
accordingly, we ceased development of ofra-vec in August 2002. Our
current product candidate, VB-601, is in very early stages and it will be a few years, if ever, before we have a
product candidate
ready for commercialization. Even if we decided to pursue future clinical trials of VB-601 or any other product candidates and they
are successful such that we
obtain regulatory approval to market a product, our future revenues will depend upon the size of any markets
in which such product receives approval, and our ability to achieve
sufficient market acceptance, reimbursement from third-party
payers and adequate market share for any approved product in those markets.
 
We
expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses
will increase substantially if and as we:
 
●
continue
our research, preclinical, and clinical development activities for our product candidate
and future product candidates;
●
conduct
current clinical trials for our product candidate;
●
initiate
additional research, preclinical, clinical or other studies for our product candidate;
●
seek
regulatory and marketing approvals for our product candidate if such candidate successfully
completes clinical trials;
●
further
develop the manufacturing process for our product candidate using a third-party manufacturer;
●
change
or add additional manufacturers or suppliers;
●
establish
a sales, marketing and distribution infrastructure to commercialize any product for which
we may obtain marketing approval;
●
seek
to identify and validate additional product candidates;
●
acquire
or in-license other product candidates and technologies;
●
make
milestone or other payments under any in-license or other intellectual property related agreements
from any licensing arrangements we may enter into the future;
●
maintain,
protect and expand our intellectual property portfolio;
●
attract
and retain skilled personnel;
●
create
additional infrastructure to support our operations as a public company;
●
transition
from being a foreign private issuer to a U.S. reporting company; and
●
experience
any delays or encounter issues with any of the above.
 
26

 
 
The
net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of
our results of operations may not be a good
indication of our future performance. In any particular quarter or quarters, our operating
results could be below the expectations of securities analysts or investors, which could cause
our share price to decline.
 
We
have never generated any revenue from product sales and may never be profitable.
 
Our
ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully
complete the development of, obtain the
regulatory approvals of, and commercialize a product candidate. We do not anticipate generating
revenues from product sales for the foreseeable future, if ever. Our ability to generate
future revenues from product sales depends heavily
on our success in:
 
●
completing
research, preclinical, and clinical development activities for a product candidate;
●
successful
outcomes from our current and future trials evaluating a product candidate;
●
obtaining
regulatory and marketing approvals for a product candidate for which we complete successful
clinical trials;
●
developing
a sustainable, scalable, reproducible, and transferable manufacturing process for a product
candidate;
●
establishing
and maintaining supply and manufacturing relationships with third parties that can provide
products and services adequate, in amount and quality, to support
clinical development and
the market demand for a product candidate, if approved;
●
launching
and commercializing any product candidate for which we obtain regulatory and marketing approval,
 either by collaborating with a partner or, if launched
independently, by establishing a sales,
marketing and distribution infrastructure;
●
obtaining
market acceptance of any product candidate that receives regulatory approval as a viable
treatment options;
●
addressing
any competing technological and market developments;
●
implementing
additional internal systems and infrastructure, as needed;
●
identifying
and validating new product candidates;
●
negotiating
favorable terms in any collaboration, licensing or other arrangements into which we may enter;
●
maintaining,
protecting and expanding our portfolio of intellectual property rights, including patents,
trade secrets and know-how; and
●
attracting,
hiring and retaining qualified personnel.
 
Even
if one or more of our product candidates are approved for commercial sale, we anticipate incurring significant costs associated with
commercializing any approved product
candidate. Our expenses could increase beyond expectations if we are required by the FDA, the EMA,
or other regulatory agencies, domestic or foreign, to perform clinical and other
studies in addition to those that we currently anticipate.
Even if we are able to generate revenues from the sale of any approved product, we may not become profitable and may need to
obtain additional
funding to continue operations.
 
We
are not in compliance with Nasdaq’s minimum bid price requirement and if we fail to regain compliance with Nasdaq’s continued
listing requirements, our ordinary
shares could be delisted, which could adversely affect the liquidity of our ordinary shares and our
ability to raise additional capital or complete the Merger. The Merger is a
“change of control” and the combined company will need to satisfy
all of Nasdaq’s initial listing criteria to remain listed on Nasdaq.
 
On
August 31, 2022, we received a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC, or Nasdaq,
notifying us that our listed securities did
not maintain the minimum bid price requirement of $1.00 per ordinary share for continued
listing on The Nasdaq Global Market for a period of 30 consecutive business days as
required under Nasdaq Listing Rule 5450(a)(1). Nasdaq
Listing Rule 5550(a)(2) requires listed securities to maintain a minimum closing bid price of $1.00 per share, and Nasdaq
Listing Rule
5810(c)(3)(A) provides that a failure to meet the minimum closing bid price requirement exists if the deficiency continues for a period
of 30 consecutive business days.
 
In
accordance with Nasdaq’s Listing Rule 5810(c)(3)(A), we had a period of 180 calendar days, or until February 27, 2023, or the
Compliance Period, to regain compliance with the
minimum closing bid price requirement. If at any time during the Compliance Period,
our ordinary shares had a closing bid price of at least $1.00 for 10 consecutive business days,
Nasdaq would have provided us a
written confirmation of compliance and the matter would have been closed. However, we did not regain compliance by February 27,
2023, requested
a transfer of our listing to the Nasdaq Capital Market, and received an additional 180 day period to regain
compliance. If, compliance with the minimum closing bid price requirement
cannot be demonstrated by the end of this second
compliance period, Nasdaq will provide written notification that our ordinary shares will be delisted. At that time, we may appeal
Nasdaq’s determination to a Hearings Panel. We intend to monitor the closing bid price of our ordinary shares and may, if
appropriate, consider available options to regain compliance
with the minimum bid price requirement. If we complete the merger with Notable, this will be deemed a “change in control” under Nasdaq’s
rules, and the combined company will
need to satisfy all of Nasdaq’s initial listing criteria. If the merger is consummated and
the combined entity fails to either qualify for listing or timely complete Nasdaq’s initial listing
process prior to consummation,
this could also result in a suspension of trading and possible delisting.
 
27

 
 
We
have undergone a significant workforce reduction to reduce operating expenses and extend our cash runway, but such efforts may not
yield the anticipated benefits,
which could have a material effect on our operations.
 
On
August 2, 2022, we announced an organizational streamlining designed to reduce operating expenses and preserve capital. As a result,
to date, we reduced have significantly
reduced our workforce and currently have only seven full-time employees. As part of the organizational
streamlining, Dr. Ron Cohen, Dr. Bennett Shapiro and Ms. Alison Finger
resigned from our board of directors, effective August 1, 2022,
reducing the number of members of our board of directors from nine to six. The reduction in workforce is expected to
reduce operating
expenses and extend our cash runway, but the reduction in workforce may not have as significant a benefit as anticipated. As a result,
we may need to raise additional
capital or take additional measures to be able to continue our operations as expected and consummate
any strategic transaction, including the Merger or any transaction involving VB-
601.
 
We
 are exploring strategic alternatives to enhance shareholder value, including the proposed Merger with Notable, transactions involving
 VB-601 and the recently
completed sale of our Modi’in facility lease rights. We may not be successful in consummating the Merger
or any other strategic transaction or they may not deliver the
value to our shareholders that we anticipate.
 
Based
on the results of the Phase 3 OVAL clinical trial, we began exploring strategic alternatives to enhance shareholder value and engaged Chardan
as our exclusive financial advisor
to assist in this process. The strategic alternatives that we explored included some or all
of the following: license, divestiture, or monetization of current assets; license or acquisition of
additional assets; merger, reverse
merger, joint venture, partnership, or other business combination with another entity, public or private.
 
Following
this review process, on February 15, 2023, we entered into an asset purchase agreement providing for the sale of our rights to lease the
Modi’in facility and certain related
assets (which sale closed on March 9, 2023). Further, on February 22, 2023, we entered
into the Merger Agreement, pursuant to which, and subject to the satisfaction or waiver of the
conditions set forth therein,
Notable will become our wholly-owned subsidiary and its management and stockholders will control our company and its financial
statements will become
our financial statements under applicable accounting rules. There can be no assurance that we will be able to
successfully consummate the proposed Merger on a timely basis or at all,
or that this transaction as well as any transaction we may
pursue for VB-601, will successfully enhance shareholder value. If we are unable to execute on this or other strategic
alternatives, we may be
forced to liquidate.
 
The
process of pursuing these or any other strategic alternatives could adversely impact our business, financial condition and results of
operations and we have incurred and will
continue to incur substantial expenses associated with these processes, including those related
to equity compensation, severance pay and insurance, legal, accounting and financial
advisory fees. In addition, the process is time
consuming and may be disruptive to our business operations, could divert the attention of management and the board of directors from
our business, has led to additional resignations from our workforce and could interfere with our ability to retain our remaining employees,
and could expose us to potential litigation in
connection with this process or any resulting transaction. Further, speculation regarding
any developments related to the consummation of our strategic alternatives and perceived
uncertainties related to our future could cause
our stock price to fluctuate significantly.
 
We
may need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital
when needed may force us to
delay, limit or terminate our product development efforts or other operations.
 
Developing pharmaceutical products is expensive,
 and we expect our research and development expenses to increase substantially in connection with any expanded activities,
particularly
as we advance any product candidate in clinical trials.
 
As
of December 31, 2022, our cash and cash equivalents, restricted cash, and short-term bank deposits were $21.1 million. We estimate
that the balance of cash, cash equivalents,
restricted cash, and short-term bank deposits be sufficient to fund our operations for
at least 12 months from the date of this filing and , together with the proceeds from the sale of
rights to lease the Modi’in
facility and certain related assets, meet our minimum cash requirements in the Merger Agreement. However, our operating plan may change as a result of
many
factors including our ability to consummate the Merger or the asset sale, and we may need to seek additional funds sooner than
planned through public or private equity or debt
financings, government or other third-party funding, marketing and distribution
arrangements and other collaborations, strategic alliances and licensing arrangements or a combination
of these approaches. In any
event, even if we can complete the Merger and sale of our rights, we will require additional capital to obtain regulatory approval
for any product candidate,
and commercialize and market any product that receives regulatory approval. Raising funds in the current
economic environment may present additional challenges. Global health
concerns resulting from the outbreak of the coronavirus and
worldwide macroeconomic turmoil may have long-term lasting effects on our ability to raise capital, many of which are
difficult for
us to predict at this time. Even if we believe we have sufficient funds for our current or potential future operating plans, we may
seek additional capital if market conditions
are favorable or if we have specific strategic considerations.
 
Any
 additional fundraising efforts may divert our management from their day-to-day activities, which may compromise our ability to develop
 and commercialize any product
candidate. In addition, we cannot guarantee that future financing will be available in sufficient amounts
or on terms acceptable to us, if at all. Moreover, the terms of any financing may
adversely affect the holdings or the rights of our
shareholders, and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause
the
market price of our ordinary shares to decline. The sale of additional equity or convertible securities would dilute all of our shareholders.
The incurrence of indebtedness would result
in increased fixed payment obligations, and we may be required to agree to certain restrictive
covenants such as limitations on our ability to incur additional debt, limitations on our
ability to acquire, sell or license intellectual
property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required
to
seek funds through arrangements with collaborative partners or otherwise at an earlier stage than would be desirable, and we may be
required to relinquish rights to our technology or
product candidate or otherwise agree to terms unfavorable to us.
 
28

 
 
If
we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue our research or
development program or the commercialization of
any product candidate, and we may be unable to expand our operations or otherwise capitalize
 on our business opportunities, as desired. We may also need to curtail or cease
operations.
 
We
have received Israeli governmental grants to assist in the funding of our research and development activities. If we monetize the programs
funded by these grants, we
would owe royalties and other payments which could harm our operating results.
 
Through
December 31, 2022 we had received an aggregate of $29.4 million in grants from the Israeli Innovation Authority, or IIA. Under the Israel
Encouragement of Research and
Development in Industries, or the Research Law, royalties of 3% to 3.5% on the revenues derived from sales
of products or services developed in whole or in part using these IIA
grants are payable to the Israeli government. The maximum aggregate
royalties paid for each technology or program separately, generally cannot exceed 100% of the grants made to us
for such technology or
program, plus annual interest. We developed ofra-vec and another previously developed program utilizing IIA funds, neither of which we
expect to be able to
commercialize, and would therefore do not expect to be liable for repayment of such grants. As of December 31, 2022,
the balance of the principal and interest in respect of our
commitments for these potential future payments to the IIA totaled approximately
$38.4 million. To date, we have paid the IIA in relation to our license agreement, royalties of
approximately $0.6 million. If we monetize
the programs funded by these grants, we would owe royalties and other payments, which could harm our operating results.
 
The
Israeli government grants we have received for research and development expenditures restrict our ability to manufacture product candidates
and transfer technologies
outside of Israel and require us to satisfy certain conditions. If we fail to satisfy these conditions, we
may be required to refund grants previously received together with
interest and penalties.
 
Under
 the Research Law, we are required to manufacture the majority of any product candidate developed using these grants in the State of
 Israel or otherwise ask for special
approvals. We may not receive the required approvals for any proposed transfer of manufacturing
activities outside of Israel. Even if we do receive approval to manufacture a product
candidate developed with government grants
outside of Israel, the royalty rate may be increased and we may be required to pay up to 300% of the grant amounts plus interest,
depending on the manufacturing volume that is performed outside of Israel. This restriction may impair our ability to outsource
manufacturing or engage in our own manufacturing
operations for those product candidates or technologies. See “Item 7.
 Management’s Discussion and Analysis of Financial Condition and Results of Operations” for additional
information.
 
Additionally,
under the Research Law, we are prohibited from transferring, including by way of license, the IIA-financed technologies and related intellectual
property rights and
know-how outside of the State of Israel, except under limited circumstances and only with the approval of the IIA
Research Committee. We may not receive the required approvals for
any proposed transfer and, even if received, we may be required to
pay the IIA a portion, to be set by the IIA upon their approval of such transaction, of the consideration or milestone
and royalties
payments that we receive upon any sale or out licensing of such technology to a non-Israeli entity, up to 600% of the grant amounts plus
interest. The scope of the support
received, the royalties that we have already paid to the IIA, the amount of time that has elapsed
between the date on which the know-how or the related intellectual property rights were
transferred and the date on which the IIA grants
were received and the sale price and the form of transaction will be taken into account in order to calculate the amount of the payments
to the IIA. For Israeli entities, approval of the transfer of technology to residents of the State of Israel is required, and may be
granted in specific circumstances only if the recipient
abides by the provisions of applicable laws, including the restrictions on the
transfer of know-how and the obligation to pay royalties. No assurance can be made that approval to any
such transfer, if requested,
will be granted.
 
These
restrictions may impair our ability to sell our technology assets or to perform or outsource manufacturing outside of Israel, engage
in change of control transactions or otherwise
transfer our know-how outside of Israel and may require us to obtain the approval of the
IIA for certain actions and transactions and pay additional royalties and other amounts to the
IIA. In addition, any change of control
and any change of ownership of our ordinary shares that would make a non-Israeli citizen or resident an “interested party,”
as defined in the
Research Law, requires prior written notice to the IIA, and our failure to comply with this requirement could result
in criminal liability.
 
These
restrictions will continue to apply even after we have repaid the full amount of royalties on the grants. For the years ended December
31, 2022, 2021 and 2020, we recorded
grants totaling $0.05 million, $0.5 million and $1.5 million from the IIA, respectively. If we fail
to satisfy the conditions of the Research Law, we may be required to refund certain
grants previously received together with interest
and penalties, and may become subject to criminal charges.
 
We may not receive the full €2.5 million grant from the Horizon Europe
EIC Accelerator Program, which funding is subject to a lengthy process prior to receipt and which
we may not successfully achieve, particularly
in light of our decision to terminate the ofra-vec program and pursue the Merger with Notable.
 
On
December 20, 2021, we announced that we had been selected for €17.5 million of blended funding by the EIC Accelerator. The funding is comprised of a €2.5 million grant and an
additional €15 million direct equity investment
by the EIC. To date, we have received $1.1 million, and have performed activities as part of the project of an additional $1.4 million.
The funding is subject to meeting the specific requirements of the program and there can be no assurance that we meet and will continue
to meet these requirements in order to receive
the final grant funding amount. We will not be pursuing the additional €15 million
direct equity investment by the EIC due to the OVAL trial outcome and termination of the ofra-vec
program.
 
29

 
 
Risks
Related to the Discovery and Development of Our Product Candidate and Platform Technology
 
We
are highly dependent on the success of VB-601 in inflammatory indications, and our platform technology in general, and we cannot be certain
that either will receive
regulatory approval or be commercialized. Any failure to successfully develop, obtain regulatory approval for
and commercialize VB-601 for inflammatory indications, or
any other product candidates, independently or in cooperation with a third
party collaborator, or the experience of significant delays in doing so, would compromise our
ability to generate revenue and become
profitable.
 
We
have spent time, money and effort on the development of our platform technology and product candidate VB-601. To date, we have not received
regulatory approval for any current
and historical product candidates. Positive results obtained during early development do not necessarily
mean later development will succeed or that regulatory approvals will be
obtained.
 
Our
ability to generate product revenue from any product candidate depends heavily on the successful development and commercialization of
our product candidate, which, in turn,
depends on several factors, including the following:
 
●
successfully
enrolling and completing any planned and future trials for VB-601 or any future product candidates;
●
our
ability to raise additional funding sufficient to conduct future clinical trials and commercialization
of a product candidate, if approved;
●
demonstrating
that VB-601 or any future product candidates are safe and effective at a sufficient level
of statistical or clinical significance and otherwise obtaining marketing
approvals from
regulatory authorities;
●
manufacturing
our product candidate in large scale and qualifying such processes in compliance with the
regulatory requirements for clinical and commercial supply;
●
establishing
successful manufacturing arrangements with third-party manufacturers that are compliant with
cGMP requirements to ensure adequate supply of VB-601 and any
future product candidates for
clinical development and commercial use, if approved;
●
establishing
successful sales and marketing arrangements for VB-601 and any future product candidates,
if approved;
●
maintaining
an acceptable safety and efficacy profile for our product candidates;
●
the
availability of coverage and reimbursement to patients from healthcare payers for our VB-601
and any future product candidates, if approved; and
●
other
risks described in these “Risk Factors.”
 
Our
 product candidate is based on novel technology, which makes it difficult to predict the time and cost of product candidate development
 and potential regulatory
approval.
 
We
have historically concentrated our product research and development efforts on our distinct platform technologies, and our future success
depends on the successful development of
our technology. We could experience development problems in the future related to our technology,
which could cause significant delays or unanticipated costs, and we may not be able
to solve such development problems. We may also experience
delays in developing sustainable, reproducible and scalable manufacturing processes or transferring those processes to
commercial partners,
if we decide to do so, which may prevent us from completing our clinical trials or commercializing our product, if approved, on a timely
or profitable basis, if at
all. If an issue is identified in our platform technology, it may cause us to cease development of the product
candidate that utilizes the underlying technology.
 
In
addition, the clinical trial requirements of the FDA, the EMA and other regulatory agencies and the criteria these regulators use to
determine the safety and efficacy of a product
candidate vary substantially according to the type, complexity, novelty and intended use
and market of the potential products. The regulatory approval process for a novel product
candidate such as ours can be more expensive
and take longer than for other, better known or extensively studied pharmaceutical or other product candidates. Approvals by the FDA
may not be indicative of what the EMA or other regulatory agencies may require for approval, and vice versa.
 
In
addition, adverse developments in clinical trials of pharmaceutical products conducted by others may cause the FDA or other regulatory
bodies to change the requirements for
approval of any product candidate.
 
These
 regulatory agencies and review committees and the new requirements and guidelines they promulgate may lengthen the regulatory review
 process, require us to perform
additional studies, increase our development costs, lead to changes in regulatory positions and interpretations,
 delay or prevent approval and commercialization of a treatment
candidate or lead to significant post-approval limitations or restrictions.
As we advance our product candidate, we will be required to consult with these regulatory groups, and comply
with applicable requirements
and guidelines. If we fail to do so, we may be required to delay or discontinue development of our product candidate. Delay or failure
to obtain, or
unexpected costs in obtaining, the regulatory approval necessary to bring a potential product candidate to market could
impair our ability to generate product revenue and to become
profitable.
 
30

 
 
We
may find it difficult to enroll patients in our clinical trials, and patients could discontinue their participation in our clinical trials,
which could delay or prevent clinical
trials of our product candidate.
 
Identifying
and qualifying patients to participate in clinical trials of our product candidate is critical to our success. The timing of our clinical
trials depends on the speed at which we
can recruit patients to participate in testing our product candidates. We have experienced delays
in some of our previous clinical trials, and we may experience similar delays in the
future. If patients are unwilling to participate
in our clinical trials because of negative publicity from adverse events in the biotechnology or pharmaceutical industries or for other
reasons, including competitive clinical trials for similar patient populations, the timeline for recruiting patients, conducting trials
 and obtaining regulatory approval of potential
products may be delayed. These delays could result in increased costs, delays in advancing
 our product development, delays in testing the effectiveness of our technology or
termination of the clinical trials altogether.
 
We
may not be able to identify, recruit and enroll a sufficient number of patients, or those with required or desired characteristics to
achieve diversity in a trial, to complete our clinical
trials in a timely manner. Patient enrollment is affected by factors including:
 
●
severity
of the disease under investigation;
●
design
of the trial protocol;
●
size
of the patient population;
●
eligibility
criteria for the trial in question;
●
perceived
risks and benefits of the product candidate under study, and specifically in reference to
studies in other indications, with the same product;
●
proximity
and availability of clinical trial sites for prospective patients;
●
availability
of competing therapies and clinical trials;
●
efforts
to facilitate timely enrollment in clinical trials;
●
patient
referral practices of physicians; and
●
ability
to monitor patients adequately during and after treatment.
 
In
particular, some of the indications we may develop our candidates for may be for rare disorders with limited patient pools from which
to draw for clinical trials. The eligibility
criteria of our clinical trials will further limit the pool of available trial participants.
Additionally, the process of finding and diagnosing patients may prove costly.
 
We
plan to seek initial marketing approval in established global markets, in addition to the United States. We may not be able to initiate
or continue clinical trials if we cannot enroll a
sufficient number of eligible patients to participate in the clinical trials required
by the EMA or other foreign regulatory agencies. Our ability to successfully initiate, enroll and
complete a clinical trial in any foreign
country is subject to numerous risks unique to conducting business in foreign countries, including:
 
●
difficulty
in establishing or managing relationships with CRO and physicians;
●
different
standards for the conduct of clinical trials;
●
our
inability to locate qualified local consultants, physicians and partners; and
●
the
potential burden of complying with a variety of foreign laws, medical standards and regulatory
requirements, including the regulation of pharmaceutical and biotechnology
products and treatment.
 
If
we have difficulty enrolling a sufficient number of patients to conduct our clinical trials, we may need to delay, limit or terminate
ongoing or planned clinical trials.
 
In
addition, patients enrolled in our clinical trials may discontinue their participation at any time during the trial as a result of a
number of factors, including withdrawing their consent
or experiencing adverse clinical events, which may or may not be judged related
to our product candidate under evaluation. The discontinuation of patients in any one of our trials may
cause us to delay or abandon
our clinical trial, or cause the results from that trial not to be positive or sufficient to support a filing for regulatory approval
of the applicable product
candidate.
 
31

 
 
We
may encounter substantial delays in our clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable
regulatory authorities.
 
Before
obtaining marketing approval from regulatory authorities for the sale of a product candidate, we must conduct extensive clinical trials
to demonstrate the safety and efficacy of
the product candidate in humans. Clinical testing is expensive, time-consuming and uncertain
as to outcome. We cannot guarantee that any clinical trials will be conducted as planned
or completed on schedule, if at all, and that
the trial will result in a positive outcome. For example, our Phase 3 clinical trial of ofra-vec in platinum-resistant ovarian cancer
did not
successfully meet either primary endpoint, PFS or OS, and we made the decision to cease development of ofra-vec in August 2022.
We also cannot guarantee that we will receive
regulatory approval if we achieve statistical significance absent clinically meaningful
benefit in a confirmatory trial. A failure of one or more clinical trials can occur at any stage of
testing. Events that may prevent
successful or timely completion of clinical development include:
 
●
delays
in reaching a consensus with regulatory agencies on trial design;
●
delays
in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;
●
delays
in obtaining required IRB or ethics committee approval at each clinical trial site;
●
delays
in recruiting suitable patients to participate in our clinical trials including in particular
for those trials for rare diseases;
●
delays
in clinical trial supply, due to manufacturing delays or other issues;
●
imposition
of a clinical hold by regulatory agencies, including due to safety reasons with either our
product candidate or other product candidates in the same class or after an
inspection of
our clinical trial operations or trial sites;
●
failure
by our CROs, other third parties or us to adhere to clinical trial requirements;
●
failure
to perform in accordance with the FDA’s GCP requirements or applicable regulatory requirements
in other countries;
●
delays
in the testing, validation, manufacturing and delivery of our product candidate to the clinical
sites;
●
delays
in having patients complete participation in a trial or return for post-treatment follow-up;
●
clinical
trial sites or patients dropping out of a trial;
●
occurrence
of serious adverse events associated with the product candidate that are viewed to outweigh
its potential benefits;
●
changes
in regulatory requirements and guidance that require amending or submitting new clinical
trial protocols.
 
Any
inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability
to generate revenue from product sales. In
addition, if we make manufacturing or formulation changes to our product candidate, we may
need to conduct additional studies to bridge our modified product candidates to earlier
versions. Clinical trial delays could also shorten
any periods during which we may have the exclusive right to commercialize our product candidate or allow our competitors to bring
products
to market before we do, which could impair our ability to successfully commercialize our product candidates.
 
If
the results of our clinical trials are inconclusive or if there are safety concerns or adverse events associated with any product candidate,
we may:
 
●
fail
to obtain, or be delayed in obtaining, marketing approval for our product candidate;
●
obtain
approval for indications or patient populations that are not as broad as intended or desired;
●
obtain
approval with labeling that includes significant use or distribution restrictions or safety
warnings;
●
need
to change the way the product is administered;
●
be
unable to compete with other approved products;
●
be
required to perform additional clinical trials to support approval or be subject to additional
post-marketing testing requirements;
●
have
regulatory authorities withdraw their approval of the product or impose restrictions on its
distribution or use in the form of a REMS or modified REMS;
●
be
subject to the addition of labeling statements, such as warnings or contraindications;
●
be
sued; or
●
experience
damage to our reputation.
 
Any
of these events could prevent us from achieving or maintaining market acceptance of our product candidate and impair our ability to commercialize
our product candidate.
 
Side
effects may occur following treatment with our product candidate, which could make it more difficult for our product candidate to receive
regulatory approval.
 
Treatment
with our product candidate may cause side effects or adverse events. In addition, because our product candidate may in some cases be
administered in combination with
other therapies, patients or clinical trial participants may experience side effects or other adverse
events that are unrelated to our product candidate, but may still impact the success of
our clinical trials. Additionally, our product
candidates could potentially cause other unforeseen adverse events that we cannot predict. The inclusion of critically ill patients in
our
clinical trials may result in deaths or other adverse medical events due to other therapies or medications that such patients may
be using or the severity of the medical condition treated.
The experience of side effects and adverse events in our clinical trials could
make it more difficult to achieve regulatory approval of our product candidate, if at all, or could negatively
impact the market acceptance
of such products, if approved.
 
Success
in early and prior clinical trials may not be indicative of results obtained in later trials.
 
There
is a high failure rate for drugs and biologics proceeding through clinical trials. A number of companies in the pharmaceutical and biotechnology
industries have suffered
significant setbacks in later stage clinical trials even after achieving promising results in earlier stage
and prior clinical trials. The results of nonclinical and preclinical studies and
clinical trials may not be predictive of the results
of later-stage clinical trials, and interim results of a clinical trial do not necessarily predict final results. The results of preclinical
studies and clinical trials in one set of patients or disease indications may not be predictive of those obtained in another. In some
instances, there can be significant variability in safety
or efficacy results between different clinical trials of the same product candidate
due to numerous factors, including changes in trial procedures and timing of such procedures as set
forth in protocols, differences in
the size and type of the patient populations, changes in and adherence to the dosing regimen and the rate of dropout among clinical trial
participants,
among other factors. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy
profile despite having progressed through nonclinical studies
and initial clinical trials. Data obtained from preclinical and clinical
activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. In addition,
regulatory delays
or rejections may be encountered as a result of many factors, including changes in regulatory policy during the period of product development.
 
32

 
 
The
results from our future clinical trials may not be sufficiently robust to support the submission for marketing approval for our
product candidate. Before we submit any
product candidate for marketing approval, the FDA and the EMA may require us to conduct
additional clinical trials, or evaluate subjects for an additional follow-up
period.
 
It
is possible that, even if we achieve favorable results in our clinical trials, the FDA or the EMA may require us to conduct additional
clinical trials, possibly involving a larger sample
size or a different clinical trial design, particularly if the FDA or the EMA does
not find the results from our completed clinical trials to be sufficiently persuasive to support a BLA or
an NDA. For example, achieving
statistical significance is no guarantee of approval if there is no clinically meaningful benefit.
 
It
is also possible that the FDA or the EMA may not consider the results of our clinical trials to be sufficient for approval of our product
candidate for its target indications. If the FDA
or the EMA requires additional studies for any reason, we would incur increased costs
and delays in the marketing approval process, which may require us to expend more resources
than we have available. In addition, it is
possible that the FDA and the EMA may have divergent opinions on the elements necessary for a successful NDA or BLA and Marketing
Authorisation
Application, which is the equivalent of an NDA and BLA, respectively, which may cause us to alter our development, regulatory or commercialization
strategies.
 
Even
 if we complete the necessary preclinical studies and clinical trials, we cannot predict when or if we will obtain regulatory approval
 to commercialize a product
candidate or the approval may be for a more narrow indication than we expect.
 
We
cannot commercialize a product until the appropriate regulatory authorities have reviewed and approved the product candidate. Even if
our product candidate demonstrates safety
and efficacy in clinical trials, the regulatory agencies may not complete their review processes
in a timely manner, or we may not be able to obtain regulatory approval. Additional
delays may result if an FDA advisory committee or
other regulatory authority recommends non-approval or restrictions on approval, or if the FDA is unable to conduct a timely
inspection
 of our third party manufacturing facility. In addition, we may experience delays or rejections based upon additional government regulation
 from future legislation or
administrative action, or changes in regulatory agency policy during the period of product development, clinical
trials and the review process. Regulatory agencies also may approve a
treatment candidate for fewer or more limited indications than
requested or may grant approval subject to the performance of post-marketing studies. In addition, regulatory agencies
may not approve
the labeling claims that are necessary or desirable for the successful commercialization of our treatment candidates.
 
Even
if we obtain regulatory approval for a product candidate, our product will remain subject to regulatory scrutiny.
 
Even
if we obtain regulatory approval in a jurisdiction, the regulatory authority may still impose significant restrictions on the indicated
uses or marketing of our product candidate, or
impose ongoing requirements for potentially costly post-approval studies or post-market
surveillance. For example, the holder of an approved BLA is obligated to monitor and report
adverse events and any failure of a product
to meet the specifications in the BLA. The FDA may also impose a REMS which could entail requirements for a medication guide,
physician
communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other
risk minimization tools. The holder of an
approved BLA must also submit new or supplemental applications and obtain FDA approval for
certain changes to the approved product, product labeling or manufacturing process.
Advertising and promotional materials must comply
with FDA rules and are subject to FDA review, in addition to other potentially applicable federal and state laws.
 
In
addition, product sponsors and their manufacturers and manufacturing facilities are subject to payment of user fees and continual review
and periodic inspections by the FDA and
other regulatory authorities for compliance with cGMP and other regulatory requirements, such
as product tracking and tracing, and adherence to commitments made in the BLA as the
case may be. If we or a regulatory agency discover
previously unknown problems with a product such as adverse events of unanticipated severity or frequency, or problems with the
facility
where the product is manufactured, a regulatory agency may impose restrictions relative to that product or the manufacturing facility,
including requiring recall or withdrawal
of the product from the market or suspension of manufacturing.
 
If
we fail to comply with applicable regulatory requirements following approval of any product candidate, a regulatory agency may:
 
●
issue
a warning letter asserting that we are in violation of the law;
●
seek
an injunction or impose civil or criminal penalties or monetary fines;
●
suspend
or withdraw regulatory approval or suspend or revoke a license;
●
suspend
any ongoing clinical trials;
●
refuse
to approve a pending BLA or supplements to a BLA submitted by us for other indications or
new biological products;
●
impose
restrictions on the marketing or manufacturing of our product;
●
seize
our product; or
●
refuse
to allow us to enter into supply contracts, including government contracts.
 
Any
government investigation of alleged violations of law could require us to expend significant time and resources in response and could
generate negative publicity. The occurrence
of any event or penalty described above may inhibit our ability to commercialize our product
candidate and generate revenues.
 
33

 
 
We
have only limited experience in regulatory affairs and intend to rely on consultants and other third parties for regulatory matters,
which may affect our ability or the
time we require to obtain necessary regulatory approvals.
 
We
have limited experience in filing and prosecuting the applications necessary to gain regulatory approvals for investigational product
candidates. We intend to rely on independent
consultants for purposes of our regulatory compliance and product development and approvals
in the United States and elsewhere. Any failure by our consultants to properly advise us
regarding, or properly perform tasks related
to, regulatory compliance requirements could compromise our ability to develop and seek regulatory approval of our product candidate.
 
In
addition to the level of commercial success of our product candidate, if approved, our future prospects are also dependent on our ability
to successfully develop a pipeline
of additional product candidates, and we may not be successful in our efforts in using our platform
to identify or discover additional product candidates.
 
The
success of our business depends primarily upon our ability to identify, develop and commercialize product candidates based on our platform
technology. Our research programs
may fail to identify other potential product candidates for clinical development for a number of reasons.
Our research methodology may be unsuccessful in identifying potential
product candidates or our potential product candidates may be shown
to have harmful side effects or may have other characteristics that may make the products unmarketable or
unlikely to receive marketing
 approval. We may also be limited in our ability to pursue multiple indications with any one product candidate, due to financial or other
 resource
constraints, development issues or regulatory obstacles.
 
If
any of these events occur, we may be forced to abandon our development efforts for a program or programs. For example, we ceased development
of ofra-vec in August 2022 after
its Phase 3 trial in platinum-resistant ovarian cancer did not meet its primary endpoints. Research
programs to identify new product candidates require substantial technical, financial
and human resources. We may focus our efforts and
resources on potential programs or product candidates that ultimately prove to be unsuccessful.
 
Risks
Related to Our Reliance on Third Parties
 
We
expect to rely on third parties to conduct some or all aspects of our product manufacturing, protocol development, research and preclinical
and clinical testing, and these
third parties may not perform satisfactorily.
 
We
do not expect to independently conduct all aspects of our product manufacturing, protocol development, research and preclinical and clinical
testing. We currently rely, and expect
to continue to rely, on third parties with respect to these items.
 
We
do not have the ability to independently conduct clinical trials. We rely and expect to continue to rely on medical institutions, clinical
investigators, contract laboratories and other
third parties, such as CROs, to conduct or otherwise support clinical trials for our product
candidate. We may also rely on academic and private non-academic institutions to conduct
and sponsor clinical trials relating to a product
candidate. We will not control the design or conduct of any investigator-sponsored trials, and it is possible that the FDA or non-U.S.
regulatory authorities will not view these investigator-sponsored trials as providing adequate support for future clinical trials, whether
controlled by us or third parties, for any one or
more reasons, including elements of the design or execution of the trials or safety
concerns or other trial results. Such arrangements will likely provide us certain information rights
with respect to the investigator-sponsored
 trials, including access to and the ability to use and reference the data, including for our own regulatory filings, resulting from the
investigator-sponsored trials. However, we would not have control over the timing and reporting of the data from investigator-sponsored
trials, and we may not own the data from
certain investigator-sponsored trials. If we are unable to confirm or replicate the results
from the investigator-sponsored trials or if negative results are obtained, we would likely be
further delayed or prevented from advancing
further clinical development of our product candidate. Further, if investigators or institutions breach their obligations with respect
to the
clinical development of our product candidate, or if the data proves to be inadequate compared to the first-hand knowledge we
might have gained had the investigator-sponsored trials
been sponsored and conducted by us, then our ability to design and conduct any
future clinical trials ourselves may be adversely affected.
 
Any
of these third parties may terminate their engagements with us at any time. If we need to enter into alternative arrangements, it could
delay our product development activities. Our
reliance on these third parties for research and development activities will reduce our
control over these activities but will not relieve us of our responsibility to ensure compliance with
all required regulations and study
protocols. For example, for a product candidate that we develop and commercialize on our own, we will remain responsible for ensuring
that each of
our IND-enabling studies and clinical trials are conducted in accordance with the study plan and protocols. For any violations
of laws and regulations during the conduct of our clinical
trials, we could be subject to warning letters or enforcement action that
may include civil penalties up to and including criminal prosecution.
 
If
these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our studies in accordance
with regulatory requirements or our stated
study plans and protocols, we will not be able to complete, or may be delayed in completing,
the preclinical studies and clinical trials required to support future IND submissions and
approval of our product candidates.
 
34

 
 
Reliance
on third-party manufacturers entails risks to which we would not be subject if we manufactured the product candidate ourselves, including:
 
●
the
inability to negotiate manufacturing agreements with third parties under commercially reasonable
terms;
●
reduced
control as a result of using third-party manufacturers for all aspects of manufacturing activities;
●
termination
or nonrenewal of manufacturing agreements with third parties in a manner or at a time that
is costly or damaging to us; and
●
disruptions
to the operations of our third-party manufacturers or suppliers caused by conditions unrelated
to our business or operations, including the bankruptcy of the
manufacturer or supplier.
 
Any
of these events could lead to clinical trial delays or failure to obtain regulatory approval, or impact our ability to successfully commercialize
future products. Some of these events
could be the basis for FDA action, including injunction, recall, seizure or total or partial suspension
of production.
 
We
and our CDMOs are subject to significant regulation with respect to manufacturing our product candidate. The manufacturing facilities
on which we rely may not
continue to meet regulatory requirements and have limited capacity.
 
We
currently have relationships with a limited number of suppliers for the manufacturing of our product candidate. Each supplier may require
licenses to manufacture components of
our product candidate or to utilize certain processes for the manufacture of our product candidate.
If such components or licenses are not owned by the supplier or in the public domain,
we may be unable to transfer or sublicense the
intellectual property rights we may have with respect to such activities.
 
All
entities involved in the preparation of therapeutics for clinical trials or commercial sale, including our existing contract manufacturers
for our product candidate, are subject to
extensive regulation. Components of a finished therapeutic product approved for commercial
sale or used in late-stage clinical trials must be manufactured in accordance with cGMP
requirements. These regulations govern manufacturing
processes and procedures (including record keeping) and the implementation and operation of systems to control and assure the
quality
of investigational products and products approved for sale. Poor control of production processes can lead to the introduction of contaminants,
or to inadvertent changes in the
properties or stability of our product candidate that may not be detectable in final product testing.
We or our contract manufacturers must supply all necessary documentation in support
of a BLA, as applicable, on a timely basis and must
adhere to the FDA’s cGMP regulations enforced by the FDA through its facilities inspection program. Information requests from
the
FDA or failure to meet FDA requirements can result in delays in clinical trials, and any future commercial supply. The facilities and
controls of some or all of our third-party
contractors must pass a pre-approval inspection for compliance with the applicable regulations
as a condition of regulatory approval of our product candidate or any of our other
potential products. In addition, the regulatory authorities
may, at any time, audit or inspect a manufacturing facility involved with the preparation of our product candidate or our other
potential
 products or the associated controls for compliance with the regulations applicable to the activities being conducted. If these facilities
 do not pass a pre-approval plant
inspection, FDA or other regulatory authority approval of the product candidate will not be granted.
 
The
 regulatory authorities also may, at any time following approval of a product for sale, audit our manufacturing facilities or those of
 our third-party contractors. If any such
inspection or audit identifies a failure to comply with applicable regulations or our product
specifications, or if a violation of applicable regulations, including a failure to comply with
the product specifications, occurs independent
of such an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly and/or time-
consuming
for us or a third party to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales
or the temporary or permanent
closure of a facility.
 
If
we or any of our third-party manufacturers fail to maintain regulatory compliance, the FDA can impose regulatory sanctions including,
among other things, refusal to approve a
pending application for a new product, or revocation of a pre-existing approval.
 
If
any manufacturer with whom we contract fails to perform its obligations, we may be forced to manufacture the materials ourselves, for
which we may not have the capabilities or
resources, or enter into an agreement with a different manufacturer, which we may not be able
to do on reasonable terms, if at all. In either scenario, our clinical trial supply could be
delayed significantly as we establish alternative
 supply sources. In some cases, the technical skills required to manufacture our product or product candidate may be unique or
proprietary
to the original manufacturer and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such
skills to a back-up or alternate
supplier, or we may be unable to transfer such skills at all. In addition, if we are required to change
 manufacturers for any reason, we will be required to verify that the new
manufacturer maintains facilities and procedures that comply
with quality standards and with all applicable regulations. We will also need to verify, such as through a manufacturing
comparability
study, that any new manufacturing process will produce our product candidate according to the specifications previously submitted to
the FDA or another regulatory
authority. The delays associated with the verification of a new manufacturer could negatively affect our
ability to develop a product candidate or commercialize a product in a timely
manner or within budget. In addition, changes in manufacturers
often involve changes in manufacturing procedures and processes, which could require that we conduct bridging
studies between our prior
clinical supply used in our clinical trial and that of any new manufacturer. We may be unsuccessful in demonstrating the comparability
of clinical supplies
which could require the conduct of additional clinical trials. Additionally, if any of our product candidate receives
regulatory approval and supply from a manufacturer is interrupted,
there could be a significant disruption in commercial supply. An alternative
manufacturer would need to be qualified through a BLA supplement which could result in further delay.
The regulatory agencies may also
require comparability studies if a new manufacturer is relied upon for commercial production. Switching manufacturers may involve substantial
costs
and is likely to result in a delay in our desired clinical and commercial timelines.
 
35

 
 
In
addition, there are risks associated with large scale manufacturing for clinical trials or commercial scale including, among others,
supplier delays, cost overruns, potential problems
with process scale-up, process reproducibility, stability issues, compliance with
 cGMP requirements, lot consistency and timely availability of raw materials. Even if we obtain
marketing approval for any product candidate
or any future product candidates, there is no assurance that we or our manufacturers will be able to manufacture the approved product
to
specifications acceptable to the FDA or other comparable foreign regulatory authorities, to produce it in sufficient quantities to
meet the requirements for the potential commercial
launch of the product or to meet potential future demand. If we or our manufacturers
are unable to produce sufficient quantities for clinical trials or for commercialization, our
development and commercialization efforts
would be impaired, which would have an adverse effect on our business, financial condition, results of operations and growth prospects.
 
These
factors could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of a product candidate,
cause us to incur higher costs and prevent
us from commercializing our product successfully. Furthermore, if our suppliers fail to meet
contractual requirements, and we are unable to secure one or more replacement suppliers
capable of production at a substantially equivalent
cost, our clinical trials and potential commercialization may be delayed or we could lose potential revenue.
 
We
have relied, and expect to continue to rely on third parties to conduct, supervise and monitor our clinical trials, and if these third
parties perform in an unsatisfactory
manner, it may harm our business.
 
We
have relied, and expect to continue to rely on CROs and clinical trial sites, including clinical investigators, to ensure our clinical
trials are conducted properly and on time. While
we will have agreements governing their activities, we will have limited influence over
 their actual performance. We will control only some aspects of our CROs’ activities.
Nevertheless, we will be responsible for ensuring
that each of our clinical trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific requirements
and standards, and our reliance on the CROs does not relieve us of our regulatory responsibilities.
 
We
and our CROs are required to comply with the FDA’s GCP requirements for conducting, recording and reporting the results of clinical
trials to assure that the data and reported
results are credible and accurate and that the rights, integrity and confidentiality of clinical
trial participants are protected. The FDA enforces these GCP requirements through periodic
inspections of study sponsors, principal investigators
and clinical trial sites. If we or our CROs fail to comply with applicable GCP requirements, the clinical data generated in our
clinical
trials may be deemed unreliable and the FDA may require us to perform additional clinical trials before approving any marketing applications.
Upon inspection, the FDA may
determine that our clinical trials did not comply with GCP requirements. In addition, our clinical trials
will require a sufficient number of test subjects to evaluate the safety and
effectiveness of a product candidate. Recruitment in rare
diseases may be challenging and require the performance of trials in a significant number of sites which may be harder to
monitor. Accordingly,
if our CROs fail to comply with these regulations or fail to recruit a sufficient number of patients, we may be required to repeat such
clinical trials, which would
result in significant additional costs and delay the regulatory approval process.
 
Our
CROs are not our employees, and we are therefore unable to directly monitor whether or not they devote sufficient time and resources
to our clinical and nonclinical programs.
These CROs may also have relationships with other commercial entities, including parties developing
potentially competitive products, for whom they may also be conducting clinical
trials or other drug development activities that could
harm our competitive position. If our CROs do not successfully carry out their contractual duties or obligations, fail to meet
expected
deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical
protocols or regulatory requirements, or for
any other reason, our clinical trials may be extended, delayed or terminated, and we may
not be able to obtain regulatory approval for, or successfully commercialize our product
candidates. As a result, the commercial prospects
for our product candidate would be harmed, our costs could increase, and our ability to generate revenues could be delayed.
 
We
also expect to rely on other third parties to store and distribute our product candidate for any clinical trials that we may conduct.
Any performance failure on the part of our
distributors could delay clinical development or marketing approval of our product candidate
or commercialization of our product candidate, if approved, producing additional losses
and depriving us of potential product revenue.
 
Our
reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them
or that our trade secrets will be
misappropriated or disclosed.
 
Because
we rely on third parties to manufacture our product candidate, and because we collaborate with various organizations and academic institutions
on the advancement of our
technology, we must, at times, share trade secrets with them. We seek to protect our proprietary technology
in part by entering into confidentiality agreements and, if applicable,
material transfer agreements, collaborative research agreements,
consulting agreements or other similar agreements with our collaborators, advisors, employees and consultants prior to
beginning research
or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential
information, such as trade
secrets. Despite these contractual provisions, the need to share trade secrets and other confidential information
increases the risk that such trade secrets become known by potential
competitors, are inadvertently incorporated into the technology
of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part,
on our know-how
and trade secrets, discovery by a third party of our trade secrets or other unauthorized use or disclosure would impair our intellectual
property rights and protections
in any product candidate.
 
In
 addition, these agreements typically restrict the ability of our collaborators, advisors, employees and consultants to publish data potentially
 relating to our trade secrets. Our
academic collaborators typically have rights to publish data, provided that we are notified in advance
and may delay publication for a specified time in order to secure our intellectual
property rights arising from the collaboration. In
other cases, publication rights are controlled exclusively by us, although in some cases we may share these rights with other parties.
Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of these agreements,
independent development or publication of
information including our trade secrets in cases where we do not have proprietary or otherwise
protected rights at the time of publication.
 
36

 
 
Risks
Related to Our Business Operations
 
Our
future success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified
personnel.
 
We
are highly dependent on the principal members of our executive team, including Prof. Dror Harats, our chief executive officer, the loss
of whose services may adversely impact the
achievement of our objectives. While we have entered into employment agreements with each
of our named executive officers and have provided for additional retention benefits as we
pursue strategic alternatives, any of them
could leave our employment at any time, as all of our employees are “at will” employees. Recruiting and retaining other qualified
employees,
consultants and advisors for our business, including scientific and technical personnel, will also be critical to our success.
There is currently a shortage of skilled executives in our
industry, which is likely to continue. As a result, competition for skilled
personnel is intense and the turnover rate can be high. Our recent reduction in force and uncertainty around our
pursuit of strategic
alternatives has resulted in significant employee turnover and difficulty retaining staff. We may not be able to attract and retain personnel
on acceptable terms given
the competition among numerous pharmaceutical and biotechnology companies for individuals with similar skill
sets and greater financial resources than us. In addition, failure to
succeed in preclinical studies or clinical trials may make it more
challenging to recruit and retain qualified personnel. The inability to recruit or loss of the services of any executive,
key employee,
consultant or advisor may impede the progress of our research, development and strategic objectives.
 
Our
collaborations with outside scientists and consultants may be subject to restriction and change.
 
We
work with medical experts, chemists, biologists and other scientists at academic and other institutions, and consultants who assist us
in our research, development and regulatory
efforts, including the members of our scientific advisory board. In addition, these scientists
and consultants have provided, and we expect that they will continue to provide, valuable
advice regarding our programs and regulatory
approval processes. These scientists and consultants are not our employees and may have other commitments that would limit their
future
availability to us. If a conflict of interest arises between their work for us and their work for another entity, we may lose their services.
In addition, we are limited in our ability to
prevent them from establishing competing businesses or developing competing products. For
example, if a key scientist acting as a principal investigator in any of our clinical trials
identifies a potential product or compound
that is more scientifically interesting to his or her professional interests, his or her availability to remain involved in our clinical
trials could
be restricted or eliminated.
 
We
are experiencing difficulties retaining employees, which could disrupt our operations.
 
As
of March 1, 2023, we had seven employees. Our recent reduction in force and uncertainty around our pursuit of strategic alternatives
has resulted in significant employee turnover
and difficulty retaining staff. Our management may need to divert a disproportionate amount
of its attention away from our day-to-day activities and devote a substantial amount of
time retaining employees. We may not be able
to effectively manage our operations, which may result in weaknesses in our infrastructure, operational mistakes, loss of business
opportunities,
loss of employees and reduced productivity among remaining employees. If our management is unable to effectively manage our staff, our
expenses may increase more
than expected, our ability to generate or grow revenue could be compromised, and we may not be able to implement
our business strategy. Our future financial performance and our
ability to and compete effectively will depend, in part, on our ability
to effectively manage any future operational growth.
 
Our
 employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including
 non-compliance with
regulatory standards and requirements and insider trading.
 
We
are exposed to the risk of fraud or other misconduct by our employees, principal investigators, consultants and commercial partners.
Misconduct by these parties could include
intentional failures to comply with the regulations of the FDA and non-U.S. regulators, provide
accurate information to the FDA and non-U.S. regulators, comply with healthcare fraud
and abuse laws and regulations in the United States
and abroad, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing
and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct,
kickbacks, self-dealing and other abusive
practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting,
marketing and promotion, sales commission, customer incentive programs and other
business arrangements. Such misconduct could also involve
the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and
cause serious
harm to our reputation. We have adopted a code of conduct applicable to all of our employees, but it is not always possible to identify
and deter employee misconduct,
and the precautions we take to detect and prevent this activity may not be effective in controlling unknown
or unmanaged risks or losses or in protecting us from governmental
investigations or other actions or lawsuits stemming from a failure
to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in
defending ourselves
or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines
or other sanctions.
 
37

 
 
Our
business was negatively impacted by the ongoing COVID-19 pandemic and may in the future be impacted by any future pandemics. In addition,
this pandemic may
continue to, and any future pandemics may, adversely impact economies worldwide, which could result in adverse effects
on our business and operations.
 
We
experienced disruptions in our business as we and our CROs navigated the initial outbreak and subsequent governmental restrictions imposed
due to the ongoing COVID-19
pandemic. Although our employees have returned to work, there are a number of vaccines available, and many
restrictions have been lifted, there is still uncertainty about the overall
impact of COVID-19 on our business, as well as its continuing
impact on economies worldwide. Future pandemics may arise, and they, like the COVID-19 pandemic, could impact our
company and our CDMOs
and CROs, creating disruptions that affect our ability to initiate and complete preclinical studies or clinical trials, disrupt our supply
chain for our research
and development activities, and disrupt any planned or ongoing clinical trials for any number of reasons. Any
future pandemics could similarly impact patient recruitment or retention
for clinical trials, or result in resources being redirected
in a way that adversely impacts our ability to progress regulatory approvals and protect our intellectual property. In addition, as
with
the COVID-19 pandemic, we may face impediments to regulatory meetings and approvals due to recommended safety measures intended to limit
in-person interactions in any
future pandemic.
 
The
 ongoing COVID-19 pandemic already caused significant disruptions in the financial markets, and it may continue to, and any future pandemic
 could similarly, cause such
disruptions, which could impact our ability to raise additional funds through public offerings and may also
impact the volatility of our stock price and trading in our ordinary shares.
We cannot be certain what the overall impact of the ongoing
COVID-19 pandemic or any future pandemic will be on our business. The extent of the impact of COVID-19 and any
future pandemic on our
business, financial condition, results of operations and prospects will depend on future developments that are uncertain.
 
Inadequate
funding for the FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’
operations, could
hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from
being developed or commercialized in a timely manner or
otherwise prevent those agencies from performing normal business functions on
which the operation of our business may rely, which could negatively impact our business.
 
The
ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding
levels, ability to hire and retain key
personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average
review times at the agency have fluctuated in recent years as a result. Disruptions
at the FDA and other agencies may also slow the time
necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely
affect our
business. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those
that fund research and development
activities, is subject to the political process, which is inherently fluid and unpredictable.
 
Separately,
since March 2020 when foreign and domestic inspections of facilities were largely placed on hold due to the COVID-19 pandemic, the FDA
has been working to resume
pre-pandemic levels of inspection activities, including routine surveillance, bioresearch monitoring and pre-approval
inspections. Should FDA determine that an inspection is necessary
for approval and an inspection cannot be completed during the review
cycle due to restrictions on travel, and the FDA does not determine a remote interactive evaluation to be
adequate, the agency has stated
that it generally intends to issue, depending on the circumstances, a complete response letter or defer action on the application until
an inspection can be
completed. During the COVID-19 public health emergency, a number of companies announced receipt of complete response
letters due to the FDA’s inability to complete required
inspections for their applications. Regulatory authorities outside the
U.S. may adopt similar restrictions or other policy measures in response to the ongoing COVID-19 pandemic and
may experience delays in
their regulatory activities. If a prolonged government shutdown or other disruption occurs, it could significantly impact the ability
of the FDA to timely
review and process our regulatory submissions, which could have a material adverse effect on our business. Future
shutdowns or other disruptions could also affect other government
agencies such as the SEC, which may also impact our business by delaying
review of our public filings, to the extent such review is necessary, and our ability to access the public
markets.
 
We
face potential product liability, and, if successful claims are brought against us, we may incur substantial liability and costs. If
the use of our product candidate harms
patients, or is perceived to harm patients even when such harm is unrelated to our product candidate,
our regulatory approvals could be revoked or otherwise negatively
impacted and we could be subject to costly and damaging product liability
claims.
 
The
use of our product candidates in clinical trials and the sale of any products for which we obtain marketing approval exposes us to the
risk of product liability claims. Product
liability claims might be brought against us by consumers, healthcare providers, pharmaceutical
 companies or others selling or otherwise coming into contact with our product
candidate. There is a risk that our product candidate may
induce adverse events. If we cannot successfully defend against product liability claims, we could incur substantial liability
and costs.
In addition, regardless of merit or eventual outcome, product liability claims may result in:
 
●
impairment
of our business reputation;
●
withdrawal
of clinical trial participants;
●
costs
due to related litigation;
●
distraction
of management’s attention from our primary business;
●
substantial
monetary awards to patients or other claimants;
●
the
inability to commercialize a product candidate;
●
decreased
demand for a product candidate, if approved for commercial sale; and
●
impairment
of our ability to obtain product liability insurance coverage.
 
38

 
 
We
carry combined public and products liability (including human clinical trials extension) insurance. We believe our product liability
insurance coverage is sufficient in light of our
current status; however, we may not be able to maintain insurance coverage at a reasonable
cost or in sufficient amounts to protect us against losses due to liability. If we obtain
marketing approval for any product candidate,
we intend to expand our insurance coverage to include the sale of commercial products, but we may not be able to obtain product
liability
insurance on commercially reasonable terms or in adequate amounts. On occasion, large judgments have been awarded in class action lawsuits
based on drugs or medical
treatments that had unanticipated adverse effects. A successful product liability claim or series of claims
brought against us could cause our share price to decline and, if judgments
exceed our insurance coverage, could materially and adversely
affect our financial position.
 
Patients
with the diseases targeted by some of our product candidates are often already in severe and advanced stages of disease and have both
known and unknown significant pre-
existing and potentially life-threatening health risks. During the course of treatment, patients may
suffer adverse events, including death, for reasons that may be related to our product
candidates. Such events could subject us to costly
litigation, require us to pay substantial amounts of money to injured patients, delay, negatively impact or end our opportunity to
receive
or maintain regulatory approval to market our products, or require us to suspend or abandon our commercialization efforts. Even in a
circumstance in which we do not believe
that an adverse event is related to our product candidate, the investigation into the circumstance
may be time-consuming or inconclusive. These investigations may harm our reputation,
delay our regulatory approval process, limit the
type of regulatory approvals our product candidates receive or maintain, and compromise the market acceptance of any of our product
candidates
that receive regulatory approval. As a result of these factors, a product liability claim, even if successfully defended, could hurt
our business and impair our ability to
generate revenue.
 
We
may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs
or product candidates that
may be more profitable or for which there is a greater likelihood of success.
 
Because
we have very limited resources, we may forego or delay pursuit of opportunities with certain programs or product candidates or for indications
that later prove to have greater
commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable
commercial products or profitable market opportunities. Our spending on current
and future research and development programs for product
candidates may not yield any commercially viable products. For example, we devoted significant time and effort, as well as
capital, on
the development of ofra-vec, only to not meet the primary endpoint in the OVAL trial and we ceased development of the program. If we
do not accurately evaluate the
commercial potential or target market for a particular product candidate, we may relinquish valuable rights
to that product candidate through strategic collaboration, licensing or other
royalty arrangements in cases in which it would have been
more advantageous for us to retain sole development and commercialization rights to such product candidate, or we may
allocate internal
resources to a product candidate in a therapeutic area in which it would have been more advantageous to enter into a collaboration arrangement.
 
We
will continue to incur significant increased costs as a result of operating as a public company, and our management will continue to
be required to devote substantial time
to new compliance initiatives.
 
As
a public company, we will continue to incur significant legal, accounting and other expenses. In addition, the Sarbanes-Oxley Act, as
well as rules subsequently implemented by the
SEC and the Nasdaq have imposed various requirements on public companies.
On January 1, 2023, we ceased to be a “foreign private issuer” and are now required to comply with
U.S. reporting requirements
and subject to additional obligations due to our change in status. Shareholder activism, the current political environment and the current
high level of
government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which
may lead to additional compliance costs and impact the
manner in which we operate our business in ways we cannot currently anticipate.
Our management and other personnel will need to devote a substantial amount of time to these
compliance initiatives. Moreover, these
rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly.
For
example, we expect these rules and regulations, as well as the increase in the number of class actions and other securities litigation
filed against publicly traded life sciences companies,
to make it more difficult and more expensive for us to obtain director and officer
liability insurance and we may be required to incur substantial costs to maintain our current levels of
such coverage. While compliance
with these additional requirements and the transition from being a foreign private issuer will result in increased costs to us, we cannot
accurately
predict or estimate at this time the amount of additional costs we may incur as a public company under both U.S. and Israeli
laws.
 
Additionally,
we are no longer an “emerging growth company,” as defined in the JOBS Act, and are now required to comply with
additional disclosure and reporting requirements even
though we now also qualify as a “smaller reporting company” due to the loss of foreign private issuer
status. These additional reporting requirements may increase our legal and
financial
 compliance costs and cause management and other personnel to divert attention from operational and other business matters to devote
 substantial time to these public
company requirements.
 
As
a “smaller reporting company,” we are permitted to provide only two years of audited financial statements, in addition to
any required unaudited interim financial statements, with
correspondingly reduced “Management’s Discussion and Analysis of
 Financial Condition and Results of Operations” disclosure; and reduced disclosure obligations regarding
executive compensation.
We have taken advantage of reduced reporting burdens in this Annual Report on Form 10-K. We cannot predict whether investors will find
our ordinary
shares less attractive if we rely on these exemptions. If some investors find our ordinary shares less attractive as a result,
there may be a less active trading market for our ordinary
shares and our share price may be more volatile.
 
Moreover,
as a smaller reporting company, we are not required to include an auditor attestation regarding our internal control over financial
reporting assessment. If we identify
material weaknesses in our internal control over financial reporting, if we are unable to
 assert that our internal control over financial reporting is effective, investors may lose
confidence in the accuracy and
completeness of our financial reports and the trading price of our ordinary shares could be negatively affected. We could also
become subject to
investigations by the stock exchange on which our securities are listed, the SEC or other regulatory authorities,
which could require additional financial and management resources.
 
39

 
 
Irrespective
of compliance with Sections 404(a) and 404(b) of the Sarbanes-Oxley Act, any failure of our internal control could have a material adverse
effect on our stated results of
operations and harm our reputation. In order to implement changes to our internal control over financial
reporting triggered by a failure of those controls, we could experience higher
than anticipated operating expenses, as well as higher
independent auditor fees during and after the implementation of these changes.
 
We
are subject to foreign currency exchange risk, and fluctuations between the U.S. dollar and the NIS, the Euro and other non-U.S. currencies
may negatively affect our
earnings and results of operations.
 
We
operate in a number of different currencies. While the dollar is our functional and reporting currency and investments in our share capital
have been denominated in dollars, our
financial results may be adversely affected by fluctuations in currency exchange rates as a significant
portion of our operating expenses, including our salary-related and manufacturing
expenses are denominated in the NIS.
 
We
are exposed to the risks that the NIS may appreciate relative to the dollar, or, if the NIS instead devalues relative to the dollar,
that the inflation rate in Israel may exceed such rate
of devaluation of the NIS, or that the timing of such devaluation may lag behind
inflation in Israel. In any such event, the dollar cost of our operations in Israel would increase and our
dollar- denominated results
of operations would be adversely affected. We cannot predict any future trends in the rate of inflation in Israel or the rate of devaluation
(if any) of the NIS
against the dollar. Market volatility and currency fluctuations may limit our ability to cost- effectively hedge
against our foreign currency exposure and, in addition, our ability to hedge
our exposure to currency fluctuations in certain emerging
markets may be limited. Hedging strategies may not eliminate our exposure to foreign exchange rate fluctuations and may
involve costs
 and risks of their own, such as devotion of management time, external costs to implement the strategies and potential accounting implications.
 Foreign currency
fluctuations, independent of the performance of our underlying business, could lead to materially adverse results or
could lead to positive results that are not repeated in future periods.
 
Under
applicable employment laws, we may not be able to enforce covenants not to compete.
 
We
generally enter into non-competition agreements with our employees. These agreements prohibit our employees, if they cease working for
us, from competing directly with us or
working for our competitors or clients for a limited period. We may be unable to enforce these
agreements under the laws of the jurisdictions in which our employees work and it may
be difficult for us to restrict our competitors
from benefitting from the expertise our former employees or consultants developed while working for us. For example, Israeli labor courts
have required employers seeking to enforce non-compete undertakings of a former employee to demonstrate that the competitive activities
of the former employee will harm one of a
limited number of material interests of the employer which have been recognized by the courts,
such as the protection of a company’s trade secrets or other intellectual property. We
have expanded operations into the United
States and entered into U.S. employment agreements. As employment law varies from U.S. state to state, we may not be able to enforce
non-
compete rights in such agreements if U.S. employees reside in states that do not recognize such rights.
 
Our
internal information technology systems, or those of our third-party CROs, contractors, consultants or others who process sensitive information
on our behalf, may fail
or suffer security incidents, loss or leakage of data and other compromises, any of which could result in a material
disruption of our product candidate’s development
program, compromise sensitive information related to our business or prevent
us from accessing such information, expose us to liability or otherwise adversely affect our
business.
 
In
the ordinary course of our business, we may collect, store and transmit confidential information, including intellectual property, proprietary
business information and personal
information (including health information). It is critical that we do so in a secure manner to maintain
the confidentiality, integrity and availability of such information. We also have
outsourced certain of our operations to third parties,
and as a result we manage a number of third parties who have access to our information. Despite the implementation of security
measures,
our internal computer systems, and those of our CROs and other third parties on which we rely, are vulnerable to damage from computer
viruses, unauthorized access,
cyberattacks by sophisticated nation-state and nation-state supported actors or by malicious third parties
(including the deployment of harmful malware (such as malicious code,
viruses and worms), natural disasters, global pandemics, fire,
terrorism, war and telecommunication and electrical failures, fraudulent activity, as well as security incidents from
inadvertent or
intentional actions (such as error or theft) by our employees, contractors, consultants, business partners, and/or other third parties,
phishing attacks, ransomware, denial-
of-service attacks, social engineering schemes and other means that affect service reliability and
threaten the confidentiality, integrity and availability of information), which may
compromise our system infrastructure as well as lead
to unauthorized access, disclosure or acquisition of information. Cyberattacks are increasing in their frequency, sophistication and
intensity. The techniques used to sabotage or to obtain unauthorized access to our information technology systems or those upon whom
we rely on to process our information change
frequently, and we may be unable to anticipate such techniques or implement adequate preventative
measures or to stop security incidents in all instances. The recovery systems,
security protocols, network protection mechanisms and
other security measures that we have integrated into our information technology systems, which are designed to protect against,
detect
and minimize security breaches, may not be adequate to prevent or detect service interruption, system failure or data loss.
 
Significant
disruptions of our information technology systems or security incidents could adversely affect our business operations and/or result
in the loss, misappropriation, and/or
unauthorized access, use or disclosure of, or the prevention of access to, confidential information
(including trade secrets or other intellectual property, proprietary business information
and personal information including health information),
 and could result in financial, legal, business and reputational harm to us. If such disruptions were to occur and cause
interruptions
in our operations, it could result in a material disruption of our product development programs. For example, the loss of clinical trial
data from completed, ongoing or
planned clinical trials could result in delays in our regulatory approval efforts and significantly increase
our costs to recover or reproduce the data. To the extent that any disruption or
security incident results in a loss of, or damage to,
our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the
further
development of our future product candidates could be delayed.
 
40

 
 
We
may also be required to comply with laws, regulations, rules, industry standards, and other legal obligations that require us to maintain
the security of personal data. We may also
have contractual and other legal obligations to notify collaborators, our clinical trial participants,
or other relevant stakeholders of security incidents. Failure to prevent or mitigate
cyberattacks could result in unauthorized access
to data, including personal data. Most jurisdictions have enacted laws requiring companies to notify individuals, regulatory authorities,
and others of security breaches involving certain types of data. Such disclosures are costly, could lead to negative publicity, may cause
our collaborators or other relevant stakeholders
to lose confidence in the effectiveness of our security measures and require us to expend
significant capital and other resources to respond to and/or alleviate problems caused by the
actual or perceived security breach. In
addition, the costs to respond to a cybersecurity event or to mitigate any identified security vulnerabilities could be significant,
including costs
for remediating the effects of such an event, paying a ransom, restoring data from backups, and conducting data analysis
to determine what data may have been affected by the breach.
In addition, our efforts to contain or remediate a security incident or
any vulnerability exploited to cause an incident may be unsuccessful, and efforts and any related failures to contain
or remediate them
could result in interruptions, delays, harm to our reputation, and increases to our insurance coverage.
 
In
addition, litigation resulting from security breaches may adversely affect our business. Unauthorized access to our information technology
systems could result in litigation with our
collaborators, our clinical trial participants, or other relevant stakeholders. These proceedings
could force us to spend money in defense or settlement, divert management’s time and
attention, increase our costs of doing business,
or adversely affect our reputation. We could be required to fundamentally change our business activities and practices in response to
such litigation, which could have an adverse effect on our business. If a security breach were to occur and the confidentiality, integrity
or availability of our data or the data of our
collaborators were disrupted, we could incur significant liability, which could negatively
affect our business and damage our reputation.
 
Furthermore,
we may not have adequate insurance coverage or otherwise protect us from, or adequately mitigate, liabilities or damages. The successful
assertion of one or more large
claims against us that exceeds our available insurance coverage, or results in changes to our insurance
policies (including premium increases or the imposition of large deductible or co-
insurance requirements), could have an adverse effect
on our business. In addition, we cannot be sure that our existing insurance coverage and coverage for errors and omissions will
continue
to be available on acceptable terms or that our insurers will not deny coverage as to any future claim.
 
Risks
Related to Our Intellectual Property
 
If
we are unable to obtain or protect intellectual property rights related to our product candidates, we may not be able to obtain exclusivity
for our product candidates or
prevent others from developing similar competitive products.
 
We
rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related
to our product candidates. The strength of
patents in the biotechnology and pharmaceutical field involves complex legal and scientific
questions and can be uncertain. The patent applications that we own or in-license may fail
to result in issued patents with claims that
cover our product candidates in the United States or in other foreign countries. There is no assurance that all of the potentially relevant
prior
art relating to our patents and patent applications has been found, which can invalidate a patent or prevent a patent from issuing
from a pending patent application. Even if patents do
successfully issue and even if such patents cover our product candidates, third
parties may challenge their validity, enforceability or scope, which may result in the patent claims being
narrowed or invalidated. Furthermore,
even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property, provide exclusivity
for
our product candidates or prevent others from designing around our claims. Any of these outcomes could impair our ability to prevent
competition from third parties and materially
affect our operations and financial condition.
 
If
the patent applications we hold with respect to our programs or product candidates fail to issue, if the breadth or strength of our patent
protection is threatened, or if our patent
portfolio fails to provide meaningful exclusivity for our product candidates, it could dissuade
companies from collaborating with us to develop product candidates and threaten our
ability to commercialize future products. Several
patent applications covering our product candidates have been filed recently. We cannot offer any assurances about which, if any,
applications
will issue as patents, the breadth of any such issued patent claims or whether any issued claims will be found invalid and unenforceable
or will be threatened by third
parties. Any successful opposition to these patents or any other patents owned by or licensed to us could
deprive us of rights necessary for the successful commercialization of any
product candidates that we may develop. Further, if we encounter
delays in regulatory approvals, the period of time during which we could market a product candidate under patent
protection could be
reduced. Because patent applications in the United States and most other countries are confidential for a period of time after filing,
and some remain so until issued,
we cannot be certain that we or our licensors were the first to file any patent application related
to a product candidate. Furthermore, if third parties have filed such patent applications,
an interference proceeding in the United States
can be initiated by a third party to determine who was the first to invent any of the subject matter covered by the patent claims of
our
applications. In addition, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally
20 years after it is filed. Various extensions may be
available, but the life of a patent, and the protection it affords, is limited.
Even if patents covering our product candidates are obtained, once the patent life has expired for a product, we
may be open to competition
from generic medications. This risk is material in light of the length of the development process of our products and lifespan of our
current patent portfolio.
 
41

 
 
In
addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary
know-how that is not patentable or that we
elect not to patent, processes for which patents are difficult to enforce and any other elements
of our product candidate discovery and development processes that involve proprietary
know-how, information or technology that is not
covered by patents. However, trade secrets can be difficult to protect. We seek to protect our proprietary technology and processes,
in
part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors. We also seek
to preserve the integrity and confidentiality of our
data and trade secrets by maintaining physical security of our premises and physical
 and electronic security of our information technology systems. Security measures may be
breached, and we may not have adequate remedies
 for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors.
Although we
expect all of our employees and consultants to assign their inventions to us, and all of our employees, consultants, advisors and any
third parties who have access to our
proprietary know-how, information or technology to enter into confidentiality agreements, we cannot
provide any assurances that all such agreements have been duly executed or that
our trade secrets and other confidential proprietary
information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop
substantially
equivalent information and techniques. Misappropriation or unauthorized disclosure of our trade secrets could impair our competitive
position and may have a material
adverse effect on our business. Additionally, if the steps taken to maintain our trade secrets are deemed
 inadequate, we may have insufficient recourse against third parties for
misappropriating the trade secret. In addition, others may independently
discover our trade secrets and proprietary information. For example, the FDA, as part of its Transparency
Initiative, is currently considering
whether to make additional information publicly available on a routine basis, including information that we may consider to be trade
secrets or other
proprietary information, and it is not clear at the present time how the FDA’s disclosure policies may change
in the future, if at all.
 
Further,
the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United
States. As a result, we may encounter
significant problems in protecting and defending our intellectual property both in the United States
and abroad. If we are unable to prevent material disclosure of the non-patented
intellectual property related to our technologies to
third parties, and there is no guarantee that we will have any such enforceable trade secret protection, we may not be able to establish
or maintain a competitive advantage in our market.
 
Third-party
claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
 
Our
commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. There is a substantial
amount of litigation, both within and
outside the United States, involving patent and other intellectual property rights in the biotechnology
 and pharmaceutical industries, including patent infringement lawsuits,
interferences, oppositions and inter partes review proceedings
before the U.S. Patent and Trademark Office, or U.S. PTO, and corresponding foreign patent offices. Numerous U.S. and
foreign issued
patents and pending patent applications, which are owned by third parties, exist in the fields in which we are pursuing development candidates.
As the biotechnology and
pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates
may be subject to claims of infringement of the patent rights of third
parties.
 
Third
parties may assert that we are employing their proprietary technology without authorization. There may be third-party patents or patent
applications with claims to materials,
formulations, methods of manufacture or methods for treatment related to the use or manufacture
of our product candidates. Because patent applications can take many years to issue,
there may be currently pending patent applications
which may later result in issued patents that our product candidates may be accused of infringing. In addition, third parties may
obtain
patents in the future and claim that use of our technologies infringes upon these patents. If any third-party patents were held by a
court of competent jurisdiction to cover the
manufacturing process of any of our product candidates, any molecules formed during the
manufacturing process or any final product itself, the holders of any such patents may be
able to block our ability to commercialize
such product candidate unless we obtained a license under the applicable patents, or until such patents expire. Similarly, if any third-party
patents were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of
use, the holders of any such patents may be able to
block our ability to develop and commercialize the applicable product candidate unless
we obtained a license or until such patent expires. In either case, such a license may not be
available on commercially reasonable terms
or at all.
 
Parties
making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop
and commercialize one or more of our
product candidates. Defense of these claims, regardless of their merit, would involve substantial
litigation expense and would be a substantial diversion of employee resources from our
business. In the event of a successful claim of
infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement,
pay royalties, redesign our infringing products or obtain one or more licenses from third parties, which may be impossible or require
substantial time and monetary expenditure.
 
We
 may not be successful in obtaining or maintaining necessary rights to pharmaceutical product components and processes for our development
 pipeline through
acquisitions and in-licenses.
 
Presently
we have rights to the intellectual property, through licenses from Janssen Vaccines & Prevention B.V. and under patents that we own,
to develop our product candidates.
Because our programs may involve additional product candidates that may require the use of proprietary
rights held by third parties, the growth of our business may depend in part on
our ability to acquire, in-license or use these proprietary
rights. In addition, our product candidates may require specific formulations to work effectively and efficiently and these rights
may
be held by others. We may be unable to acquire or in-license any compositions, methods of use, processes or other third- party intellectual
property rights from third parties that
we identify. The licensing and acquisition of third-party intellectual property rights is a competitive
area, and a number of more established companies are also pursuing strategies to
license or acquire third-party intellectual property
rights that we may consider attractive. These established companies may have a competitive advantage over us due to their size, cash
resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor
may be unwilling to assign or license rights to
us. We also may be unable to license or acquire third-party intellectual property rights
on terms that would allow us to make an appropriate return on our investment.
 
42

 
 
We
may enter into license agreements with third parties, and if we fail to comply with our obligations in such agreements under which we
license intellectual property rights
from third parties or otherwise experience disruptions to our business relationships with our licensors,
we could lose license rights that are important to our business.
 
We
may need to obtain licenses from third parties to advance our research or allow commercialization of our product candidates, and we have
done so from time to time. We may fail
to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that
event, we may be required to expend significant time and resources to develop or license
replacement technology. If we are unable to
do so, we may be unable to develop or commercialize the affected product candidates.
 
In
many cases, patent prosecution of our in-licensed technology is controlled solely by the licensor. If our licensors fail to obtain and
maintain patent or other protection for the
proprietary intellectual property we license from them, we could lose our rights to the intellectual
property or our exclusivity with respect to those rights, and our competitors could
market competing products using the intellectual
property. In some cases, we control the prosecution of patents resulting from licensed technology. In the event we breach any of our
obligations related to such prosecution, we may incur significant liability to our licensing partners. Licensing of intellectual property
is of critical importance to our business and
involves complex legal, business and scientific issues and is complicated by the rapid
pace of scientific discovery in our industry. Disputes may arise regarding intellectual property
subject to a licensing agreement, including:
 
 
●
the
scope of rights granted under the license agreement and other interpretation-related issues;
 
●
the
extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing
agreement;
 
●
the
sublicensing of patent and other rights under any collaboration relationships we might enter into in the future;
 
●
our
diligence obligations under the license agreement and what activities satisfy those diligence obligations;
 
●
the
ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and
our partners; and
 
●
the
priority of invention of patented technology.
 
If
disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements
on acceptable terms, we may be unable to
successfully develop and commercialize the affected product candidates.
 
We
may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming
and unsuccessful.
 
Competitors
may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we may be required to file infringement
claims, which can be
expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours
or our licensors is not valid, is unenforceable or is not infringed, or
may refuse to stop the other party from using the technology
at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or
defense proceedings
could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk
of not issuing.
 
Interference
proceedings provoked by third parties or brought by us may be necessary to determine the priority of inventions with respect to our patents
or patent applications or those
of our licensors. An unfavorable outcome could require us to cease using the related technology or to
attempt to license rights to it from the prevailing party. Our business could be
harmed if the prevailing party does not offer us a license
on commercially reasonable terms. Our defense of litigation or interference proceedings may fail and, even if successful, may
result
in substantial costs and distract our management and other employees. We may not be able to prevent, alone or with our licensors, misappropriation
of our intellectual property
rights, particularly in countries where the laws may not protect those rights as fully as in the United
States.
 
Furthermore,
because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some
of our confidential information could
be compromised by disclosure during this type of litigation. There could also be public announcements
 of the results of hearings, motions or other interim proceedings or
developments. If securities analysts or investors perceive these
results to be negative, it could have a material adverse effect on the trading price of our ordinary shares.
 
43

 
 
Patent
reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement
or defense of our issued
patents.
 
Patent
reform legislation continues to increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement
or defense of our issued patents.
The Leahy-Smith Act introduced a number of significant changes to U.S. patent law, including provisions
that affect the way patent applications are prosecuted and patent litigation is
conducted. The U.S. PTO continues to develop regulations
and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law
associated therewith,
in particular, the inter partes review proceedings. It remains to be seen what impact the Leahy-Smith Act will have on the operation
of our business. However, its
implementation increases the uncertainties and costs surrounding the prosecution of our patent applications
and the enforcement or defense of our issued patents, all of which could
have a material adverse effect on our business and financial
condition.
 
We
may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information
of third parties or that
our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
 
Certain
of our key employees and personnel are or were previously employed at universities, medical institutions or other biotechnology or pharmaceutical
companies, including our
competitors or potential competitors.
 
Although
we try to ensure that our employees, consultants and independent contractors do not use the proprietary information or know-how of others
in their work for us, we may be
subject to claims that we or our employees, consultants or independent contractors have inadvertently
or otherwise used or disclosed intellectual property, including trade secrets or
other proprietary information, of any of our employee’s
former employer or other third parties. Litigation may be necessary to defend against these claims. If we fail in defending any
such
claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful
in defending against such claims,
litigation could result in substantial costs and be a distraction to management and other employees.
Furthermore, universities or medical institutions who employ some of our key
employees and personnel in parallel to their engagement
 by us may claim that intellectual property developed by such person is owned by the respective academic or medical
institution under
the respective institution intellectual property policy or applicable law.
 
We
may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result
in litigation and adversely affect
our business.
 
A
significant portion of our intellectual property has been developed by our employees in the course of their employment for us. Under
the Israeli Patent Law, 5727-1967, or the Patent
Law, inventions conceived by an employee during the term and as part of the scope of
his or her employment with a company are regarded as “service inventions,” which belong to the
employer, absent a specific
 agreement between the employee and employer giving the employee service invention rights. The Patent Law also provides that if there
 is no such
agreement between an employer and an employee, the Israeli Compensation and Royalties Committee, or the Committee, a body
constituted under the Patent Law, shall determine
whether the employee is entitled to remuneration for his inventions. Recent decisions
by the Committee (which have been upheld by the Israeli Supreme Court on appeal) have created
uncertainty in this area, as it held that
 employees may be entitled to remuneration for their service inventions despite having specifically waived any such rights. Further, the
Committee has not yet determined the method for calculating this remuneration nor the criteria or circumstances under which an employee’s
waiver of his right to remuneration will be
disregarded. We generally enter into assignment-of-invention agreements with our employees
pursuant to which such individuals assign to us all rights to any inventions created in the
scope of their employment or engagement with
us. Although our employees have agreed to assign to us service invention rights, we may face claims demanding remuneration in
consideration
for assigned inventions. As a consequence of such claims, we could be required to pay additional remuneration or royalties to our current
or former employees, or be
forced to litigate such claims, which could negatively affect our business.
 
We
may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
 
We
may be subject to claims that former employees, collaborators or other third parties have an ownership interest in our patents or other
intellectual property. We may have in the
future, ownership disputes arising, for example, from conflicting obligations of consultants
 or others who are involved in developing our product candidates. Litigation may be
necessary to defend against these and other claims
challenging inventorship or ownership. If we fail in defending any such claims, in addition to paying monetary damages, we may
lose valuable
intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could
have a material adverse effect on our
business. Even if we are successful in defending against such claims, litigation could result in
substantial costs and be a distraction to management and other employees.
 
Obtaining
and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements
imposed by
governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
 
Periodic
maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and applications will be due to be paid to
the U.S. PTO and various governmental
patent agencies outside of the United States in several stages over the lifetime of the patents
and applications. The U.S. PTO and various non-U.S. governmental patent agencies
require compliance with a number of procedural, documentary,
fee payment and other similar provisions during the patent application process. There are situations in which non-
compliance can result
in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
 
44

 
 
Issued
patents covering our product candidates could be found invalid or unenforceable if challenged in court. Changes in
U.S. patent law could diminish the value of
patents in general, thereby impairing our ability to protect our products.
 
As
is the case with other biotechnology companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining
and enforcing patents in the biotechnology
industry involve both technological and legal complexity, and is therefore costly, time-consuming
and inherently uncertain. In addition, the United States has enacted and is currently
implementing wide-ranging patent reform legislation.
 Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and
weakened the rights
of patent owners in some situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future,
this combination of events has
created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the
U.S. Congress, the federal courts, and the U.S. PTO, the laws and regulations
governing patents could change in unpredictable ways that
would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the
future.
 
We
have not yet registered trademarks for a commercial trade name for some of our product candidates and failure to secure such registrations
could adversely affect our
business.
 
We
 have not yet registered trademarks for a commercial trade name for some of our product candidates. During trademark registration proceedings,
 we may receive rejections.
Although we would be given an opportunity to respond to those rejections, we may be unable to overcome such
rejections. In addition, in the U.S. PTO and in comparable agencies in
many foreign jurisdictions, third parties are given an opportunity
to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation
proceedings may be filed
against our trademarks, and our trademarks may not survive such proceedings. Moreover, any name we propose to use with our product candidates
in the
United States must be approved by the FDA, regardless of whether we have registered it, or applied to register it, as a trademark.
The FDA typically conducts a review of proposed
product names, including an evaluation of potential for confusion with other product
names. If the FDA objects to any of our proposed proprietary product names, we may be required
to expend significant additional resources
in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe the existing rights
of third
parties and be acceptable to the FDA.
 
We
may not be able to protect our intellectual property rights throughout the world.
 
Filing,
prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our
intellectual property rights in some
countries outside the United States can be less extensive than those in the United States. In addition,
the laws of some foreign countries do not protect intellectual property rights to the
same extent as federal and state laws in the United
States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United
States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Potential
 competitors may use our technologies in
jurisdictions where we have not obtained patent protection to develop their own products and
further, may export otherwise infringing products to territories where we have patent
protection, but enforcement is not as strong as
that in the United States. These products may compete with our product candidates, if approved, and our patents or other intellectual
property rights may not be effective or sufficient to prevent them from competing.
 
Many
 companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The
 legal systems of certain countries,
particularly certain developing countries, do not favor the enforcement of patents, trade secrets
and other intellectual property protection, particularly those relating to biotechnology
products, which could make it difficult for
us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings
to
enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other
aspects of our business, could put our patents at risk of
being invalidated or interpreted narrowly and our patent applications at risk
of not issuing and could provoke third parties to assert claims against us. We may not prevail in any
lawsuits that we initiate and the
damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property
rights
around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop
or license.
 
45

 
 
Risks
Related to Ownership of Our Ordinary Shares
 
The
market price of our ordinary shares may be highly volatile, and you may not be able to resell your shares at the purchase price.
 
An
active trading market for our ordinary shares may not be available. You may not be able to sell your shares quickly or at the market
price if trading in our ordinary shares is not
active.
 
The
market price of our ordinary shares has been and is likely to remain volatile. Our share price could be subject to wide fluctuations
in response to a variety of factors, including the
following:
 
 
●
adverse
results or delays in preclinical studies or clinical trials, and resulting changes in our clinical development programs;
 
●
reports
of adverse events in other similar products or clinical trials of such products;
 
●
inability
to obtain additional funding or funding on acceptable terms or such time as it would be required;
 
●
any
delay in filing an IND or BLA for any product candidate and any adverse development or perceived adverse development with respect
to the FDA’s review of that IND or
BLA;
 
●
failure
to develop successfully and commercialize a product candidate for the proposed indications and future product candidates for other
indications or new candidates;
 
●
failure
to maintain our licensing arrangements or enter into strategic collaborations;
 
●
failure
by us or our licensors and strategic collaboration partners to prosecute, maintain or enforce our intellectual property rights;
 
●
changes
in laws or regulations applicable to future products;
 
●
inability
or delay in scaling up our manufacturing capabilities, inability to obtain adequate product supply for a product candidate or the
inability to do so at acceptable prices;
 
●
adverse
regulatory decisions, including by the IIA under the Research Law;
 
●
introduction
of new products, services or technologies by our competitors;
 
●
failure
to meet or exceed the estimates, expectations, and projections of the investment community and our shareholders;
 
●
the
perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;
 
●
announcements
of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us (such as the Merger or the recent
sale of our rights to lease the
Modi’in facility) or our competitors;
 
●
disputes
or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection
for our technologies;
 
●
additions
or departures of key scientific or management personnel;
 
●
significant
lawsuits, including patent or shareholder litigation;
 
●
changes
in the market valuations of similar companies;
 
●
general
economic and market conditions and overall fluctuations in the U.S. equity market;
 
●
any
identified material weakness in our internal control over financial reporting;
 
●
changes
in the Nasdaq listing of our stock;
 
●
recommendations
of equity analysts covering our stock;
 
●
the
outcome of our strategic processes;
 
●
sales
of our ordinary shares by us or our shareholders in the future; and
 
●
trading
volume of our ordinary shares.
 
In
addition, companies trading in the stock market in general, and biopharmaceutical companies in particular, have experienced extreme price
and volume fluctuations that have often
been unrelated or disproportionate to the operating performance of these companies. Broad market
and industry factors may negatively affect the market price of our ordinary shares,
regardless of our actual operating performance.
 
There
has been limited trading volume for our ordinary shares.
 
Even
though our ordinary shares have been listed on Nasdaq, there has been limited liquidity in the market for the ordinary
shares, which could make it more difficult for holders to sell
their ordinary shares. There can be no assurance that an active trading
market for our ordinary shares will be sustained. In addition, the stock market generally has experienced extreme
price and volume fluctuations
that have often been unrelated or disproportionate to the operating performance of listed companies. Broad market and industry factors
may negatively
affect the market price of our ordinary shares, regardless of our actual operating performance. The market price and liquidity
of the market for our ordinary shares that will prevail in
the market may be higher or lower than the price you pay and may be significantly
affected by numerous factors, some of which are beyond our control.
 
Our
principal shareholders and management own a significant percentage of our shares and will be able to exert significant control over matters
subject to shareholder
approval.
 
As
of December 31, 2022, to the best of our information, our executive officers, key management, directors, 5% shareholders and their affiliates
beneficially owned approximately
32% of our voting shares. Therefore, these shareholders have the ability to influence us through their
ownership positions. These shareholders may be able to determine all matters
requiring shareholder approval. For example, these shareholders,
 if they were to act together, may be able to control elections of directors, amendments of our organizational
documents, or approval
of any merger, sale of assets, or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals
or offers for our ordinary
shares that you may believe are in your best interest as one of our shareholders.
 
46

 
 
Future
sales and issuances of our ordinary shares or rights to purchase ordinary shares, including pursuant to our equity incentive plans and
at-the-market offering, could
result in additional dilution of the percentage ownership of our shareholders and could cause our share
price to fall.
 
Additional
 capital will be needed in the future to continue our planned operations. To the extent we raise additional capital by issuing equity
 securities, our shareholders may
experience substantial dilution. We may sell ordinary shares, convertible securities or other equity
securities in one or more transactions at prices and in a manner we determine from
time to time, including pursuant to the at-the-market
facility with Jefferies LLC, or the Jefferies ATM. If we sell ordinary shares, convertible securities or other equity securities in one
or more transactions, investors may be materially diluted by subsequent sales. These sales may also result in material dilution to our
existing shareholders, and new investors could
gain rights superior to our existing shareholders.
 
We
also have equity plans that provide for the grant of share options and other equity-based awards to our employees, directors and consultants,
and have issued warrants. The exercise
of any of these options and warrants would result in additional share issuances and may be dilutive.
As these securities are registered, many are available for resale into the public
market. Sales of a substantial number of shares of
our ordinary shares by our existing shareholders in the public market, or the perception that these sales might occur, could depress
the market price of our ordinary shares and could impair our ability to raise capital through the sale of additional equity securities.
We are unable to predict the effect that such sales
may have on the prevailing market price of our ordinary shares.
 
We
could be subject to securities class action litigation.
 
In
the past, securities class action litigation has often been brought against a company following a decline in the market price of its
securities. This risk is especially relevant for us
because pharmaceutical companies have experienced significant share price
volatility in recent years. In July 2022 we announced the OVAL Phase 3 trial did not meet its primary
endpoint, which resulted in a
significant reduction in our share price and increase the volatility of our ordinary shares. We are also now pursuing the Merger,
exploring options for VB-
601 and recently completed the sale of our rights to lease the Modi’in facility, which transactions may not
maximize shareholder value as intended. If we face any such litigation, it
could result in substantial costs and a diversion of
management’s attention and resources, which could harm our business.
 
We
do not intend to pay dividends on our ordinary shares in the foreseeable future, so any returns will be limited to the value of our shares.
 
We
have never declared or paid any cash dividends on our share capital. We currently anticipate that we will retain future earnings for
the development, operation and expansion of our
business and do not anticipate declaring or paying any cash dividends for the foreseeable
future. Any return to shareholders will therefore be limited to the appreciation of their shares.
In addition, Israeli law limits our
ability to declare and pay dividends, and may subject our dividends to Israeli withholding taxes. Furthermore, our payment of dividends
(out of tax-
exempt income) may retroactively subject us to certain Israeli corporate income taxes, to which we would not otherwise be
subject.
 
If
equity research analysts do not publish research reports about our business or if they issue unfavorable commentary or downgrade our
ordinary shares, the price of our
ordinary shares could decline.
 
The
trading market for our ordinary shares relies in part on the research and reports that equity research analysts publish about us and
our business. The price of our ordinary shares
could decline if we do not obtain research analyst coverage, or one or more securities
analysts downgrade our ordinary shares, or if those analysts issue other unfavorable commentary
or expectations that we are unable to
meet, or cease publishing reports about us or our business.
 
Risks
Related to Our Incorporation and Operations in Israel
 
We
have lost our foreign private issuer status, which requires us to comply with the Exchange Act’s domestic reporting regime and
cause us to incur significant legal,
accounting and other expenses.
 
As
a foreign private issuer, we were permitted by the SEC to file an annual report on Form 20-F and copies of certain home country materials
on Form 6-K in lieu of filing annual,
quarterly and current reports on Forms 10-K, 10-Q and 8-K. We were exempt from SEC proxy statement
requirements and certain SEC tender offer requirements and our affiliates are
exempt from Section 16 of the Exchange Act.
 
We
ceased to be a foreign private issuer and ceased to be eligible for the foregoing exemptions and privileges effective January 1, 2023.
We are required to comply with all of the
periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S.
domestic issuers as of January 1, 2023, which are more detailed and extensive than the
requirements for foreign private issuers. We may
also be required to make changes in our corporate governance practices in accordance with various SEC and Nasdaq rules. Although
we already
report under U.S. GAAP and voluntarily publish quarterly financial information, the regulatory and compliance costs to once we are required
to comply with the reporting
requirements applicable to a U.S. domestic issuer may be significantly higher than the cost we incur as
a foreign private issuer even though we are able to qualify as a “smaller
reporting company.”
 
As
a result, we expect that our recent loss of foreign private issuer status will increase our legal and financial compliance costs and
may make some activities highly time consuming
and costly. It will also impose additional burdens on holders of our securities, which
may make an investment in our company less attractive. We expect that complying with the rules
and regulations applicable to United States
domestic issuers may make it more difficult and expensive for us to obtain director and officer liability insurance, and we may be required
to accept reduced coverage or incur substantially higher costs to obtain coverage. These rules and regulations could also make it more
difficult for us to attract and retain qualified
members of our board of directors.
 
47

 
 
Potential
political, economic and military instability in the State of Israel, where the majority of our senior management and employees are located,
may adversely affect our
results of operations.
 
We
are incorporated under Israeli law and our offices and core operations are located in the State of Israel, with a small operational base
in the United States. In addition, most of our
key employees and officers and three of our directors are residents of Israel. Accordingly,
political, economic and military conditions in Israel directly affect our business. Since the
State of Israel was established in 1948,
a number of armed conflicts have occurred between Israel and its neighboring countries.
 
Any
hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners, or a significant
downturn in the economic or financial
condition of Israel, could affect adversely our operations. Since October 2000, there have been
increasing occurrences of terrorist violence. Ongoing and revived hostilities or other
Israeli political or economic factors could harm
our operations, product development and results of operations.
 
In
addition, Israel faces threats from more distant neighbors, in particular, Iran. Our insurance policies do not cover us for the damages
incurred in connection with these conflicts or for
any resulting disruption in our operations. The Israeli government, as a matter of
law, provides coverage for the reinstatement value of direct damages that are caused by terrorist
attacks or acts of war; however, the
government may cease providing such coverage or the coverage might not be enough to cover potential damages. In the event that hostilities
disrupt the ongoing operation of our facilities or the airports and seaports on which we depend to import and export our supplies and
products, our operations may be materially
adversely affected.
 
In
addition, numerous acts of protest and civil unrest have taken place in several countries in the Middle East and North Africa, many of
which involved significant violence, including
Egypt and Syria, which border Israel. The ultimate effect of these developments on the
political and security situation in the Middle East and on Israel’s position within the region is
not clear at this time. Such
instability may lead to deterioration in the political and trade relationships that exist between the State of Israel and certain other
countries.
 
Popular
uprisings in various countries in the Middle East and North Africa are affecting the political stability of those countries. Such instability
may lead to deterioration in the
political and trade relationships that exist between the State of Israel and these countries. Several
countries, principally in the Middle East, still restrict doing business with Israel and
Israeli companies, and additional countries
may impose restrictions on doing business with Israel and Israeli companies if hostilities in Israel or political instability in the
region
continues or increases. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present
 trading partners, or significant downturns in the
economic or financial condition of Israel, could adversely affect our operations and
product development and adversely affect our share price. Similarly, Israeli companies are limited
in conducting business with entities
from several countries. For instance, in 2008, the Israeli legislature passed a law forbidding any investments in entities that transact
business with
Iran.
 
Additionally,
the Israeli government is currently advancing significant changes in Israeli legislation concerning judiciary nomination and oversight.
If such proposals will be enacted by
the Israeli Knesset, they will change the current balance between the three branches of government
in Israel in a manner that is expected to add significant power to the executive and
the legislative branches. Such changes may have
actual or perceived effects regarding the risks associated with conducting business or investing in Israel. Since the proposals have
not
yet been enacted as law, the uncertainty of their effect on the Company and its business may not be estimated at this time.
 
Our
operations may be disrupted by the obligations of personnel to perform military service.
 
As
of March 1, 2023, we had seven employees, six of whom were based in Israel. Israeli employees may be called upon to perform
up to 36 days (and in some cases more) of annual
military reserve duty until they reach the age of 40 (and in some cases, up to 45 or
older) and, in emergency circumstances, could be called to immediate and unlimited active duty. In
the event of severe unrest or other
conflict, individuals could be required to serve in the military for extended periods of time. Since September 2000, in response to increased
tension
and hostilities, there have been occasional call-ups of military reservists and it is possible that there will be additional
 call-ups in the future. Although our current streamlined
workforce does not include any employees subject to this obligation, if our Israeli workforce grows and becomes subject to this duty, it could impact our operations, which disruptions
could materially
adversely affect our business and results of operations. Additionally, the absence of a significant number of the employees of our Israeli
suppliers and contractors
related to military service or the absence for extended periods of one or more of their key employees for military
service may disrupt their operations.
 
The
tax benefits that are available to us if and when we generate taxable income require us to meet various conditions and may be prevented
or reduced in the future, which
could increase our costs and taxes.
 
If
and when we generate taxable income, we would be eligible for certain tax benefits provided to “Benefited Enterprises” under
the Israeli Law for the Encouragement of Capital
Investments, 1959, as amended, or the Investment Law. In order to remain eligible for
the tax benefits for “Benefited Enterprises” we must continue to meet certain conditions
stipulated in the Investment Law
and its regulations, as amended. In addition, we informed the Israeli Tax Authority of our choice of 2012 as a “Benefited Enterprise”
election year, all
under the Investment Law. The benefits available to us under this tax regulation are subject to the fulfillment of
conditions stipulated in the regulation. Further, in the future these tax
benefits may be reduced or discontinued. If these tax benefits
are reduced, cancelled or discontinued, our Israeli taxable income would be subject to regular Israeli corporate tax rates.
The standard
corporate tax rate for Israeli companies is 23% for 2018 and thereafter. Additionally, if we increase our activities outside of Israel
through acquisitions, for example, our
expanded activities might not be eligible for inclusion in future Israeli tax benefit programs.
 
48

 
 
It
may be difficult to enforce a U.S. judgment against us, our officers and directors and the Israeli experts named in this document in
Israel or the United States, or to assert
U.S. securities laws claims in Israel or serve process on our officers and directors and these
experts.
 
We
were incorporated in Israel, and our corporate headquarters and substantially all of our operations are located in Israel. Most of our
executive officers and three of our directors, and
the Israeli experts named in this document, are located in Israel. The majority of
our assets and the assets of these persons are located outside the United States. Therefore, it may be
difficult for an investor, or
any other person or entity, to enforce a U.S. court judgment based upon the civil liability provisions of the U.S. federal securities
laws against us or any of
these persons in a U.S. or Israeli court, or to effect service of process upon these persons in the United
States. Additionally, it may be difficult for an investor, or any other person or
entity, to assert U.S. securities law claims in original
actions instituted in Israel. Israeli courts may refuse to hear a claim based on an alleged violation of U.S. securities laws against
us
or our officers and directors on the grounds that Israel is not the most appropriate forum in which to bring such a claim. Even if
an Israeli court agrees to hear a claim, it may determine
that Israeli law and not U.S. law is applicable to the claim. If U.S. law is
found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-
consuming and costly process.
Certain matters of procedure will also be governed by Israeli law. There is little binding case law in Israel addressing the matters
described above.
 
Your
rights and responsibilities as our shareholder will be governed by Israeli law, which may differ in some respects from the rights and
responsibilities of shareholders of
U.S. corporations.
 
Because
 we are incorporated under Israeli law, the rights and responsibilities of our shareholders are governed by our articles of association
 and Israeli law. These rights and
responsibilities differ in some material respects from the rights and responsibilities of shareholders
of U.S. corporations. In particular, a shareholder of an Israeli company has a duty to
act in good faith and in a customary manner in
exercising its rights and performing its obligations towards the company and other shareholders and to refrain from abusing its power
in
the company, including, among other things, in voting at the general meeting of shareholders on certain matters, such as an amendment
to the company’s articles of association, an
increase of the company’s authorized share capital, a merger of the company
and approval of related party transactions that require shareholder approval. A shareholder also has a
general duty to refrain from discriminating
against other shareholders. In addition, a controlling shareholder or a shareholder who knows that it possesses the power to determine
the
outcome of a shareholder vote or to appoint or prevent the appointment of an officer of the company has a duty to act in fairness
towards the company with regard to such vote or
appointment. However, Israeli law does not define the substance of this duty of fairness.
There is limited case law available to assist us in understanding the nature of this duty or the
implications of these provisions. These
provisions may be interpreted to impose additional obligations and liabilities on our shareholders that are not typically imposed on
shareholders
of U.S. corporations. See “Item 13. “Certain Relationships and Related Transactions, and Director Independence—Approval
of Related Party Transactions Under Israeli Law.”
 
Provisions
of Israeli law and our amended and restated articles of association could make it more difficult for a third party to acquire us or increase
the cost of acquiring us,
even if doing so would benefit our shareholders.
 
Israeli
law regulates mergers, requires tender offers for acquisitions of shares above specified thresholds, requires special approvals for transactions
involving directors, officers or
significant shareholders and regulates other matters that may be relevant to such types of transactions.
For example, a tender offer for all of a company’s issued and outstanding shares
can only be completed if the acquirer receives
positive responses from the holders of at least 95% of the issued share capital. Completion of the tender offer also requires approval
of a
majority of the offerees that do not have a personal interest in the tender offer, unless at least 98% of the company’s outstanding
shares are tendered. Furthermore, the shareholders,
including those who indicated their acceptance of the tender offer (unless the acquirer
stipulated in its tender offer that a shareholder that accepts the offer may not seek appraisal
rights), may, at any time within six
 months following the completion of the tender offer, petition an Israeli court to alter the consideration for the acquisition. See Exhibit
 4.1
“Description of Capital Stock—Memorandum and Articles of Association-Acquisitions under Israeli Law” for additional
information.
 
Further,
Israeli tax considerations may make potential transactions undesirable to us or to some of our shareholders whose country of residence
does not have a tax treaty with Israel
granting tax relief to such shareholders from Israeli tax. For example, Israeli tax law does not
recognize tax-free share exchanges to the same extent as U.S. tax law. With respect to
mergers, Israeli tax law allows for tax deferral
in certain circumstances but makes the deferral contingent on the fulfillment of a number of conditions, including, in some cases, a
holding period of two years from the date of the transaction during which sales and dispositions of shares of the participating companies
are subject to certain restrictions. Moreover,
with respect to certain share swap transactions, the tax deferral is limited in time,
and when such time expires, the tax becomes payable even if no disposition of the shares has
occurred.
 
Certain
U.S. shareholders may be subject to adverse tax consequences if we are characterized as “Controlled Foreign Corporation.”
 
Each
“Ten Percent Shareholder” in a non-U.S. corporation that is classified as a “controlled foreign corporation,”
or a CFC, for U.S. federal income tax purposes generally is required
to include in income for U.S. federal tax purposes such Ten Percent
Shareholder’s pro rata share of the CFC’s “Subpart F income” and investment of earnings in U.S. property, even
if
the CFC has made no distributions to its shareholders. A non-U.S. corporation generally will be classified as a CFC for U.S. federal
income tax purposes if Ten Percent Shareholders
own, directly or indirectly, more than 50% of either the total combined voting power
of all classes of stock of such corporation entitled to vote or of the total value of the stock of such
corporation. A “Ten Percent
Shareholder” is a U.S. person (as defined by the U.S. Internal Revenue Code of 1986, as amended), who owns or is considered to
own 10% or more of the
total combined voting power of all classes of stock entitled to vote of such corporation. The determination of
CFC status is complex and includes attribution rules, the application of
which is not entirely certain.
 
49

 
 
We
do not believe that we were a CFC for the taxable year ended December 31, 2022 or that we are currently a CFC. It is possible, however,
that a shareholder treated as a U.S. person
for U.S. federal income tax purposes will acquire, directly or indirectly, enough shares
to be treated as a Ten Percent Shareholder after application of the constructive ownership rules
and, together with any other Ten Percent
 Shareholders of our company, cause us to be treated as a CFC for U.S. federal income tax purposes. We believe that certain of our
shareholders
are Ten Percent Shareholders for U.S. federal income tax purposes. Holders should consult their own tax advisors with respect to the
potential adverse U.S. federal income
tax consequences of becoming a Ten Percent Shareholder in a CFC.
 
We
might be classified as a passive foreign investment company in future years, and our U.S. shareholders may suffer adverse tax consequences
as a result.
 
Generally,
if, for any taxable year, at least 75% of our gross income is passive income, or at least 50% of the value of our assets is attributable
to assets that produce passive income or
are held for the production of passive income, including cash, we would be characterized as
a passive foreign investment company, or PFIC, for U.S. federal income tax purposes. For
purposes of these tests, passive income includes
dividends, interest, and gains from the sale or exchange of investment property and rents and royalties other than rents and royalties
which are received from unrelated parties in connection with the active conduct of a trade or business. If we are characterized as a
PFIC, our U.S. shareholders may suffer adverse tax
consequences, including having gains realized on the sale of our ordinary shares treated
as ordinary income, rather than capital gain, the loss of the preferential rate applicable to
dividends received on our ordinary shares
by individuals who are U.S. holders, and having interest charges apply to distributions by us and the proceeds of share sales.
 
Because
PFIC status depends on the composition of our income and the composition and value of our assets (which may be determined in part by
reference to the market value of our
ordinary shares, which may be volatile) from time to time, there can be no assurance that we will
not be considered a PFIC for any taxable year. We believe that we were not a PFIC for
our 2022 taxable year. However, the determination
of whether are a PFIC is a fact-intensive determination made on an annual basis applying principles and methodologies that in some
circumstances
are unclear and subject to varying interpretation. As a result, there can be no assurance that we will not be treated as a PFIC for the
current or any future taxable year.
 
Item
1B.
UNRESOLVED
STAFF COMMENTS
 
Not
applicable.
 
Item
2.
PROPERTIES
 
Our
corporate headquarters are currently located in Modi’in, Israel, where we continue to occupy office space for a nominal fee in
our former Modi’in facility that we sold in March
2023. We are evaluating alternative locations to support future operations, as appropriate, for our current needs.
We do not anticipate that we will have difficulty finding suitable office
space for our streamlined operations as we look to
complete the Merger, or if we are unsuccessful in consummating such transaction. We also have a small U.S. office rented on a
monthly basis located at 1 Blue Hill Plaza, Suite 1509, Pearl River, NY 10965.
 
Item
3.
LEGAL
PROCEEDINGS
 
From
time to time, we may become involved in litigation or other legal proceedings relating to claims arising from the ordinary course of
business. We are currently not party to any
legal proceedings that are likely to have a material adverse effect on our results of operations,
financial condition or cash flows.
 
Item
4.
MINE
SAFETY DISCLOSURES
 
Not
applicable.
 
50

 
 
PART
II
 
Item
5.
MARKET
FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
 
Market
Information
 
Our
ordinary shares are listed on the Nasdaq Capital Market under the symbol “VBLT.”
 
We are not currently in compliance with the listing requirements and our
ordinary shares could be subject to delisting. See “Item 1A. Risk Factors—We are not in compliance with
Nasdaq’s
 minimum bid price requirement and if we fail to regain compliance with Nasdaq’s continued listing requirements, our ordinary shares
 could be delisted, which could
adversely affect the liquidity of our ordinary shares and our ability to raise additional capital or complete
the Merger. The Merger is a ‘change of control’ and the combined company
will need to satisfy all of Nasdaq’s initial
listing criteria to remain listed on Nasdaq.”
 
Holders
of Record
 
According
 to our transfer agent, as of March 10, 2023, there were 12 record holders of our ordinary shares. None of our shareholders have different voting rights from other
shareholders. Certain shares
are held in “street” name and accordingly, the number of beneficial owners of such shares is not known or included in the
foregoing number. This number
of holders of record also does not include shareholders whose shares may be held in trust by other entities.
 
Dividends
 
We
have never declared or paid any cash dividends to our shareholders. We currently anticipate that we will retain all of our future earnings,
if any, for use in the operation of our
business. Additionally, our ability to pay dividends on our ordinary shares is limited by restrictions
under the terms of the agreements governing our indebtedness and under Israeli law.
 
Recent
Sales of Unregistered Securities
 
In
January 2022, we issued 10,362 restricted shares for services provided.
 
In
April 2022, we issued 11,627 restricted shares for services provided.
 
In
July 2022, we issued 12,269 restricted shares for services provided.
 
Item
6.
[RESERVED]
 
51

 
 
Item
7.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
The
following discussion of our financial condition and results of operations should be read in conjunction with our financial statements
and the related notes to those statements
included elsewhere in this Annual Report. In addition to historical financial information,
the following discussion and analysis contains forward-looking statements that involve risks,
uncertainties and assumptions. See “Cautionary
Note Regarding Forward-Looking Statements.” Our actual results and timing of selected events may differ materially from those
anticipated
in these forward-looking statements as a result of many factors, including those discussed under “Item 1A. Risk Factors”
and elsewhere in this Annual Report.
 
Overview
 
We
are a biopharmaceutical company that has historically focused on developing targeted therapies for immune-inflammatory diseases and
cancer. Our goal is to provide differentiated
targeted therapeutics to address the underlying cause of diseases where treatment
 options are limited. Our sole product candidate, VB-601, is a targeted antibody for immune-
inflammatory applications that has shown
disease-modifying activity across multiple preclinical models including multiple sclerosis, rheumatoid arthritis and inflammatory
bowel
disease. VB-601 was developed using our monocyte targeting technology, or MTT, and is designed to specifically inhibit
monocyte migration. In October 2022, we submitted an
application to the Israel Ministry of Health and institutional review board for
a first-in-human Phase 1 trial evaluating VB-601 in healthy volunteers. Production of cGMP grade
material of VB-601 for the Phase 1
trial was completed using a third party vendor, and the procedures required for study launch are being finalized. Initiation of this
trial is subject to
the progress and outcome of our corporate strategic process, and we may look to monetize this asset rather than
continue development internally.
 
We
commenced operations in 2000, and historically our operations to date have been limited to organizing and staffing our company, business
planning, raising capital, developing our
platform technologies and our product candidates, including conducting preclinical studies
and clinical trials of ofra-vec and VB-601, and other programs we are no longer pursuing.
To date, we have funded our operations through
private sales of preferred shares, a convertible loan, public offerings, revenues from licensing agreements, grants from the Israeli
Office
of Chief Scientist, or OCS, which has later transformed to the IIA under the Research Law, and the European Innovation Commission.
We have no products that have received
regulatory approval and accordingly have never generated regular revenue streams from sales of
our products. Since our inception through December 31, 2022, we had raised an
aggregate of $327.0 million to fund our operations, including
$29.4 million from IIA grants.
 
Since
inception, we have incurred significant losses. For the years ended December 31, 2022 and 2021, our loss was $32.3 million and $29.9
million, respectively. We expect to
continue to incur significant expenses and losses for at least the next several years and increased
expenses related to our development programs, including expenses related to initiation
of new clinical trials. As of December 31, 2022,
we had an accumulated deficit of $294.4 million. Our losses may fluctuate significantly from quarter to quarter and year to year,
depending
on the timing of our clinical trials, the receipt of payments under any future collaborations we may enter into, and our expenditures
on other research and development
activities.
 
As
of December 31, 2022, we had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $21.1 million. To fund
further operations and obtain regulatory
approval for our product candidates if we determine to proceed with development, we will need to raise additional capital. We may seek to raise capital to pursue
additional activities,
which may be through a combination of private and public equity offerings, government grants, strategic collaborations
and licensing arrangements. Additional financing may not be
available when we specifically need it or may not be available on terms that
are favorable to us. As of the date of this Annual Report, we had seven employees.
 
Recent
Developments
 
Prior
to July 2022, our lead candidate was ofra-vec (VB-111), a custom designed therapeutic candidate comprised of a viral vector, promoter,
and therapeutic gene. In July 2022, we
announced that our Phase 3 OVAL clinical trial did not meet the primary endpoints and subsequently,
we ceased further development of ofra-vec in all indications.
 
In
August 2022, we announced a process to explore strategic alternatives to enhance shareholder value and engaged Chardan, as our exclusive financial advisor to assist in this process.
Potential strategic options explored or evaluated
as part of the process included, but were not limited to merger, reverse merger, other business combination, sale of assets, licensing,
or
other strategic transactions. We also announced an organizational streamlining designed to reduce operating expenses and preserve
capital as we explored strategic options to maximize
shareholder value and as a result, to date, have we reduced our workforce by approximately
84% and our board of directors was reduced from nine to six.
 
52

 
 
Proposed
Merger with Notable Labs, Inc.
 
On
February 22, 2023, we entered into the Merger Agreement with Notable and Merger Sub, pursuant to which, and subject to the satisfaction
or waiver of the conditions set forth in
the Merger Agreement, Notable will be merged with and into Merger Sub at the Effective Time,
with Notable continuing after the Merger as the surviving corporation and our wholly-
owned subsidiary. The Merger is intended to qualify
as a tax-free reorganization for U.S. federal income tax purposes.
 
At
the Effective Time, each outstanding share of Notable capital stock will be converted into the right to receive our ordinary shares,
as set forth in the Merger Agreement. Under the
exchange ratio formula in the Merger Agreement, immediately following the Effective Time,
the former Notable securityholders are expected to own approximately 76% of our
ordinary shares on a fully diluted basis and subject
to adjustment and our securityholders of VBL as of immediately prior to the Effective Time are expected to own approximately 24%
of our
ordinary shares on a fully diluted basis and subject to adjustment. Under certain circumstances further described in the Merger Agreement,
the ownership percentages may be
adjusted upward or downward based on the level of our net cash at the closing of the Merger, and the
terms and net proceeds of Notable’s pre-merger financing. There can be no
assurances as to our level of net cash between the signing
of the Merger Agreement and the closing of the Merger.
 
The
Merger Agreement also provides that, immediately following the Effective Time, the board of directors of the combined company will consist
of up to seven directors, with one
director designated by us. Upon the closing of the transaction, the combined company will be led by
Notable’s chief executive officer and executive management team. In connection
with the Merger, we will seek to amend our articles
of incorporation to: (i) effect an increase of our registered share capital and/or effect a reverse split of our ordinary shares at a
ratio
to be determined; (ii) change our name to “Notable Labs, Ltd.”; and (iii) make other such changes as mutually agreeable
to our company and Notable.
 
While
the accounting treatment of the Merger is not yet finalized, it is expected to be accounted for as a reverse merger, and the historical financial
statements of Notable will be our
historical financial statements upon completion of the Merger.
 
For
additional information regarding the proposed Merger, see “Item 1. Business—Recent Developments.”
 
Although
we have entered into the Merger Agreement and intend to consummate the proposed Merger, there is no assurance that we will be able to
successfully consummate the
proposed Merger on a timely basis, or at all. If, for any reason, the proposed Merger is not completed, we
will reconsider our strategic alternatives and could pursue one or more of the
following courses of action:
 
 
●
Pursue
potential collaborative, partnering or other strategic arrangements for our assets, including a sale or other divestiture of VB-601 and any of our other
assets; or in-
licensing additional programs and assets to develop internally.
 
●
Pursue
another strategic transaction like the proposed Merger. Our board of directors may elect to pursue an alternative strategy, one of
which may be a strategic transaction
similar to the proposed Merger.
 
●
Dissolve
and liquidate our assets. If, for any reason, the proposed Merger is not consummated and we are unable to identify and complete an
alternative strategic transaction
like the Merger or potential collaborative, partnering or other strategic arrangements for our
 assets, or to continue to operate our business due to our inability to raise
additional funding, we may be required to dissolve and
liquidate our assets. In such case, we would be required to pay all of our debts and contractual obligations, and to set
aside certain
reserves for potential future claims, and there can be no assurances as to the amount or timing of available cash left to distribute
to our shareholders after paying
our debts and other obligations and setting aside funds for reserves.
 
Sale
of Assets in the Modi’in Facility
 
On
February 15, 2023, we entered into the Purchase Agreement providing for the sale of our rights to lease the Modi’in manufacturing facility,
along with certain tangible assets and
equipment located therein for $7.1 million. We intend to use the proceeds from the asset sale
to meet the $15.0 million minimum net cash closing condition provided in the Merger
Agreement and are disposing of such rights in contemplation
of the Merger (although completion of such asset sale is not a condition to the Merger). There can be no guarantee that we
will have
sufficient funds to satisfy the minimum net cash closing required pursuant to the Merger Agreement. We closed the asset sale on March
9, 2023. We have retained the right to
use a portion of the space for a nominal fee until May 31, 2023.
 
Financial
Overview
 
Revenues
and Cost of Revenues
 
Since
 inception, we have generated cumulative revenues of approximately $17.4 million primarily from an exclusive license agreement with Nanocarrier
 for the development,
commercialization, and supply of ofra-vec in Japan for all indications. In light of the determination to discontinue
development of ofra-vec in all indications, this license agreement has
been terminated and we do not expect to generate additional revenues
from the achievement of new milestones or royalties under this agreement. The generated revenues comprise
upfront and milestone payments.
The cost of revenues associated with these revenues was approximately $1.6 million.
 
We
do not expect to receive any revenue from VB-601 or any product candidates that we develop unless and until we obtain regulatory approval
and commercialize our products, meet
regulatory milestones in relation to our existing collaborative agreements, or enter into new collaborative
agreements with third parties.
 
Research
and Development Expenses
 
Research
and development expenses consist of costs incurred for the development of our platform technology and product candidate. Those expenses
include:
 
 
●
employee-related
expenses, including salaries and share-based compensation expenses for employees in research and development functions;
 
●
expenses
incurred in operating our laboratories and manufacturing facility;
 
●
expenses
incurred under agreements with clinical research organizations and investigative sites that conduct our clinical trials;
 
●
expenses
relating to outsourced and contracted services, such as external laboratories, consulting and advisory services;
 
●
supply,
development and manufacturing costs relating to clinical trial materials;
 
●
maintenance
of facilities, depreciation and other expenses, which include direct and allocated expenses for rent and insurance; and
 
●
costs
associated with preclinical and clinical activities.
 
53

 
 
Historically,
 research and development activities were the primary focus of our business. Our research and development expenses are likely to decrease
 significantly with the
termination of the OVAL study and ofra-vec program, partially offset by an increase of research and development
expenses as we move our VB-601 product candidate into clinical
development.
 
Research
and development expenses are recognized as incurred. An intangible asset arising from the development of our product candidates is recognized
if certain capitalization
conditions are met. As of December 31, 2022, we did not have any capitalized development costs.
 
We
 have received grants for the ofra-vec program and another historical program from the Israeli Office of Chief Scientist, or OCS, which
 has later transformed to the Israeli
Innovation Authority, or IIA, under the Israel Encouragement of Research and Development in Industry,
or the Research Law, as part of the research and development programs. The
requirements and restrictions for such grants are found in
the Research Law. These grants are subject to repayment through future royalty payments on any products resulting from
these research
and development programs that received grant funding. The total gross amount of grants actually received by us from the IIA, including
accrued interest as of December
31, 2022, totaled $38.4 million.
 
Under
applicable accounting rules, grants from the IIA have been accounted for as an off-set against the related research and development expenses
in our financial statements. As a
result, our research and development expenses are shown on our financial statements net of the IIA
grants.
 
In
August 2022, we received $1.1 million as part of the grant from the European Innovation Council, or EIC, for development of ofra-vec.
The grant has been accounted for as an off-
set against the related research and development expenses in the financial statements. We
may be entitled to an additional $1.4 million in grant funds for project activities conducted
prior to the termination of the ofra-vec
project; however, there can be no assurance that we will receive these funds.
 
Due
to the closure of our ofra-vec program, early nature of the VB-601 program, and our strategic process, we expect research and development
expenses to be significantly less than
prior periods.
 
General
and Administrative Expenses
 
General
 and administrative expenses consist principally of salaries and related costs for personnel in executive and finance functions such as
 salaries, benefits and share-based
compensation. Other general and administrative expenses include facility costs not otherwise included
 in research and development expenses, communication expenses, and
professional fees for legal services, patents and portfolio maintenance,
 consulting, commercialization, auditing and accounting services. Given the significant reduction in our
workforce, we expect our general
and administrative expenses for personnel to decrease.
 
Financial
Expenses (Income), Net
 
Financial
income is comprised of interest income generated from interest earned on our cash, cash equivalents and short-term bank deposits and
gains and losses due to fluctuations in
foreign currency exchange rates, mainly in the appreciation and depreciation of the NIS exchange
rate against the U.S. dollar.
 
Financial
expenses primarily consist of calculated interest expenses from our lease liabilities and gains and losses due to fluctuations in foreign
currency exchange rates.
 
Taxes
on Income
 
We
have not generated taxable income since our inception and had carry forward tax losses as of December 31, 2022, of $250.5 million. We
anticipate that we will be able to carry
forward these tax losses indefinitely to future tax years. Accordingly, we do not expect to
pay taxes in Israel until we have taxable income after the full utilization of our carry forward
tax losses.
 
We
recognize full valuation allowance because we do not expect taxable income.
 
Critical
Accounting Policies and Significant Judgments and Estimates
 
The
preparation of financial statements in conformity with U.S. GAAP requires the use of estimates and assumptions that affect the
reported amounts of assets and liabilities, revenues
and expenses, and related disclosures in the financial statements. Critical
accounting policies are those accounting policies that may be material due to the levels of subjectivity and
judgment necessary to
 account for highly uncertain matters or the susceptibility of such matters to change, and that have a material impact on financial
 condition or operating
performance. While we base our estimates and judgments on our experience and on various other factors that we
believe to be reasonable under the circumstances, actual results may
differ from these estimates under different assumptions or conditions. Our most critical accounting
estimates include the following. For additional information relating to these and
other accounting policies, see Note 1 in the Notes to the Financial Statements, appearing elsewhere in this this Annual Report on Form 10-K.
 
Revenue
Recognition
 
The
 recognition of revenue under our former NanoCarrier license agreement (which was terminated in 2022) required the exercise of judgment
 by management. Notably, our
management exercised judgment in the following areas:
 
54

 
 
Identifying
the performance obligations in the agreement and determining whether the license provided is distinct - based on our analysis, the license
is distinct as the licensee is able to
benefit from the license on its own at its current stage (inter alia, due to sublicensing rights,
rights and responsibility for development in the territory, etc.).
 
Allocation
of the transaction price - we estimated the standalone selling prices of the services to be provided based on expected cost plus margin
and used the residual approach to
estimate the standalone selling price of the license as we have not yet established a price for the
license, and it has not previously been sold on a standalone basis.
 
Variable
consideration consists of potential future milestone payments. We determined that all such variable consideration shall be allocated
to the license (the satisfied performance
obligation).
 
See
also Note 7 in the Notes to the Financial Statements.
 
Share-Based
Compensation
 
With
respect to grants to employees, the value is measured on the date of grant based on the fair value of the equity instruments granted
to the employees. We determine grant date fair
value using the Black-Scholes model, which requires the management to make significant
estimates and judgments. See Note 9 in the Notes to the Financial Statements, appearing
elsewhere in this this Annual Report on Form 10-K, for information regarding the various assumptions used.
 
The
value of the transactions, measured as aforesaid, is expensed over the period during which the right of the employees and non-employees
to exercise or receive the underlying
equity instruments vests; commensurate with every periodic recognition of the expense, a corresponding
increase is recorded to additional paid in capital, included under our equity
(see also Note 9 in the Notes to the Financial Statements).
 
Results
of Operations
 
Comparison
of Years Ended December 31, 2022 and 2021 (in thousands)
 
 
 
 
   
 
   
2022
 
 
 
 
   
 
   
Increase
 
 
 
Year
ended December 31,
   
(Decrease)
 
 
 
2022
   
2021
   
$
 
 
 
 
   
 
   
 
 
Revenues
 
$
658   
 
768   
 
(110)
Cost
of Revenues
 
 
(104)  
 
(365)  
 
261 
Gross
profit
 
 
554   
 
403   
 
151 
Expenses:
 
 
    
 
    
 
  
Research
and development, gross
 
$
22,814   
$
23,206   
$
(392)
Government
grants
 
 
(1,161)  
 
(511)  
 
(650)
Research
and development, net
 
$
21,653   
$
22,695   
$
(1,042)
General
and administrative
 
 
11,754   
 
7,704   
 
4,050 
Operating
loss
 
 
32,853   
 
29,996   
 
2,857 
Financial
income, net
 
 
(549)  
 
(76)  
 
(473)
Loss
for the year
 
$
32,304   
$
29,920   
$
2,384 
 
55

 
 
Revenues
 
Revenues
for the year ended December 31, 2022 were $0.7 million, compared to $0.8 million for the year ended in 2021, a decrease of $0.1 million.
The decrease is due to the winding
down of the revenue recognized from the Nanocarrier license agreement.
 
Cost
of revenues for the year ended December 31, 2022 were $0.1 million compared to $0.4 million for the year ended in 2021. The cost of revenues
is attributed to the labor costs and
other expenses related to the performance obligations that were delivered during the period. Cost
 of revenues decreased due to the reduction of labor costs associated with the
Nanocarrier license agreement.
 
Research
and development expenses, net
 
Research
and development expenses are presented net of grants. Research and development expenses, net, for the year ended December 31, 2022
were $21.7 million, compared to
$22.7 million for the year ended December 31, 2021, a decrease of $1.0 million.
 
The
decrease in research and development expenses, net, in 2022 was mainly related to the increase in labor severance costs due to our August
2022 reduction in workforce of
approximately
$0.6 million, offset by a decrease in VB-601 development of about $1.0 million and $0.7 million in funding by EIC accelerator received
in 2022 compared to 2021.
 
General
and administrative expenses
 
General
and administrative expenses for the year ended December 31, 2021 were $11.8 million, compared to $7.7 million for the year ended December
31, 2021, an increase of $4.1
million.
 
This
increase in 2022 is mainly attributed to share-based compensation expense and U.S. operational and professional costs incurred in 2022
compared to 2021 as we established our
U.S. subsidiary in September 2021, in addition to an increase in legal costs and labor severance
obligations for terminated employees due to the reduction in workforce and strategic
process.
 
56

 
 
Financial
income, net
 
Financial
income, net for the year ended December 31, 2022 was $0.5 million, compared to $0.1 million for the year ended December 31, 2021, an
increase of $0.4 million in income.
The increase in 2022 in mainly due to favorable exchange rates compared to 2021.
 
Liquidity,
Capital Resources, and Financial Requirements
 
Since
our inception and through December 31, 2022, we have raised an aggregate of $327.0 million to fund our operations, including $29.4 million
from IIA grants and $1.1 million
from the EIC. Our primary uses of cash have historically been to fund working capital requirements and
research and development, and we expect these will continue to represent our
primary uses of cash subject to our strategic process. Subject
to the outcome of this process, we intend to use our cash resources, together with the proceeds from our previous
offerings, to advance
clinical programs, working capital, and other general corporate purposes.
 
During
the year ended December 31, 2021, we received $26.4 million in net proceeds from the sale of ordinary shares and pre-funded warrants
in an underwritten public offering and
an aggregate of $23.1 million in gross proceeds from warrant exercises, sales under our at-the-market
facility with Oppenheimer & Co. Inc., or the Oppenheimer ATM, and direct
shares sales under the ordinary share purchase agreement.
 
In
February 2022, we terminated the Oppenheimer ATM and entered into the Jefferies ATM pursuant to an Open Market Sale AgreementSM
with Jefferies LLC or Jefferies, providing
for the offer and sale from time to time of our ordinary shares having an aggregate
offering price of up to $50.0 million. To date we have not sold any shares under the Jefferies ATM.
 
In
December 2022, we terminated an ordinary share purchase agreement with an institutional investor (pursuant to which we had issued in
aggregate year to date 1,400,000 shares for
gross proceeds of approximately $3.0 million).
 
On
December 31, 2022, we had cash, cash equivalents, short-term bank deposits and restricted bank deposits of $21.1 million and working
capital of $15.4 million. Based on our
current cash resources, and successful implementation of our reduction in workforce, we
 believe our current cash as of December 31, 2022 will be sufficient to fund estimated
operating expenses and capital expenditure
requirements for at least 12 months from the date of the filing of these financial statements. We undertook a review of our
strategic options
and any transaction resulting therefrom (such as the Merger and the proposed sale of our rights to lease the
Modi’in facility and certain related assets) may impact our projection.
Further, our losses may fluctuate significantly from quarter to quarter and year
to year, depending on the timing of any clinical trials, the receipt of payments under any future
collaboration agreements it may
enter into, our expenditures on other research and development activities, as well as any strategic options we may pursue. We may
seek to raise more
capital to pursue additional activities, including through a combination of private and public equity offerings,
 debt, government grants, strategic collaborations and licensing
arrangements. Additional financing may not be available when we need
it or may not be available on terms that are favorable to us. We are unable to estimate the amounts of increased
capital outlays and
operating expenses associated with completing the development of VB-601 and any other product candidates.
 
Until
such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity
offerings, debt financings, collaborations,
strategic alliances and licensing arrangements. In any event, we will require additional
capital to obtain regulatory approval for our product candidates. We do not currently have any
committed external source of funds. To
the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our
shareholders
will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your
rights as a holder of our ordinary shares. Debt financing, if
available, may involve agreements that include covenants limiting or restricting
our ability to take specific actions such as incurring additional debt, making capital expenditures or
declaring dividends. If we raise
additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish
valuable rights to
our technology, future revenue streams or research program or grant licenses on terms that may not be favorable to
us. If we are unable to raise additional funds through equity or debt
financings when needed, we may be required to delay, limit, reduce
or terminate our product development or grant rights to develop and market our product candidate that we would
otherwise prefer to develop
and market ourselves.
 
57

 
 
Cash
Flows
 
The
following table sets forth the primary sources and uses of cash for each of the periods set forth below:
 
 
 
Year
ended December 31,
 
 
 
2022
 
 
2021
 
 
 
 
 
 
(in
thousands)
 
Cash
used in operating activities
 
$
(31,594)  
$
(24,984)
Cash
generated from (used in) investing activities
 
 
27,296   
 
(15,489)
Cash
provided by financing activities
 
 
22   
 
49,109 
Net
increase (decrease) in cash and cash equivalents and restricted cash
 
$
(4,276)  
$
8,636 
 
Operating
Activities
 
Cash
used in operating activities for the year ended December 31, 2022 was $31.6 million and consisted primarily of a net loss of $32.3 million
arising primarily from research and
development activities in addition to net working capital of $2.6 million, offset by a $3.3 million
in net aggregate non-cash charges.
 
Cash
used in operating activities for the year ended December 31, 2021 was $25.0 million and consisted primarily of a net loss of $29.9 million
arising primarily from research and
development activities, and partially offset by a $1.7 million in net increase in working capital
and an aggregate of $3.2 million in non-cash charges.
 
Investing
Activities
 
Net
cash generated from investing activities was $27.3 million for the year ended December 31, 2022. This was primarily due to $31.1 million
maturation of short-term bank deposits,
offset by $3.0 million investments in short-term bank deposits.
 
Net
cash used in investing activities was $15.5 million for the year ended December 31, 2021. This was primarily due to $51.1 million of
investments in short-term bank deposits,
offset by the maturation of $37.1 in short-term bank deposits.
 
Financing
Activities
 
Net
cash provided by financing activities was $0.02 million for the year ended December 31, 2022.
 
Net
cash provided by financing activities was $49.1 million for the year ended December 31, 2021 and was mainly the result of the proceeds
from the April underwritten public
offering of ordinary shares and pre-funded warrants, as well as the sales of shares pursuant to the
Oppenheimer ATM and direct sales under an agreement with an institutional investor.
 
Item
7A.
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
Not
applicable.
 
58

 
 
Item
8.
FINANCIAL
STATEMENTS AND SUPPLEMENTARY DATA
 
Our
consolidated financial statements, together with the report of our independent registered public accounting firm, appear beginning on
page F-1 of this Annual Report for the year
ended December 31, 2022.
 
Item
9.
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
 
None
 
Item
9A.
CONTROLS
AND PROCEDURES
 
Disclosure
Controls and Procedures
 
We
have performed an evaluation of the effectiveness of our disclosure controls and procedures that are designed to ensure that the material
financial and non-financial information
required to be disclosed to the SEC is recorded, processed, summarized and reported timely. Based
on our evaluation, our management, including the Chief Executive Officer, or CEO,
and the Chief Financial Officer, or CFO, has concluded
that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of
1934, as amended)
as of the end of the period covered by this report are effective. Notwithstanding the foregoing, there can be no assurance that our disclosure
controls and procedures
will detect or uncover all failures of persons within our company to disclose material information otherwise
required to be set forth in our reports.
 
Management’s
Annual Report on Internal Control Over Financial Reporting
 
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined
in Rule 13a-15(f) promulgated under the
Exchange Act. Our internal control system was designed to provide reasonable assurance to our
management and board of directors regarding the reliability of financial reporting and
the preparation and fair presentation of published
financial statements for external purposes in accordance with generally accepted accounting principles. All internal control systems,
no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable
assurance with respect to financial
statement preparation and presentation and may not prevent or detect misstatements. Also, projections
of any evaluation of effectiveness to future periods are subject to the risk that
controls may become inadequate because of changes in
conditions, or that the degree of compliance with policies or procedures may deteriorate.
 
Our
management, including our 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 our internal control over financial reporting based on the
framework in Internal Control-Integrated Framework issued by the Committee of
Sponsoring Organizations of the Treadway Commission (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 (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
that occurred during the fiscal year ended
December 31, 2022, that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
 
Item
9B.
OTHER
INFORMATION
 
None
 
Item
9C.
DISCLOSURE
REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
 
Not
applicable
 
59

 
 
PART
III
 
Item
10.
DIRECTORS,
EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
 
The
following table sets forth certain information relating to our executive officers and directors, including their ages as of February
1, 2023.
 
Name
 
Age
 
Position
Executive
Officers and Executive Director
 
 
 
 
Dror
Harats
 
66
 
Chief
Executive Officer and Director
Sam
Backenroth
 
38
 
Chief
Financial Officer
 
 
 
 
 
Non-Executive
Directors
 
 
 
 
Marc
Kozin (1)(3)(4)
 
61
 
Chairman
and Director
Ruth
Alon (2)(3)(4)
 
71
 
Director
Shmuel
(Muli) Ben Zvi (1)(2)(4)
 
62
 
Director
David
Hastings (2)(4)
 
61
 
Director
Michael
Rice (1)(4)
 
58
 
Director
 
(1) Member
of the compensation committee.
(2) Member
of the audit committee.
(3) Member
of the nominating and corporate governance committee.
(4) Independent
director under the rules of the Nasdaq Stock Market.
 
Executive
Officers
 
Dror
Harats, M.D., founded our company in 2000 and has served as our chief executive officer since January 2001. He has been a member
of our board of directors since January
2001. Prof. Harats received his M.D. from Hadassah Medical School at the Hebrew University of
 Jerusalem, Israel. Following a residency in internal medicine, he conducted
fellowship in pulmonary medicine and post-doctoral work at
the University of California, San Francisco. Prof. Harats has also served as a visiting scientist at Syntax Discovery
Research. Prof.
Harats has more than 30 years of both research in the field of medicine and biotechnology as well as a professional and experienced consultant
specializing in the
biotechnology & pharmaceutical industry for healthcare organizations and companies. Prof. Harats currently serves
on the board of directors of ART Healthcare Ltd, and as a part time
chair of the R&D division at the Chaim Sheba Medical Center at
Tel Hashomer and as chair of its Institute Review Board. Prof. Harats is also a Professor of Medicine in the
Departments of Internal
Medicine and Biochemistry at the Sackler Faculty of Medicine of Tel-Aviv University, Israel. We believe Prof. Harats is qualified to
serve on our board of
directors because of his extensive technical and industry experience, as well as his knowledge of our company.
 
Sam
Backenroth has served as our chief financial officer since October 2021. Prior to joining our company, from 2019 to 2021, Mr. Backenroth
was the chief financial officer at
NeuBase Therapeutics, a novel genetic medicine platform company focused on rare genetic diseases and
oncology. Prior to that, from 2010 to 2019, Mr. Backenroth was the chief
financial officer of Ohr Pharmaceutical, where he was instrumental
in the company’s growth and helped move its lead program from preclinical into late-stage clinical development.
He is also a founder
of Orphion Therapeutics, a company focused on one-time gene therapy treatments for ocular and central nervous system manifestations of
ultra-rare diseases, and
DepYmed, Inc., a pharmaceutical company focused on a novel phosphatase inhibition technology platform for rare
diseases and cancer. From 2008 to 2010, he was an investment
banker with The Benchmark Company LLC, where he raised capital and provided
advisory services for biotechnology companies. Mr. Backenroth holds a B.Sc. degree in finance from
Touro College.
 
Non-Executive
Directors
 
Marc
Kozin joined our board of directors in November 2020 as vice chairman and was appointed to chairman in July 2021. Mr. Kozin has three
decades of industry expertise advising
biopharmaceutical, life sciences and medtech companies. He is a member of the board of HCRx (HealthCare
Royalty Partners), a leading investment firm in healthcare, providing
royalty monetization and senior debt, having been Chair of the
strategy advisory board for 7 years. Previously, Mr. Kozin was a career strategy consultant, having served as president of
L.E.K. Consulting’s
North American practice from 1997 to 2012 and as senior advisor from 2012 to 2018. He began his career at L.E.K. in 1987 by helping establish
the Boston office
and led the development of L.E.K.’s industry-leading life science strategic planning practice. Mr. Kozin has
served on more than a dozen boards in a variety of roles and on all
committees. He serves as director and serves on the compensation
committee of UFP Technologies (Nasdaq: UFPT). Previously, he served as director for Dicerna Pharmaceuticals
(Nasdaq: DRNA), prior to
its acquisition by Novo Nordisk. He also served on the board of Endocyte (Nasdaq: ECYT), and was also a board member of Dyax (Nasdaq:
DYAX), which
was acquired by Shire Plc in 2015. He also served on the boards of directors of Brandwise, Inc., Lynx Therapeutics, Inc.,
Assurance Medical, Inc., Medical Simulation Corporation,
Advizex, and CrunchTime! Information Systems. Mr. Kozin has served as director
of The Greenlight Fund, a non-profit focused on improving the lives of inner city children in
families, since 2017. He was also on the
board of governors at New England Medical Center and the board of DukeEngage for several years. Mr. Kozin received a B.S. degree in
economics
from Duke University in Durham, N.C. and a M.B.A. in finance from The Wharton School of the University of Pennsylvania in Philadelphia.
We believe Mr. Kozin is
qualified to serve on our board of directors because of his extensive industry and business background.
 
60

 
 
Ruth
Alon has served on our board of directors since March 2010. Ms. Alon is currently the founder and chief executive officer of Medstrada,
an advisory and consultancy firm in the
healthcare and foodtech sectors. From 1997 to 2016, Ms. Alon has served as a general partner
in Pitango Venture Capital, where she headed the life sciences activities and has led
several of its portfolio companies to successful
acquisitions, among them Disc-O-Tech, Colbar, Ventor and Optonol. Prior to her tenure at Pitango, Ms. Alon held senior analyst
positions
 with Montgomery Securities from 1981 to 1987, Kidder Peabody & Co. from 1987 to 1993 and Genesis Securities, LLC from 1993 to 1996,
 and managed her own
independent consulting business in San Francisco in the medical devices industry from 1995 to 1996. Ms. Alon was
the founder and chairperson of Israel Life Science Industry, a not-
for-profit organization representing the mutual goals of the then
approximately 1000 Israeli life science companies. She was also the co-founder of the Israeli Advanced Technology
Industries, or IATI,
 an umbrella organization of the hi-tech and life sciences industries in Israel, which includes venture capital funds, research and development
 centers of
multinational corporations and others. Ms. Alon is also a board member of Moringa Acquisition Corp (Nasdaq: MACA) and of several
privately held companies, including Treos Bio
and Phoska Biopharma. She is the chairperson of Brainsgate (privately held). Ms. Alon has
a B.A. in Economics from the Hebrew University of Jerusalem, Israel, an M.B.A. from
Boston University, and an M.Sc. from the Columbia
University School of Physicians and Surgeons. We believe Ms. Alon is qualified to serve on our board of directors because of her
extensive
business and industry background, as well as her experience as a seasoned investor.
 
Shmuel
(Muli) Ben Zvi, Ph.D., has served on our board of directors since September 2018. Dr. Ben Zvi is currently a board member at Bank
Leumi, the largest bank in Israel, and a
member of its credit, technology and strategy committees. Dr. Ben Zvi is also a board member
 of SOL-GEL Technologies (Nasdaq: SLGL) and a member of the audit and
compensation committees and a board member and chair of the audit
committee of Protalix Biotherapeutics. From 2004 to 2014, Dr. Ben Zvi held various managerial positions at Teva
Pharmaceuticals Industries
Ltd., dual listed on Nasdaq and the TASE, including as vice president of finance and vice president of strategy. From 2000 to 2004, Dr.
Ben Zvi was the
financial advisor to the chief of general staff of the Israel Defense Forces and head of the Defense Ministry budget
department. Dr. Ben Zvi holds a Ph.D. in economics from Tel-Aviv
University, Israel and participated in the Harvard Business School Advanced
Management Program (AMP). We believe Dr. Ben Zvi is qualified to serve on our board of directors
because of his extensive finance and
industry background.
 
David
 Hastings has served on our board of directors since January 2018. Mr. Hastings has more than 20 years of finance, accounting and
 operations experience in the bio-
pharmaceutical industry. Mr. Hastings joined Arbutus BioPharma in June 2018 and currently serves as
its chief financial officer. Mr. Hastings previously served as the chief financial
officer and executive vice president of Incyte Corporation
from 2003 until 2014. During this time, Mr. Hastings oversaw all financial aspects as Incyte transitioned from research and
development
to commercialization, following the launch of Jakafi (ruxolitinib). Mr. Hastings also previously served as vice president, chief financial
officer and treasurer of ArQule
Inc. During his tenure at ArQule, he played an important role in ArQule’s transition into a drug
discovery and development organization, and in two strategic acquisitions, including the
purchase of Cyclis Pharmaceuticals Inc. Prior
to that, Mr. Hastings was with Genzyme Corporation as its vice president and corporate controller, and with Sepracor, Inc. where he was
director of finance. Most recently, Mr. Hastings served as the chief financial officer and senior vice president of Unilife Corporation
(a medical device company that filed for Chapter
11 bankruptcy in April 2017) from 2015 to 2017 and as its chief accounting officer and
treasurer from 2016 to 2017. He is a member of the Board Director of SCYNEXIS, Inc.
(Nasdaq: SCYX) and chairs their Audit Committee.
We believe Mr. Hastings is qualified to serve on our board of directors because of his extensive financial and business background.
 
Michael
Rice joined our board in July 2021. Mr. Rice has deep experience in portfolio management, investment banking, and capital markets.
Mr. Rice is a founding partner of LifeSci
Advisors LLC, a life sciences investor relations consultancy, since 2010 and of LifeSci Capital
LLC, a research-driven investment bank, since 2013. Previously, Mr. Rice was the co-
head of Health Care Investment Banking at Canaccord
Adams, where he was involved in debt and equity financing. Mr. Rice was also a managing director at Think Equity Partners,
where he was
responsible for managing Healthcare Capital Markets, which included structuring and executing numerous transactions. Prior to that, he
served as a managing director at
Bank of America serving large hedge funds and private equity healthcare funds while working closely
 with Investment Banking. Previously, he was a managing director at JP
Morgan/Hambrecht & Quist. Mr. Rice graduated from the University
of Maryland with a degree in Economics and currently sits on the board of 9 Meters Biopharma Inc. (Nasdaq:
NMTR) and Navidea Biopharmaceuticals,
Inc. (NYSE: NAVB). We believe Mr. Rice is qualified to serve on our board of directors because of his extensive banking and industry
background.
 
61

 
 
Board
Diversity Matrix
 
We
have no formal policy regarding board diversity. Our board of directors believes that each director should have a basic
understanding of our principal operational and financial
objectives and plans and strategies, our results of operations and
 financial condition and relative standing in relation to our competitors. We take into consideration the overall
composition and
 diversity of the board and areas of expertise that director nominees may be able to offer, including business experience, knowledge,
 abilities and customer
relationships. Generally, we will strive to assemble a board that brings to us a variety of perspectives and
skills derived from business and professional experience as we may deem are
in our and our shareholders’ best interests. In
doing so, we will also consider candidates with appropriate non-business backgrounds. Pursuant to Rules 5605(f) and 5606 of the
Nasdaq
Listing Rules, we have made our board diversity matrix available on our website at www.vblrx.com in the “Corporate
Governance” section under the “Investor Relations” tab.
 
In
addition to the information presented above regarding each of the nominees and continuing directors’ specific experience, qualifications,
attributes and skills that our board of
directors and our nominating and corporate governance committee considered in determining that
he or she should serve as a director, we also believe that each of our directors has
demonstrated business acumen, integrity and an ability
to exercise sound judgment, as well as a commitment of service to our company and our board of directors.
 
Audit
Committee
 
Under
the Companies Law, we are required to appoint an audit committee. The audit committee must be comprised of at least three directors,
including all of the external directors, one
of whom must serve as chairman of the committee. In accordance with the exemption available
to certain Israeli public companies, whose shares are traded on Nasdaq, we chose as of
November 7, 2016 and for as long the required
conditions precedent are met and unless otherwise decided by our board of directors, not to follow the requirements of Companies Law
with regard to the composition of the audit committee, and instead, will follow the Nasdaq rules applicable to U.S. domestic companies
 with respect to the appointment and
composition of the audit committee.
 
Under
the Nasdaq listing requirements, we are required to maintain an audit committee consisting of at least three independent directors, all
of whom are financially literate and at least
one of whom has accounting or related financial management expertise. Our audit committee
consists of David Hastings, Ruth Alon and Shmuel (Muli) Ben Zvi and is chaired by Mr.
Hastings. Mr. Hastings and Dr. Ben Zvi are the
audit committee financial experts as defined by SEC rules and all of the members of our audit committee have the requisite financial
literacy as defined by the Nasdaq Stock Market rules. All the members of our audit committee are “independent” as such term
is defined in Rule 10A-3(b)(1) under the Exchange Act
and under the listing standards of Nasdaq.
 
Audit
Committee Financial Expert
 
All
members of our audit committee meet the requirements for financial literacy under the applicable rules and regulations of the SEC and
the Nasdaq corporate governance rules. Our
board of directors has determined that David Hastings and Shmuel (Muli) Ben Zvi are the audit
committee financial experts as defined by the SEC rules, has the requisite financial
experience and is independent as defined by the
Nasdaq corporate governance rules.
 
Code
of Ethics
 
We
have adopted a Code of Business Conduct and Ethics applicable to all of our directors and employees, including our CEO, CFO, controller
or principal accounting officer, or other
persons performing similar functions. The full text of the Code of Business Conduct and Ethics
is posted on our website at https://ir.vblrx.com/corporate-governance. Information
contained on, or that can be accessed through,
our website does not constitute a part of this Form 10-K and is not incorporated by reference herein. If we make any substantive
amendments
to, or grant any waivers from, our Code of Business Conduct and Ethics for any officer or director, we will disclose the nature of such
amendment or waiver on our
website or in a current report on Form 8-K.
 
62

 
 
Item
11.
EXECUTIVE
COMPENSATION
 
Our
named executive officers for the year ended December 31, 2022 are:
 
 
●
Dror
Harats, M.D., our Chief Executive Officer; and
 
●
Sam
Backenroth, our Chief Financial Officer.
 
2022
Summary Compensation Table
 
The
following table presents the compensation awarded to, earned by or paid to each of our named executive officers for the years indicated.
We did not provide any “nonqualified
deferred compensation” in either period so we have eliminated that column from the table
below.
 
Name and Principal Position
 
Year
 
Salary
($)
   
Bonus
($)(1)
   
Stock
Awards
($)(2)
   
Option
Awards
($)(2)
   
Non-Equity
Incentive Plan
Compensation
($)(3)
   
All Other
Compensation
($)(4)
   
Total
($)
 
Dror Harats, M.D.
 
2022
 
 
357,462  
 
-   
 
168,000   
 
275,291   
 
-   
 
86,871  
 
887,624 
Chief Executive(5)
Officer and Director
 
2021
 
 
349,190   
 
-   
 
-   
 
457,249   
 
219,244   
 
79,759  
  1,105,442 
Sam Backenroth(6)
 
2022
 
 
410,000   
 
-   
 
168,000   
 
91,082   
 
-   
 
   
 
669,082 
Chief Financial Officer
 
2021
 
 
100,792   
 
100,000   
 
-   
 
681,188   
 
41,000   
 
   
 
922,980 
 
 
(1) For
Mr. Backenroth, 2021 reflects a $100,000 sign on bonus.
 
(2) Amounts
represent the aggregate grant date fair value of the stock and option awards granted to our named executive officers during the corresponding
fiscal year, computed
in accordance with Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC,
 Topic 718. A discussion of the assumptions used in
determining grant date fair value may be found in Note 9 to our annual audited
consolidated financial statements included elsewhere herein. This amount does not correspond
to the actual value that may be recognized
by the named executive officer upon exercise of the applicable award or sale of the underlying ordinary shares.
 
(3) Amounts
represent the annual bonuses paid with respect to achievement of pre-defined corporate and, if applicable, individual performance,
objectives for the corresponding
fiscal year. Performance bonuses for 2022, if any, have not yet been determined by the compensation
committee.
 
(4) For
Prof. Harats, 2022 includes $45,512 for a car provided by us, $36,802 for tax gross up for the car, $375 for phone services provided
to our executives, as well as $4,182
for security services. In 2021, includes $36,778 for a car provided by us, $38,245 for tax gross
up for the car, $390 for phone services provided to our executives, as well as
$4,346 for security services.
 
(5) Prof.
Harats receives an aggregate of $30,000 per month (NIS 100,000), which is allocated between his employment agreement and consulting agreement.
 
(6) Mr.
Backenroth joined our company as Chief Financial Officer in October 2021. Accordingly, the amounts reported in the Salary and Non-Equity Incentive Plan
columns,
above, have been prorated to reflect Mr. Backenroth’s shortened year of service.
 
Narrative
to 2022 Summary Compensation Table
 
Our
board of directors and compensation committee review compensation annually for our executive officers. In setting executive base salaries
and bonuses and granting equity
incentive awards, we consider compensation for comparable positions in the market, the historical compensation
levels of our executives, individual performance as compared to our
expectations and objectives, our desire to motivate our employees
to achieve short- and long-term results that are in the best interests of our shareholders, and a long-term commitment
to our company.
We target a general competitive position, based on independent third-party benchmark analytics to inform the mix of compensation of base
salary, bonus or long-term
incentives.
 
63

 
 
Our
compensation committee is authorized to retain the services of one or more executive compensation advisors, as it sees fit, in connection
with the establishment of our executive
compensation programs and related policies. In fiscal year 2022, the compensation committee utilized
the Radford database to provide it with market information, analysis and other
advice relating to executive compensation on an ongoing
basis. The compensation committee utilized this information to, among other things, help us determine overall compensation
for our executive
officers, as well as to assess each separate element of compensation. The goal was to ensure that the compensation we offer to our executive
officers, individually as
well as in the aggregate, is competitive and aligned with our business and executive talent requirements. We
do not believe our access if this information creates any conflict of interest
because Radford performs no other work for our company
besides advising the compensation committee.
 
Our
compensation committee is responsible for determining the compensation for all executive officers. Based on its discretion, taking into
account the factors noted above, the
compensation committee sets the compensation for each executive officer, including for the Chief
Executive Officer, without the Chief Executive Officer present.
 
Base
salaries
 
Our
named executive officers each receive a base salary to compensate them for services rendered to our company. The base salary payable
to each named executive officer is intended
to provide a fixed component of compensation reflecting the executive’s skill set,
experience, role and responsibilities. Base salaries are reviewed annually, typically in connection with
our annual performance review
process, approved by our board of directors or the compensation committee, and may be adjusted from time to time to realign salaries
with market
levels after taking into account individual responsibilities, performance, and experience.
 
For
fiscal year 2022, the annual base salary for each of Prof. Harats and Mr. Backenroth were NIS 1,200,000 ($357,462) and $410,000, respectively.
For Prof. Harats, his monthly
compensation is allocated as amongst his employment agreement (20%) and consulting agreement (80%).
 
We
pay cash bonuses to reward our executives for their performance over the fiscal year, based on the achievement of certain corporate performance
goals and, if applicable, individual
performance goals. We believe such bonuses properly incentivize our named executive officers and
allow us to remain competitive within the marketplace. The target annual bonuses
for Prof. Harats and Mr. Backenroth for the fiscal year
ended December 31, 2022, were 50% and 40% of annual base salary, respectively. Considering the outcome of the OVAL study
and our ongoing
strategic process, the compensation committee has not yet determined if there will be any bonuses awarded for service in 2022, and if
there is, what these reduced
amounts would be.
 
Equity
Compensation
 
Although
we do not have a formal policy with respect to the grant of equity incentive awards to our executive officers, we believe that equity
grants provide our executives with a
strong link to our long-term performance, create an ownership culture and help to align the interests
of our executives and our shareholders. In addition, we believe that equity grants
promote executive retention because they incentivize
 our executive officers to remain in our employment during the vesting period. Accordingly, our board of directors or our
compensation
committee periodically review the equity incentive compensation of our named executive officers and may grant equity incentive awards
to them from time to time.
During fiscal year 2022, we granted both options to purchase ordinary shares and RSUs to Prof. Harats and
Mr. Backenroth, as described in more detail in the “Outstanding Equity
Awards at 2022 Fiscal Year End” table.
 
Perquisites
 
We
generally do not provide perquisites to our executives, other than reimbursements for certain travel and relocation expenses. However, we do provide our executive officers with
cell phone plans, and for Prof. Harats, we also provide a company
car (along with tax gross up on the value), as well as a security detail when in Israel.
 
401(k)
Plan
 
We
currently maintain a 401(k) retirement savings plan for our U.S. employees who satisfy certain eligibility requirements. Currently, our
sole U.S. employee is Sam Backenroth and
he is eligible to participate in the 401(k) plan on the same terms as other U.S. full-time employees,
if any. Our 401(k) plan is intended to qualify for favorable tax treatment under
Section 401(a) of the Internal Revenue Code of 1986,
as amended, or the Code, and contains a cash or deferred feature that is intended to meet the requirements of Section 401(k) of
the Code.
We believe that providing a vehicle for tax-deferred retirement savings though our 401(k) plan adds to the overall desirability of our
executive compensation package and
further incentivizes our employees, including our named executive officers, in accordance with our
compensation policies. We do not provide matching contributions.
 
64

 
 
Executive
Employment and Other Compensation Arrangements
 
Prof.
Dror Harats, M.D.
 
On
January 20, 2022, we entered into a restated executive employment agreement and consulting agreement (through Grand H Services Ltd.)
with Prof. Harats pursuant to which he
provides services as our Chief Executive Officer. His agreements sets forth his gross monthly
salary of NIS 100,000 (approx. $30,000) and fringe benefits, which is allocated 20% to
his employment agreement and 80% to his
consulting agreement, at his discretion. In addition, we provide Prof. Harats with a company car for his use and a gross-up for any
taxes due
in connection with Prof. Harats’ automobile and an annual bonus target equal to 50% of the annual compensation
payable to be paid according to milestones to be determined by our
board of directors, and in accordance with our Compensation
Policy. Prof. Harats is also subject to confidentiality, noncompetition and nonsolicitation covenants under his employment
agreement
and is eligible for equity awards under our equity compensation plans.
 
In
August 2022, the Compensation Committee awarded Prof. Harats a grant of 700,000 RSUs as retention to remain employed with us
through the strategic process. The award vests
75% at March 31, 2023, with the reminder on the two year anniversary of the grant, subject
to acceleration upon change of control (such as completion of the Merger).
 
We
can terminate Prof. Harats’ employment agreement (as can he) for any reason by giving nine months prior written notice of
termination. However, in the event that Prof. Harats’
employment is terminated other than for “cause” (as defined
therein) or if Prof. Harats resigns for “good reason” (as defined therein), Prof. Harats will be entitled to receive an
aggregate of 15 months of salary and benefits continuation under his agreements.
 
Mr.
Sam Backenroth
 
On
October 4, 2021, we entered into an offer letter with Mr. Backenroth for his services as our Chief Financial Officer. Pursuant to his
offer letter, Mr. Backenroth’s initial annual
salary was $410,000, with an annual performance target bonus equal to 40% of his
base salary. Mr. Backenroth’s employment is on an “at will” basis. Additionally, pursuant to his offer
letter, we granted
 Mr. Backenroth an option to purchase 305,537 ordinary shares under the 2014 Plan and Mr. Backenroth is eligible for additional grants
 under our equity
compensation plans from time to time as determined by our compensation committee. Mr. Backenroth also received a $100,000
one-time signing bonus paid upon commencement of
his employment.
 
In
August 2022, the Compensation Committee awarded Mr. Backenroth a grant of 700,000 RSUs as retention to remain employed with us
through the strategic process. The award
vested 75% at March 31, 2023, with the reminder on the two year anniversary of the grant,
subject to acceleration upon change of control (such as completion of the Merger).
 
Mr.
 Backenroth’s employment with us is at-will, meaning either we or Mr. Backenroth could terminate the employment relationship at
 any time, with or without cause. If Mr.
Backenroth is terminated by us without cause or Mr. Backenroth resigns for good reason (defined
 generally as a reduction in his salary amongst similarly-situated employees,
relocation, or a material diminution in title, duties or
responsibilities) regardless of whether such termination or resignation was a result of a change of control, then, subject to
execution
and delivery of a general release of all claims, his then outstanding, unvested options, if any, will vest and be exercisable as to all
of the covered shares. We will also be
obligated to pay Mr. Backenroth (1) severance pay at a rate equal to one hundred percent (100%)
of his base salary for a period of twelve (12) months from the date of termination, and
(2) reimbursement of 12 months of health benefits
(COBRA subsidization) in accordance with our standard expense reimbursement procedures.
 
Mr.
Backenroth also entered into our standard indemnification agreement, confidentiality and invention assignment agreement, and non-competition
agreement.
 
65

 
 
Outstanding
Equity Awards at Fiscal 2022 Year-End
 
The
following table sets forth information regarding outstanding equity awards held by our named executive officers as of fiscal year 2022:
 
 
 
OPTION AWARDS (1)
   
STOCK AWARDS
 
NAME
 
Number of
Securities
Underlying
Unexercised
Options
Exercisable
(#)
   
Number of
Securities
Underlying
Unexercised
Options
Unexercisable
(#)
 
 
Option
Exercise
Price
($)
   
Option
Expiration
Date
   
Number of
Shares or
Units of
Stock
That Have
Not Vested
(#)
 
 
Market
Value
of
Shares or
Units of
Stock
That Have
Not Vested
($) (2)
 
Dror Harats
 
 
—   
 
— 
 
 
—   
 
—   
 
700,000(3) 
$
84,000 
 
 
 
-   
 
160,000(4) 
 
2.12   
  01/02/2042   
 
— 
 
 
— 
 
 
 
60,000   
 
180,000(5) 
 
2.31   
  12/07/2041   
 
— 
 
 
— 
 
 
 
120,000   
 
120,000(5) 
 
1.22   
  12/08/2041   
 
— 
 
 
— 
 
 
 
180,000   
 
60,000(5) 
 
1.22   
  12/19/2039   
 
— 
 
 
— 
 
 
 
240,000   
 
— 
 
 
1.22   
  12/17/2038   
 
— 
 
 
— 
 
 
 
80,000   
 
— 
 
 
5.99   
  10/24/2037   
 
— 
 
 
— 
 
 
 
75,000   
 
— 
 
 
5.08   
  11/07/2036   
 
— 
 
 
— 
 
 
 
45,000   
 
— 
 
 
3.32   
  09/30/2033   
 
— 
 
 
— 
 
 
 
45,000   
 
— 
 
 
3.32   
  12/17/2032   
 
— 
 
 
— 
 
 
 
30,002   
 
— 
 
 
3.32   
  12/20/2031   
 
  
 
 
  
 
 
 
59,999   
 
— 
 
 
3.32   
  08/10/2031   
 
  
 
 
  
 
 
 
223,029   
 
— 
 
 
2.47   
  06/16/2028   
 
  
 
 
  
 
 
 
148,470   
 
— 
 
 
2.47   
  03/27/2028   
 
  
 
 
  
Sam Backenroth
 
 
—   
 
— 
 
 
—   
 
—   
 
700,000(3) 
$
84,000 
 
 
 
-   
 
52,937(4) 
 
2.12   
  01/02/2042   
 
— 
 
 
— 
 
 
 
19,851   
 
59,554(5) 
 
2.31   
  12/07/2041   
 
— 
 
 
— 
 
 
 
76,875   
 
230,625(5) 
 
2.22   
  10/04/2041   
 
— 
 
 
— 
 
(1) Each
of the outstanding equity awards in the table above granted prior to our initial public offering was granted pursuant to our Employee
Share Ownership and Option Plan
(2000), or the 2000 Plan, or our Employee Share Ownership and Option Plan (2011), or the 2011 Plan.
Each of the outstanding equity awards in the table above granted
following our initial public offering was granted pursuant to our
Employee Share Ownership and Option Plan (2014), or the 2014 Plan.
 
 
 
 
(2) Amounts
are equal to $0.12, the closing price of our ordinary shares on December 30, 2022, the last business day of 2022, times the number
of unvested RSUs.
 
 
 
 
(3) The
RSUs vest as follows: 75% of the RSUs shall vest on March 31, 2023, with the remaining 25% vesting on August 9, 2024 (or, if earlier, upon completion of the Merger).
 
 
 
 
(4) The
shares vest over three years commencing on the grant date such that 1/3 vest on the first anniversary of the date of grant and then
quarterly thereafter for two years, such
that they are vested in full on the three-year anniversary of the grant date.
 
 
 
 
(5) The
shares vest over four years commencing on the grant date such that 25% vest on the first anniversary of the date of grant and quarterly
thereafter for three years such that
they are vested in full on the four-year anniversary of the grant date.
 
66

 
 
2022
Director Compensation Table
 
The
following table presents the total compensation for each person who served as a non-employee member of our board of directors and
received compensation for such service
during fiscal year 2022. Other than as set forth in the table below, we did not pay any
compensation, make any additional equity awards or non-equity awards to, or pay any other
compensation to any of the non-employee
members of our board of directors in fiscal year 2022. Directors who also serve as employees received no additional compensation for
their
service as directors. During fiscal year 2022, Dror Harats, M.D., our Chief Executive Officer, was a member of our board of
directors, as well as an employee, and received no
additional compensation for his services as a director. See “—2022
Summary Compensation Table” above for more information about his compensation in fiscal year 2022. Our non-
employee directors
did not receive any stock awards, non-equity incentive plan compensation, non-qualified deferred compensation or any other
compensation. Accordingly, we have
eliminated those columns from the table below.
 
NAME
 
FEES
EARNED
OR
PAID IN
CASH ($)
   
OPTION
AWARDS
($) (1)
   
TOTAL
($)
 
Ruth Alon
   
53,751     
40,497     
94,248 
Shmuel (Muli) Ben Zvi
   
56,387     
40,497     
96,884 
Ron Cohen(2)
   
25,083     
40,497     
65,680 
Alison Finger(2)
   
25,083     
40,497     
65,680 
David Hastings
   
60,801     
40,497     
101,298 
Marc Kozin
   
115,000     
90,665     
205,665 
Bennett Shapiro(2)
   
75,000     
40,497     
115,497 
Michael Rice
   
56,000     
40,497     
96,497 
(1) Amounts
represent the aggregate grant date fair value of option awards granted to our directors during our fiscal year ended December 31,
2022, computed in accordance with
FASB ASC Topic 718. A discussion of the assumptions used in determining grant date fair value may
be found in Note 9 to our annual audited consolidated financial statements
included elsewhere herein. This amount does not
correspond to the actual value that may be recognized by the director upon exercise of the applicable award or sale of the
underlying shares of stock. Except as noted below, none of our directors held options to purchase ordinary shares or any other stock
awards as of December 31, 2022.
 
 
(2) Resigned
from our board of directors in August 2022.
 
NAME
 
AGGREGATE NUMBER
OF SHARES
SUBJECT TO STOCK
OPTIONS HELD AS OF
DECEMBER 31, 2022 (#)
 
Marc Kozin
 
 
432,343 
Ruth Alon
 
 
221,113 
Shmuel (Muli) Ben Zvi
 
 
194,113 
Ron Cohen
 
 
- 
Alison Finger
 
 
- 
David Hastings
 
 
224,113 
Bennett Shapiro
 
 
- 
Michael Rice
 
 
146,113 
 
Non-Employee
Director Compensation Policy
 
At
our annual general meeting held on October 19, 2021, our shareholders approved the terms of the Non-Employee Directors New Compensation
Scheme, effective as of the date of
the said annual general meeting, which provides for the following:
 
Board of Directors:
 
 
  
Members
 
$
35,000 
Annual retainer for non-executive chair
 
$
100,000 
Audit Committee:
 
 
  
Members (other than chair)
 
$
7,500 
Retainer for chair
 
$
15,000 
Compensation Committee:
 
 
  
Members (other than chair)
 
$
6,000 
Retainer for chair
 
$
12,000 
Nominating and Corporate Governance Committee:
 
 
  
Members (other than chair)
 
$
4,000 
Retainer for chair
 
$
8,000 
 
In
addition, the non-employee director compensation policy provides that, upon initial election to our board of directors, each non-employee
director will be granted an equity grant
equal to 0.1% of our capital on a fully diluted basis as of the date of grant. The initial grant
will vest upon and in the manner approved by the compensation committee and the board of
directors, but not less than two years until
full vesting. Furthermore, each non-employee director who continues as a non-employee director will be granted an equity grant equal
to
0.067% of our share capital on a fully diluted basis as of the date of grant. The annual grant will vest upon and in the manner approved
by the compensation committee and the board
of directors, but not less than two years until full vesting. Such awards are subject to
full accelerated vesting upon the sale of our company (such as the proposed Merger).
 
We
also reimburse all reasonable out-of-pocket expenses incurred by directors for their attendance at meetings of our board of directors
or any committee thereof. employee directors
additional compensation for their service as a director.
 
Compensation
Risk Assessment
 
We
believe that although a portion of the compensation provided to our executive officers and other employees is performance-based, our
executive compensation program does not
encourage excessive or unnecessary risk taking. This is primarily due to the fact that our compensation
programs are designed to encourage our executive officers and other employees
to remain focused on both short-term and long-term strategic
goals, in particular in connection with our pay-for-performance compensation philosophy. As a result, we do not believe
that our compensation
programs are reasonably likely to have a material adverse effect on us.
 
67

 
 
Item
12.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
 
The
following table sets forth information with respect to the beneficial ownership of our ordinary shares, as of March 10, 2023,
by:
 
 
●
each
person or entity known by us to own beneficially more than 5% of our outstanding ordinary shares;
 
●
each
of our executive officers and directors individually; and
 
●
all
of our executive officers and directors as a group.
 
The
beneficial ownership of our ordinary shares is determined in accordance with the rules of the SEC and generally includes any shares over
which a person exercises sole or shared
voting or investment power, or the right to receive the economic benefit of ownership. For purposes
of the table below, we deem ordinary shares issuable pursuant to options that are
currently exercisable or exercisable within 60 days
of March 10, 2023 to be outstanding and to be beneficially owned by the person holding the options for the purposes of computing
the percentage ownership of that person, but we do not treat them as outstanding for the purpose of computing the percentage ownership
of any other person. The percentage of
ordinary shares beneficially owned is based on 69,750,117 ordinary shares outstanding as of March 10, 2023.
 
Except
as contemplated by the Merger, we do not know of any arrangements, including any pledge by any person of our securities, the operation
of which may at a subsequent date
result in a change of control of our company.
 
Information
with respect to beneficial ownership by 5% shareholders has been based on information filed with the SEC pursuant to Section 13(d) or
Section 13(g) of the Exchange Act,
as well as our records and other information provided to the company. Except as otherwise set forth
in the footnotes to the following table, the address of each beneficial owner is c/o
Vascular Biogenics Ltd., 8 HaSatat St., Modi’in,
Israel 7178106,
 
 
 
Number of
   
 
 
 
 
Ordinary Shares
   
Percentage of
 
Name
 
Beneficially Owned
   
Ownership
 
>5% Shareholders
 
 
    
 
  
Thai Lee (1)
 
 
7,400,000   
 
9.6%
Aurum Ventures M.K.I. Ltd (2)
 
 
6,839,059   
 
9.8%
David M. Slager (3)
 
 
4,203,082   
 
6.0%
 
 
 
    
 
  
Executive Officers and Directors
 
 
    
 
  
Dror Harats (4)
 
 
3,082,142   
 
4.3%
Ruth Alon (5)
 
 
171,758   
 
* 
Shmuel (Muli) Ben Zvi (6)
 
 
204,758   
 
* 
David Hastings (7)
 
 
174,758   
 
* 
Marc Kozin (8)
 
 
296,714   
 
* 
Michael Rice (9)
 
 
69,571   
 
* 
Sam Backenroth† (10)
 
 
687,184   
 
* 
All directors and executive officers as a group (7 individuals total) (11)
 
 
4,686,885   
 
6.4%
 
*
Less than 1%
 
†
Address is 1 Blue Hill Plaza, Suite 1509, Pearl River, NY 10965.
 
(1) Consists
of 7,400,000 pre-funded warrants to purchase ordinary shares exercisable as of March 10, 2023. Such pre-funded warrants are only
exercisable to the extent that Thai
Lee, together with her affiliates, would beneficially own no more than 19.99% of the outstanding
ordinary shares after giving effect to such exercise, or the Lee Beneficial
Ownership Limitation. The principal business address
of Ms. Lee is 70 Rainey Street, Austin, TX 78701.
 
 
(2) Consists
of 6,839,059 ordinary shares held directly by Aurum Ventures M.K.I. Ltd. Voting and investment power over such shares are vested
with Mr. Morris Kahn, who controls
Aurum Ventures M.K.I. Ltd. As such, Mr. Kahn may be deemed to have beneficial ownership over our
shares held by Aurum Ventures M.K.I. Ltd. The address of Aurum Ventures
M.K.I. Ltd. is 16 Abba Hillel Silver Rd., Ramat Gan, 5250608,
Israel.
 
 
(3) Consists
of (i) 1,812,913 ordinary shares held by Regals Capital Management LP, (ii) 1,740,169 ordinary shares held directly by David M. Slager
and (iii) 650,000 pre-funded
warrants held by Regals Fund LP. Mr. Slager may be deemed to have beneficial ownership over our shares
and warrants held by Regals Capital Management LP and Regals Fund
LP. The address of Regals Capital Management LP and Regals Fund
LP is 152 West 57th Street, 9th Floor, New York, NY 10019.
 
 
(4) Consists
of (a) 1,138,975 ordinary shares held by or for Prof. Harats; (b) 1,418,167 shares underlying options exercisable within 60 days of February 15, 2023; and (c) 525,000
RSU’s vesting within 60 days of March 10, 2023.
 
 
(5) Consists
of 171,758 shares underlying options exercisable within 60 days
of February 15, 2023.
 
 
(6) Consists
of (a) 60,000 ordinary shares held by or for Dr. Ben Zvi; and (b) 144,758 shares underlying options exercisable within 60 days of March 10, 2023.
 
 
(7) Consists
of 174,758 shares underlying options exercisable within 60 days of
March 10, 2023.
 
 
(8) Consists
of (a) 39,000 ordinary shares held by the Marc D. Kozin Irrevocable Trust; and (b) 257,714 shares underlying options exercisable within 60 days of March 10, 2023.
 
 
(9) Consists
of 69,571 shares underlying options exercisable
within 60 days of March 10, 2023.
 
 
(10)Consists
of (a) 162,184 shares underlying options exercisable within 60 days of February 15, 2023; and (b) 525,000 RSU’s vesting within 60 days of March 10, 2023.
 
 
(11) Consists
of (a) 1,237,975 ordinary shares; (b) 2,398,910 shares issuable to our current directors and executive officers pursuant to outstanding
options to purchase our ordinary
shares which are exercisable within 60 days of March 10, 2023; and (c) 1,050,000 shares to be issued
pursuant to RSUs vesting within 60 days of March 10, 2023.
 
68

 
 
Equity
Compensation Plan Information
 
The
following table provides information as of December 31, 2022, with respect to the ordinary shares that may be issued under our existing
equity compensation plans.
 
Plan Category
 
Number of
securities
to be issued
upon exercise
of outstanding
options, warrants
and rights (#)
(a)
 
 
Weighted
average
exercise
price of
outstanding
options,
warrants
and rights ($)
(b)
 
 
Number of
securities
remaining
available
for future
issuance
under equity
compensation
plans
(excluding
securities in
column (a)) (#)
(c)
 
Equity compensation plans approved by security holders(1)
 
 
8,518,617(3) 
 
2.08(3) 
 
3,867,230(4)
Equity compensation plans not approved by security holders(2)
 
 
- 
 
 
- 
 
 
2,000,000(5)
 
 
 
  
 
 
  
 
 
  
Total
 
 
8,518,617 
 
 
2.08 
 
 
5,867,230 
 
(1) Includes
the following plans: the 2000 Plan, the 2011 Plan, and the 2014 Plan.
 
(2) Reflects
the Vascular Biogenics Ltd. Inducement Plan (2022), or the Inducement Plan.
 
(3) Consists
of 6,818,617 shares issuable upon the exercise of outstanding options under the 2000 Plan, the 2011 Plan, and the 2014 Plan and 1,700,000
shares issuable upon the
vesting of RSUs.
 
(4) As
of December 31, 2022, a total of 3,867,230 ordinary shares have been reserved for issuance pursuant to the 2014 Plan, which number
excludes the shares that were added
to the plan as a result of the automatic annual increase on January 1, 2023 (which has yet to be ratified by our board of directors as required under Israeli law). The 2014
Plan
provides that the number of shares reserved and available for issuance under the plan will automatically increase each January
1, beginning on January 1, 2022, by 4% of the
outstanding number of ordinary shares on the immediately preceding December 31. This
number will be subject to adjustment in the event of a stock split, stock dividend or
other change in our capitalization. The ordinary
shares underlying any awards that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the
exercise
price or tax withholding, reacquired by us prior to vesting, satisfied without the issuance of stock, expire or are otherwise terminated,
other than by exercise, under
the 2014 Plan, the 2011 Plan and the 2000 Plan will be added back to the ordinary shares available
for issuance under the 2014 Plan. The Company no longer makes grants
under the 2000 Plan and 2011 Plan.
 
(5) As
of December 31, 2022, no ordinary shares of have been reserved for issuance pursuant to outstanding awards under the Inducement
Plan.
 
69

 
 
Item
13.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
 
Certain
Relationships and Transactions
 
Other
than the compensation agreements and other arrangements described under “Executive Compensation” and “Non-Employee
Director Compensation” in this Form 10-K and the
transactions described below, since January 1, 2021, there has not been and there
is not currently proposed, any transaction or series of similar transactions to which we were, or will
be, a party in which the amount
involved exceeded, or will exceed, $120,000 (or, if less, 1% of the average of our total assets amounts at December 31, 2021 and 2022)
and in which
any director, executive officer, holder of 5% or more of any class of our capital stock or any member of the immediate family
of, or entities affiliated with, any of the foregoing
persons, had, or will have, a direct or indirect material interest.
 
In
December 2021, we entered into a master service agreement with LifeSci Advisors for investor relations services. Michael Rice, VBL independent
Director, is a principal in the
firm. The Audit Committee reviewed and approved the arrangement for a monthly retainer of $20,000. In
August 2022, following the results of the OVAL study, the monthly retainer
was reduced to $5,000 per month.
 
On
July 7, 2022, our shareholders approved the compensation policy for our directors and other officers of the Company. See “Item
11. Executive Compensation—Non-Employee
Director Compensation Policy” for additional discussion on our compensation
policy.
 
Approval
of Related Party Transactions Under Israeli Law
 
Fiduciary
Duties of Directors and Executive Officers
 
The
Companies Law codifies the fiduciary duties that office holders owe to a company. Each person listed in the table under “Management-Executive
Officers, Senior Management
and Directors” and management members of at least a VP level are considered an office holder under
the Companies Law.
 
An
office holder’s fiduciary duties consist of a duty of care and a duty of loyalty. The duty of care requires an office holder to
act with the level of care with which a reasonable office
holder in the same position would have acted under the same circumstances.
The duty of loyalty requires that an office holder act in good faith and in the best interests of the company.
 
The
duty of care includes a duty to use reasonable means to obtain:
 
 
●
information
on the advisability of a given action brought for his or her approval or performed by virtue of his or her position; and
 
 
 
 
●
all
other important information pertaining to these actions.
 
The
duty of loyalty includes a duty to:
 
●
refrain
from any conflict of interest between the performance of his or her duties to the company and his or her other duties or personal
affairs;
 
 
 
 
●
refrain
from any activity that is competitive with the company;
 
 
 
 
●
refrain
from exploiting any business opportunity of the company to receive a personal gain for himself or herself or others; and
 
 
 
 
●
disclose
to the company any information or documents relating to the company’s affairs which the office holder received as a result
of his or her position as an office holder.
 
Disclosure
of Personal Interests of an Office Holder and Approval of Certain Transactions
 
The
Companies Law requires that an office holder promptly disclose to the company any personal interest that he or she may be aware of and
all related material information or
documents concerning any existing or proposed transaction by the company. An interested office holder’s
disclosure must be made promptly and in any event no later than the first
meeting of the board of directors at which the transaction
is considered. An office holder is not obliged to disclose a personal interest if it derives solely from the personal interest of his
or her relative in a transaction that is not considered as an extraordinary transaction.
 
A
“personal interest” is defined under the Companies Law to include a personal interest of any person in an act or transaction
of a company, including the personal interest of such
person’s relative or of a corporate body in which such person or a relative
of such person is a 5% or greater shareholder, director or general manager or in which he or she has the right
to appoint at least one
director or the general manager, but excluding a personal interest stemming from one’s ownership of shares in the company.
 
70

 
 
A
personal interest furthermore includes the personal interest of a person for whom the office holder holds a voting proxy or the personal
interest of the office holder with respect to his
or her vote on behalf of a person for whom he or she holds a proxy even if such shareholder
has no personal interest in the matter. An office holder is not, however, obliged to disclose
a personal interest if it derives solely
from the personal interest of his or her relative in a transaction that is not considered an extraordinary transaction.
 
Under
the Companies Law, an extraordinary transaction is defined as any of the following:
 
●
a
transaction other than in the ordinary course of business;
 
●
a
transaction that is not on market terms; or
 
●
a
transaction that may have a material impact on the company’s profitability, assets or liabilities.
 
If
it is determined that an office holder has a personal interest in a transaction, approval by the board of directors is required for the
transaction, unless the company’s articles of
association provide for a different method of approval. Further, so long as an office
holder has disclosed his or her personal interest in a transaction, the board of directors may approve
an action by the office holder
that would otherwise be deemed a breach of duty of loyalty. However, a company may not approve a transaction or action that is adverse
to the
company’s interest or that is not performed by the office holder in good faith. An extraordinary transaction in which an
office holder has a personal interest requires approval first by
the company’s audit committee and subsequently by the board of
directors. The compensation of, or an undertaking to indemnify or insure, an office holder who is not a director
requires approval first
by the company’s compensation committee, then by the company’s board of directors, and, if such compensation arrangement
or an undertaking to indemnify or
insure is inconsistent with the company’s stated compensation policy or if the office holder
is the chief executive officer (apart from a number of specific exceptions), then such
arrangement is subject to a special majority approval.
Arrangements regarding the compensation, indemnification or insurance of a director require the approval of the compensation
committee,
board of directors and shareholders by ordinary majority, in that order, and under certain circumstances, a special majority approval.
If shareholders of a company do not
approve the compensation terms of office holders, other than directors, but including the chief executive
officer, the compensation committee and board of directors may override the
shareholders’ decision, subject to certain conditions.
 
Generally,
a person who has a personal interest in a matter which is considered at a meeting of the board of directors or the audit committee may
not be present at such a meeting or
vote on that matter unless the chairman of the relevant committee or board of directors (as applicable)
determines that he or she should be present in order to present the transaction that
is subject to approval. If a majority of the members
of the audit committee or the board of directors (as applicable) has a personal interest in the approval of a transaction, then all
directors
may participate in discussions of the audit committee or the board of directors (as applicable) on such transaction and the voting on
approval thereof, but shareholder approval
is also required for such transaction.
 
Disclosure
of Personal Interests of Controlling Shareholders and Approval of Certain Transactions
 
Pursuant
 to Israeli law, the disclosure requirements regarding personal interests that apply to directors and executive officers also apply to
 a controlling shareholder of a public
company. In the context of a transaction involving a shareholder of the company, a controlling shareholder also includes
a shareholder who holds 25% or more of the voting rights in
the company if no other shareholder holds more than 50% of the voting rights
in the company. For this purpose, the holdings of all shareholders who have a personal interest in the
same transaction will be aggregated.
The approval of the audit committee, the board of directors and a special majority, in that order, is required for (a) extraordinary
transactions with
a controlling shareholder or in which a controlling shareholder has a personal interest, (b) the engagement with a
controlling shareholder or his or her relative, directly or indirectly, for
the provision of services to the company, (c) the terms of
engagement and compensation of a controlling shareholder or his or her relative who is not an office holder or (d) the
employment of
a controlling shareholder or his or her relative by the company, other than as an office holder.
 
To
the extent that any such transaction with a controlling shareholder is for a period extending beyond three years, approval is required
once every three years, unless, with respect to
certain transactions, the audit committee determines that the duration of the transaction
is reasonable given the circumstances related thereto.
 
71

 
 
Arrangements
regarding the compensation, indemnification or insurance of a controlling shareholder in his or her capacity as an office holder require
the approval of the compensation
committee, board of directors and shareholders by a special majority and the terms thereof may not be
inconsistent with the company’s stated compensation policy.
 
Pursuant
to regulations promulgated under the Companies Law, certain transactions with a controlling shareholder or his or her relative, or with
directors, that would otherwise require
approval of a company’s shareholders may be exempt from shareholder approval upon certain
determinations of the audit committee and board of directors. Under these regulations, a
shareholder holding at least 1% of the issued
share capital of the company may require, within 14 days of the publication of such determinations, that despite such determinations
by
the audit committee and the board of directors, such transaction will require shareholder approval under the same majority requirements
 that would otherwise apply to such
transactions.
 
Director
Independence
 
Our
ordinary shares are listed on The Nasdaq Capital Market. Under the Nasdaq listing rules, independent directors must
comprise a majority of a listed company’s board of directors
within twelve months from the date of listing. In addition, the
Nasdaq listing rules require that, subject to specified exceptions, each member of a listed company’s audit, compensation
and
 nominating and corporate governance committees be independent within twelve months from the date of listing. Audit committee members
 must also satisfy additional
independence criteria, including those set forth in Rule 10A-3 under the Securities Exchange Act of
1934, as amended, or the Exchange Act, and compensation committee members
must also satisfy the independence criteria set forth in
Rule 10C-1 under the Exchange Act. Under Nasdaq listing rules, a director will only qualify as an “independent director”
if, in
the opinion of that company’s board of directors, that person does not have a relationship that would interfere with
 the exercise of independent judgment in carrying out the
responsibilities of a director. In order to be considered independent for
purposes of Rule 10A-3 under the Exchange Act, a member of an audit committee of a listed company may not,
other than in his or her
capacity as a member of the audit committee, the board of directors, or any other board committee: (1) accept, directly or
indirectly, any consulting, advisory, or
other compensatory fee from the listed company or any of its subsidiaries, other than
compensation for board service; or (2) be an affiliated person of the listed company or any of its
subsidiaries. In order to be
considered independent for purposes of Rule 10C-1, the board of directors must consider, for each member of a compensation committee
of a listed
company, all factors specifically relevant to determining whether a director has a relationship to such company which is
material to that director’s ability to be independent from
management in connection with the duties of a compensation
committee member, including, but not limited to: the source of compensation of the director, including any consulting
advisory or
other compensatory fee paid by such company to the director, and whether the director is affiliated with the company or any of its
subsidiaries or affiliates.
 
In
 March 2022, our board of directors undertook a review of the composition of our board of directors and its committees and the independence
 of each director. Based upon
information requested from and provided by each director concerning his or her background, employment and
affiliations, including family relationships, our board of directors has
determined that all members of the board of directors, except
Dror Harats, M.D., are independent directors, including for purposes of Nasdaq and the SEC rules. In making that
determination, our board
of directors considered the relationships that each director has with us and all other facts and circumstances the board of directors
deemed relevant in
determining independence, including the potential deemed beneficial ownership of our capital stock by each director
and respective affiliations, including non-employee directors that
are affiliated with certain of our major shareholders. We expect that
the composition and functioning of our board of directors and each of our committees will continue to comply with
all applicable requirements
of Nasdaq and the rules and regulations of the SEC. There are no family relationships among any of our directors or executive officers.
Dror Harats, M.D.,
is not an independent director under these rules because he is currently employed as the chief executive officer and
president of our Company.
 
72

 
 
Item
14.
PRINCIPAL
ACCOUNTING FEES AND SERVICES
 
The
 following table sets forth, for each of the years indicated, the fees billed by Kesselman & Kesselman, a member firm of PricewaterhouseCoopers
 International Ltd., our
independent registered public accounting firm:
 
 
 
Year Ended December 31,
 
 
 
2022
   
2021
 
 
 
(in thousands)
 
Audit fees (1)
 
$
303    $
330 
Tax fees (2)
 
 
5     
5 
All other fees (3)
 
 
1     
- 
Total fees
 
$
309    $
335 
 
 
(1) Audit
fees consist of services that would normally be provided in connection with statutory and regulatory filings or engagements, including
services that generally only the
independent accountant can reasonably provide, including work regarding the public listing or offerings
during 2021 and 2022.
 
 
 
 
(2) Tax
fees consist of tax compliance, planning, and advice.
 
 
 
 
(3) All
other fees consist of a disclosure checklist license.
 
Our
board of directors reviews and pre-approves all audit services and permitted non-audit services (including the fees and other terms)
to be provided by our independent auditors
pursuant to pre-approval policies and procedures established by the audit committee, which
are detailed as to the particular service and the audit committee is informed of each service.
The pre-approval policies and procedures
do not delegate audit committee responsibilities under the Securities Exchange Act of 1934 to management.
 
73

 
 
PART
IV
 
Item
15.
EXHIBITS
AND FINANCIAL STATEMENT SCHEDULES
 
(1) For a list of the consolidated financial statements included
 herein, see Index to the Consolidated Financial Statements on page F-1 of this Annual Report on Form 10-K,
incorporated into this Item
15 by reference.
 
 
(2) Financial statement schedules have been omitted because they are either not required
or not applicable or the information is included in the financial statements or the notes
thereto.
 
 
(3) Exhibits:
 
Exhibit
No.   Description
2.1+
  Agreement and Plan of Merger, dated as of February 22, 2023, by and among Vascular Biogenics Ltd., Vibrant Merger Sub, Inc., and Notable Labs, Inc. (incorporated
by reference to Exhibit 2.1 to the Form 8-K filed with the Securities and Exchange Commission on February 23, 2023).
2.2*+
  Asset Purchase Agreement, dated as of February 15, 2023, by and between the Registrant and Aleph Farms Ltd.
3.1*
  Articles of Association of the Registrant, as currently in effect.
3.2*
  Memorandum of Association of the Registrant, as currently in effect.
4.1*
  Description of Securities.
10.1#
  Employee Ownership and Share Option Plan (2011) of the Registrant, and form of agreement thereunder (incorporated by reference to Exhibit 10.1 of the Registration
Statement on Form F-1 filed with the Securities and Exchange Commission on June 6, 2014).
10.2#
  Employee Share Ownership and Option Plan (2014) of the Registrant, and form of Capital Gains Option Agreement thereunder (incorporated by reference to Exhibit
10.17 of the Registration Statement on Form F-1 filed with the Securities and Exchange Commission on June 25, 2014).
10.3#
  Vascular Biogenics Ltd. Inducement Plan (2022) of the Registrant and form of award agreements thereunder (incorporated by reference to Exhibit 99.1 of the Current
Report on Form 6-K filed with the Securities and Exchange Commission on February 15, 2022).
10.4#
  Form of Release and Indemnification Agreement to be entered into between the Registrant and its officers and directors (incorporated by reference to Exhibit 10.2 of the
Registration Statement on Form F-1 filed with the Securities and Exchange Commission on June 25, 2014).
10.5*#
  Restated Executive Employment Agreement between the Registrant and Dror Harats, dated January 20, 2022.
10.6*#
  Restated Consulting and Services Agreement between the Registrant and Grand H Services Ltd., dated January 20, 2022, as amended on August 23, 2022.
10.7*#
  Employment Offer Letter between the Registrant and Sam Backenroth, dated October 4, 2021.
21.1*
  List of Subsidiaries of the Registrant.
23.1*
  Consent of Kesselman & Kesselman, a member firm of PricewaterhouseCoopers International Limited, Independent Registered Public Accounting Firm.
24.1
  Power of attorney (included on signature page hereto)
31.1*
  Certification of Chief Executive Officer Pursuant to Rule 13a-14(a)/15d-14(a).
31.2*
  Certification of Chief Financial Officer Pursuant to Rule 13a-14(a)/15d-14(a).
32.1*¥
  Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002.
101.INS
  Inline
XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded
within the Inline XBRL
document.
101.SCH
  Inline
XBRL Taxonomy Extension Schema 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.
 
#
Management compensatory plan or arrangement.
+
Schedules have been omitted from this filing pursuant to Item 601(b)(2) of Regulation S-K. We agree to furnish supplementally
a copy of any omitted schedule to the SEC upon its
request; provided, however, that we may request confidential treatment pursuant to
Rule 24b-2 of the Exchange Act for any schedule so furnished.
*
Filed herewith
¥
The certification furnished in Exhibit 32.1 hereto is deemed
to accompany this Form 10-K and is not deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise
subject
to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange
Act.
 
Item 16.
FORM
10-K SUMMARY.
 
Not
applicable.
 
74

 
 
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
 
 
Page
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB: 1309)
F-2
Consolidated Balance Sheets
F-3
Consolidated Statements of Net Loss and Comprehensive Loss
F-4
Consolidated Statements of Changes in Shareholders’ Equity
F-5
Consolidated Statements of Cash Flows
F-6
Notes to Consolidated Financial Statements
F-7
 
F-1

 
 
 
Report of Independent Registered
Public Accounting Firm
 
To
the board of directors and shareholders of Vascular Biogenics Ltd.
 
Opinion
on the Financial Statements
 
We
have audited the accompanying consolidated balance sheets of Vascular Biogenics Ltd. and its subsidiary (the “Company”)
as of December 31, 2022 and 2021, and the related
consolidated statements of net loss and comprehensive loss, changes in
shareholders’ equity and cash flows for the years then ended, including the related notes (collectively referred to
as the
“consolidated financial statements”). In our opinion, the consolidated 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 the years then ended in conformity with accounting
principles generally accepted in the United
States of America.
 
Basis
for Opinions
 
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on the Company’s consolidated 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 of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require
that we plan and perform the audits to
obtain reasonable assurance about whether the consolidated financial statements are free of material
misstatement, whether due to error or fraud. The Company is not required to have,
nor were we engaged to perform, an audit of its internal
control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over
financial
reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.
Accordingly, we express no such
opinion.
 
Our
 audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
 due to error or fraud, and performing
procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated 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 consolidated
financial statements.
We believe that our audits provide a reasonable basis for our opinion.
 
Subsequent
Event
 
As discussed in Note 1 to the consolidated financial statements, the Company entered into a merger agreement with Notable Labs, Inc. (“Notable”) whereby Notable’s securityholders
will own the
majority of the Company’s outstanding shares upon consummation of the merger. Additionally, as discussed in Note 1, the Company entered
into an agreement to sell its
rights to lease the manufacturing facility and certain related assets.
 
Critical
Audit Matters
 
Critical audit matters are matters arising
from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit
committee and that (i) relate to accounts or disclosures that are material to the consolidated financial statements and (ii) involved
our especially challenging, subjective, or complex
judgments. We determined there are no critical audit matters.
 
/s/
Kesselman & Kesselman C.P.A.s
Certified
Public Accountants (Isr.)
A
member of PricewaterhouseCoopers International Limited
 
Tel
Aviv, Israel
March
14, 2023
We
have served as the Company’s auditor since 2001.
 
Kesselman
& Kesselman, Derech Menachem Begin 146 Tel Aviv-Yafo 6492103 Israel,
P.O
Box 7187 Tel-Aviv 6107120 Telephone: +972 -3- 7954555, Fax:+972 -3- 7954556, www.pwc.com/il]
 
F-2

 
 
VASCULAR
BIOGENICS LTD.
CONSOLIDATED
BALANCE SHEETS
(U.S. dollars in thousands, except share and per share
amounts)
 
 
 
December
31
 
 
 
2022
 
 
2021
 
 
 
U.S.
dollars in thousands
 
ASSETS
 
 
    
 
  
Current assets:
 
 
    
 
  
Cash and cash equivalents
 
$
17,665   
$
21,986 
Restricted cash
 
 
360   
 
- 
Short-term bank deposits
 
 
3,054   
 
31,164 
Other current assets
 
 
1,070   
 
1,697 
Total
current assets
 
 
22,149   
 
54,847 
 
 
 
    
 
  
Non-current assets:
 
 
    
 
  
Restricted bank deposits
 
$
-   
 
362 
Long-term prepaid expenses
 
 
-   
 
182 
Funds in respect of employee rights upon retirement
 
 
368   
 
415 
Property, plant and equipment, net
 
 
6,601   
 
6,847 
Operating lease right-of-use
assets
 
 
541   
 
2,008 
Total
non-current assets
 
 
7,510   
 
9,814 
Total
assets
 
$
29,659   
$
64,661 
 
 
 
    
 
  
LIABILITIES AND SHAREHOLDERS’
EQUITY
 
 
    
 
  
Current liabilities:
 
 
    
 
  
Accounts payable and accruals:
 
 
    
 
  
Trade
 
$
808   
$
4,331 
Other
 
 
5,359   
 
4,408 
Deferred revenue
 
 
-   
 
658 
Current maturity of
operating leases
 
 
564   
 
529 
Total
current liabilities
 
 
6,731   
$
9,926 
 
 
 
    
 
  
Non-current liabilities:
 
 
    
 
  
Liability for employee rights upon retirement
 
 
477   
 
546 
Operating lease liability
 
 
-   
 
1,823 
Other non-current liability
 
 
-   
 
188 
Total
non-current liabilities
 
 
477   
 
2,557 
 
 
 
    
 
  
Commitments (Note 8)
 
 
    
 
  
 
 
 
    
 
  
Total
liabilities
 
$
7,208   
$
12,483 
 
 
 
    
 
  
Ordinary shares subject to possible redemption, as of December 31,
2022 and December 31, 2021, zero
and 615,366 shares, respectively, at redemption value (Note 9)
 
 
-   
 
1,598 
 
 
 
    
 
  
Shareholders’ equity:
 
 
    
 
  
Ordinary shares, NIS 0.01 par value; Authorized as of December 31, 2022
and 2021, 200,000,000 and
150,000,000 shares, respectively; issued and outstanding
as of December 31, 2022 and 2021, 69,750,117 and
68,711,584
shares, respectively (excluding – zero - and 615,366 subject to possible redemption as of
December 31, 2022 and December 31,
2021, respectively)
 
 
174   
 
171 
 
 
 
    
 
  
Additional paid in capital
 
 
316,654   
 
309,355 
Warrants
 
 
-   
 
3,127 
Accumulated deficit
 
 
(294,377)  
 
(262,073)
Total
equity
 
 
22,451   
 
50,580 
Total
liabilities and equity
 
$
29,659   
$
64,661 
 
The
accompanying notes are an integral part of the consolidated financial statements.
 
F-3

 
 
VASCULAR
BIOGENICS LTD.
CONSOLIDATED
STATEMENTS OF NET LOSS AND COMPREHENSIVE LOSS
(U.S.
dollars in thousands, except share and per share amounts)
 
 
 
Year
ended December 31
 
 
 
2022
 
 
2021
 
 
 
U.S.
dollars in thousands
 
Revenues
 
$
658   
$
768 
Cost of revenues
 
 
(104)  
 
(365)
Gross profit
 
 
554   
 
403 
 
 
 
    
 
  
Research and development expenses, net
 
 
21,653   
 
22,695 
General and administrative
expenses
 
 
11,754   
 
7,704 
Operating loss
 
 
32,853   
 
29,996 
 
 
 
    
 
  
Financial income
 
 
(634)  
 
(120)
Financial expenses
 
 
85   
 
44 
Financial income, net
 
 
(549)  
 
(76)
 
 
 
    
 
  
Net loss and comprehensive
loss
 
$
32,304   
$
29,920 
 
 
 
U.S. dollars
 
Loss per ordinary share
 
 
    
 
  
Basic and diluted
 
$
0.42   
$
0.45 
 
 
 
    
 
  
 
 
 
Number of shares
 
Weighted average ordinary shares outstanding
 
 
    
 
  
Basic and diluted
 
 
77,554,740   
 
66,346,506 
 
The
accompanying notes are an integral part of the consolidated financial statements.
 
F-4

 
 
VASCULAR
BIOGENICS LTD.
CONSOLIDATED
STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
(U.S. dollars in thousands, except share and per share
amounts)
 
 
 
 
Number
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
of
 
 
 
 
  Additional  
 
 
 
 
 
 
 
 
 
 
Ordinary shares
 
 
 
ordinary
 
  Ordinary  
 
paid in
 
 
 
 
  Accumulated  
 
Total
 
 
subject to
possible
 
 
 
shares
 
 
shares
 
 
capital
 
  Warrants  
 
deficit
 
 
equity
 
 
redemption
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Shares
 
 
Amount  
 
 
 
 
 
 
 
 
 
 
 
U.S.
dollars in thousands
 
 
 
 
 
 
 
 
 
 
Balance at January 1, 2021
 
  48,187,463   
 
108   
 
252,561   
 
10,401   
 
(232,153)  
 
30,917   
 
-   
 
- 
Changes during the year
ended
 
 
    
 
    
 
    
 
    
 
    
 
    
 
    
 
  
December 31, 2021:
 
 
    
 
    
 
    
 
    
 
    
 
    
 
    
 
  
Net loss
 
 
-   
 
-   
 
-   
 
-   
 
(29,920)  
 
(29,920)  
 
-   
 
- 
Issuance of ordinary shares
 
 
28,334   
 
*   
 
-   
 
-   
 
    
 
    
 
    
 
  
 Issuance of ordinary shares and warrants, net of
issuance costs of $2.2
million
 
 
8,971,790   
 
27   
 
30,925   
 
-   
 
-   
 
30,952   
 
-   
 
- 
Exercised warrants
 
  11,523,997   
 
36   
 
20,974   
 
(4,347)  
 
-   
 
16,663   
 
    
 
  
Expired warrants
 
 
-   
 
-   
 
2,927   
 
(2,927)  
 
-   
 
-   
 
-   
 
- 
Issuance of ordinary shares subject to possible
redemption
 
 
-   
 
-   
 
-   
 
-   
 
    
 
--   
 
615,366   
$
1,598 
Share-based compensation
 
 
-   
 
-   
 
1,968   
 
-   
 
-   
 
1,968   
 
-   
 
- 
Balance at December 31, 2021
 
  68,711,584   
 
171   
 
309,355   
 
3,127   
 
(262,073)  
 
50,580   
 
615,366   
$
1,598 
Changes during the year
ended
 
 
    
 
    
 
    
 
    
 
    
 
    
 
    
 
  
December 31, 2022:
 
 
    
 
    
 
    
 
    
 
    
 
    
 
    
 
  
Net loss
 
 
-   
 
-   
 
-   
 
-   
 
(32,304)  
 
(32,304)  
 
-   
 
- 
Expired warrants
 
 
-   
 
-   
 
3,127   
 
(3,127)  
 
-   
 
-   
 
-   
 
- 
Reclassification of redemption shares into
ordinary shares
 
 
615,366   
 
2   
 
1,596   
 
    
 
    
 
1,598   
  (615,366)  
 
(1,598)
Share-based compensation to employees and
service
provider
 
 
34,258   
 
*   
 
2,555   
 
-   
 
-   
 
2,555   
 
-   
 
- 
Employee exercise of stock options
 
 
388,909   
 
1   
 
21   
 
    
 
    
 
22   
 
    
 
  
Balance at December
31, 2022
 
  69,750,117   
$
174   
$ 316,654   
$
-   
$
(294,377)  
$
22,451   
$
-   
$
- 
 
*Amount less than $1
thousand
 
The
accompanying notes are an integral part of the consolidated financial statements.
 
F-5

 
 
VASCULAR
BIOGENICS LTD.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(U.S.
dollars in thousands)
 
 
 
Year
ended December 31,
 
 
 
2022
 
 
2021
 
 
 
U.S.
dollars in thousands
 
CASH FLOWS FROM OPERATING
ACTIVITIES:
 
 
    
 
  
Net loss
 
$
(32,304)  
$
(29,920)
Adjustments to reconcile net loss to net cash
used in operating
 
 
    
 
  
activities:
 
 
    
 
  
Depreciation
 
 
1,058   
$
1,256 
Interest expense (income)
 
 
2   
 
(31)
Net changes in operating leases
 
 
(321)  
 
46 
Interest expenses on leases
 
 
-   
 
(2)
Exchange loss (gain) on cash and cash
equivalents and restricted cash
 
 
47   
 
(15)
Changes in accrued liability for employee rights
upon retirement
 
 
(22)  
 
11 
Share-based compensation
 
 
2,555   
 
1,968 
Changes in operating assets and liabilities:
 
 
    
 
  
Decrease (increase) in other current assets
and long-term prepaid expenses
 
 
809   
 
(219)
Decrease in trade receivables
 
 
-   
 
129 
Increase (decrease) in accounts payable and
accruals:
 
 
    
 
  
Trade
 
 
(3,523)  
 
2,371 
Other (including other non-current liability)
 
 
763   
 
193 
Decrease in deferred
revenue
 
 
(658)  
 
(771)
Net cash used in operating
activities
 
$
(31,594)  
$
(24,984)
 
 
 
    
 
  
CASH FLOWS FROM INVESTING
ACTIVITIES:
 
 
    
 
  
Purchase of property and equipment
 
 
(812)  
 
(1,465)
Investment in short-term bank deposits
 
 
(3,000)  
 
(51,109)
Maturity of short-term
bank deposits
 
 
31,108   
 
37,085 
Net cash provided by
(used in) investing activities
 
$
27,296   
$
(15,489)
 
 
 
    
 
  
CASH FLOWS FROM FINANCING
ACTIVITIES:
 
 
    
 
  
Proceeds from issuance of ordinary shares and
warrants
 
$
22   
$
33,155 
Issuance costs
 
 
-   
 
(2,202)
Proceeds from issuance of ordinary shares subject
to possible redemption
 
 
-   
 
1,598 
Proceeds from exercised warrants
 
 
-   
 
16,662 
Finance lease payments
 
 
-   
 
(104)
Net cash provided by
(used in) financing activities
 
$
22   
$
49,109 
 
 
 
    
 
  
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS AND RESTRICTED
CASH
 
$
(4,276)  
$
8,636 
CASH AND CASH EQUIVALENTS
AND RESTRICTED CASH AT BEGINNING OF
YEAR
 
 
22,348   
 
13,697 
EFFECT OF EXCHANGE RATE
ON CASH AND CASH EQUIVALENTS AND RESTRICTED
CASH
 
 
(47)  
 
15 
CASH
AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF YEAR
 
$
18,025   
$
22,348 
SUPPLEMENTARY INFORMATION
ON INVESTING AND FINANCING ACTIVITIES NOT
INVOLVING CASH FLOWS:
 
 
    
 
  
Non cash activity - Purchase of property and
equipment in payables
 
$
-   
$
6 
Right of use assets
obtained in exchange for new operating lease liabilities
 
$
-   
$
240 
 
 
 
    
 
  
RECONCILIATION OF CASH,
CASH EQUIVALENTS, AND RESTRICTED CASH REPORTED
IN
THE STATEMENT OF FINANCIAL POSITION
 
 
    
 
  
Cash and cash equivalents
 
$
17,665   
$
21,986 
Restricted cash included in current assets
 
 
360   
 
- 
Restricted bank deposits
included in non-current assets
 
 
-   
 
362 
Total cash, cash equivalents,
and restricted cash shown in the statement of cash flows
 
$
18,025   
$
22,348 
 
 
 
    
 
  
SUPPLEMENTARY DISCLOSURE
ON CASH FLOWS
 
 
    
 
  
Interest received
 
$
225   
$
141 
Interest paid
 
$
-   
$
(2)
 
The
accompanying notes are an integral part of the consolidated financial statements.
 
F-6

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS
 
NOTE
1 – SIGNIFICANT ACCOUNTING POLICIES:
 
a.
General
 
Vascular
Biogenics Ltd. (“VBL” or the “Company”) is a biotechnology company developing targeted medicines for
immune-inflammatory diseases. VBL’s lead immunology product
candidate, VB-601, is a clinic ready targeted antibody for
immune-inflammatory applications expected to enter a Phase 1 first-in-human trial, subject to the
Company’s ongoing
strategic process.
 
On
 July 19, 2022, VBL announced top-line results from its Phase 3 OVAL clinical trial. The trial did not meet the primary endpoints of achieving
 a statistically significant
improvement in progression-free survival (“PFS”) or overall survival (“OS”) and VBL
discontinued the trial. VBL has conducted a strategic review of the ofra-vec program and ceased
further development of ofra-vec in
all indications. As these results are considered a triggering event, VBL performed an impairment test on all of its assets in the third
quarter of 2022.
The Company concluded that the value of its manufacturing facility is in excess of its carrying value and
therefore is not subject to impairment. Upon evaluation of the remaining
assets
 and liabilities, (i) VBL wrote off all long term prepaids assets, (ii) recorded severance provisions (including additional termination
 benefits) for the remaining full time
employees, (iii) modified the term of the lease right-of- use assets and liabilities due to reassessment
of exercise of the renewal option and reduced the remaining period from 4.5 years
to 18 months, and (iv) recognized the remaining deferred
revenue from the exclusive license agreement with Nanocarrier for the development, commercialization, and supply of ofra-
vec in Japan
for all indications (the “NanoCarrier License”), which has since been terminated.
 
In
August 2022, VBL announced an organizational streamlining designed to reduce operating expenses and preserve capital. As a result, to
date, the Company reduced its workforce by
approximately 84%
of its full-time employees, and its board of directors was also reduced from nine to six members. In August 2022, VBL also announced
that it was exploring
strategic alternatives to enhance shareholder value and engaged Chardan Capital Markets, LLC (“Chardan”)
as its exclusive financial advisor to assist in this process. Potential strategic
options explored or evaluated as part of the process
included, but were not limited to merger, reverse merger, other business combination, sale of assets, licensing, or other strategic
transactions.
As a result of this process, on February 15, 2023, VBL entered into an Asset Purchase Agreement (the “Purchase Agreement”)
providing for the sale of its rights to lease
the Modi’in facility along with certain tangible assets and equipment located therein
for $7.1
million in cash, which sale closed on March 9,
2023. In addition, and on February 22,
2023, VBL entered into an Agreement and Plan of Merger with Notable Labs, Inc. (“Notable”)
and a wholly-owned merger subsidiary (the “Merger Agreement”), see more fully
described below.
 
On
February 22, 2023, VBL entered into Merger Agreement with Notable and Vibrant Merger Sub, Inc., a Delaware corporation and VBL’s
direct, wholly-owned subsidiary (“Merger
Sub”), pursuant to which, and subject to the satisfaction or waiver of the conditions
set forth in the Merger Agreement, Notable will be merged with and into Merger Sub (such
transaction, the “Merger”) at the
effective time of the Merger (the “Effective Time”), with Notable continuing after the Merger as the surviving corporation
and a wholly-owned
subsidiary of VBL. The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes.
 
At
the Effective Time, each outstanding share of Notable capital stock will be converted into the right to receive VBL ordinary shares,
as set forth in the Merger Agreement. Under the
exchange ratio formula in the Merger Agreement, immediately following the Effective Time,
the former Notable securityholders are expected to own approximately 76% of the VBL
ordinary shares on a fully diluted basis and subject
to adjustment and securityholders of VBL as of immediately prior to the Effective Time are expected to own approximately 24% of
the VBL
ordinary shares on a fully diluted basis and subject to adjustment. Under certain circumstances further described in the Merger Agreement,
the ownership percentages may be
adjusted upward or downward based on the level of VBL’s net cash at the closing of the Merger,
and the terms and net proceeds of Notable’s pre-merger financing. There can be no
assurances as to VBL’s level of net cash
between the signing of the Merger Agreement and the closing of the Merger.
 
The
Merger Agreement contains a customary “no-shop” provision under which neither VBL nor Notable is permitted to (i) solicit
any alternative acquisition proposals, (ii) furnish any
non-public information to any person in connection with or in response to any
alternative acquisition proposal, (iii) engage in any negotiations or discussions with any person with
respect to any alternative acquisition
proposal, (iv) approve, endorse or recommend any alternative acquisition proposal, or (v) execute or enter into any agreement relating
to any
alternative acquisition proposal. The “no-shop” provision is subject to certain exceptions that permit the board of
directors of either party to comply with its fiduciary duties, which,
under certain circumstances, would enable VBL or Notable to provide
information to, and enter into discussions or negotiations with, third parties in response to any alternative
acquisition proposals.
 
The
Merger Agreement contains customary representations, warranties and covenants made by Notable and VBL, including representations relating
to obtaining the requisite approvals
of the securityholders of Notable and VBL, agreements relating to indemnification of directors and
 officers, and covenants relating to Notable’s and VBL’s conducting of their
respective businesses between the date of signing
the Merger Agreement and the Effective Time.
 
F-7

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
The
Merger Agreement provides each of VBL and Notable with specified termination rights, and further provides that, upon termination of the
Merger Agreement under specified
circumstances, the terminating party may be required to pay the other party a termination fee of $2,500,000.
 In addition, in connection with certain terminations of the Merger
Agreement, VBL may be required to pay Notable’s out-of-pocket
fees and expenses up to $500,000, or Notable may be required to pay VBL’s out-of-pocket fees and expenses up to
$500,000.
 
The
Merger Agreement provides that, immediately following the Effective Time, the board of directors of the combined company will consist
of up to seven directors, with one
director designated by us. Upon the closing of the transaction, the combined company will be led by
Notable’s chief executive officer and executive management team. In connection
with the Merger, VBL will seek to amend its articles
of incorporation to: (i) effect an increase of its registered share capital and/or effect a reverse split of its ordinary shares at a
ratio
to be determined; (ii) change its name to “Notable Labs, Ltd.”; and (iii) make other such changes as mutually agreeable
to VBL and Notable.
 
VBL
and Notable’s obligations to consummate the Merger are subject to the satisfaction or waiver of customary closing conditions, including,
among others, obtaining the requisite
approval of VBL’s shareholders, obtaining the requisite approval of Notable’s stockholders,
proceeds of Notable’s pre-closing financing, net of certain specified expenses, not being
less than $5,000,000 and VBL’s
net cash not being less than $15,000,000.
 
In
connection with the execution of the Merger Agreement, VBL and Notable entered into shareholder support agreements with their current
directors and executive officers who
collectively beneficially own or control an aggregate of approximately 2% of VBL’s outstanding
ordinary shares. These shareholder support agreements provide that, among other
things, each of the shareholders has agreed to vote or
cause to be voted all of its ordinary shares beneficially owned by such shareholder in favor of the issuance of VBL’s ordinary
shares in the Merger at the VBL shareholder meeting to be held in connection with the Merger.
 
In
August 2022, VBL also received a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC, or
Nasdaq, notifying that the Company’s listed
securities did not maintain the minimum bid price requirement of $1.00
per ordinary share for continued listing on the Nasdaq Global Market for a period of 30 consecutive business
days as required under
Nasdaq Listing Rule 5450(a)(1). The Nasdaq deficiency letter does not result in the immediate delisting of VBL’s ordinary
shares, and the Company’s ordinary
shares will continue to trade uninterrupted under the symbol “VBLT.” Pursuant
to Nasdaq Listing Rule 5810(c)(3)(A), VBL had a compliance period of 180 calendar days, or until
February 27, 2023, to regain
compliance with Nasdaq’s minimum bid price requirement. If at any time during the compliance period, the Company’s
ordinary shares had a closing bid
price of at least $1.00
for 10 consecutive business days, Nasdaq would have provided the Company with a written confirmation of compliance and the matter
would have closed. The
Company did not regain compliance by February 27, 2023, requested the transfer of its listing to
 Nasdaq’s Capital Market and received an additional 180 day period to regain
compliance. Further, under Nasdaq Listing Rules
5810(c)(1) and 5810(c)(3)(A)(iii), if VBL’s trading price falls below $0.10
for ten consecutive trading days, the Company will receive
a Staff Delisting Determination providing for automatic suspension and
delisting. VBL can appeal in writing to be granted an exception to remain listed for up to an additional 180 day
period to regain
compliance if the Hearings Panel believes the Company will be able to regain compliance with the $1.00
minimum bid price requirement within that timeframe. VBL
intends to monitor the closing bid price of its ordinary shares and may, if
appropriate, consider available options to regain compliance with the minimum bid price requirement. If the
Company does not regain
compliance with the bid price requirement by the end of the second compliance period, or if its trading price falls below $0.10
for ten consecutive trading
days, VBL’s stock will be subject to delisting.
 
The
Merger with Notable (discussed below) is considered a “change in control” under Nasdaq’s rules, and the combined company
will need to satisfy all of Nasdaq’s initial listing
criteria. If the merger is consummated and the combined entity fails to either
qualify for listing or timely complete Nasdaq’s initial listing process prior to consummation, this could
also result in a suspension
of trading and possible delisting.
 
In
August 2022, VBL received $1.1
million as part of the grant from the European
Innovation Council (“EIC”) for development of ofra-vec.
 
Since
inception, VBL has incurred significant losses, and it expects to continue to incur significant expenses and losses for at least the
next several years. As of December 31, 2022,
VBL had an accumulated deficit of $294.4 million and cash, cash equivalents, short-term
bank deposits and restricted bank deposits of $21.1 million. Based on its current cash
resources, and successful implementation of its
reduction in workforce, VBL believes its current cash will be sufficient to fund estimated operating expenses and capital expenditure
requirements for at least 12 months from the date of the filing of these financial statements. VBL is undertaking a review of its strategic
options and any transaction resulting from such
review may impact this projection. Further, its losses may fluctuate significantly from
quarter to quarter and year to year, depending on the timing of its clinical trials, the receipt of
payments under any future collaboration
agreements it may enter into, its expenditures on other research and development activities, as well as any strategic options it may
pursue.
VBL may seek to raise more capital to pursue additional activities, including through a combination of private and public equity
 offerings, debt, government grants, strategic
collaborations and licensing arrangements. Additional financing may not be available when
VBL needs it or may not be available on terms that are favorable to VBL.
 
If
VBL is unable to raise additional funds through equity or debt financings or through strategic alliances when needed, or conclude any
strategic transaction for its assets to maximize
shareholder value, it may be required to delay, limit, reduce or terminate its product
development efforts or cease operations altogether. Failure to obtain additional financing will have
a material, adverse impact on the
Company’s business operations and there can be no assurance that VBL will be able to obtain the needed financing to achieve its
goals on acceptable
terms or at all.
 
b.
Basis of preparation of the financial statements
 
The
Company’s financial statements have been prepared in accordance with generally accepted accounting principles in the United States
of America (“U.S. GAAP”).
 
F-8

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
1 – SIGNIFICANT ACCOUNTING POLICIES (continued):
 
c.
Use of estimates in the preparation of financial statements
 
The
 preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the
 reported amounts of assets and
liabilities, the disclosure of contingent liabilities at the date of the financial statements and the
reported amounts of expenses during the reporting period. Actual results may differ from
those estimates.
 
d.
Functional and presentation currency:
 
1)
Functional and presentation currency
 
The
U.S. dollar (“dollar”) is the currency of the primary economic environment in which the operations of the Company are conducted.
Accordingly, the functional and presentation
currency of the Company and its U.S. subsidiary is the dollar.
 
2)
Transactions and balances
 
Transactions
and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated
into dollars using historical and
current exchange rates for non-monetary and monetary balances, respectively. For non-dollar transactions
 and other items in the statements of operations (indicated below), the
following exchange rates are used: (i) for transactions - exchange
rates at transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items
such as depreciation
and amortization, etc.) - historical exchange rates.
 
All
foreign exchange gains and losses are presented in the statements of operations within financial income or expenses.
 
e.
Cash, cash equivalents and restricted cash deposits
 
The
Company considers all short-term, highly liquid investments, to be a cash or cash equivalents, which includes short-term bank deposits
with original maturities of three months or
less from the date of purchase that are not restricted as to withdrawal or use and are readily
convertible to known amounts of cash, in addition to restricted cash required to be set aside
for operating lease contractual agreements
and recorded in current assets on the balance sheet.
 
f.
Property, plant and equipment:
 
1)
All property and equipment (including leasehold improvements) are stated at cost less accumulated depreciation and impairment. Cost includes
 expenditures that are directly
attributable to the acquisition of the items.
 
Repairs
and maintenance are recorded in the statement of comprehensive loss during the period in which they are incurred.
 
2)
The assets are depreciated using the straight-line method to allocate their cost over their estimated useful lives. Annual rates of depreciation
are as follows:
 
 
 
Years
 
Laboratory equipment
 
 
7-15 
Computers
 
 
3-4 
Office furniture and equipment
 
 
15 
 
Leasehold
improvements are depreciated using the
straight-line method over the shorter of the term of the lease or
the estimated useful life of the improvements.
 
F-9

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
1 – SIGNIFICANT ACCOUNTING POLICIES (continued):
 
3)
Gains and losses on disposals are determined by comparing proceeds with the associated carrying amount. These are included in the statements
of operations.
 
g.
Held-for-sale
 
A
long-lived asset (disposal group) to be sold shall be classified as held for sale in the period in which all of the following criteria
are met:
 
 
A.
Management,
having the authority to approve the action, commits to a plan to sell the asset (disposal group).
 
B.
The
asset (disposal group) is available for immediate sale in its present condition subject only to terms that are usual and customary for
sales of such assets (disposal
groups).
 
C.
An
active program to locate a buyer and other actions required to complete the plan to sell the asset (disposal group) have been initiated.
 
D.
The
sale of the asset (disposal group) is probable, and transfer of the asset (disposal group) is expected to qualify for recognition as a completed sale, within one
year. The
term probable refers to a future sale that is likely to occur.
 
E.
The
asset (disposal group) is being actively marketed for sale at a price that is reasonable in relation to its current fair value.
 
F.
Actions
required to complete the plan indicate that it is unlikely that significant changes to the plan will be made or that the plan will
be withdrawn.
 
In
October 2022, VBL decided to sell the Company’s long-lived assets related to the GMP manufacturing facility in Israel. Per ASC
360-10, from that date forward these assets are
measured at the lower of their carrying amount or fair value less cost to sell.
 
h.
Impairment of long-lived assets
 
Assets
that are subject to depreciation are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount
may not be recoverable. If the sum
of expected future cash flows (undiscounted and without interest charges) of the assets is less than
the carrying amount of such assets, an impairment loss would be recognized. The
assets would be written down to their estimated fair
values, calculated based on the present value of expected future cash flows (discounted cash flows), or some other fair value
measure.
 
Through
December 31, 2022, no impairment has been recognized (see also note 1).
 
i.
Deferred income tax
 
Deferred
taxes are recognized using the asset and liability method on temporary differences arising between the tax bases of assets and liabilities
and their carrying amounts in the
financial statements.
 
A
valuation allowance is recognized to the extent that it is more likely than not that the deferred taxes will not be realized in the foreseeable
future. Given the Company’s losses, the
Company has provided a full valuation allowance with respect to its deferred tax assets.
 
j.
Uncertainty in income tax
 
The
Company follows a two-step approach in recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position
for recognition by determining if the
available evidence indicates that it is more likely than not that the position will be sustained
based on technical merits. If this threshold is met, the second step is to measure the tax
position as the largest amount that has more
than a 50% likelihood of being realized upon ultimate settlement.
 
k.
Employee benefits:
 
a.
Post-employment benefit obligation
 
Israeli
labor laws and the Company’s agreements require the Company to pay retirement benefits to employees terminated or leaving their
employment in certain other circumstances.
Most of the Company’s employees are covered by a defined contribution plan under Section
14 of the Israel Severance Pay Law from the beginning of their employment with the
Company.
 
With
respect to the remaining employees, which are not covered by a defined contribution plan under Section 14 of the Israel Severance Pay
Law only from January 1, 2010, the
Company records an asset and liability in its balance sheet.
 
F-10

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
1 – SIGNIFICANT ACCOUNTING POLICIES (continued):
 
b.
Vacation and recreation pay
 
Under
Israeli law, each employee is entitled to vacation days and recreation pay, both computed on an annual basis. The entitlement is based
on the length of the employment period.
US employees are offered a similar benefit. The Company recognizes a liability and expense for
vacation and recreation pay based on the entitlement of each employee.
 
k.
Share-based compensation
 
The
Company accounts for employees’ and directors’ share-based payment awards classified as equity awards using the grant-date
fair value method. The fair value of share-based
payment transactions is recognized as an expense over the requisite service period.
 
The
Company elected to recognize compensation costs for awards conditioned only on continued service that have a graded vesting schedule
using the accelerated method over the
related service period.
 
Share
based payments to employees and directors were measured by reference to the fair value of the options and restricted share (hereinafter
“RSUs”) granted at date of grant.
 
The
Company calculates the fair value of stock-based option awards on the date of grant using the Black-Scholes option pricing model. This
option pricing model requires estimates as
to the option’s expected term and the price volatility of the underlying stock.
 
The
Company measures compensation expense for the restricted stock units based on the market value of the underlying stock at the date of
grant. Performance vesting conditions are
included in assumptions about the number of options and RSU’s that are expected to vest.
 
The
total expense is recognized over the vesting period, which is the period over which all of the specified vesting conditions are to be
satisfied.
 
When
options are exercised, the Company issues new shares, with proceeds less directly attributable transaction costs recognized as share
capital (par value) and additional paid in
capital.
 
The
Company has elected to recognize forfeitures as they occur.
 
l.
Contingencies:
 
Certain
conditions may exist as of the date of the financial statements, which may result in a loss to the Company, but which will only be resolved
when one or more future events
occur or fail to occur. If the assessment of a contingency indicates that it is probable that a material
loss has been incurred and the amount of the liability can be estimated, then the
estimated liability is recorded as accrued expenses
in the Company’s financial statements. If the assessment indicates that a potential material loss contingency is not probable but
is
reasonably possible, or is probable but cannot be estimated, then the nature of the contingent liability, together with an estimate
of the range of possible loss if determinable and
material are disclosed.
 
As
of December 31, 2022, no contingent liabilities have been recognized.
 
F-11

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
1 – SIGNIFICANT ACCOUNTING POLICIES (continued):
 
m.
Revenue from contracts with customers:
General
 
 
The
Company recognizes revenues from the NanoCarrier License Agreement (“License Agreement”) according to ASC 606, “Revenues
from Contracts with Customers”.
 
In
determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each of its agreements,
the Company performs the following steps:
 
1.
identify
the contract with a customer;
 
 
2.
identify
the performance obligations in the contract;
 
 
3.
determine
the transaction price;
 
 
4.
allocate
the transaction price to the performance obligations in the contract;
 
 
5.
recognize
revenue when (or as) the entity satisfies a performance obligation.
 
Revenues
from licensing agreement
 
According
to ASC 606, a performance obligation is a promise to provide a distinct good or service or a series of distinct goods or services. A
good or service promised to a customer is
distinct if the customer can benefit from the good or service either on its own or together
with other resources that are readily available to the customer and the entity’s promise to
transfer the good or service to the
customer is separately identifiable from other promises in the contract.
 
The
Company has identified two performance obligations in The License Agreement: (1) Grant of the license and use of its IP; and (2) Company’s
participation and consulting
assistance services. In addition, there is a potential performance obligation regarding future manufacturing.
 
ASC
606 defines the ‘Transaction Price’ as the amount of consideration to which the entity expects to be entitled in exchange
for transferring the promised goods or services to a
customer. The Company estimates the standalone selling prices of the services to
be provided based on expected cost-plus margin approach and uses the residual approach to estimate
the selling price of the license.
 
The
Grant of the license and use of its IP performance obligation considered to be a right to use IP in accordance with ASC 606. Therefore,
revenue is recognized at a point in time,
upon transfer of control over the license to the licensee.
 
The
Company’s participation and consulting assistance services performance obligation is recognized as revenue over the service period,
based on input method, which is costs
incurred and labor hours expended.
 
The
 transaction price contains variable consideration contingent upon the licensee achieving certain milestones, as well as sales-based royalties,
 in accordance with the relevant
agreement. Variable payments, contingent on achieving additional milestones, are included in the transaction
price based on most likely amount method. Amounts included in the
transaction price are recognized only when it is probable that a significant
reversal of cumulative revenues will not occur, usually upon achievement of the specific milestone, in
accordance with the relevant agreement.
Sales-based royalties are not included in the transaction price. Rather, they are recognized as the related sale occurs, due to the specific
exception of ASC 606 for sales-based royalties in licensing of intellectual properties.
 
In
September 2022, the License Agreement was terminated. As VBL does not expect to generate additional revenues from the achievement of
new milestones or royalties under the
License Agreement, VBL recognized the remaining deferred revenue. Accordingly, during the twelve
months ended December 31, 2022, VBL recognized revenue of $0.7 million.
 
F-12

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
1 – SIGNIFICANT ACCOUNTING POLICIES (continued):
 
n.
Research and development expenses:
 
Research
and development expenses include costs directly attributable to the conduct of research and development programs, including the cost
of clinical trials, clinical trial supplies,
salaries, share-based compensation expenses, payroll taxes and other employee benefits,
lab expenses, consumable equipment and consulting fees. All costs associated with research
and developments are expensed as incurred.
 
Clinical
trial expenses are charged to research and development expense as incurred. The Company accrues for expenses resulting from obligations
under contracts with clinical
research organizations (CROs). The financial terms of these contracts are subject to negotiations, which
vary from contract to contract and may result in payment flows that do not
match the periods over which materials or services are provided.
The Company’s objective is to reflect the appropriate trial expense in the financial statements by matching the
appropriate expenses
with the period in which services and efforts are expended.
 
o.
Government grants
 
Government
grants, which are received from the Israeli Innovation Authority or IIA (formerly known as the Israeli Office of Chief Scientist, or
the “OCS”) by way of participation in
research and development that is conducted by the Company, are received in installments
 as the program progresses based on qualified research spending. Grants received are
recognized when the grant becomes receivable, provided
there is reasonable assurance that the Company will comply with the conditions attached to the grant and there is reasonable
assurance
the grant will be received.
 
In
August 2022, the Company received $1.1
million as part of the €2.5 million grant from the European Innovation Council, or EIC, for development of ofra-vec. VBL may be
entitled
to an additional $1.4
million in grant funds for project activities conducted prior to the termination of the ofra-vec project; however, there can be no
assurance that the Company will
receive these funds.
 
The
grants are deducted from the research and development expenses as the applicable costs are incurred. Research and development expenses,
net, for the years ended December 31,
2022 and 2021, include participation in research and development expenses in the amount of approximately
$1.2 million and $0.5 million, respectively.
 
p.
Leases
 
The
Company determines if an arrangement is a lease at inception. Balances related to operating leases are included in operating lease right-of-use
(“ROU”) assets, other current
liabilities, and operating lease liabilities in the consolidated balance sheets.
 
The
Company also elected to combine lease and non-lease components and to keep leases with an initial term of 12 months or less off the balance
sheet and recognize the associated
lease payments in the consolidated statements of income on a straight-line basis over the lease term.
 
ROU
assets represent the Company’s 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. Operating lease ROU assets and liabilities are recognized as of the commencement
date based on the present value of lease payments over the lease term. The Company’s
lease terms may include options to extend
or terminate the lease when it is reasonably certain that the Company will exercise that option. The discount rate for the lease is the
rate
implicit in the lease unless that rate cannot be readily determined. As the Company’s leases do not provide an implicit rate,
the Company’s uses its estimated incremental borrowing
rate based on the information available at the commencement date in determining
the present value of lease payments. Lease expense for lease payments is recognized on a straight-
line basis over the lease term (see
also note 5).
 
The Company
shall reassess the lease term only if and at the point in time that any of the following occurs:
 
 
1.
There
is a significant event or a significant change in circumstances that is within the control of the Company that directly affects whether
the Company is reasonably
certain to exercise or not to exercise an option to extend or terminate the lease.
 
2.
There
is an event that is written into the contract that obliges the Company to exercise (or not to exercise) an option to extend or terminate
the lease.
 
3.
The
Company elects to exercise an option even though the Company had previously determined that the Company was not reasonably certain
to do so.
 
4.
The
Company elects not to exercise an option even though the Company had previously determined that the Company was reasonably certain
to do so.
  
In
September 2022, the company re-evaluated the manufacturing’s lease agreement and reduced the lease period to 7 years (see also
note 1) as the lease extension was no longer
reasonably certain to be exercised.
 
F-13

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
1 – SIGNIFICANT ACCOUNTING POLICIES (continued):
 
q.
Segment reporting
 
An
operating segment is defined as a component that engages in business activities whose operating results are reviewed by the chief operating
decision maker for the purpose of
assessing performance and allocating resources and for which discrete financial information is available.
The Company has one operating segment.
 
r.
Loss per Ordinary Share
 
VBL
complies with accounting and disclosure requirements of FASB ASC Topic 260, Earnings Per Share. Basic loss per share of common stock
is computed by dividing the net loss
by the weighted average number of ordinary shares (including fully vested RSUs and PSUs) outstanding
during the period. Due to the existence of Ordinary shares subject to possible
redemption, the Company follows the two-class method in
calculating loss per share. In computing diluted earnings per share, basic earnings per share are adjusted to take into account
the potential
dilution that could occur upon the exercise of options and non-vested RSUs and PSUs, using the treasury stock method.
 
Accretion
associated with the ordinary shares subject to possible redemption is excluded from loss per ordinary share.
 
Potentially
dilutive securities have been excluded from VBL’s computation of dilutive loss per share as such securities would have been anti-dilutive.
There were 8,518,616 and
12,191,029 ordinary shares underlying outstanding options and warrants on December 31, 2022 and 2021, respectively.
 
s.
Concentration of credit risks
 
Credit
and interest risk arise from cash and cash equivalents and deposits with banks. A substantial portion of the liquid instruments of the
Company are invested in short-term deposits
in a leading Israeli bank. The Company estimates that since the liquid instruments are mainly
invested for short-term and with a highly rated institution, the credit and interest risk
associated with these balances is immaterial.
 
t.
Recently adopted accounting pronouncements
 
In
November 2021, the FASB issued ASU 2021-10, “Government Assistance (Topic 832): Disclosures by Business Entities About Government
Assistance.” ASU 2021-10 requires
disclosures about transactions with a government that have been accounted for by a grant or contribution
accounting model to increase transparency about the types of transactions, the
accounting for the transactions, and the effect on the
financial statements. The ASU is an annual disclosure effective for fiscal years beginning after December 15, 2021 and will be
applied
on a prospective basis. The Company evaluated the impact this new standard has on the consolidated financial statements and related disclosures
and concluded there is a
material impact.
 
In
March 2020, the FASB issued ASU 2020-04 “Reference Rate Reform (Topic 848)—Facilitation of the Effects of Reference Rate
Reform on Financial Reporting.” This guidance
provides optional expedients and exceptions for applying generally accepted accounting
principles to contracts, hedging relationships, and other transactions affected by reference rate
reform if certain criteria are met.
The guidance applies only to contracts, hedging relationships, and other transactions that reference LIBOR or another reference rate
expected to be
discontinued because of reference rate reform. This guidance is effective for all entities as of March 12, 2020 through
December 31, 2024. The Company adopted the new standard
effective January 2022. The Company has completed negotiations to transform the
 facility base rate of its EU securitization program and evaluated the potential impact of the
replacement of the LIBOR benchmark on its
interest rate risk management activities. The adoption of this guidance did not have a material impact on the Company’s consolidated
financial results of operations, financial position or cash flows.
 
F-14

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
2 – FAIR VALUE MEASUREMENTS
 
The
different levels of valuation of financial instruments are defined 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 prices that are based on inputs not quoted on active markets, but corroborated by market data or active market data of similar
or identical assets or liabilities.
 
Level
3 Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level
3 inputs.
 
As
of December 31, 2022 and 2021, the fair value of financial instruments (cash and cash equivalents, short term bank deposits, restricted
bank deposits, other current assets and
accounts payable) approximate their carrying amounts.
 
NOTE
3 – SHORT-TERM BANK DEPOSITS
 
The
bank deposit as of December 31, 2022 for $3.1 million was for a term of nine months and carried interest at annual rate of 3.15%. The
bank deposits as of December 31, 2021 of
$31.2 million were for terms of three months to one year and carried interest at annual rates
of 0.65%-0.85%.
 
NOTE 4 – PROPERTY AND EQUIPMENT  
 
 
December 31
 
 
 
2022
   
2021
 
 
 
(in thousands)
 
Cost:
 
 
   
 
 
Laboratory equipment*
 
$
6,778   
$
6,005 
Computers
 
 
352   
 
328 
Office furniture and equipment
 
 
200   
 
200 
Leasehold improvements
 
$
6,722   
 
6,707 
 
 
$
14,052   
$
13,240 
Less:
 
 
    
 
  
Accumulated depreciation*
 
$
7,451   
$
6,393 
Property and Equipment, net
 
$
6,601   
$
6,847 
 
*Laboratory equipment
includes the finance lease (see Note 5) with a cost of $1.1 million as of December 31, 2022 and 2021. The related accumulated
depreciation for the finance
lease as of December 31, 2022 and 2021 was $0.8 million and $0.6 million, respectively.
 
Depreciation
expense totaled $1.1 million and $1.3 million for the years ended December 31, 2022 and December 31, 2021, respectively.
 
During
the year ended December 31, 2022, the Company did not dispose of any fixed assets. During the year ended December 31, 2021, the Company
disposed of $0.1 million of fixed
assets.
 
F-15

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
5 – LEASES
 
Operating
leases
 
1)
In October 2016, the Company entered into a long-term lease contract for approximately $2.2 million over 7 years commencing May 2017
for a new facility in Modi’in, Israel with
the option to extend for an additional two periods of three years each. As of 2022,
due to VBL’s strategic process and monetization of the facility, the Company will not utilize the
extension options,
reducing its right of use assets and right of use liabilities by approximately $3.5 million each. The facility houses the Company’s local manufacturing facility,
headquarters, discovery research and clinical development. The lease requires a restricted bank deposit
of $0.4 million which is included in current assets on the balance sheet.
 
2)
The Company maintains operating lease agreements for vehicles it uses. The lease periods are generally for three years. As a result of
the 2022 organizational streamlining and
accordingly the workforce reduction, the Company terminated the majority of its employee vehicle
leases, reducing its operating lease assets and liabilities by approximately $0.07
million each.
 
Finance
Lease
 
In
July 2017, the Company entered into a long-term lease contract for approximately $1.1 million over 3 years commencing April 2018 for
a laboratory water purification system used
in our manufacturing process. As of 2021, the finance lease was fully amortized.
 
The
following table sets forth data regarding the Company’s leases:
 
 
 
Year ended December 31,
 
 
 
2022
   
2021
 
 
 
 
(in thousands)
 
Lease cost
 
 
    
 
  
Finance lease cost:
 
 
    
 
  
Amortization of right-of-use assets
 
$
-   
$
168 
Interest on lease liabilities
 
 
-   
 
1 
Operating lease cost
 
 
560   
 
595 
 
 
 
    
 
  
Other information
 
 
    
 
  
Cash paid for amounts included in the measurement of lease liabilities:
 
 
    
 
  
Financing cash flows from finance leases
 
$
-   
$
104 
Operating cash flows from operating leases
 
$
575   
$
586 
Financing cash flows from finance leases
 
$
-   
$
1 
Right-of-use assets obtained in exchange for new operating lease liabilities
 
$
-   
$
368 
 
 
 
December 31,
 
 
 
2022
   
2021
 
Weighted-average discount rate - finance leases
 
 
-   
 
3.0%
Weighted-average discount rate - operating leases
 
 
5.7% 
 
4.0%
Weighted-average remaining lease term – finance lease
 
 
-   
 
- 
Weighted-average remaining lease term - operating leases
 
 
1.25   
 
4.80 
 
Future
minimum lease payments under non-cancellable leases as of December 31, 2022 were as follows:
 
 
 
Operating Leases
 
 
 
(Dollars in thousands)
 
Year ending December 31,
 
 
  
2023
 
 
456 
2024
 
 
131 
2025 and thereafter
 
 
- 
Total future minimum lease payments
 
 
587 
Less imputed interest
 
 
(23)
Total
 
$
564 
 
F-16

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
6 – SEVERANCE PAY OBLIGATIONS
 
Israeli
law generally requires payment of severance pay upon dismissal of an employee or upon termination of employment in certain other circumstances.
The Israel pension and
severance pay liability to employees are covered mainly by regular deposits with recognized pension and severance
pay funds under the employees’ names and through the purchase of
insurance policies.
 
Most
of the Company’s employees are covered by a defined contribution plan under Section 14 of the Israel Severance Pay Law. According
to the plan, the Company regularly makes
payments to severance pay or pension funds without having a legal or constructive obligation
to pay further contributions if the funds do not hold sufficient assets to pay all employees
in the plan the benefits relating to employee
service in the current and prior periods. Neither severance pay liability nor severance pay funds under Section 14 for such employees
is
recorded on the Company’s balance sheet as the Company is relieved of its obligation upon contribution.
 
For
certain Israeli employees, the Company accrues severance pay liability, calculated pursuant to Israeli Severance Pay Law based on the
most recent salary of the employees
multiplied by the number of years of employment as of the balance sheet date (the “Shut-Down
method”). The liability is recorded as if it was payable at each balance sheet date on an
undiscounted basis.
 
The
Company’s liability with respect to Israeli employees’ is covered by monthly deposits with severance pay funds. The value
of the deposited funds is based on the cash surrender
value of these policies and includes profits (or loss) accumulated through the
balance sheet date. The deposited funds may be withdrawn only upon the fulfillment of the obligations
pursuant to Israeli Severance Pay
Law or labor agreements. The amounts funded are presented separately in the balance sheet as funds in respect to employees’ rights
upon retirement.
 
The
amounts of severance pay expenses were approximately $0.1 million and $0.3 million for each of the years ended December 31, 2022, and
2021, respectively, which were
substantially made up of company payments to the Contribution Plans. Gains on amounts funded in respect
of employee rights upon retirement for the years ended December 31, 2022
and 2021 were immaterial.
 
The
Company expects to contribute approximately $0.1 million in the year ending December 31, 2022 to insurance companies in connection with
its severance liabilities for its
operations for that year, approximately all of which will be contributed to one or more Contribution
Plans.
 
The
above amounts were determined based on the employees’ current salary rates and the number of years’ service that will have
been accumulated at their retirement date. These
amounts do not include amounts that might be paid to employees that will cease working
with the Company before reaching their normal retirement age.
 
F-17

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
7 – LICENSE AND SUPPLY AGREEMENTS
 
In
November 2017, the Company signed an exclusive license agreement with NanoCarrier Co., Ltd. for the development, commercialization, and
supply of ofra-vec in Japan. VBL
retains rights to ofra-vec globally except for Japan (“The License Agreement”). Under the
terms of the agreement, VBL has granted NanoCarrier an exclusive license to develop and
commercialize ofra-vec in Japan for all indications.
VBL will supply NanoCarrier with ofra-vec, and NanoCarrier will be responsible for all regulatory and other clinical activities
necessary
for commercialization in Japan. In exchange, the Company received an up-front nonrefundable payment of $15.0 million, and is entitled
to receive greater than $100.0
million in additional payments if certain development and commercial milestones are achieved. VBL will
also receive tiered royalties on net sales. In addition, if NanoCarrier enters
into a sublicense agreement, the Company would be entitled
to receive royalties from the sublicense income received by NanoCarrier.
 
The
performance obligation relating to the Company’s participation and consulting assistance services during the development period
is recognized over the service period. During
2022 and 2021, the Company recognized revenue in an amount of $0.7 million and $0.8 million,
respectively related to the Company’s participation and consulting assistance services
of ofra-vec in Japan for all indications.
In September 2022, the License Agreement was terminated. As VBL does not expect to generate additional revenues from the achievement
of
new milestones or royalties under the License Agreement, VBL expensed the remaining deferred revenue.
 
Revenues
recognized in 2022 and 2021 were related to the Company’s participation and consulting assistance services from the License Agreement.
All of the revenues recognized in
2022 were included in the opening balance of the deferred revenue in the balance sheets.
 
F-18

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
8 – COMMITMENTS:
 
a. In April 2011, the Company executed a Commercial License Agreement with Janssen Vaccines & Prevention B.V. (“Janssen”), for incorporating the adenovirus 5 in ofra-vec and
other historical drug candidates for cancer for consideration including the following potential future payments:
 
●
an
annual license fee of €0.1 million ($0.1 million) that is linked to Consumer Price Index (in each of 2022 and 2021, the Company
paid $0.1 million) continuing until the
termination of the agreement, which will occur upon (i) the later of the expiration date
of the last related patent or 10 years from the first commercial sale of ofra-vec or (ii) the
termination of the agreement by the
Company, which is permitted, upon three months’ written advance notice to Janssen;
 
 
●
a
milestone payment of €0.4 million ($0.4 million) upon receipt of the first regulatory approval for the marketing of the first
indication for each product covered under the
agreement; and
 
 
●
royalties
of 0.5% to 2.0% on net sales.
 
There
are no limits or caps on the amount of potential royalties. In August 2022, the Company terminated the agreement with Janssen and has
no further obligations.
 
b.
In February 2013, the Company entered into an agreement with Tel Hashomer-Medical Research, Infrastructure and Services Ltd. (“Tel
Hashomer”). The agreement with Tel
Hashomer provides that the Company will pay 1% of any net sales of any product covered by the
intellectual property covered under the agreement and 2% of any consideration
received by the Company for granting a license or similar
rights to such intellectual property. Such amounts will be recorded as part of the Company’s cost of revenues. In addition,
upon
the occurrence of an exit event such as a merger, sale of all shares or assets or the closing of an initial public offering such as the
IPO, the Company is required to pay to Tel
Hashomer 1% of the proceeds received by the Company or its shareholders as the case may be.
Royalty and all other payment obligations under this agreement will expire once the
Company has paid an aggregate sum of NIS 100 million
 (approximately $29 million) to Tel Hashomer by way of pay out, exit proceeds and licensing consideration. Amounts
previously paid as
royalties on any net sales will not be taken into account when calculating this aggregate sum. Amounts payable upon occurrence of an
exit event are not considered
to be probable until actual occurrence. Upon occurrence of such event, as such event does not represent
a substantive milestone with regard to the Company’s intellectual property, the
amount to be paid is recorded in the Statement
of comprehensive loss under research and development costs.
 
Through
December 31, 2022, the Company paid Tel Hashomer a total amount of $0.7 million in consideration for the payments received for granting
the licenses or similar rights to
this intellectual property. As of December 31, 2022, the Tel Hashomer agreement was terminated, and the Company has no further commitments.
 
c.
The Company is committed to pay royalties to the Government of Israel on proceeds from sales of products in the research and development
of which the Government participates
by way of grants. At time the grants were received, successful development of the related project
was not assumed. In the case of failure of the project that was partly financed by the
Government of Israel, the Company is not obligated
to pay any such royalties. As the Company did not meet the trial’s primary endpoints and accordingly discontinued the trial in
2022, VBL is not pursuing further development with an IIA funded project; and therefore, the Company is no longer obligated to pay additional
royalties. Under the terms of the
Company’s funding from the Israeli Government, royalties of 3%-3.5% are payable on sales of products
developed from projects funded up to 100% of the amount of the grant
received by the Company (dollar linked) with the addition of an
annual interest. As of December 31, 2022, the total additional royalty amount that may be payable by the Company,
before the additional
interest, is approximately $29.4 million ($38.4 million including interest). To date, the Company has paid the IIA approximately $0.6
million in royalties.
 
F-19

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
8 – COMMITMENTS (continued):
 
In
addition, under the Research Law, the Company is prohibited from transferring, including by way of license, the IIA-financed technologies
and related intellectual property rights
and know-how outside of the State of Israel, except under limited circumstances and only with
the approval of the IIA Research Committee. The Company may not receive the
required approvals for any proposed transfer and, even if
received, may be required to pay the IIA a portion of the consideration that it receives upon any sale of such technology to a
non-Israeli
entity up to 600% of the grant amounts plus interest.
 
NOTE
9 – SHARE CAPITAL:
 
 
a.
Common
Stock
 
The
Company has authorized 200
million shares of common stock, NIS 0.01
par value per share as of December 31, 2022 and 150
million shares of common stock, NIS 0.01
par
value per share as of December 31, 2021. Each share of common stock is entitled to one voting right. Common stock owners are
entitled to dividends when funds are legally
available and declared by the Company’s board of directors.
 
 
b.
Common
Stock Offerings
 
On
January 14, 2021, the Company entered into an ordinary share purchase agreement of up to $20
million of VBL’s ordinary shares, par value NIS 0.01
per share, with an institutional
investor. The ordinary shares may be sold from time to time based on our notice to the investor
over the 30-month term of the purchase Agreement. On December 6, 2022, the ordinary
share purchase agreement terminated. During the
 term of the ordinary share purchase agreement, the Company issued an aggregate of 1,400,000
 shares for gross proceeds of
approximately $3.0
million.
 
On
April 9, 2021, VBL entered into an underwriting agreement pursuant to which the Company issued (a) 5,150,265 of its ordinary shares to
certain investors at a price of $1.90 per
ordinary share and (b) pre-funded warrants to purchase 8,050,000 ordinary shares at price of
$1.89 per pre-funded warrant with an exercise price of each pre-funded warrant equal to
$0.01 per share. In addition, the underwriters
exercised an option to purchase additional shares and purchased 1,751,525 additional ordinary shares. Net proceeds from the issuance
and
sale of the 6,901,790 ordinary shares and 8,050,000 pre-funded warrants was approximately $26.4 million, after deducting the underwriting
 discounts and commissions and the
estimated offering expenses.
 
On
February 11, 2022, the Company entered into an Open Market Sale AgreementSM with Jefferies LLC (“Jefferies”),
to offer and sell from time to time its ordinary shares, NIS 0.01
par value, having an aggregate offering price of up to $50.0 million
(the “ATM Facility”). From February 11, 2022 through March 10, 2023, no shares were sold under the ATM
Facility.
 
In
February 2022, the 615,366 shares that were classified as redeemable shares in 2021 were no longer subject to redemption and were classified
as shareholders’ equity.
 
 
c.
Warrants
 
There
were no outstanding warrants as of December 31, 2022:
 
 
 
 
   
 
   
Weighted
 
 
 
 
   
Weighted
   
Average
 
 
 
 
   
Average
   
Remaining
 
 
 
 
   
Exercise
   
Contractual Life
 
 
 
Warrants
   
Price
   
(in years)
 
Outstanding as of December 31, 2020
 
 
15,726,378   
$
2.38   
 
                
Exercised
 
 
(11,523,997)  
 
1.57   
 
  
Expired
 
 
(1,250,000)  
 
7.50   
 
  
Outstanding as of December 31, 2021
 
 
2,952,381   
 
3.00   
 
  
Expired
 
 
(2,952,381)  
 
3.00   
 
  
Outstanding as of December 31, 2022
 
 
-   
 
-   
 
- 
Exercisable as of December 31, 2022
 
 
-  
 
-   
 
- 
 
During
the years ended December 31, 2022 and 2021, no additional warrants were issued.
 
F-20

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
9 – SHARE CAPITAL: (continued):
 
 
d.
Pre-funded
Warrants
 
In
April 2021, the Company issued 8,050,000 pre-funded warrants in lieu of ordinary shares in an underwritten public offering at a price
per share of $1.89. The pre-funded warrants
are exercisable for $0.01 per share and have no expiration date. As of December 31, 2022,
none of the pre-funded warrants have been exercised.
 
 
e.
Stock-Based
Compensation
 
In
February 2000, the Company’s Board of Directors approved an option plan (the “Plan”) as amended through 2008. Under
the Plan, the Company reserved up to 1,423,606 Ordinary
Shares of NIS 0.01 par value of the Company for allocation to employees and non-employees.
Each option provides the holder the right to exercise such option and acquire one
Ordinary Share per option. Any option granted under
the Plan that is not exercised within ten years from the date upon which it becomes exercisable, will expire.
 
In
April 2011, the Company’s board of directors approved a new option plan (the “New Plan”). Under the New Plan, the Company
reserved up to 766,958 Ordinary Shares (of which
159,458 Ordinary Shares shall be taken from the unallocated pool reserved under the
Plan) for allocation to employees and non-employees. Any option which was granted under the
New Plan and was not exercised within twenty
years from the date when it becomes exercisable, will expire.
 
In
September 2014, the Company’s shareholders approved the adoption of the Employee Share Ownership and Option Plan (2014) (“2014
Plan”) effective as of the closing of the
public offering. Under the 2014 Plan, the Company reserved up to 928,000 Ordinary Shares
(of which 28,000 Ordinary Shares shall be taken from the unallocated pool reserved under
the New Plan). The Ordinary Shares to be issued
upon exercise of the options confer the same rights as the other Ordinary Shares of the Company, immediately upon allotment. Any
option
which was granted under the 2014 Plan and was not exercised within twenty years from the date when it becomes exercisable, will expire.
 
Effective
February 13, 2022, the board of directors of VBL approved the adoption of the Inducement Plan (2022) to reserve an additional two million
(2,000,000) of VBL’s ordinary
shares, NIS 0.01 par value per ordinary share, to be exclusively for grants of awards to individuals
 who were not previously employees or non-employee directors of VBL (or
following a bona fide period of non-employment with VBL), as an
inducement material to each such individual’s entry into employment with VBL within the meaning of Rule 5635(c)
(4) of the Nasdaq
Listing Rules (Rule 5635(c)(4)). The Inducement Plan (2022) was approved by the board of directors without shareholder approval pursuant
to Nasdaq Listing Rule
5635(c)(4). The term of each option granted under this plan will be determined by the board of directors, but
no option shall be exercisable more than 10 years from the date of its
grant.
 
Option
exercise prices and vesting periods are determined by the board of directors of the Company on the date of the grant.
 
The
options are subject to the terms stipulated by section 102(b)(2) of the Ordinance. According to these provisions, the Company will not
be allowed to claim as an expense for tax
purposes the amounts credited to the employees as a capital gain benefit in respect of the
options granted.
 
Options
granted to related parties or non-employees of the Company are governed by Section 3(i) of the Ordinance. The Company will be allowed
to claim as an expense for tax
purposes the amounts equal to the expenses it recorded in the financial statements in the year in which
the related parties or non-employees exercised the options into shares.
 
F-21

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
The
Company recorded stock-based compensation expense in the following expense categories of its consolidated statements of comprehensive
loss for the years ended December 31,
2022 and 2021:
 
 
Year Ended December 31,
 
 
 
2022
   
2021
 
 
 
U.S. dollars in thousands
 
General and administrative
 
$
2,188   
$
1,194 
Research and development
 
 
367   
 
774 
Total
 
$
2,555   
$
1,968 
 
 
Stock
Options
 
Below
is a table summarizing the options issued and outstanding as of and for the years ended December 31, 2022 and 2021:
 
 
 
 
   
 
   
Weighted
   
 
 
 
 
 
   
Weighted
   
Average
   
Total
 
 
 
 
   
Average
   
Remaining
   
Aggregate
 
 
 
 
   
Exercise
   
Contractual
   
Intrinsic
 
 
 
Stock Options
   
Price
   
Life (in years)
   
Value
 
Outstanding at December 31, 2020
 
 
7,435,360   
$
2.52   
 
    
 
            
Granted
 
 
1,794,787   
 
2.29   
 
    
 
  
Forfeited
 
 
(65,500)  
 
3.01   
 
    
 
  
Outstanding at December 31, 2021(1)
 
 
9,164,647   
 
2.49   
 
    
 
  
Granted
 
 
1,264,189   
 
0.80   
 
    
 
  
Exercised
 
 
(388,909)  
 
0.05   
 
    
 
  
Forfeited
 
 
(3,221,311)  
 
2.34   
 
    
 
  
Outstanding at December 31, 2022 (1)
 
 
6,818,616   
 
2.07   
 
14.77   
$
0 
Exercisable as of December 31, 2022
 
 
4,735,356   
$
2.89   
 
14.62   
$
0 
 
 
(1) Excluding
RSUs of 1,700,000 and 74,001 for the years ended December 31, 2022 and 2021, respectively.
 
As
of December 31, 2022, the unrecognized compensation costs of $1.5 million will be recognized over an estimated weighted-average amortization
period of 1.8 years.
 
The
intrinsic value of stock options exercised during the years ended December 31, 2022 and 2021 was $0.09 million and $0, respectively.
 
The
weighted average grant date fair value of options granted during the year ended December 31, 2022 and 2021 was $1.49 and $1.90.
 
Key
assumptions used to estimate the fair value of the stock options granted during the years ended December 31, 2022 and 2021 included:
 
 
Year Ended December 31,
 
 
 
2022
   
2021
 
Expected term of options (years)
 
 
5.9-11   
 
11 
Expected common stock price volatility
 
 
91.22% 
 
91%
Risk-free interest rate
 
 
1.5% - 3.3%   
 
1.48%-1.64% 
Expected dividend yield
 
 
—   
 
— 
 
 
f.
Restricted
Stock Units
 
Below
is a table summarizing the restricted stock units granted and outstanding as of and for the year ended December 31, 2022 and 2021:
 
 
 
 
 
 
Weighted Average
 
 
 
 
 
 
 
 
Grant Date
 
 
 
 
Restricted Stock
 
 
 
Fair Value
 
 
 
 
Units
 
 
 
Price
 
 
 
 
    
 
  
Unvested as of December 31, 2020
 
 
102,334   
$
5.47 
Vested
 
 
(28,333)  
 
4.20 
Unvested as of December 31, 2021
 
 
74,001   
 
6.45 
Granted
 
 
1,700,000   
 
0.24 
Forfeited
 
 
(74,001)  
 
6.45 
Unvested as of December 31, 2022
 
 
1,700,000   
 
0.24 
Total unrecognized expense remaining
 
$
153,287   
 
0.24 
Weighted-average years expected to be recognized over
 
 
0.25   
 
  
 
F-22

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
10 – TAXES ON INCOME
 
a.
Measurement
of results for tax purposes
 
The
Company as a “foreign-investment company” measures its results for tax purposes in dollar based on Income Tax Regulations
(Bookkeeping Principles of Foreign Invested
Companies and of Certain Partnerships and the Determination of Their Taxable Income), 1986.
 
b.
Tax
rates
 
The
Company is taxed according to Israeli tax laws. The taxable income of the Company, other than income from Benefited Enterprises (see
c below), is subject to the regular Israeli
corporate tax rate, which is currently 23%.
 
c.
Tax
benefits under the Law for the Encouragement of Capital Investments, 1959 (the “Investment Law”)
 
Under
the Investment Law, including Amendment No. 60 to the Investment Law that was published in April 2005, by virtue of the Benefited Enterprise
program for certain of its
production facilities, the Company may be entitled to various tax benefits.
 
The
main benefit arising from such status is the reduction in tax rates on income derived from a Benefited Enterprise. The extent of such
benefits depends on the location of the
enterprise. Since the Company’s facilities are not located in “national development
zone A,” income derived from Benefited Enterprises will be tax exempt for a period of two years
and then have a reduced tax rate
for a period of up to an additional eight years.
 
The
period of tax benefits, as described above, is limited to 12 years from the beginning of the Benefited Enterprise election year (2012).
As of December 31, 2022, the period of
benefits has not yet commenced.
 
In
the event of distribution or deemed distribution of dividends from income, which was tax exempt as above, the amount distributed will
be subject to the tax rate it was exempted
from.
 
The
Company is entitled to claim accelerated depreciation in respect of equipment used by the Benefited Enterprises during five tax years.
 
Entitlement
to the above benefits is conditioned upon the Company fulfilling the conditions stipulated by the Investment Law and regulations published
thereunder.
 
In
the event of failure to comply with these conditions, the benefits may be canceled and the Company may be required to apply the regular
tax depreciation rates and pay tax on the
income in question at the regular corporate tax rates with the addition of linkage differences
to the Israeli consumer price index and interest.
 
The
Investment Law was amended as part of the Economic Policy Law for the years 2011-2012 (the “Amendment”), which became effective
on January 1, 2011.
 
The
Amendment sets alternative benefit tracks to the ones currently in place under the provisions of the Investment Law, including a reduced
corporate tax rate. Tax rate for “Preferred
Enterprise” income of companies not located in national development zone A is
16% for fiscal year 2014 and thereafter.
 
F-23

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
10 – TAXES ON INCOME (continued):
 
The
benefits are granted to companies that qualify under criteria set forth in the Investment Law; for the most part, those criteria are
similar to the criteria that have existed in the
Investment Law prior to its amendment and the benefit period is unlimited in time. However,
in accordance with the Amendment, the classification of licensing income as Preferred
income may be subject to the issuance of a pre-ruling
by the Israel Tax Authority.
 
Additional
amendments to the Investment Law became effective in January 2017 (the “2017 Amendment”). Under
the 2017 Amendment, and provided the conditions stipulated therein
are met, income derived by Preferred Companies from
‘Preferred Technological Enterprises’ (“PTE”) (as defined in the 2017 Amendment), would be subject to
reduced corporate tax
rates of 7.5% in Development Zone “A” and 12% elsewhere, or 6% in case of a ‘Special
Preferred Technological Enterprise’ (“SPTE”) as defined in the 2017 Amendment) regardless
of the company’s
geographical location within Israel. A Preferred Company distributing dividends from income derived from its PTE or SPTE, would
subject the recipient to a 20% tax
(or lower, if so provided under an applicable tax treaty). The 2017 Amendment further provides
that, in certain circumstances, a dividend distributed to a corporate shareholder who is
not an Israeli resident for tax purposes
 would be subject to a 4% tax (if at least 90% of the shares of the distributing company are held by one or more non-Israeli resident
corporations). Such taxes would generally be withheld at source by the distributing company.
 
On
June 14, 2017, the Encouragement of Capital Investments Regulations (Preferred Technology Income and Capital Profits for a Technological
Enterprise), 2017 (the “Regulations”)
were published, which adopted Action 5 under the base erosion and profit shifting (“BEPS”)
regulations. The Regulations describe, inter alia, the mechanism used to determine the
calculation of the benefits under the PTE and
under the SPTE Regime and determine certain requirements relating to documentation of intellectual property for the purpose of the PTE.
According to these provisions, a company that complies with the terms under the PTE regime may be entitled to certain tax benefits with
respect to income generated during the
company’s regular course of business and derived from the preferred intangible asset (as
determined in the Investments Law), excluding income derived from intangible assets used for
marketing and income attributed to production
activity. In the event that intangible assets used for marketing purposes generate over 10% of the PTE’s income, the relevant portion,
calculated using a transfer pricing study, would be subject to regular corporate income tax. If such income does not exceed 10%, the
PTE will not be required to exclude the marketing
income from the PTE’s total income. The Regulations set a presumption of direct
production expenses plus 10% with respect to income related to production, which can be countered
by the results of a supporting transfer
pricing study. Tax rates applicable to such production income expenses will be similar to the tax rates under the Preferred Enterprise
regime, to
the extent such income would be considered as eligible. In order to calculate the preferred income, the PTE is required to
 take into account the income and the research and
development expenses that are attributed to each single preferred intangible asset.
Nevertheless, it should be noted that the transitional provisions allow companies to take into account
the income and research and development
expenses attributed to all of the preferred intangible assets they have. Under the Regulations, the Company’s corporate tax rate
is expected to
be between 12% to 16%.
 
Under
the transitional provisions of the Investment Law, a company is allowed to continue to enjoy the tax benefits available under the Investment
Law prior to its amendment until the
end of the period of benefits, as defined in the Investment Law.
 
In
each year during the period of benefits of its Benefited Enterprise, the Company will be able to opt for application of the Amendment,
thereby making available to itself the tax rate
described above. The Company’s election to apply the Amendment is irrevocable.
 
As
of December 31, 2022, the Company’s management decided not to adopt the application of the Amendment.
 
There
is no assurance that future taxable income of the Company will qualify as Benefited, Preferred or Preferred Technological income or that
the benefits described above will be
available to the Company in the future.
 
F-24

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
10 – TAXES ON INCOME (continued):
 
d.
Losses
for tax purposes carried forward to future years
 
The
balance of carry forward losses of the Company as of December 31, 2022 is $250.5 million. Under Israeli tax laws, carryforward tax losses
have no expiration date.
 
Deferred
tax assets on losses for tax purposes carried forward to subsequent years are recognized if utilization of the related tax benefit against
a future taxable income is expected.
 
As
the achievement of required future taxable income is not likely, the Company recorded a full valuation allowance.
 
e.
Tax
assessments
 
The
Company has tax assessments that are considered to be final through tax year 2017.
 
f.
Deferred
Taxes
 
The
following table presents summary of information concerning the Company’s deferred taxes as of December 31, 2022 and December 31,
2021.
 
December
31
 
 
 
2022
   
2021
 
 
 
 
U.S. dollars
 
 
 
 
in thousands
 
In respect of:
 
 
    
 
  
Net operating loss carry forwards
 
 
57,618   
 
51,070 
Research and development expenses
 
 
4,710   
 
4,310 
Other timing differences
 
 
586   
 
309 
Less – valuation allowance
 
 
(62,914)  
 
(55,690)
Net deferred tax assets
 
 
-   
 
- 
 
Deferred
taxes are computed using the tax rates expected to be in effect when those differences reverse.
 
The
changes in valuation allowance are comprised as follows:
 
 
Year ended December 31,
 
 
 
2022
   
2021
 
 
 
(U.S. dollars in thousands)
 
Balance at the beginning of year
 
$
55,690   
$
49,172 
Additions during the year
 
 
7,224   
 
6,158 
Balance at end of year
 
$
62,914   
$
55,690 
 
Losses
for tax purposes carried forward to future years:
 
The
main reconciling item between the statutory tax rate of the Company and the effective rate is the provision for a full valuation allowance
in respect of tax benefits from carry
forward tax losses due to the uncertainty of the realization of such tax benefits and the Company’s
three year cumulative loss position (see above).
 
F-25

 
 
VASCULAR
BIOGENICS LTD.
NOTES
TO THE FINANCIAL STATEMENTS (continued)
 
NOTE
11 – SUPPLEMENTARY FINANCIAL INFORMATION:
 
 
December 31
 
 
 
2022
   
2021
 
 
 
U.S. dollars in thousands
 
a. Other current assets:
 
 
    
 
  
Institutions - VAT
 
$
102   
$
280 
Prepaid expenses
 
 
954   
 
1,217 
Government grants receivable
 
 
-   
 
185 
Other
 
 
14   
 
15 
 
$
1,070   
$
1,697 
 
 
 
    
 
  
b. Accounts payable-other:
 
 
    
 
  
 
 
 
    
 
  
Accrued expenses
 
$
2,925   
$
3,611 
Employee-related accrued expenses(1)
 
 
2,209   
 
489 
Provision for vacation
 
 
225   
 
308 
 
$
5,359   
$
4,408 
 
 
(1) Includes
$1.9 million of severance provision for remaining employee terminations.
 
NOTE
12 – LOSS PER SHARE:
 
Basic
and diluted loss per share:
 
Basic
 
Basic
loss per share is calculated by dividing the result attributable to equity holders of the Company by the weighted average number of Ordinary
Shares in issue during the year.
 
Diluted
 
All
Ordinary Shares underlying outstanding options, RSU’s and warrants have been excluded from the calculation of the diluted loss
per share for the years ended December 31, 2022
and 2021 since their effect was anti-dilutive. The following potentially dilutive securities
outstanding for the year ended December 31, 2022 and 2021 have been excluded from the
computation of diluted weighted average shares
outstanding, as they would be anti-dilutive:
 
 
 
As of December 31,
 
 
 
2022
   
2021
 
Common stock purchase options
 
 
6,818,616   
 
9,164,647 
Restricted stock units
 
 
1,700,000   
 
74,001 
Common stock purchase warrants
 
 
-   
 
2,952,381 
 
 
8,518,616   
 
12,191,029 
 
 
 
 
Year ended December 31
 
 
 
2022
   
2021
 
 
 
 
   
 
 
Basic and diluted:
 
 
    
 
  
Loss attributable to equity holders of the Company
 
$
32,304   
$
29,920 
 
 
 
    
 
  
Weighted average number of ordinary shares in issue
 
 
77,554,740   
 
66,346,506 
 
 
 
    
 
  
Loss per ordinary share
 
$
0.42   
$
0.45 
 
NOTE
13 – SUBSEQUENT EVENTS:
 
a.
On February
15, 2023, VBL entered into an Asset Purchase Agreement which closed on March 9, 2023. For more details see Note 1.
 
 
b.
On February 22, 2023, VBL
entered into Merger Agreement with Notable and Vibrant Merger Sub, Inc., a Delaware corporation and VBL’s direct, wholly-owned
subsidiary
(“Merger Sub”). For more details see Note 1.
 
F-26

 
 
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.
 
 
VASCULAR
BIOGENICS LTD.
 
 
 
Date:
March 14, 2023
By: /s/
Dror Harats
 
 
Dror
Harats
 
 
Chief
Executive Officer
 
POWER
OF ATTORNEY
 
KNOW
ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Dror Harats and Sam Backenroth,
and each of them,
as his or her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him
or her and in his or her name, place and stead, in any and all
capacities, to sign any and all amendments to this annual report on Form
10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the
Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every
act and thing
requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might or
could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents, or any of them, or their or his substitutes,
may lawfully do or cause to be done by virtue thereof.
 
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 capacities
and on the dates indicated.
 
Name
 
Title
 
Date
 
 
 
 
 
/s/
Dror Harats
 
Chief
Executive Officer and Director
 
March 14, 2023
Dror
Harats
 
 
 
 
 
 
 
 
 
/s/
Sam Backenroth
 
Chief
Financial Officer
 
March 14, 2023
Sam
Backenroth
 
(Principal
Financial Officer and Principal Accounting Officer)
 
 
 
 
 
 
 
/s/
Marc Kozin
 
Chairman
of the Board of Directors
 
March 14, 2023
Marc
Kozin
 
 
 
 
 
 
 
 
 
/s/
Ruth Alon
 
Director
 
March 14, 2023
Ruth
Alon
 
 
 
 
 
 
 
 
 
/s/
Shmuel Ben Zvi
 
Director
 
March 14, 2023
Shmuel
Ben Zvi
 
 
 
 
 
 
 
 
 
/s/
David Hastings
 
Director
 
March 14, 2023
David
Hastings
 
 
 
 
 
 
 
 
 
/s/
Michael Rice
 
Director
 
March 14, 2023
Michael
Rice
 
 
 
 
 
75

 
Exhibit
2.2
 
ASSET
PURCHASE AGREEMENT
 
by
and between
 
ALEPH
FARMS LTD.
 
and
 
VASCULAR
BIOGENICS LTD.
 
Dated
as of February 15, 2023
 
 
 
-1-

 
 
This
ASSET PURCHASE AGREEMENT (this “Agreement”), dated as of February 15, 2023, by and between Vascular Biogenics
Ltd. an Israeli company (“Seller”), with its
registered offices at 8 Hasatat Street, Modi’in, Israel and Aleph
Farms Ltd., an Israeli company (“Buyer”), with its registered offices at 1 Haim Holtzman Street Rehovot 7670401,
Israel.
The Seller and the Buyer may be individually referred to as a “Party” and collectively as the “Parties”.
 
W
I T N E S S E TH:
 
Whereas,
the
Seller leases and has made adaptations and improvements in the Facility (defined below);
and
 
Whereas,
Seller
wishes to discontinue its operations at the Facility; and
 
 
Whereas,
subject
to the terms and conditions set forth herein, Seller desires to sell and assign to Buyer
and Buyer desires to purchase from Seller, all of the Purchased Assets and to
assume the
Assumed Liabilities all as hereinafter set forth (collectively, the “Transactions”);
 
NOW,
THEREFORE, in consideration of the premises and of the mutual covenants of the Parties, it is hereby agreed as follows:
 
For
purposes of this Agreement:
 
“Additional
Equipment” – has the meaning set forth in Section 6.
 
“Affiliate”
means, with respect to any Person, any other Person directly or indirectly controlling, controlled by, or under direct or indirect common
control with, such Person. For the
purposes of this definition, “control,” when used with respect to any Person, means the
power to direct the management and policies of such Person, directly or indirectly, whether
through the ownership of voting securities,
by contract or otherwise; and the terms “controlling” and “controlled” have meanings correlative
of the foregoing.
 
“Agreement”
has the meaning set forth in the recitals.
 
“As-Is
Basis” means the present condition of the Facility as of the Closing Date.
 
“Assumed
Liabilities” has the meaning set forth in Section 3.
 
“Bioreactors”
means the 50L, 250L and 1000L single use bioreactors their controllers, and any related items specified in Export License D1127676, dated
May 22, 2018 acquired by
the Seller from Thermo Fisher/Finesse Solutions Inc.
 
“Business
Day” means any day other than (a) a Friday, Saturday or Sunday or (b) a day on which banking institutions located in Israel
are permitted or required by applicable Law or
governmental decree, to remain closed.
 
 
 
-2-

 
 
“Buyer
Indemnified Person” has the meaning set forth in Section 8.1.
 
“Closing”
means the consummation of the Transactions.
 
“Closing
Date” means March 9, 2023.
 
“Excluded
Liabilities” has the meaning set forth in Section 3.
 
“Facility”
means the manufacturing facility constructed on the Real Property by the Landlord and/or the Seller, including the building and permanently
attached fixtures located
thereon. Unless specifically stated otherwise, all references to the Facility hereunder shall not be deemed
to include the Real Property.
 
“Governmental
 Entity” means any Israeli or any authorized state, provincial or local or municipal government, administrative authority, governmental
 department, agency,
commission, bureau, official, minister, court, board, tribunal or body exercising executive, legislative, judicial,
regulatory or administrative functions of any such government, and any
supranational organization of sovereign states exercising such
functions for such sovereign states.
 
“Knowledge”
means the actual knowledge of any of the officers or directors of the applicable Party after reasonable enquiry.
 
“Law(s)”
means any statutes, ordinances, regulations, rules, standards, codes, orders, writs, injunctions, decrees, arbitration award, agency
or regulatory requirements or license or
permits of any kind whatsoever of any Governmental Entity, all as amended from time to time.
 
“Landlord”
means P.S.D Investment Ltd. and or Mr. Shalom Darwish.
 
“Lien”
means, with respect to the rights of the Seller to any Purchased Asset, any lien, pledge, charge, debt, security interest, option, charge,
claim, equitable interest, encumbrance,
attachment, assignment, hypothecation, right of first refusal or preemption, option, right to
acquire, any other encumbrance or Third Party right, restriction on transfer, of any kind or
nature whatsoever with respect to any Purchased
Asset (other than restrictions imposed by any Law).
 
“Party”
or “Parties” has the meaning set forth in the recitals.
 
“Person”
means an individual, corporation, partnership, limited liability company, association, trust, unincorporated organization, or other legal
entity including any Governmental
Entity.
 
“Purchased
Assets “– has the meaning set forth in Section 1.
 
“Purchase
Price” means the full consideration that is due to the Seller for the Purchased Assets hereunder, being the amount of US$ 6,000,000
in consideration for assignment of the
right to lease the Facility and US$ 1,100,000 as consideration for the Purchased Assets.
 
 
 
-3-

 
 
“Seller
Indemnified Person” has the meaning set forth in Section 8.2.
 
“Real
Property” means the property located at 8 Hasatat Street, Modi’in, on which the Facility is located, which is leased
to VBL under the VBL Lease Agreement.
 
“Third
Party” means any Person other than the Seller, the Buyer or their respective Affiliates.
 
“Transactions”
has the meaning set forth in the recitals.
 
“US
Government Approval” means the issuance of a license, by the US Department of Commerce, Bureau of Industry & Security,
authorizing the in-country transfer, from the Seller
to the Buyer, of the items specified in Export License D1127676, dated May 22, 2018.
 
“VBL
Lease Agreement” means the Lease Agreement dated October 16, 2016 between the Landlord and the Seller, as amended.
 
“VBL
Lease Assignment Agreement” means an agreement between the Landlord and VBL, allowing the assignment of the VBL Lease Agreement
to Buyer pursuant to Section 1, or
a de-novo direct lease agreement in respect of the Facility, to be entered into by the Buyer
and the Landlord directly, in either case a copy of which is attached as Exhibit A.
 
1.
THE
PURCHASED ASSETS
 
Upon
the terms and subject to the conditions contained in this Agreement, at the Closing, the Seller shall sell, convey, transfer, assign
and deliver to Buyer and Buyer shall
acquire, assume and accept from Seller free and clear of any Lien and third-party rights, all of
Seller’s right, title and interest in and to all of the following properties, assets
and rights:
 
(a)
the
assignment of the right to lease the Facility; and
 
(b)
the
tangible assets and equipment located at the Facility, as listed on Schedule
1.1(b) (the “Purchased Assets”);
 
(Sub-section
(a) and (b) shall be collectively referred to as the “Purchased Assets”).
 
2.
CONVEYANCE
AND TRANSFER
 
2.1
At
the Closing, Seller shall assign to Buyer the VBL Lease Agreement, and transfer possession
of the Facility to the Buyer on an As-Is Basis and the Buyer shall
accept possession thereof.
 
2.2
At
the Closing, the Seller shall further sell, assign, and deliver to Buyer, and Buyer shall
accept possession and purchase from Seller, free and clear of any Liens, all
of Seller’s
right, title and interest in the Purchased Assets, which shall be delivered to Buyer in the
form and order in which they are maintained by Seller on the date
hereof, other than the
Bioreactors, whose transfer shall be subject to receipt of US Government Approval.
 
 
 
-4-

 
 
3.
ASSUMED
LIABILITIES
 
At
the Closing Date, Buyer will be granted all contractual rights relating to the Facility and the Purchased Assets from Seller, free and
clear of any Lien. Subject to the
aforesaid, Buyer shall assume and discharge Seller from all liabilities and obligations relating to
the Facility and included in the VBL Lease Agreement (the “Assumed
Liabilities”) as of the Closing Date.. Obligations
 of VBL under the VBL Lease Agreement, preceding the Closing Date shall not be deemed Assumed Liabilities. All
liabilities and obligations
which are not Assumed Liabilities are “Excluded Liabilities” and each is an “Excluded Liability.”
 
4.
CLOSING;
PAYMENT OF PURCHASE PRICE.
 
4.1
The
Closing.
 
The
Closing shall take place on March 9, 2023.
 
4.2
Closing
Deliveries by Seller.
 
4.2.1
At
 the Closing, Seller shall deliver, or cause to be
delivered, to Buyer the following:
 
(A)
a
certification, dated as of the Closing Date, by a proper officer of Seller that certifies
that the resolution of the board of directors of Seller (in such
form reasonably satisfactory
 to Buyer) authorizing the execution, delivery and performance of this Agreement and the performance
 of the
Transaction are contemplated hereby, has not been amended, modified or rescinded,
and that such resolution remain in full force and effect;
 
(B)
a
certification, dated as of the Closing Date, by a proper officer of Seller that certifies
that each of the representations and warranties set forth in
‎Section 7.1 are true and
correct in all respects on the Closing Date; and
 
(c)
the
final and fully executed copy of the VBL Lease Assignment Agreement. Alternatively, a de-novo
direct lease Agreement that shall be entered by
and between Buyer and Landlord (fully signed
by both parties thereto) shall serve as a pre-condition for Closing.
 
4.2.2
At
 the Closing, Buyer shall deliver, or cause to be
delivered, to Seller the following:
 
(A)
a
certification, dated as of the Closing Date, by a proper officer of Buyer that certifies
that the resolution of the board of directors of Buyer (in such
form reasonably satisfactory
to Seller) authorizing the execution, delivery and performance of this Agreement and the
performance of the Transaction
are contemplated hereby, has not been amended, modified or
rescinded, and that such resolution remain in full force and effect;
 
 
 
-5-

 
  
(B)
a
certification, dated as of the Closing Date, by a proper officer of Buyer that certifies
that each of the representations and warranties set forth in
‎Section 6.2 are true and
correct in all respects on the Closing Date; and
 
(C)
confirmation
of the transfer of the payment on account of the Purchase Price set forth in Section 5.1
below to the Seller’s bank account.
 
4.3
Simultaneous
Transactions.
 
All
transactions occurring at the Closing shall be deemed to take place simultaneously and no transaction shall be deemed to have been completed
and no document
or certificate shall be deemed to have been delivered until all transactions are completed and all documents delivered.
 
5.
PURCHASE
PRICE AND PAYMENT; VAT; WITHHOLDING TAX
 
5.1
As
consideration for the transfer to Buyer of the Facility and the Purchased Assets, and following
receipt of an invoice for payment, the Buyer shall: (i) pay to
Seller’s bank account
 an aggregate amount equal to US$ 7,100,000, in immediately available funds (the “Purchase
Amount”), as follows: US$6,000,000 in
consideration for assignment of the right
to lease the Facility and the Purchased Assets; and US$ 1,100,000 as consideration for the
Purchased Assets; and (ii) assume
the Assumed Liabilities in accordance with the terms and
conditions of this Agreement.
 
5.2
The
Purchase Amount shall be accompanied by VAT against Seller’s tax invoice, to the extent
required by Law.
 
5.3
Seller
has provided Buyer with a tax exemption certificate prior to Closing and therefore Buyer
shall not deduct any amounts from the Purchase Price.
 
6.
OTHER
EQUIPMENT
 
6.1
It
is hereby agreed that Seller can use a certain pre-defined locked space in the Facility,
for storing Seller’s equipment detailed in Schedule 6.1 (the “Additional
Equipment”) and the Bioreactors for a period of 3 months and no later than May
31, 2023, except that if US Approval for Bioreactors is not obtained prior to May
31, 2023
– the parties will mutually consider an extension, or earlier if requested by Seller
(“Storage Period”). During the Storage Period, Seller shall be permitted
access to the Additional Equipment, for the purpose of selling it to third parties, subject
to in-advance accommodation of such access with Buyer, in a reasonable and
timely manner.
Buyer undertakes to ensure that only Seller shall have access to the Additional Equipment.
Upon completion of the Storage Period – Buyer shall be
entitled to evacuate the Additional
Equipment from the Facility and/or to do with it as it deems fit, provided however that Buyer
provided Seller with a 10 day prior
written notice and enabled Seller to evacuate the Additional
Equipment from the Facility. For the avoidance of doubt, other than as set forth herein,
Buyer assumes no
responsibility, whatsoever, in respect of the Additional Equipment and/or
the Bioreactors, and shall not be liable for any outcome of the storage thereof, including
(without limitations) any damage, loss, wear and tear, or any Assumed Liability in respect
thereof, and Seller shall adequately insure the Additional Equipment and
the Bioreactors
during the Storage Period.
 
 
 
-6-

 
 
7.
REPRESENTATIONS
AND WARRANTIES.
 
7.1
Representations
and Warranties of Seller.
 
Seller
represents and warrants to Buyer as follows:
 
7.1.1
Due
Organization; Power; Capacity; Good Standing; Ownership.
 
Seller
is a corporation duly organized, validly existing, and in good standing under the laws of Israel and has the requisite corporate power
and authority to
own, lease and operate its properties and assets and to conduct its business as now conducted by it. Seller has all
requisite corporate and other power and
authority to enter into this Agreement and to perform Seller’s obligations hereunder and
thereunder.
 
7.1.2
Authorization
and Validity.
 
The
execution, delivery and performance by Seller of this Agreement and the consummation by Seller of the Transactions have been duly authorized
by all
necessary corporate action. This Agreement has been duly executed and delivered by Seller and this Agreement constitutes a legal,
 valid and binding
obligation of Seller, enforceable against Seller in accordance with its terms, except as affected by bankruptcy, insolvency,
reorganization, moratorium and
other similar laws relating to or affecting creditors’ rights generally.
 
7.1.3
The
Purchased assets; Condition of the Facility and Title to and Condition of the Purchased Assets.
 
Seller
has, and Buyer upon the Closing shall receive, good and marketable title to all of the Purchased Assets, free and clear of all Liens.
The Facility and all
Purchased Assets are on an As Is Basis, subject to Seller’s representations hereof, and suitable for use ,
and conform to all applicable Laws.
 
7.1.4
Leasehold
Interests in the Facility.
 
The
Seller has a good and valid leasehold interest in the Facility. Seller has heretofore furnished to Buyer a true and complete copy of
the VBL Lease
Agreement and the VBL Lease Assignment Agreement and all amendments thereto.
 
 
 
-7-

 
 
Seller
hereby warrants and declares that:
 
(a)
There
are no condemnation proceedings or other proceedings of any kind pending or, to the Knowledge
of the Seller, threatened against the Facility
or against the Seller in respect of its lease
in the Facility.
 
(b)
All
improvements on the Facility constructed by or on behalf of Seller or any other Person were
constructed in compliance with all applicable
Laws.
 
(c)
The
VBL Lease Agreement is valid and binding and in full force and effect, and there are no threatened
or known claims against VBL in respect of
its lease or use of the Facility.
 
(d)
The
rental set forth in the VBL Lease Agreement is the actual rental being paid, and there are
no separate agreements or understandings with
respect to the same.
 
7.1.5
Legal
Proceedings.
 
There
is no litigation, proceeding or, no governmental investigation to which Seller is a party pending, or to Seller’s Knowledge, threatened
against Seller
relating to the Facility, the Purchased Assets, the Assumed Liabilities, or which seeks to restrain or enjoin the consummation
of any of the Transactions
contemplated hereby. Seller is not in violation of any term of any judgment, writ, decree, injunction or order
entered by any court or Governmental Entity
(domestic or foreign) and outstanding against Seller or with respect to the Facility or any
of the Purchased Assets.
 
7.1.6
Insurance.
 
The
properties and assets of Seller which are of an insurable character and are used or useful in the Facility and the operation of the Facility
are insured
pursuant to the policies listed in Schedule 7.1.6. The coverage
under each such policy is in full force and effect, until and including the Closing, at which
time they shall expire. No notice cancellation
or nonrenewal with respect to any such policy has been received by Seller.
 
7.1.7
Brokers’
Fees.
 
Neither
Seller nor any of Seller’s respective officers, directors or employees or Affiliates, on behalf of Seller, has employed any broker
or finder or incurred
any other liability for any brokerage fees, commissions or finder’s fees in connection with the Transactions.
 
 
 
-8-

 
 
7.2
Representations
and Warranties of Buyer.
 
Buyer
represents and warrants to Seller as follows:
 
7.2.1
Due
Organization and Power.
 
Buyer
is a corporation duly organized and validly existing and in good standing under the laws of Israel. Buyer has all requisite corporate
and other power
and authority to enter into this Agreement and to perform its obligations hereunder.
 
7.2.2
Authorization
and Validity.
 
The
execution, delivery and performance by Buyer of this Agreement and the consummation by Buyer of the Transactions have been duly authorized
by all
necessary corporate action. This Agreement has been duly executed and delivered by Buyer and this Agreement constitutes, a legal,
valid and binding
obligation of Buyer, enforceable against Buyer in accordance with its terms, except as affected by bankruptcy, insolvency,
reorganization, moratorium and
other similar laws relating to or affecting creditors’ rights generally.
 
7.2.3
Inspection
of Facility.
 
Buyer
 has made prior to the Closing Date its own inspection and investigation of the Facility and surrounding area, including, without limitation,
 its
subsurface, soil, engineering and other conditions and requirements, and all zoning and regulatory matters pertinent to the Facility
and to the present use or
occupancy of the Facility. Buyer is entering into this Agreement and purchasing the Purchased Assets based
upon its own inspection and investigation and
not in reliance on any statement, representation, inducement or agreement of Seller except
as specifically provided herein. Buyer acknowledges that neither
Seller nor anyone acting on behalf of Seller has made any representation,
guarantee or warranty whatsoever, either written or oral, concerning the Facility
except as specifically set forth herein.
 
7.2.4
Brokers’
Fees.
 
Neither
Buyer nor any of its officers, directors or employees or Affiliates, on behalf of Buyer, has employed any broker or finder or incurred
any other
liability for any brokerage fees, commissions or finders’ fees in connection with the Transactions.
 
7.2.5
Availability
of Funds.
 
Buyer
has available sufficient funds to enable it to consummate the transactions contemplated herein and to pay the total Purchase Price at
the Closing.
 
7.3
Survival
of Representations.
 
The
representations and warranties contained in Sections ‎7.1 and 7.2 of this Agreement shall survive the Closing and until one (1) year
after the Closing
Date, at which time they shall terminate.
 
 
 
-9-

 
 
8.
AGREEMENTS.
 
8.1
Confidentiality,
No Trading.
 
8.1.1
Each
Party shall not, and shall cause its representatives to not, disclose the existence and terms
of this Agreement to any Third Party (other than a Party’s
representatives who have
a need to know and who are subject to written confidentiality obligations or, with respect
to tax advisors and legal counsel only,
confidentiality obligations under applicable Law
and professional conduct standards no less restrictive than those set forth herein) without
the other Party’s
prior consent.
 
8.1.2
Neither
 Buyer nor
 any of its Affiliates, respective security holders,
 officers, directors, employees, agents or representatives shall use any non-public
information of Seller which it has received hereunder to purchase, sell, make any short sale
of, loan, grant any option for the purchase of, or otherwise
transfer, dispose of any securities
of Seller.
 
8.2
Further
Actions.
 
8.2.1
Seller
and Buyer agree to use their reasonable efforts to take, or cause to be taken, all action
and to do, or cause to be done, all things necessary, proper or
advisable to consummate and
 make effective the Transaction, including using its reasonable efforts (without payment of
 money, commencement of
litigation, the assumption of any material obligation or the entering
of any agreement to divest or hold separate any assets) (i) to furnish to each
other such
information and assistance as reasonably may be requested in connection with the
foregoing; and (ii) to assist Buyer at Buyer’s sole expense, as reasonably
requested by Buyer, in obtaining all Licenses as are necessary in order to enable Buyer to
operate the Facility in the ordinary course of business.
 
8.2.2
The
office space designated as “Future Area” and the R&D Lab, both as more fully
specified and marked on the script attached hereto as Schedule
8.2.2
(jointly and severally, the “VBL Space”),
will be vacated on or prior to May 31, 2023. Until the time of evacuation, Seller shall pay
Buyer an amount of
20,000 NIS plus VAT on a monthly basis, at the beginning of each calendar
month, for covering the expenses and taxes related to the VBL Space It is hereby
acknowledged
that, as between the Parties hereto, VBL shall assume any and all legal liability, of whatever
kind or nature, in respect of the Additional
Equipment and Bioreactors stored at the Facility
pursuant to Section 6.1 and/or in respect of any VBL employee, agent, or representative entering
the
Facility prior to the above-mentioned date of evacuation and/or using the VBL Space in
accordance with the aforesaid. To such extent, VBL shall secure
adequate insurance and shall
hold the Company harmless and indemnify it against any claim cost or demand, in accordance
 with the indemnification
provisions set forth in Section 9.1 below.
 
 
 
-10-

 
 
8.2.3
Notwithstanding
anything to the contrary that may be inferred from any other provision of this Agreement,
transfer of possession and ownership of the
Bioreactors to Buyer is subject to the US Government
Approval. Therefore, until such US Government Approval will be obtained, the Parties hereby
agree
that the Bioreactors will remain in the locked storage space at the Facility, as set
forth in Section 6.1 above, that Buyer will not have access to, and Buyer
hereby warrants
and undertakes that it will not take possession of, access or use the Bioreactors, provided
however, if by July 31 2023 the US Government
Approval is not obtained Seller will be responsible
to evacuate the Bioreactors’ controller unit from the Facility and shall assume all
liability in respect to
the Bioreactors’ controller unit, and the parties shall endeavor
to reach a mutual solution in respect thereto.
 
8.2.4
Except
for the VBL Space and the Additional Equipment, which shall be vacated on May 31, 2023, as
aforesaid, Seller shall vacate and cease to occupy the
Facility as of the Closing Date and
shall surrender possession of the Facility to Buyer as of the close of business on the Closing
Date.
 
9.
INDEMNIFICATION.
 
9.1
Seller’s
Indemnity.
 
Seller
agrees to indemnify and hold harmless Buyer, its Affiliates, each of their respective directors, officers, employees and agents and each
of the heirs, executors,
successors and assigns of any of the foregoing (collectively, “Buyer Indemnified Persons”
and each a “Buyer Indemnified Person”) from and against any claim,
cost, loss, liability or damage directly incurred
or sustained by any Buyer Indemnified Person as a result of: (i) Excluded Liabilities ; (ii) any misrepresentation
or
breach of warranty by Seller or a breach by Seller of any covenant or other agreement contained herein; and (iii) any
and all liabilities for sales, use, income and other
taxes that relate to the Purchased Assets arising prior to the Closing Date (iv)
 all reasonable costs and expenses (including reasonable attorneys’ fees and
disbursements) incurred by any Buyer Indemnified
Person in connection with any action, suit, proceeding, demand, assessment or judgment incident to any of the
matters indemnified against
 in this Section 9.1. All amounts payable by the Seller to a Buyer Indemnified Person hereunder shall be limited to $300,000 (the
“Indemnification Amount”).
 
9.2
Buyer
Indemnity.
Buyer
agrees to indemnify and hold harmless Seller and its Affiliates, each of their respective directors, officers, employees and agents,
and each of the heirs,
executors, successors and assigns of any of the foregoing (collectively, the “Seller Indemnified Persons”
and each a “Seller Indemnified Person”) from and against
(i) any claim, cost, loss, liability or damage
directly incurred or sustained by any Seller Indemnified Person as a result of any misrepresentation or breach of warranty
by Buyer or
 a breach by Buyer of any covenant or other agreement contained herein, or under any other agreement executed and delivered by the Parties
 in
furtherance of the Transactions, (ii) any claim, cost, loss, liability or damage incurred or sustained by any Seller
Indemnified Person as a result of the operation of the
Facility or the use of the Purchased Assets by Buyer or any other Third Party
following the Closing Date, (iii) any claim, cost, loss, liability or damage incurred or
sustained by any Assumed Liability,
and (iv) all reasonable costs and expenses (including reasonable attorneys’ fees and disbursements) incurred by any
Seller
Indemnified Person in connection with any action, suit, proceeding, demand, assessment or judgment incident to any of the matters
indemnified against in this
Section 9.2. All amounts payable by the Seller to a Buyer Indemnified Person hereunder shall be limited
to the Indemnification Amount.
 
 
 
-11-

 
 
9.3
Third
Party Claims.
 
If
a claim by a Third Party against an indemnified Person hereunder, and if such indemnified Person intends to seek indemnity with respect
thereto under this Article,
such indemnified Person shall promptly notify the indemnifying Person in writing of such claims setting forth
such claim in reasonable detail, provided that failure of
such indemnified Person to give prompt notice as provided herein shall not
relieve the indemnifying Person of any of its obligations hereunder, except to the extent
that the indemnifying Person is materially
prejudiced by such failure. With respect to any such claim relating solely to the payment of monetary damages and which
will not result
in the indemnified Person’s becoming subject to injunctive or other equitable relief and as to which the indemnifying Person shall
have acknowledged
in writing its obligations to indemnify the indemnified Person hereunder, the indemnifying Person shall have twenty
 (20) days after receipt of such notice to
undertake, through counsel of its own choosing, subject to the reasonable approval of such
indemnified Person, and at its own expense, the settlement or defense
thereof, and the indemnified Person shall cooperate with it in
 connection therewith; provided, however, that the indemnified Person may participate in such
settlement or defense through counsel chosen
by such indemnified Person, provided that the fees and expenses of such counsel shall be borne by such indemnified
Person. If the indemnifying
Person shall assume the defense of a claim, the indemnifying Person shall not settle or compromise such claim without the prior written
consent of the indemnified Person, which consent shall not be unreasonably withheld, unless: (i) such settlement or compromise
includes as an unconditional term
thereof the giving by the claimant of a release of the indemnified Person from all liability with respect
to such claim, or (ii) such settlement or compromise involves
the imposition of equitable remedies or the imposition of
any material obligations on such indemnified Person, the indemnified Person will be indemnified hereunder.
If the indemnifying Person
 shall assume the defense of a claim, the fees of any separate counsel retained by the indemnified Person shall be borne by such
indemnified
Person unless there exists a conflict between them as to their respective legal defenses in accordance with advice of legal counsel (other
than one that is
of a monetary nature), in which case the indemnified Person shall be entitled to retain separate counsel, the reasonable
 fees and expenses of which shall be
reimbursed by the indemnifying Person. If the indemnifying Person does not notify the indemnified
 Person within twenty (20) days after the receipt of the
indemnified Person’s notice of a claim or indemnity hereunder that it elects
to undertake the defense thereof and acknowledges its obligations to indemnify the
indemnified Person hereunder, the indemnified Person
shall (upon delivering notice to such effect to the indemnifying Person) have the right to contest, settle or
compromise the claim; provided,
however, that such claim shall not be compromised or settled without the written consent of the indemnifying Person, which
consent shall
not be unreasonably withheld.
 
 
 
-12-

 
 
9.4
Additional
Agreements.
 
9.4.1
The
obligations to indemnify and hold harmless a Person hereunder, pursuant to Sections ‎8.1
and ‎8.2 with respect to any misrepresentation or breach of
warranty contained
in this Agreement shall terminate when the applicable representation or warranty terminates
in accordance with Section ‎6.3; provided,
however, that such obligation
to indemnify and hold harmless shall not terminate with respect to any item as to which the
Person to be indemnified shall
have, before the expiration of the applicable period, previously
made a claim by delivering a notice (stating in reasonable detail the basis of such claim)
to
the indemnifying Person.
 
9.4.2
No
monetary amount shall be payable by Seller to any Buyer Indemnified Person or by Buyer to
 any Seller Indemnified Person, with respect to the
indemnification of any claims under Section
8.1 or Section 8.2 in excess of the Indemnification Amount.
 
9.4.3
Notwithstanding
 the foregoing, nothing in this Section 8.4 shall limit the rights of an Indemnified
 Party with respect to intentional or willful
misrepresentation of material facts regarding
the representations and warranties made herein or in any schedule, exhibit or certificate
delivered pursuant
hereto which constitute fraud under applicable Law.
 
9.4.4
No
indemnification amount shall be payable to any indemnified Person under this Section 8
until the aggregate amount of all damages actually incurred by
all indemnified Persons
exceeds US$ 50,000 (or the equivalent thereof), following such time damages shall be paid
from the first dollar.
 
9.4.5
Notwithstanding
anything herein to the contrary, no party shall be entitled to recover any indirect, consequential,
special, exemplary, punitive or similar
damages hereunder.
 
10.
MISCELLANEOUS.
 
10.1
Public
Announcements.
 
Press
releases and other publicity concerning the Transactions shall be made only with the prior written agreement of both Parties. The Parties
shall maintain the
confidentiality of this Agreement and the Transactions contemplated thereunder, except (i) to the extent required
by applicable law, including any fillings with the
Securities and Exchange Committee, or (ii) in connection with a due diligence inquiry,
subject to customary confidentiality undertakings of the recipient.
 
 
 
-13-

 
 
10.2
Expenses.
 
Whether
or not the Transactions are completed, each of the Parties shall pay the fees and expenses incurred by it in connection with the negotiation,
preparation,
execution and performance of this Agreement, including, without limitation, attorneys’ and accountants’ fees,
and, in no event, shall any such fees and expenses of
Seller constitute “Assumed Liabilities” under this Agreement. The foregoing
shall not affect the legal right, if any, that a Party may have to recover expenses from a
Party that breaches its obligations hereunder.
 
10.3
Notices.
 
All
notices, requests, claims, demands, consents, approvals and other communications under this Agreement shall be in writing and shall be
deemed given or made
(a) as of the date delivered, if delivered personally, (b) as of the date transmitted,
if sent by email (provided that no notice is received by the electronic mail sender
indicating that such electronic mail was undeliverable
or otherwise not delivered), or (c) one (1) Business Day after being sent by a nationally recognized overnight
courier
(providing proof of delivery), to the Parties at the following addresses (or at such other address for a Party as shall be specified
by like notice):
 
If
to Seller:
 
Vascular
Biogenics Ltd.
c/o:
Prof. Dror Harats
 
With
a copy (that will not constitute notice) to:
Horn
& Co., Law Offices
Amot
Investments Tower,
2
Weizmann St., 24th Floor
Tel-Aviv
6423902, Israel.
 
Attn:
Adv. Yuval Horn
Fax:
+972-3-637-8200
Email:
yhorn@hornlaw.co.il
 
If
to the Buyer:
Aleph
Pharms Ltd.
 
Attn:
Mr. Didier Toubia, CEO and Co-Founder
Email:
 
With
copies (that will not constitute notice) to:
 
Mr.
Kevin Benmoussa, Executive VP and Global CFO.
 
Email:
 
Ms.
Galit Gilboa, External Legal Advisor
 
Email:
 
or
to such other address or to the attention of such other Person as any Party shall have specified by notice in writing to the other Party.
All such notices, requests,
demands and communications shall be deemed to have been received on the date of personal delivery or on the
third business day after the mailing thereof.
 
 
 
-14-

 
 
10.4
Entire
Agreement.
 
This
Agreement (including the Exhibits and Schedules hereto) constitutes the entire agreement between the Parties and their Affiliates with
respect to the subject
matter hereof and supersede all prior agreements and understandings, oral and written, between the Parties hereto
with respect to the subject matter hereof.
 
10.5
Binding
Effect; Benefit.
 
This
Agreement shall inure to the benefit of and be binding upon the Parties and their respective successors and assigns. Nothing in this
Agreement, expressed or
implied, is intended to confer on any Person other than the Parties or their respective successors and assigns
and any Person entitled to indemnification under Section
8.1 or 8.2, any rights, remedies, obligations or liabilities under
or by reason of this Agreement.
 
10.6
Assignability.
 
This
Agreement shall not be assignable, in whole or in part, by any Party without the prior written consent of the other Party.
 
10.7
Amendment;
Waiver.
 
This
Agreement may be amended, supplemented or otherwise modified only by a written instrument executed by the Parties. No waiver by any Party
of any of the
provisions hereof shall be effective unless explicitly set forth in writing and executed by the Party so waiving. Except
as provided in the preceding sentence, no action
taken pursuant to this Agreement, including, without limitation, any investigation by
or on behalf of any Party, shall be deemed to constitute a waiver by the Party
taking such action of compliance with any representations,
warranties, covenants, obligations or agreements contained herein, or in any documents delivered or to be
delivered pursuant to this
Agreement or in connection with the Closing hereunder. The waiver by any Party of a breach of any provision of this Agreement shall not
operate or be construed as a waiver of any subsequent breach.
 
 
 
-15-

 
 
10.8
Section
Headings.
 
The
section headings contained in this Agreement are for reference purposes only and shall not affect the meaning or interpretation of this
Agreement.
 
10.9
Severability.
 
If
 any provision of this Agreement shall be declared by any court of competent jurisdiction to be illegal, void, or unenforceable, all other
 provisions of this
Agreement shall not be affected and shall remain in full force and effect.
 
10.10
Counterparts.
 
This
Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original and all of which together shall
be deemed to be one
and the same instrument.
 
10.11
Applicable
Law; Jurisdiction; Venue.
 
This
Agreement and any and all rights and obligations hereunder, including, but not limited to, matters of construction, validity and performance,
shall be governed
by the laws of Israel, and no other jurisdiction whether the manner of resolution be by arbitration, legal proceeding
or otherwise (excluding any conflict of laws
principles that would apply the laws of another jurisdiction). If any dispute arises out
of or in connection with or related to this Agreement or the termination thereof,
or the relationship created by or described in this
Agreement, the Parties shall submit to the exclusive jurisdiction of the competent court located in Tel Aviv.
 
 
 
-16-

 
 
IN
WITNESS WHEREOF, the Parties have executed and delivered this Agreement as of the date first above written.
 
Aleph
Farms Ltd.
Vascular
Biogenics Ltd.
 
 
 
 
 
By:
/s/
Didier Toubia
 
By:
/s/
Dror Harats
 
 
 
 
 
Name:
Didier
Toubia
 
Name:
Dror
Harats
 
 
 
 
 
Title:
Co-Founder
& CEO
 
Title:
CEO
 
15
February 2023
 
 
15
February 2023
 
 
 
 
 
By:
/s/
Jonathan Berger
 
By:
 
 
 
 
 
Name:
Jonathan
Berger
 
Name:
 
 
 
 
 
Title:
Director
 
Title:
 
 
15
February 2023
 
 
 
 
 
 
-17-

 
 
Exhibit
A
 
 
 
-18-

 
Exhibit
3.1
 
AMENDED
AND RESTATED
 
ARTICLES OF ASSOCIATION
 
OF
 
VASCULAR
BIOGENICS LTD.
 
A
COMPANY LIMITED BY SHARES
 
UNDER THE COMPANIES LAW, 5759 — 1999
 
INTERPRETATION
 
1.
 
 
1.1.
In
these Articles, unless the context requires another meaning the words in the first column
of the following table shall have the meanings set opposite them in the
second column:
 
“
Alternate Nominee ”
as
defined in Article 77.1;
 
 
“
Articles ”
these
Articles of Association, as amended from time to time by a Resolution (as defined below);
 
 
“
Auditors ”
the
auditors of the Company;
 
 
“
Board of Directors ”
all
of the directors of the Company holding office pursuant to these Articles, including alternates,
substitutes or proxies;
 
 
“
Chief Executive Officer ”
chief
executive officer of the Company;
 
 
“
Chairman of the Board of Directors”
as
defined in Article 81;
 
 
“
Companies Law ”
the
Israeli Companies Law, 5759-1999, as amended from time to time, including the regulations
promulgated thereunder, or any other law
which may come in its stead, including all amendments
made thereto;
 
 
“
Company ”
Vascular
Biogenics Ltd. or וסקולר ביוג’ניקס בע”מ
 
 
“
Committee of Directors ”
as
defined in Article 93;
 
 
“
Compensation Committee ”
as
defined in the Companies Law;
 
 
“
Deed of Transfer ”
as
defined in Article 44;
 
 
“
Derivative Transaction ”
as
defined in Article 56;
 
 
“
Effective Time ”
the
closing of the initial underwritten public offering of the Company’s Ordinary Shares, at which
time these Articles shall first
become effective;
 
 

 
 
“
Director(s) ”
a
member or members of the Board of Directors elected to hold office as director(s);
 
 
“
External Directors ”
as
defined in the Companies Law;
 
 
“
General Meetings ”
all
annual and extraordinary meetings of the Shareholders;
 
 
“
Incapacitated Person ”
as
defined under the Israeli Legal Capacity and Guardianship Law, 5722-1962, as amended from time
to time, including a minor who has
not yet attained the age of 18 years, a person unsound of mind and
a bankrupt in respect of whom no rehabilitation has been granted;
 
 
“
NIS ”
New
Israeli Shekels;
 
 
“
Nominees ”
as
defined in Article 77.1;
 
 
“
Ordinary Shares ”
as
defined in Article 6;
 
 
“
Office ”
the
registered office of the Company at that time;
 
 
“
Office Holder ”
as
defined in the Companies Law;
 
 
“
Person ”
includes
an individual, corporation, company, cooperative society, partnership, trust of any kind or
any other body of persons, whether incorporated
or otherwise;
 
 
“
Proposal Request ”
as
defined in Article 56;
 
 
“
Proposing Shareholder ”
as
defined in Article 56;
 
 
“
Register ”
the
Register of Shareholders administered in accordance with the Companies Law;
 
 
“
Resolution ”
a
resolution of Shareholders. Except as required under the Companies Law or these Articles, any
Resolution shall be adopted by a majority
of the voting power present and voting at the applicable
General Meeting, in person or by proxy;
 
 
“
Rights ”
as
defined in Article 113.1;
 
 
“
Shareholder(s) ”
shall
mean the shareholder(s) of the Company, at any given time;
 
 
“
Special Fund ”
as
defined in Article 113.1;
 
 
“
Transferor ”
as
defined in Article 44;
 
 
“
Transferee ”
as
defined in Article 44;
 
 
“
U.S. Rules ”
the
applicable rules of the NASDAQ Stock Market and the U.S. securities rules and regulations, as
amended from time to time; and
 
 
“
writing ”
handwriting,
typewriting, photography, telex, email or any other legible form of writing.
 
 

 
 
1.2.
Subject
to the provisions of this Article 0, in these Articles, unless the context necessitates another
meaning, terms and expressions which have been defined in the
Companies Law shall have the
meanings ascribed to them therein.
 
1.3.
Words
in the singular shall also include the plural, and vice versa. Words in the masculine shall
include the feminine and vice versa, and words which refer to persons
shall also include
corporations, and vice versa.
 
1.4.
The
captions to articles in these Articles are intended for the convenience of the reader only,
and no use shall be made thereof in the interpretation of these Articles.
 
LIMITED
LIABILITY
 
2.
The
Company is a limited liability company and therefore each shareholder’s obligations
for the Company’s obligations shall be limited to the payment of the nominal value
of the shares held by such shareholder, subject to the provisions of the Companies Law.
 
THE
COMPANY’S OBJECTIVES
 
3.
The
principal object for which the Company was founded is to engage in any business, commercial,
industry or other activity of any kind which is not legally prohibited or
restricted by law.
 
THE
BUSINESS
 
4.
Any
branch or type of business that the Company is authorized to engage in, either expressly
or implied, may be commenced or engaged in by the Board of Directors at all or
any time as
it deems fit. The Board of Directors shall be entitled to cease the conduct of any such branch
or type of business, whether or not the actual conduct thereof has
commenced at its own discretion.
 
REGISTERED
OFFICE
 
5.
The
registered office shall be at such place as is decided from time to time by the Board of
Directors.
 
SHARE
CAPITAL
 
6.
The
share capital of the Company shall consist of NIS 700,000 divided into 70,000,000 Ordinary
Shares, of a nominal value of NIS 0.01 each (the “ Ordinary Shares “).
 
RIGHTS
ATTACHING TO THE ORDINARY SHARES
 
7.
 
7.1.
The
Ordinary Shares in respect of which all calls have been fully paid shall confer on the holders
thereof the right to attend and to vote at General Meetings of the
Company, both ordinary
as well as extraordinary meetings.
 
7.2.
The
Ordinary Shares shall confer on a holder thereof the right to receive a dividend, to participate
 in a distribution of bonus shares and to participate in the
distribution of the assets of
the Company upon its winding-up, pro rata to the nominal amount paid up on the shares or
credited as paid up in respect thereof, and
without reference to any premium which may have
been paid in respect thereof.
 
 

 
 
MODIFICATION
OF CLASS RIGHTS
 
8.
 
8.1.
Subject
to applicable law, if at any time the share capital of the Company is divided into different
classes of shares and unless the terms of issue of such class of
shares otherwise stipulate,
the rights attaching to any class of shares (including rights prescribed in the terms of
issue of the shares) may be altered, modified or
canceled, by a Resolution passed at a separate
General Meeting of the Shareholders of that class.
 
8.2.
The
provisions contained in these Articles with regard to General Meetings shall apply, mutatis
mutandis as the case may be, to every General Meeting of the holders
of each such class
of the Company’s shares.
 
8.3.
Unless
otherwise provided by these Articles, the increase of an authorized class of shares, or the
issuance of additional shares thereof out of the authorized and
unissued share capital, shall
not be deemed, for purposes of this Article 8.3, to modify or abrogate the rights attached
to previously issued shares of such class or of
any other class.
 
UNISSUED
SHARE CAPITAL
 
9.
The
unissued shares in the capital of the Company shall be under the control of the Board of
Directors, which shall be entitled to allot or otherwise grant the same to such
Persons under
such restrictions and conditions as it shall deem fit, whether for consideration or otherwise,
and whether for consideration in cash or for consideration which is
not in cash, above their
nominal value or at a discount, all on such conditions, in such manner and at such times
as the Board of Directors shall deem fit, subject to the
provisions of the Companies Law.
The Board of Directors shall be entitled, inter alia , to differentiate between Shareholders
with regard to the amounts of calls in respect of
the allotment of shares (to the extent
that there are calls) and with regard to the time for payment thereof. The Board of Directors
may also issue options or warrants for the
purchase of shares of the Company and prescribe
the manner of the exercise of such options or warrants, including the time and price for
such exercise and any other
provision which is relevant to the method for distributing the
issued shares of the Company amongst the purchasers thereof.
 
10.
The
Board of Directors shall be entitled to prescribe the times for the issue of shares of the
Company and the conditions therefore and any other matter which may arise in
connection with
the issue thereof.
 
11.
In
every case of a rights offering the Board of Directors shall be entitled, in its discretion,
to resolve any problems and difficulties arising or that are likely to arise in regard to
fractions of rights, and without prejudice to the generality of the foregoing, the Board
of Directors shall be entitled to specify that no shares shall be allotted in respect of
fractions of rights, or that fractions of rights shall be sold and the (net) proceeds shall
be paid to the persons entitled to the fractions of rights, or, in accordance with a decision
by the Board of Directors, to the benefit of the Company.
 
INCREASE
OF AND ALTERATIONS TO CAPITAL
 
12.
The
Company may, from time to time, by a Resolution, increase its share capital by way of the
creation of new shares, whether or not all the existing shares have been issued
up to the
date of the resolution, whether or not it has been decided to issue same, and whether or
not calls have been made on all the issued shares.
 
13.
The
increase of share capital shall be in such amount and divided into shares of such nominal value, and with such restrictions and conditions
and with such rights and
privileges as the Resolution dealing with the creation of the shares prescribes, and if no provisions are
contained in the Resolution, then as the Board of Directors shall
prescribe.
 
 

 
 
14.
Unless
otherwise stated in the Resolution approving the increase of the share capital, the new shares
shall be subject to those provisions in regard to issue, allotment, alteration
of rights,
payment of calls, liens, forfeiture, transfer, transmission and other provisions which apply
to the shares of the Company.
 
 
15.
By
Resolution, the Company may, subject to any applicable provisions of the Companies Law:
 
15.1.
consolidate
its existing share capital, or any part thereof, into shares of a larger denomination than
the existing shares;
 
 
 
15.2.
sub-divide
its share capital, in whole or in part, into shares of a smaller denomination than the nominal
value of the existing shares and without prejudice to the
foregoing, one or more of the shares
so created may be granted any preferred or deferred rights or any special rights with regard
to dividends, participation in assets
upon winding- up, voting and so forth, subject to the
provisions of these Articles;
 
 
 
15.3.
reduce
its share capital; or
 
 
 
15.4.
cancel
any shares which on the date of passing of the Resolution have not been issued and to reduce
its share capital by the amount of such shares.
 
16.
In
the event that the Company shall adopt any of the Resolutions described in Article 15 above,
the Board of Directors shall be entitled to prescribe arrangements necessary in
order to
resolve any difficulty arising or that are likely to arise in connection with such Resolutions,
including, in the event of a consolidation, it shall be entitled to (i) allot, in
contemplation
of or subsequent to such consolidation or other action, shares or fractional shares sufficient
to preclude or remove fractional share holdings; (ii) redeem, in the
case of redeemable shares,
and subject to applicable law, such shares or fractional shares sufficient to preclude or
remove fractional share holdings; (iii) round up, round down
or round to the nearest whole
number, any fractional shares resulting from the consolidation or from any other action which
may result in fractional shares; or (iv) cause the
transfer of fractional shares by certain
Shareholders to other Shareholders thereof so as to most expediently preclude or remove any
fractional shareholdings, and, cause the
transferees of such fractional shares to pay the
transferors thereof the fair value thereof, and the Board of Directors is hereby authorized
to act in connection with such transfer,
as agent for the transferors and transferees of
any such fractional shares, with full power of substitution, for the purposes of implementing
the provisions of this Article 16
 
SHARE
CERTIFICATES
 
17.
To
the extent shares are certificated, share certificates evidencing title to the shares of
the Company shall be issued under the seal or rubber stamp of the Company, and
together with
the signatures of two members of the Board of Directors, or one Director together with the
Chief Executive Officer, the Chief Financial Officer, the Secretary of
the Company or any
other person designated by the Board of Directors. The Board of Directors shall be entitled
to decide that the signatures be effected in any mechanical or
electronic form, provided
that the signature shall be effected under the supervision of the Board of Directors in such
manner as it prescribes.
 
 
18.
Every
Shareholder shall be entitled, free of charge, to one certificate in respect of all the shares
of a single class registered in his name in the Register.
 
 
19.
The
Board of Directors shall not refuse a request by a Shareholder to obtain several certificates
in place of one certificate, unless such request is, in the opinion of the Board of
Directors,
unreasonable. Where a Shareholder has sold or transferred some of his shares, he shall be
entitled, free of charge, to receive a certificate in respect of his remaining
shares, provided
that the previous certificate is delivered to the Company before the issuance of a new certificate.
 
 

 
 
20.
Every
share certificate shall specify the number of the shares in respect of which such certificate
is issued and also the amounts which have been paid up in respect of each
share.
 
 
21.
No
Person shall be recognized by the Company as having any right to a share unless such Person
is the registered owner of the shares in the Register. The Company shall not
be bound by
and shall not recognize any right or privilege pursuant to the laws of equity, or a fiduciary
relationship or a chose in action, future or partial, in any share, or a
right or privilege
to a fraction of a share, or (unless these Articles otherwise direct) any other right in
respect of a share, except the absolute right to the share as a whole,
where same is vested
in the owner registered in the Register.
 
 
22.
A
share certificate registered in the names of two or more persons shall be delivered to one
of the joint holders, and the Company shall not be obliged to issue more than one
certificate
to all the joint holders of shares and the delivery of such certificate to one of the joint
holders shall be deemed to be delivery to all of them.
 
 
23.
If
a share certificate should be lost, destroyed or defaced, the Board of Directors shall be
entitled to issue a new certificate in its place, provided that the certificate is delivered
to it and destroyed by it, or it is proved to the satisfaction of the Board of Directors
that the certificate was lost or destroyed and security has been received to its satisfaction
in
respect of any possible damages and after payment of such amount as the Board of Directors
shall prescribe.
 
CALLS
ON SHARES
 
24.
The
Board of Directors may from time to time, in its discretion, make calls on Shareholders in
respect of amounts which are still unpaid in respect of the shares held by each
of the Shareholders
(including premiums), and the terms of issue which do not prescribe that same be paid at
fixed times, and every Shareholder shall be obliged to pay the
amount of the call made on
him, at such time and at such place as stipulated by the Board of Directors.
 
 
25.
In
respect of any such call, prior notice of at least fourteen (14) business days shall be given,
stating to whom the amount called is to be paid, the time for payment and the
place thereof,
provided that prior to the due date for payment of such call, the Board of Directors may,
by written notice to the Shareholders to which the call was made, cancel
the call or extend
the date of payment thereof.
 
 
26.
If
according to the terms of issue of any share, or otherwise, any amount is required to be
paid at a fixed time or in installments at fixed times, whether the payment is made on
account
of the share capital in respect of the share or in form of a premium, every such payment
or every such installment shall be paid as if it was a call duly made by the
Board of Directors,
in respect of which notice was duly given, and all the provisions contained in these Articles
in regard to calls shall apply to such amount or to such
installment.
 
 
27.
Joint
holders of a share shall be jointly and severally liable for the payment of all installments
and calls due in respect of such share.
 
 
28.
In
the event that a call or installment due on account of a share is not paid on or before the
date fixed for payment thereof, the holder of the share, or the Person to whom the
share
has been allotted, shall be obliged to pay linkage differentials and interest on the amount
of the call or the installment, at such rate as shall be determined by the Board of
Directors,
commencing from the date fixed for the payment thereof and until the date of actual payment.
The Board of Directors may, however, waive the payment of the
linkage differentials or the
interest or part thereof.
 
 
29.
A
Shareholder shall not be entitled (i) to receive a dividend and (ii) to exercise any right as a Shareholder, including but not limited
to, the right to attend and vote at a General
Meeting of any type and to transfer the shares to another; unless he has paid all the
calls payable from time to time and which apply to any of his shares, whether he holds
same alone or jointly with another, plus linkage
differentials, interest and expenses, if any.
 
 

 
 
30.
The
Board of Directors may, if it deems fit, accept payment from a Shareholder wishing to advance
the payment of all moneys which remain unpaid on account of his shares,
or part thereof which
 are over and above the amounts which have actually been called, and the Board of Directors
 shall be entitled to pay such Shareholder linkage
differentials and interest in respect of
the amounts paid in advance, or that portion thereof which exceeds the amount called for
the time being on account of the shares in
respect of which the advance payment is made,
at such rate as is agreed upon between the Board of Directors and the Shareholder, with this
being in addition to dividends
payable (if any) on the paid-up portion of the share in respect
of which the advance payment is made.
 
The
Board of Directors may, at any time, repay the amount paid in advance as aforesaid, in whole or in part, in its sole discretion, without
premium or penalty. Nothing in this
Article 30 shall derogate from the right of the Board of Directors to make any call for payment before
or after receipt by the Company of any such advance.
 
FORFEITURE
AND LIEN
 
31.
If
a Shareholder fails to make payment of any call or other installment on or before the date
fixed for the payment thereof, the Board of Directors may, at any time thereafter
and for
as long as the part of the call or installment remains unpaid, serve on such Shareholder
a notice demanding that he make payment thereof, together with the linkage
differentials
and interest at such rate as is specified by the Board of Directors and all the expenses
incurred by the Company in consequence of such non-payment.
 
 
32.
The
notice shall specify a further date, which shall be at least fourteen (14) business days
after the date of the delivery of the notice, and a place or places at which such call or
installment is to be paid, together with linkage differentials and interest and expenses
as aforesaid. The notice shall further state that, if the amount is not paid on or before
the
date specified, and at the place mentioned in such notice, the shares in respect of which
the call was made, or the installment is due, shall be liable to forfeiture.
 
 
33.
If
the demands contained in such notice are not complied with the Board of Directors may treat
the shares in respect of which the notice referred to in Articles 31 and 32 was
given as
forfeited. Such forfeiture shall include all dividends, bonus shares and other benefits which
have been declared in respect of the forfeited shares which have not
actually been paid prior
to the forfeiture.
 
 
34.
Any
share so forfeited or waived shall be deemed to be the property of the Company and the Board
of Directors shall be entitled, subject to the provisions of these Articles
and the Companies
Law, to sell, re-allot or otherwise dispose thereof, as it deems fit, whether the amount
paid previously in respect of that share is credited, in whole or in
part.
 
 
35.
The
Board of Directors may, at any time before any share forfeited as aforesaid is sold or re-
allotted or otherwise dispose of, cancel the forfeiture on such conditions as it
deems fit.
 
 
36.
Any
Person whose shares have been forfeited shall cease to be a Shareholder in respect of the
forfeited shares, but shall, nonetheless remain liable for the payment to the
Company of
all calls, installments, linkage differentials, interest and expenses due on account of or
in respect of such shares on the date of forfeiture, in respect of the forfeited
shares,
together with interest on such amounts reckoned from the date of forfeiture until the date
of payment, at such rate as the Board of Directors shall from time to time
specify. However,
such Person’s liability shall cease after the Company has received all the amounts
called in respect of the shares as well as any expenses incurred by the
Company relating
to collecting the amounts called. The Board of Directors shall be entitled to collect the
moneys which have been forfeited, or part thereof, as it shall deem
fit, but it shall not
be obliged to do so.
 
 

 
 
37.
The
provisions of these Articles in regard to forfeiture shall also apply to cases of non- payment
of any amount, which, according to the terms of issue of the share, or which
under the conditions
of allotment the due date for payment of which fell on a fixed date, whether this be on account
of the nominal value of the share or in the form of a
premium, as if such amount was payable
pursuant to a call duly made and notified.
 
 
38.
The
Company shall have a first and paramount lien over all the shares which have not been fully
paid up and which are registered in the name of any Shareholder (whether
individually or
jointly with others) and also over the proceeds of the sale thereof, as security for the
debts and obligations of such Shareholder to the Company and his
contractual engagements
with it, either individually or together with others. This right of lien shall apply whether
or not the due date for payment of such debts or the
fulfillment or performance of such obligations
has arrived, and no rights in equity shall be created in respect of any share, over which
there is a lien as aforesaid. The aforesaid
lien shall apply to all dividends or benefits
which may be declared, from time to time, on such shares, unless the Board of Directors shall
decide otherwise.
 
 
39.
In
order to foreclose on such lien, the Board of Directors may sell the shares under lien at
such time and in such manner as, it shall deem fit, but no share may be sold unless
the period
referred to below has elapsed and written notice has been given to the Shareholder, his trustee,
liquidator, receiver, the executors of his estate, or anyone who
acquires a right to shares
in consequence of the bankruptcy of a Shareholder, as the case may be, stating that the Company
intends to sell the shares, if he or they should fail to
pay the aforesaid debts, or fail
to discharge or fulfill the aforesaid obligations within fourteen (14) business days from
the date of the delivery of the notice.
 
 
40.
The
net proceeds of any such sale of shares, as contemplated by Article 39 above, after deduction
of the expenses of the sale, shall serve for the discharge of the debts of such
shareholder
or for performance of such Shareholder’s obligations (including debts, undertakings
and contractual engagements the due date for the payment or performance of
which has arrived)
and the surplus, if any, shall be paid to the Shareholder, his trustee, liquidator, receiver,
guardians, the executors of his estate, or to his successors-in-title.
 
 
41.
In
every case of a sale following forfeiture or waiver, or for purposes of executing a lien
by exercising all of the powers conferred above, the Board of Directors shall be
entitled
to appoint a person to sign an instrument of transfer of the shares sold, and to arrange
for the registration of the name of the buyer in the Register in respect of the
shares sold.
 
 
42.
An
affidavit signed by the Chairman of the Board of Directors that a particular share of the
Company was forfeited, waived or sold by the Company by virtue of a lien, shall
serve as
conclusive evidence of the facts contained therein as against any person claiming a right
in the share. The purchaser of a share who relies on such affidavit shall not
be obliged
to investigate whether the sale, re-allotment or transfer, or the amount of consideration
and the manner of application of the proceeds of the sale, were lawfully
effected, and after
his name has been registered in the Register he shall have a full right of title to the share
and such right shall not be adversely affected by a defect or
invalidity which occurred in
the forfeiture, waiver, sale, re-allotment or transfer of the share.
 
TRANSFER
AND TRANSMISSION OF SHARES
 
43.
No
transfer of shares shall be registered unless a proper instrument of transfer is delivered
to the Company or, in the case of shares registered with a transfer agent, delivered
to such
transfer agent or to such other place specified for this purpose by the Board of Directors.
Subject to the provisions of these Articles, an instrument of transfer of a share
in the
Company shall be signed by the transferor and the transferee. The Board of Directors may
approve other methods of recognizing the transfer of shares in order to
facilitate the trading
of the Company’s shares on the Nasdaq Global Market or on any other stock exchange.
The transferor shall be deemed to remain the holder of the share
up until the time the name
of the transferee is registered in the Register in respect of the transferred share.
 
 

 
 
44.
Insofar
as the circumstances permit, the instrument of transfer of a share shall be substantially
in the form set out below, or in any other form that the Board of Directors may
approve (the
“Deed of Transfer “).
 
I
                       , I.D.                      of                 (the “ Transferor “), in consideration for an amount of NIS                                     (in words) paid to me by            I.D.
                  of                   
(hereinafter: the “ Transferee “), hereby transfer to the Transferee                            shares of nominal value NIS                      each, marked
with
the Numbers              to                (inclusive) of a company known as Vascular Biogenics Ltd., to be held by the Transferee, the acquires of his
rights and his successors-in
title, under all the same conditions under which I held same prior to the signing of this instrument,
and I, the Transferee, hereby agree to accept the aforementioned share
in accordance with the above mentioned conditions.
 
In
witness whereof we have hereunto signed this          day
of       20        .
 
 
Transferor ___________________      Transferee _______________
 
 
 
 
 
 
 
 
Witnesses
to Signature
___________________________
 
 
 
45.
The
Company may close the transfer registers and the Register for such period of time as the
Board of Directors shall deem fit.
 
 
46.
Every
instrument of transfer shall be submitted to the Office or to such other place as the Board
of Directors shall prescribe, for purposes of registration, together with the
share certificates
to be transferred, or if no such certificate was issued, together with a letter of allotment
of the shares to be transferred, and/or such other proof as the Board
of Directors may demand
in regard to the transferor’s right of title or his right to transfer the shares. The
Board of Directors shall have the right to refuse to recognize an
assignment of shares until
the appropriate securities under the circumstances have been provided, as shall be determined
by the Board of Directors in a specific case or from
time to time in general. Instruments
of transfer which serve as the basis for transfers that are registered shall remain with
the Company.
 
 
47.
Every
instrument of transfer shall relate to one class of shares only, unless the Board of Directors
shall otherwise agree.
 
 
48.
The
executors of the will or administrator of a deceased Shareholder’s estate (such Shareholder
 not being one of a joint owners of a share) or, in the absence of an
administrator of the
estate or executor of the will, the persons specified in Article 49 below, shall be entitled
to demand that the Company recognize them as owners of rights
in the share. The provisions
of Article 46 above shall apply, mutatis mutandis , also in regard to this Article.
 
 
49.
In
the case of the death of one of the holders of a share registered in the names of two or
more Persons, the Company shall recognize only the surviving owners as Persons
having rights
in the share. However, the aforementioned shall not be construed as releasing the estate
of a deceased joint Shareholder from any and all undertakings in respect
of the shares. Any
Person who shall become an owner of shares following the death of a Shareholder shall be
entitled to be registered as owner of such shares after having
presented to an officer of
the Company to be designated by the Chief Executive Officer an inheritance order or probation
order or order of appointment of an administrator of
estate and any other proof as required
- if these are sufficient in the opinion of such officer - testifying to such Person’s
right to appear as shareholder in accordance with these
Articles, and which shall testify
to his title to such shares. The provisions of Article 46 above shall apply, mutatis mutandis
, also in regard to this Article.
 
 

 
 
50.
The
receiver or liquidator of a Shareholder who is a company or the trustee in bankruptcy or
 the official receiver of a Shareholder who is bankrupt, upon presenting
appropriate proof
to the satisfaction of an officer of the Company to be designated by the Chief Executive
Officer that such Shareholder has the right to appear in this capacity
and which testifies
to such Shareholder’s title, may, with the consent of the Board of Directors (the Board
of Directors shall not be obligated to give such consent) be
registered as the owner of such
shares. Furthermore, such Shareholder may assign such shares in accordance with the rules
prescribed in these Articles. The provisions of
Article 46 above shall apply, mutatis
mutandis , also in regard to this Article.
 
 
51.
A
Person entitled to be registered as a Shareholder following assignment pursuant to these
Articles shall be entitled, if approved by the Board of Directors and to the extent
and under
the conditions prescribed by the Board of Directors, to dividends and any other monies paid
in respect of the shares, and shall be entitled to give the Company
confirmation of the payments;
however, he shall not be entitled to be present or to vote at any General Meeting of the
Company or, subject to the provisions of these Articles,
to make use of any rights of Shareholders,
until he has been registered as owner of such shares in the Register.
 
GENERAL
MEETING
 
52.
A
General Meeting shall be held at least once in every year, not later than 15 (fifteen) months
after the last General Meeting, at such time and at such place as the Board of
Directors
shall determine. Such General Meeting shall be called an annual meeting, and all other meetings
of the Shareholders shall be called extraordinary meetings.
 
 
53.
The
Board of Directors may call an extraordinary meeting whenever it sees fit to do so.
 
 
54.
The
Board of Directors shall be obliged to call an extraordinary meeting upon a requisition in
writing in accordance with the Companies Law.
 
 
55.
The
Company shall provide prior notice in regard to the holding of an annual meeting or an extraordinary
meeting in accordance with the requirements of these Articles, the
Companies Law and the
regulations promulgated thereunder. Subject to the provisions of the Companies Law and the
regulations promulgated thereunder, in counting the
number of days of prior notice given,
the day of publication of notice shall not be counted, but the day of the meeting shall be
counted. The notice shall specify those items
and contain such information as shall be required
by the Companies Law, the regulations promulgated thereunder and any other applicable law
and regulations.
 
 
56.
Any
Shareholder (a “ Proposing Shareholder”) requesting to add an item to the agenda of a General Meeting may submit such
a request (a “ Proposal Request “) in
accordance with the Companies Law. Subject to any requirements under the Law,
to be considered timely and thereby be added to such agenda, a Proposal Request must be
delivered, either in person or by certified mail,
postage prepaid, and received at the Office, (i) in the case of a General Meeting that is an annual meeting, no less than sixty
(60)
days nor more than one-hundred twenty (120) days prior to the date of the first anniversary of the preceding year’s annual meeting,
provided, however, that, in the event
that the date of the annual meeting is advanced more than thirty (30)
days prior to or delayed by more than thirty (30) days after the anniversary of the preceding year’s annual
meeting, notice by
the Proposing Shareholder to be timely must be so received not earlier than the close of business one-hundred twenty (120) days prior
to such annual
meeting and not later than the close of business on the later of ninety (90) days prior to such annual meeting or the
tenth (10th) day following the day on which public
announcement of the date of such meeting is first made, and (ii) in the
case of a General Meeting that is an extraordinary meeting, no earlier than one-hundred twenty (120)
days prior to such extraordinary
meeting and no later than sixty (60) days prior to such extraordinary meeting or the tenth (10th) day following the day on
which public
announcement of the date of such meeting is first made, subject to applicable law.
 
 

 
 
In
no event shall the public announcement of an adjournment or postponement of a General Meeting commence a new time period (or extend any
time period) for the giving
of a Shareholder’s notice as described above. Subject to any requirements under the Companies Law,
nominations of persons for election to the Board of Directors may only
be made at an extraordinary meeting if directors are to be elected
at such meeting (a) by or at the direction of the Board of Directors, or (b) by any shareholder who is entitled
to vote at the meeting
and who complies with the notice procedures set forth in this Article. Such request shall also set forth: (i) the name and address of
the Proposing
Shareholder making the request; (ii) a representation that the Proposing Shareholder is a holder of record of shares of
the Company entitled to vote at such meeting and
intends to appear in person or by proxy at the meeting; (iii) a description of all arrangements
or understandings between the Proposing Shareholder and any other Person or
Persons (naming such Person or Persons) in connection with
the subject which is requested to be included in the agenda; (iv) a description of all Derivative Transactions (as
defined below) by
 the Proposing Shareholder during the previous twelve (12) month period, including the date of the transactions and the class, series
 and number of
securities involved in, and the material economic terms of, such Derivative Transactions; and (v) a declaration that all
the information that is required under the Companies
Law and any other applicable law to be provided to the Company in connection with
such subject, if any, has been provided. Furthermore, the Board of Directors, may, in its
discretion, to the extent it deems necessary,
request that the Proposing Shareholder(s) provide additional information necessary so as to include a subject in the agenda of a
General
Meeting, as the Board of Directors may reasonably require.
 
A
“ Derivative Transaction “ means any agreement, arrangement, interest or understanding entered into by, or on behalf
or for the benefit of, any Proposing Shareholder or
any of its affiliates or associates, whether of record or beneficial: (a) the value
of which is derived in whole or in part from the value of any class or series of shares or other
securities of the Company, (b) which
otherwise provides any direct or indirect opportunity to gain or share in any gain derived from a change in the value of securities of
the
Company, (c) the effect or intent of which is to mitigate loss, manage risk or benefit of security value or price changes, or (d)
which provides the right to vote or increase or
decrease the voting power of such Proposing Shareholder, or any of its affiliates or
associates, with respect to any shares or other securities of the Company, which agreement,
arrangement, interest or understanding may
include, without limitation, any option, warrant, debt position, note, bond, convertible security, swap, stock appreciation right,
short
 position, profit interest, hedge, right to dividends, voting agreement, performance-related fee or arrangement to borrow or lend shares
 (whether or not subject to
payment, settlement, exercise or conversion in any such class or series), and any proportionate interest of
such Proposing Shareholder in the shares or other securities of the
Company held by any general or limited partnership, or any limited
liability company, of which such Proposing Shareholder is, directly or indirectly, a general partner or
managing member. The information
required pursuant to this Article 56 shall be updated as of the record date of the General Meeting, five (5) business days before the
General Meeting, and any adjournment or postponement thereof.
 
57.
Subject
to Article 65 below, in the event that the Company has established that an adjourned meeting
shall be held on such date which is later than the date provided for in
Section 78(b) of
the Companies Law, such later date shall be included in the notice. The Company may add additional
places for Shareholders to review the full text of the
proposed resolutions, including an
internet site. The notice shall be provided in the manner prescribed below under the heading
“Notices” in Articles 128 to 131 below.
 
PROCEEDINGS
AT GENERAL MEETING
 
58.
No
business shall be conducted at a General Meeting unless a quorum is present, and no resolution
shall be passed unless a quorum is present at the time the resolution is
voted on. Except
 in cases where it is otherwise stipulated, a quorum shall be constituted when there are personally
 present, or represented by proxy, at least two (2)
Shareholders who hold, in the aggregate,
at least 25% of the voting rights in the Company. A proxy may be deemed to be two (2) or
more Shareholders pursuant to the number
of Shareholders he represents.
 
 

 
 
59.
If
within half an hour from the time appointed for the meeting, a quorum is not present, without
there being an obligation to notify the Shareholders to that effect, the meeting
shall be
adjourned to the same day, in the following week, at the same hour and at the same place
or to a later time and date if so specified in the notice of the meeting, unless
such day
shall fall on a statutory holiday (either in Israel or in the United States), in which case
the meeting will be adjourned to the first business day afterwards which is not
a statutory
holiday.
 
If
the original meeting was convened upon requisition under Section 63 of the Companies Law, one or more Shareholders, present in person
or by proxy, and holding the
number of shares required for making such requisition, shall constitute a quorum at the adjourned meeting,
but in any other case any two (2) Shareholders present in person or
by proxy, shall constitute a quorum at the adjourned meeting.
 
60.
The
Chairman of the Board of Directors, or any other Person appointed for this purpose by the
Board of Directors, shall preside at every General Meeting. If within fifteen
(15) minutes
from the time appointed for the meeting, the designated chairman for the meeting shall not
be present, the Shareholders present at the meeting shall elect one of
their number or any
other Person to serve as chairman of the meeting.
 
 
61.
Resolutions
at the General Meeting shall be passed in accordance with the definition of “Resolution”
set forth in Article 1.1 above, unless otherwise required by Companies
Law or these Articles.
Every vote at a General Meeting shall be conducted according to the number of votes to which
each Shareholder is entitled on the basis of the number
of Ordinary Shares held by such Shareholder
(in accordance with the provisions of Article 7.1 above).
 
 
62.
Where
a poll has been demanded, the chairman of the meeting shall be entitled - but not obliged
- to accede to the demand. Where the chairman of the meeting has decided to
hold a poll,
such poll shall be held in such manner, at such time and at such place as the chairman of
 the meeting directs, either immediately or after an interval or
postponement, or in any other
way, and the results of the vote shall be deemed to be the Resolution at the meeting at which
the poll was demanded. A person demanding a poll
may withdraw his demand prior to the poll
being held.
 
 
63.
A
demand for the holding of a poll shall not prevent the continued business of the meeting
on all other questions apart of the question in respect of which a poll was
demanded.
 
 
64.
The
announcement by the chairman of the meeting that a Resolution has been passed unanimously
or by a particular majority, or has been rejected, and a note recorded to that
effect in
the Company’s minute book, shall serve as prima facie proof of such fact, and
there shall be no necessity for proving the number of votes or the proportion of votes
given
for or against the Resolution, unless otherwise required under applicable law and regulation.
 
 
65.
The
Chairman of a General Meeting at which a quorum is present may, with the consent of holders
of a majority of the voting power represented in person and by proxy and
voting on the question
of adjournment, adjourn the meeting from time to time and from place to place, but no business
shall be transacted at any adjourned meeting except
business which might lawfully have been
transacted at the meeting as originally called. Subject to these Articles, it shall not be
necessary to give any notice of an adjournment
unless the meeting is adjourned for more than
twenty-one (21) days, in which case notice thereof shall be given in the manner required
for the meeting as originally called.
Where a General Meeting has been adjourned without
changing its agenda, to a date which is not more than twenty-one (21) days, notices shall
be given for the new date, as
early as possible, and by no later than seventy-two (72) hours
before the General Meeting.
 
VOTES
OF SHAREHOLDERS
 
66.
The
voting rights of every shareholder entitled to vote at a General Meeting shall be as set
forth in Article 7.1 of these Articles.
 
 
67.
In
the case of joint Shareholders, the vote of the senior joint holder, given personally or
by proxy, shall be accepted, to the exclusion of the vote of the remaining joint
Shareholders,
and for these purposes the senior of the joint Shareholders shall be the Person amongst the joint holders whose name appears first in the Register.
 
 

 
 
68.
A
Shareholder who is an Incapacitated Person may vote solely through his guardian or other
person who fulfills the function of such guardian and who was appointed by a
court, and any
guardian or other person as aforesaid shall be entitled to vote by way of a proxy, or in
such manner as the court directs.
 
69.
Any
corporation which is a Shareholder of the Company shall be entitled, by way of resolution
of its board of directors or another organ which manages said corporation, to
appoint such
person which it deems fit, whether or not such person is a Shareholder of the Company, to
act as its representative at any General Meeting of the Company or at a
meeting of a class
of shares in the Company which such corporation is entitled to attend and to vote thereat,
and the appointed as aforesaid shall be entitled, on behalf of the
corporation whom he represents,
to exercise all of the same powers and authorities which the corporation itself could have
exercised had it been a natural person holding
shares of the Company.
 
70.
Every
Shareholder who is entitled to attend and vote at a General Meeting of the Company, shall
be entitled to appoint a proxy. A proxy can be appointed by more than one
Shareholder, and
vote in different ways on behalf of each principal.
 
The
 instrument appointing a proxy shall be in writing signed by the Person making the appointment or by his authorized representative, and
 if the Person making the
appointment is a corporation, the power of attorney shall be signed in the manner in which the corporation signs
on documents which bind it, and a certificate of an attorney
with regard to the authority of the signatories to bind the corporation
shall be attached thereto. The proxy need not be a shareholder of the Company.
 
71.
The
instrument appointing a proxy, or a copy thereof certified by an attorney, shall be lodged
at the Office, or at such other place as the Board of Directors shall specify, not
less than
forty- eight (48) hours prior to the meeting at which the proxy intends to vote based on
such instrument of proxy. Notwithstanding the above, the chairman of the
meeting shall have
the right to waive the time requirement provided above with respect to all instruments of
proxies and to accept any and all instruments of proxy until the
beginning of a General Meeting.
A document appointing a proxy shall be valid for every adjourned meeting of the meeting to
which the document relates.
 
72.
Every
instrument appointing a proxy, whether for a meeting specifically indicated, or otherwise,
shall, as far as circumstances permit, be substantially in the following form, or
in any
other form approved by the Board of Directors:
 
I
             of                  being a shareholder holding voting shares in Vascular Biogenics Ltd., hereby appoint Mr.             of              or failing him, Mr.           of                     , or
failing him,
Mr.              of               , to vote in my name, place and stead at the (ordinary/extraordinary) General Meeting of the Company to be held on the            of
        20   , and
at any adjourned meeting thereof.
 
In
witness whereof I have hereto set my hand on the             day of          .
 
73.
No
Shareholder shall be entitled to vote at a General Meeting unless he has paid all of the
calls and all of the amounts due from him, for the time being, in respect of his
shares.
 
74.
A
vote given in accordance with the instructions contained in an instrument appointing a proxy
shall be valid notwithstanding the death or bankruptcy of the appointer, or the
revocation
of the proxy, or the transfer of the share in respect of which the vote was given as aforesaid,
unless notice in writing of the death, revocation or transfer is received
at the Office,
or by the chairman of the meeting, prior to such vote.
 
 
 
 

 
 
75.
Subject
to the Companies Law, an instrument appointing a proxy shall be deemed revoked (i)
upon receipt by the Company or the chairman of the meeting, subsequent to
receipt by the Company of such instrument, of written notice
 signed by the person signing such instrument or by the Shareholder appointing such proxy canceling the
appointment thereunder (or the
authority pursuant to which such instrument was signed) or of an instrument appointing a different proxy, provided such notice of cancellation
or instrument appointing a different proxy were so received at the place and within the time for delivery of the instrument revoked thereby
as referred to in Article 71 hereof,
or (ii) if the appointing shareholder is present in person at the meeting for which such instrument
of proxy was delivered, upon receipt by the chairman of such meeting of
written notice from such shareholder of the revocation of such
appointment, or if and when such Shareholder votes at such meeting. A vote cast in accordance with an
instrument appointing a proxy shall
be valid notwithstanding the revocation or purported cancellation of the appointment, or the presence in person or vote of the appointing
Shareholder at a meeting for which it was rendered, unless such instrument of appointment was deemed revoked in accordance with the foregoing
provisions of this Article 75
at or prior to the time such vote was cast.
 
THE
BOARD OF DIRECTORS
 
76.
Unless
otherwise resolved by a Resolution, the prescribed number of Directors of the Company shall
be up to nine (9) (including the External Directors), as may be fixed,
from time to time,
by the Board of Directors. At any time the minimum number of Directors (other than the External
Directors) shall not fall below three (3). Any Director
shall be eligible for re- election
upon termination of his term of office, subject to applicable law.
 
77.1.
Prior
to every annual General Meeting of the Company, the Board of Directors of the Company (or
a Committee of Directors) shall select, via a resolution adopted by
a majority of the Board
of Directors (or such committee), a number of persons to be proposed to the Shareholders
for election as directors of the Company at such
annual General Meeting for service until
 the annual General Meeting to be held in the next year following the year of their election
 (the “Nominees”). Any
shareholder entitled under applicable law to nominate
 one or more persons for election as directors at a General Meeting (each such person, an
 “Alternate
Nominee”) may make such nomination only if a written notice
of such shareholder’s intent to make such nomination or nominations has been given
to the Secretary
of the Company (or, if there is no such Secretary, the Chief Executive Officer).
Each such notice shall set forth: (a)
the name and address of the shareholder who
intends to make the nomination and of the Alternate Nominees; (b) a representation that the
shareholder is a holder of record of shares of the Company entitled to
vote at such meeting (including the number of shares held of record
by the shareholder) and intends to appear in person or by proxy at the meeting to nominate the
Alternate Nominees; (c) a description
of all arrangements or understandings between the shareholder and each Alternate Nominee and any other person or persons
(naming such
person or persons) pursuant to which the nomination or nominations are to be made by the shareholder; and (d) the consent of each Alternate
Nominee
to serve as a director of the Company if so elected and a declaration signed by each Alternate Nominee declaring that there is
no limitation under the Companies Law
for the appointment of such a nominee and that all of the information that is required under the
Companies Law to be provided to the Company in connection with
such an appointment has been provided. The Board of Directors may refuse
to acknowledge the nomination of any person not made in compliance with the foregoing
procedure.
 
77.2.
The
Nominees or Alternate Nominees shall be elected by a Resolution at the annual General Meeting
at which they are subject to election.
 
77.3.
Every
director shall hold office until the end of the next annual General Meeting following the
annual General Meeting at which he was elected, unless his office is
vacated in accordance
with Article 79 or Article 82 below. If, at an annual General Meeting, no Nominees or Alternate
Nominees are elected, the directors then in
office shall continue to hold office until the
convening of a General Meeting at which Nominees or Alternate Nominees shall be elected.
 
 
 
 

 
 
77.4.
If
the office(s) of members(s) of the Board of Directors shall be vacated, the remaining members
of the Board of Directors shall be entitled to appoint additional
director(s) in place of
the director(s) whose office(s) have been vacated, for a term of office equal to the remaining
period of the term of office of the director(s)
whose office(s) have been vacated.
78.
The
Directors in their capacity as such shall be entitled to receive remuneration as shall be
 determined in compliance with the Companies Law and the regulations
promulgated thereunder.
The conditions (including remuneration) of the terms of office of members of the Board of
Directors shall be decided by the Board of Directors
and/or any committee thereof, but the
same shall be valid only if ratified in the manner required under the Companies Law.
The remuneration of Directors may be fixed as an
overall payment or other consideration and/or as a payment or other consideration in
 respect of attendance at meetings of the Board of Directors. In addition to his
remuneration, each Director shall be entitled to be reimbursed,
retroactively or in advance, in respect of his reasonable expenses connected with performing his functions and
services as a Director.
Such entitlement shall be determined in accordance with, and shall be subject to, a specific resolution or policy adopted by the Board
of Directors
regarding such matter and in accordance with the requirements of applicable law.
 
79.
 
 
79.1.
Subject
to the provisions of the Companies Law with regard to External Directors and subject to Article
77 above and Article 82 below, the office of a member of the
Board of Directors shall be
vacated in any one of the following events:
 
79.1.1.
if
he resigns his office by way of a letter signed by him, lodged at the Office;
 
79.1.2.
if
he is declared bankrupt;
 
79.1.3.
if
he becomes insane or unsound of mind;
 
79.1.4.
upon
his death;
 
79.1.5.
if
he is prevented by applicable law from serving as a Director of the Company;
 
79.1.6.
if
the Board terminates his office according to Section 231 of the Companies Law;
 
79.1.7.
if
a court order is given in accordance with Section 233 of the Companies Law;
 
79.1.8.
if
he is removed from office by a Resolution at a General Meeting of the Company adopted by
a majority of the voting power in the Company; or
 
79.1.9.
if
his period of office has terminated in accordance with the provisions of these Articles.
 
79.2.
If
the office of a member of the Board of Directors should be vacated, the remaining members
of the Board of Directors shall be entitled to act for all purposes, for as
long as their
number does not fall below the minimum, for the time being, specified for the Directors,
as prescribed in Article 76 above. Should their number fall
below the aforesaid minimum,
the Directors shall not be entitled to act, except for the appointment of additional directors,
or for the purpose of calling a General
Meeting for the appointment of additional directors,
or for the purpose of calling a General Meeting for the appointment of a new Board of Directors.
 
 
 
 

 
 
79.3.
The
office of an External Director shall be vacated only in accordance with the provisions for
the vacation of office and the removal of External Directors under the
Companies Law.
 
OTHER
PROVISIONS REGARDING DIRECTORS
 
80.
 
 
80.1.
Subject
to any mandatory provisions of applicable law, a Director shall not be disqualified by virtue
of his office from holding another office in the Company or in
any other company in which
the Company is a shareholder or in which it has any other form of interest, or of entering
into a contract with the Company, either as
seller or buyer or otherwise. Likewise, no contract
made by the Company or on its behalf in which a Director has any form of interest may be
nullified and a Director
shall not be obliged to account to the Company for any profit deriving
from such office, or resulting from such contract, merely by virtue of the fact that he serves
as
a Director or by reason of the fiduciary relationship thereby created, but such Director
shall be obliged to disclose to the Board of Directors the nature of any such
interest at
the first opportunity.
 
A
general notice to the effect that a Director is a shareholder or has any other form of interest in a particular firm or a particular
company and that he must be deemed
to have an interest in any business with such firm or company shall be deemed to be adequate disclosure
for purposes of this Article in relation to such Director, and
after such general notice has been given, such Director shall not be obliged
to give special notice in relation to any particular business with such firm or such
company.
 
80.2.
Subject
to the provisions of the Companies Law and these Articles, the Company shall be entitled
to enter into a transaction in which an Office Holder of the
Company has a personal interest,
directly or indirectly, and may enter into any contract or otherwise transact any business
with any third party in which contract or
business an Office Holder has a personal interest,
directly or indirectly.
 
81.
The
Board of Directors shall elect one (1) or more of its members to serve as the Chairman of
the Board of Directors (the “ Chairman of the Board of Directors “), provided
that, subject to the provisions of Section 121(c) of the Companies Law, the Chief Executive
Officer of the Company shall not serve as Chairman of the Board of Directors.
The office
of Chairman of the Board of Directors shall be vacated in each of the cases mentioned in
Articles 79.1 above and 82 below. The Board of Directors may also elect
one or more members
to serve as Vice Chairman, who shall have such duties and authorities as the Board of Directors
may assign to him or her.
 
82.
Subject
to the relevant provisions of the Companies Law, the Company may, in a General Meeting, by
a Resolution adopted by a majority of the voting power in the
Company, dismiss any Director,
prior to the end of his term of office and the Board of Directors shall be entitled, by regular
majority, with the exception of the External
Directors who shall be appointed and removed
in accordance with the Companies Law, to appoint another individual in his place as a Director.
The individual so appointed
shall hold such office only for that period of time during which
the director whom he replaces would have held office.
 
83.
A
Director shall not be obliged to hold any share in the Company.
CHIEF
EXECUTIVE OFFICER
 
84.
 
84.1.
The
Board of Directors shall, from time to time, appoint a Chief Executive Officer and subject
to the provisions of the Companies Law delineate his powers and
authorities and his remuneration.
Subject to any contract between the Chief Executive Officer and the Company, the Board of
Directors may dismiss him or replace
him at any time it deems fit.
 
 
 
 

 
 
84.2.
A
Chief Executive Officer need not be a Director or Shareholder.
 
Subject
to the provisions of any contract between the Chief Executive Officer and the Company, if the Chief Executive Officer is also a Director,
all of the same
provisions with regard to appointment, resignation and removal from office shall apply to the Chief Executive Officer
in his capacity as a Director, as apply to the
Company’s other Directors.
 
84.3.
The
Board of Directors shall be entitled from time to time to delegate to the Chief Executive
Officer for the time being such of the powers it has pursuant to these
Articles as they deem
appropriate, and the Board of Directors shall be entitled to grant such powers for such period
and for such purposes and on such conditions and
with such restrictions as it deem appropriate,
and it shall be entitled to grant such powers without renouncing the powers and authorities
of the Board of Directors in
such regard, and it may, from time to time, revoke, annul and
alter such delegated powers and authorities, in whole or in part.
 
84.4.
Subject
to the provisions of any applicable law, the remuneration of the Chief Executive Officer
shall be fixed from time to time by the Board of Directors (and, so
long as required by the
Companies Law, shall be approved by the Compensation Committee and by the Shareholders unless
exempted from Shareholders approval)
and such remuneration may be in the form of a fixed
salary or commissions or a participation in profits, or in any other manner which may be
decided by the Board
of Directors (and approved according to this Article 84.4).
 
PROCEEDINGS
OF THE BOARD OF DIRECTORS
 
85.
 
85.1.
The
Board of Directors shall convene for a meeting at least once every fiscal quarter.
 
85.2.
The
Board of Directors may meet in order to exercise its powers pursuant to Section 92 of the
 Companies Law, including without limitation to supervise the
Company’s affairs, and
it may, subject to the provisions of the Companies Law,adjourn
its meetings and regulate its proceedings and operations as it deems fit. It may
also prescribe the quorum required for the conduct of
business. Until otherwise decided a quorum shall be constituted if a majority of the Directors holding office for
the time being are
present.
 
85.3.
Should
a Director or Directors be barred from being present and voting at a meeting of the Board
of Directors pursuant to Section 278 of the Companies Law, the
quorum shall be a majority
of the Directors entitled to be present and to vote at the meeting of the Board of Directors.
 
86.
Any
Director, the Chief Executive Officer or the auditor of the Company in the event stipulated
 in Section 169 of the Companies Law, may, at any time, demand the
convening of a meeting
of the Board of Directors. The Chairman of the Board shall be obliged, on such demand, to
call such meeting on the date requested by the Director, the
Chief Executive Officer or the
auditor of the Company soliciting such a meeting, provided that proper notice pursuant to
Article 87 is given.
 
87.
Every
Director shall be entitled to receive notice of meetings of the Board of Directors, and such
notice may be in writing or by facsimile, or electronic mail, sent to the last
address (whether
physical or electronic) or facsimile number given by the Director for purposes of receiving
 notices, provided that the notice shall be given at least a
reasonable amount of time prior
to the meeting and in no event less than 48 (forty eight) hours prior notice, unless the
urgency of the matter(s) to be discussed at the meeting
reasonably require(s) a shorter notice
period.
 
 
 
 

 
 
88.
Every
meeting of the Board of Directors at which a quorum is present shall have all the powers
and authorities vested for the time being in the Board of Directors.
 
89.
Questions
which arise at meetings of the Board of Directors shall be decided by a simple majority of
the members of the Board of Directors attending such meeting and voting
on such matter. Each
Director shall have one vote when voting at the Board of Directors. In the case of an equality
of votes of the Board of Directors, the Chairman of the
Board of Directors shall not have
a second or casting vote, and the proposal shall be deemed to be defeated.
 
If
the Chairman of the Board of Directors is not present within 30 (thirty) minutes after the time appointed for the meeting, the Directors
present shall elect one of their
members to preside at such meeting.
 
90.
The
Board of Directors may adopt resolutions, without actually convening a meeting of the Board
of Directors, provided that all the Directors entitled to participate in the
meeting and
to vote on the subject brought for decision agree thereto. If resolutions are made as stated
in this Article 90, the Chairman of the Board of Directors shall record
minutes of the decisions
stating the manner of voting of each Director on the subjects brought for decision, as well
as the fact that all the Directors agreed to take the decision
without actually convening.
 
91.
The
Board of Directors may hold meetings by use of any means of communication, on condition that
all participating Directors can hear each other at the same time. In the
case of a resolution
passed by way of a telephone call or any such other means of communication, a copy of the
text of the resolution shall be sent, as soon as possible
thereafter, to the Directors.
 
GENERAL
POWERS OF THE BOARD OF DIRECTORS
 
92.
The
supervision of the Company’s affairs shall be in the hands of the Board of Directors,
which shall be entitled to exercise all of the powers and authorities to perform any act
and deed which the Company is entitled to exercise and to perform in accordance with these
Articles or according to the Companies Law, and in respect of which there is no
provision
or requirement in these Articles, or in the Companies Law or/and in the U.S. Rules, that
such powers and authorities may be exercised or done by the Shareholders
in a General Meeting
or by a Committee of Directors.
 
93.
The
Board of Directors may, as it deems fit and subject to any applicable law, delegate to a
committee (a “ Committee of Directors “) certain of its powers and authorities,
in
whole or in part (as appropriate). The curtailment or revocation of the powers and authorities
of a Committee of Directors by the Board of Directors shall not invalidate a prior
act of
such Committee of Directors or an act taken in accordance with its instructions, which would
have been valid had the powers and authorities of the Committee of
Directors not been altered
or revoked by the Board of Directors. Subject to applicable law, a Committee of Directors
may be comprised of one (1) Director or of several
Directors, and in the case of a Committee
of Directors that is appointed to advise the Board of Directors only, persons who are not
Directors may be appointed to it.
 
94.
The
meetings and proceedings of every such Committee of Directors which is comprised of 2 (two)
or more members shall be conducted in accordance with the provisions
contained in these Articles
in regard to the conduct of meetings and proceedings of the Board of Directors to the extent
that the same are suitable for such committee, and so
long as no provisions have been adopted
in replacement thereof by the Board of Directors.
 
RATIFICATION
OF ACTIONS
 
95.
Subject
to the Companies Law, all acts taken in good faith by the Board of Directors and/or a Committee
of Directors or by an individual acting as a member thereof shall be
valid even if it is
subsequently discovered that there was a defect in the appointment of the Board of Directors,
the Committee of Directors or the member, as the case may be,
or that the members, or one
of them, was/were disqualified from being appointed as a Director/s or to a Committee of
Directors.
 
 
 
 

 
 
96.
 
96.1.
The
Board of Directors or any Committee of Directors may ratify any act the performance of which
at the time of the ratification was within the scope of the
authority of the Board of Directors
or the relevant Committee of Directors.
 
96.2.
The
General Meeting shall be entitled to ratify any act taken by the Board of Directors and/or
any Committee of Directors without authority or which was tainted by
some other defect.
 
96.3.
From
the time of the ratification, every act ratified as aforesaid, shall be treated as though
lawfully performed from the outset.
 
97.
The
Board of Directors may, from time to time, in its absolute discretion, borrow or secure any
amounts of money required by the Company for the conduct of its business.
 
98.
The
Board of Directors shall be entitled to raise or secure the repayment of an amount obtained
by them, in such way and on such conditions and times as they deem fit. The
Board of Directors
shall be entitled to issue documents of undertaking, such as options, debentures or debenture
stock, whether linked or redeemable, convertible debentures
or debentures convertible into
other securities, or debentures which carry a right to purchase shares or to purchase other
securities, or any mortgage, pledge, collateral or other
charge over the property of the
Company and its undertaking, in whole or in part, whether present or future, including the
uncalled share capital or the share capital which has
been called but not yet paid.
 
The
deeds of undertaking, debentures of various types or other forms of collateral security may be issued at a discount, at a premium or
otherwise and with such preferential or
deferred or other rights, as the Board of Directors shall, from time to time, decide.
 
SIGNING
POWERS
 
99.
Subject
to any other resolution on the subject passed by the Board of Directors, the Company shall
be bound only pursuant to a document in writing bearing its seal or its
rubber stamp or its
printed name, and the signature of whomever may be authorized by the Board of Directors,
which shall be entitled to empower any person, either alone or
jointly with another, even
if he is not a Shareholder or a Director, to sign and act in the name and on behalf of the
Company.
 
100.
The
Board of Directors shall be entitled to prescribe separate signing power in regard to different
businesses of the Company and in respect of the limit of the amounts in
respect of which
various persons shall be authorized to sign.
 
SECRETARY,
OFFICE-HOLDERS, CLERKS AND REPRESENTATIVES
 
101.
The
Board of Directors shall be entitled, from time to time, to appoint, or to delegate to the
Chief Executive Officer, either alone or together with other persons designated by
the Board
of Directors, the ability to appoint Office Holders (other than Directors), a Secretary for
the Company, employees and agents to such permanent, temporary or
special positions, and
to specify and change their titles, authorities and duties, and may set, or delegate to the
Chief Executive Officer, either alone or together with other
persons designated by the Board
of Directors, the ability to set salaries, bonuses and other compensation of any employee
or agent who is not an Office Holder. Salaries,
bonuses and compensation of Office Holders
who are not Directors shall be determined and approved by the Chief Executive Officer, and/or
in such other manner as may be
required from time to time under the Companies Law. The Board
of Directors, or the Chief Executive Officer, either alone or together with other persons
designated by the
Board of Directors, (in the case of any Office Holder, employee or agent
appointed thereby), shall be entitled at any time, in its, his or their (as applicable) sole
and absolute
discretion, to terminate the services of one of more of the foregoing persons
(in the case of a Director, however, subject to compliance with Article 79 above), subject
to any
other requirements under applicable law.
 
 
 
 

 
 
102.
The
Board of Directors and the Chief Executive Officer may from time to time and at any time,
subject to their powers under these Articles and the Companies Law, empower
any person to
serve as representative of the Company for such purposes and with such powers and authorities,
instructions and discretions for such period and subject to such
conditions as the Board
of Directors (or the Chief Executive Officer, as the case may be) shall deem appropriate.
Consistent with the preceding sentence, the Board of
Directors (or the Chief Executive Officer,
as the case may be) may grant such person, inter alia , the power to transfer the
authority, powers and discretions vested in him, in
whole or in part. The Board of Directors
may (or the Chief Executive Officer, as the case may be), from time to time, revoke, annul,
vary or change any such power or
authority, or all such powers or authorities collectively.
 
DIVIDENDS,
BONUS SHARES, FUNDS AND CAPITALIZATION OF FUNDS AND PROFITS
 
103.
Unless
otherwise permitted by the Companies Law, no dividends shall be paid other than out of the
Company’s profits available for distribution as set forth in the Companies
Law.
 
104.
The
Board of Directors may decide on the payment of a dividend or on the distribution of bonus
shares.
 
105.
A
dividend in cash or bonus shares shall be paid or distributed, as the case may be, equally
to the holders of the Ordinary Shares registered in the Register, pro rata to the
nominal
amount of capital paid up or credited as paid up on par value of the shares, without reference
to any premium which may have been paid thereon. However, whenever
the rights attached to
any shares or the terms of issue of the shares do not provide otherwise, an amount paid on
account of a share prior to the payment thereof having been
called, or prior to the due date
for payment thereof, and on which the Company is paying interest, shall not be taken into
account for purposes of this Article as an amount
paid-up on account of the share.
 
106.
Unless
other instructions are given, it shall be permissible to pay any dividend by way of a check
or payment order to be sent by post to the registered address of the
Shareholder or the Person
entitled thereto, or in the case of joint Shareholders being registered, to the Shareholder
whose name appears first in the Register in relation to the
joint shareholding. Every such
check shall be made in favor of the Person to whom it is sent. A receipt by the Person whose
name, on the date of declaration of the dividend,
was registered in the Register as the owner
of the shares, or in the case of joint holders, by one of the joint holders, shall serve
as a discharge with regard to all the payments
made in connection with such share.
 
The
Board of Directors shall be entitled to invest any dividend which has not been claimed for a period of one (1) year after having
been declared, or to make use thereof in
any other way for the benefit of the Company until such time as it is claimed. The Company
shall not be obliged to pay interest or linkage in respect of an unclaimed dividend.
The payment by the Board of Directors of any
unclaimed dividend into a separate account shall not constitute the Company a trustee in respect thereof, and any dividend
unclaimed
after a period of seven (7) years from the date of declaration of such dividend, shall be forfeited and shall revert to the
Company, provided, however, that the Board
of Directors may, at its discretion, cause the Company to pay any such dividend, or any
part thereof, to a person who would have been entitled thereto had the same not
reverted to the Company.
 
107.
Unless
otherwise specified in the terms of issue of shares or securities convertible into, or which
grant a right to purchase, shares, any shares that are fully paid-up or credited
as paid-up
shall at any time confer on their holders the right to participate in the full dividends
and in any other distribution for which the determining date for the right to
receive the
same is the date at which the aforesaid shares were fully paid-up or credited as fully paid-up,
as the case may be, or subsequent to such date.
 
 
 
 

 
 
108.
A
dividend or other beneficial rights in respect of shares shall not bear interest.
 
109.
The
Board of Directors shall be entitled to deduct from any dividend or other beneficial rights,
all amounts of money which the holder of the share in respect of which the
dividend is payable
or in respect of which the other beneficial rights were given, may owe to the Company in
respect of such share, whether or not the due date for payment
thereof has arrived.
 
110.
The
Board of Directors shall be entitled to retain any dividend or bonus shares or other beneficial
rights in respect of a share in relation to which the Company has a lien, and
to utilize
any such amount or the proceeds received from the sale of any bonus shares or other beneficial
rights, for the discharge of the debts or liabilities in respect of which
the Company has
a lien.
 
111.
The
Board of Directors may decide that a dividend is to be paid, in whole or in part, by way
of a distribution of assets of the Company in kind, including by way of debentures
or debenture
stock of the Company, or shares or debentures or debenture stock of any other company, or
in any other way.
 
112.
 
112.1.
The
Board of Directors may, at any time and from time to time, decide that any portion of the
amounts standing for the time being to the credit of any capital fund
(including a fund created
as a result of a revaluation of the assets of the Company), or which are held by the Company
as profits available for distribution, shall be
capitalized for distribution subject to and
in accordance with the provisions of the Companies Law and of these Articles, amongst those
Shareholders who are entitled
thereto and pro rata to their entitlement under these Articles,
provided that the same shall not be paid in cash but shall serve for the payment up in full
either at par or
with a premium as prescribed by the Company, of shares which have not yet
been issued or of debentures of the Company which shall be allotted and distributed
amongst
the Shareholders in the aforesaid ratio as fully paid-up shares or debentures.
 
112.2.
The
Board of Directors shall be entitled to distribute bonus shares and to decide that the bonus
shares shall be of the same class which confers on the Shareholders or
the Persons entitled
thereto the right to participate in the distribution of bonus shares, or may decide that
the bonus shares shall be of a uniform class to be distributed
to each of the Shareholders
or Persons entitled to shares as aforesaid, without reference to the class of shares conferring
the right to participate in the distribution on
the holders of the shares or the Persons
entitled thereto as aforesaid.
 
113.
 
113.1.
In
every case that the Company issues bonus shares by way of a capitalization of profits or
funds at a time at which securities issued by the Company are in
circulation and confer on
the holders thereof rights to convert the same into shares in the share capital of the Company,
or options to purchase shares in the share
capital of the Company (such rights of conversion
or options shall henceforth be referred to as the “ Rights “), the Board
of Directors shall be entitled (in a case that
the Rights or part thereof shall not be otherwise
adjusted in accordance with the terms of their issue) to transfer to a special fund designated
for the distribution of
bonus shares in the future (to be called by any name that the Board
of Directors may decide on and which shall henceforth be referred to as the “ Special
Fund “) an
amount equivalent to the nominal amount of the share capital to which
some or all of the Rights holders would have been entitled as a result of the issue of bonus
shares, had they exercised their Rights prior to the determining date for the right to receive
bonus shares, including rights to fractions of bonus shares, and in the case
of a second
or additional distribution of bonus shares in respect of which the Company acts pursuant
to this Article, including entitlement stemming from a previous
distribution of bonus shares.
 
 
 
 

 
 
 
113.2.
In
the case of the allotment of shares by the Company as a consequence of the exercise of entitlement
by the owners of shares in those cases in which the Board of
Directors has made a transfer
to the Special Fund in respect of the Rights pursuant to Article 113.1 above, the Board of
Directors shall allot to each such shareholder,
in addition to the shares to which he is
entitled by virtue of having exercised his rights, such number of fully paid-up shares the
nominal value of which is equivalent
to the amount transferred to the Special Fund in respect
of his rights, by way of a capitalization to be effected by the Board of Directors of an
appropriate amount out
of the Special Fund. The Board of Directors shall be entitled to decide
on the manner of dealing with rights to fractions of shares in its sole discretion.
 
 
 
113.3.
If
after any transfer to the Special Fund has been made the Rights should lapse, or the period
should end for the exercise of Rights in respect of which the transfer
was effected without
such Rights being exercised, then any amount which was transferred to the Special Fund in
respect of the aforesaid unexercised Rights shall be
released from the Special Fund, and
the Company may deal with the amount so released in any manner it would have been entitled
to deal therewith had such amount
not been transferred to the Special Fund.
 
114.
For
the implementation of any resolution regarding a distribution of shares or debentures by
way of a capitalization of profits as aforesaid, the Board of Directors may:
 
114.1.
Resolve
any difficulty which arises or may arise in regard to the distribution in such manner as
it deems fit and may take all of the steps that it deems appropriate in
order to overcome
such difficulty.
 
114.2.
Issue
certificates in respect of fractions of shares, or decide that fractions of less than an
amount to be decided by the Board of Directors shall not be taken into
account for purposes
of adjusting the rights of the Shareholders or may sell the fractions of shares and pay the
proceeds (net) to the Persons entitled thereto.
 
114.3.
Sign,
or appoint a Person to sign, on behalf of the Shareholders on any contract or other document
which may be required for purposes of giving effect to the
distribution, and, in particular,
shall be entitled to sign or appoint a Person who shall be entitled to appoint and submit
a contract as referred to in Section 291 of the
Companies Law.
 
114.4.
Make
any arrangement or other scheme which is required in the opinion of the Board of Directors
in order to facilitate the distribution.
 
115.
The
Board of Directors shall be entitled, as it deems appropriate and expedient, to appoint trustees
or nominees for those registered Shareholders who have failed to notify the
Company of a
change of their address and who have not applied to the Company in order to receive dividends,
shares or debentures out of capital, or other benefits during the
aforesaid period. Such
trustees or nominees shall be appointed for the use, collection or receipt of dividends,
shares or debentures out of capital and rights to subscribe for
shares which have not yet
been issued and which are offered to the Shareholders but they shall not be entitled to transfer
the shares in respect of which they were appointed, or
to vote on the basis of holding such
shares. In all of the terms and conditions governing such trusts and the appointment of such
nominees it shall be stipulated by the
Company that upon the first demand by a beneficial
holder of a share being held by the trustee or nominee, such trustee or nominee shall be
obliged to return to such
shareholder the share in question and/or all of those rights held
by it on the Shareholder’s behalf (all as the case may be). Any act or arrangement
effected by any such
nominees or trustee and any agreement between the Board of Directors
and a nominee or trustee shall be valid and binding in all respects.
 
116.
The
Board of Directors may from time to time prescribe the manner for payment of dividends or
the distribution of bonus shares and the arrangement connected therewith.
Without derogating
from the generality of the foregoing, the Board of Directors shall be entitled to pay any
dividends or moneys in respect of shares by sending a check via
the mails to the address
of the holder of registered shares according to the address registered in the register of
Shareholders. Any dispatch of a check as aforesaid shall be done
at the risk of the shareholder.
 
 
 
 

 
 
In
those cases in which the Board of Directors specifies the payment of a dividend, distribution of shares or debentures out of capital,
or the grant of a right to subscribe for
shares which have not yet been issued and which are offered to the Shareholders against the
delivery of an appropriate coupon attached to any share certificate, such payment,
distribution or grant of right to subscribe against
a suitable coupon to the holder of such coupon, shall constitute a discharge of the Company’s debt in respect of such
operation
as against any person claiming a right to such payment, distribution or grant of right to subscribe, as the case may be.
 
117.
If
two (2) or more Persons are registered as joint holders of a share, each of them shall be
entitled to give a valid receipt in respect of any dividend, share or debenture out of
capital,
or other moneys, or benefits, paid or granted in respect of such share.
 
BOOKS
OF THE COMPANY
 
118.
The
Board of Directors shall comply with all the provisions of the Companies Law in regard to
the recording of charges and the keeping and maintaining of a register of
directors, register
of Shareholders and register of charges.
 
119.
Any
book, register and record that the Company is obliged to keep in accordance with the Companies
Law or pursuant to these Articles shall be recorded in a regular book, or
by digital, electronic
or other means, as the Board of Directors shall decide.
 
120.
Subject
to and in accordance with the provisions of Sections 138 and 139 of the Companies Law, the
Company may cause supplementary registers to be kept in any place
outside Israel as the Board
of Directors may deem fit, and, subject to all applicable requirements of the Companies Law,
the Board of Directors may from time to time adopt
such rules and procedures as it may deem
fit in connection with the keeping of such supplementary registers.
 
BOOKS
OF ACCOUNT
 
121.
The
Board of Directors shall keep proper books of account in accordance with the provisions of
the Companies Law. The books of account shall be kept at the Office, or at
such other place
or places as the Board of Directors shall deem appropriate, and shall at all times be open
to the inspection of members of the Board of Directors. A
Shareholder of the Company who
is not a member of the Board of Directors shall not have the right to inspect any books or
accounts or documents of the Company, unless
such right has been expressly granted to him
by the Companies Law, or if he has been permitted to do so by the Board of Directors or by
the Shareholders based on a
Resolution adopted at a General Meeting.
 
122.
The
Board of Directors shall arrange and submit for discussion at the General Meeting the financial
information prescribed under the Companies Law and any regulations
promulgated thereunder.
 
123.
At
least once each year the accounts of the Company and the correctness of the statement of
income and the balance sheet shall be audited and confirmed by an independent
auditor or
auditors.
 
124.
The
Company shall, in an annual General Meeting, appoint an independent auditor or auditors who
shall hold such position until the next annual General Meeting, and their
appointment, remuneration
and rights and duties shall be subject to the provisions of the Companies Law, provided,
however, that in exercising its authority to fix the
remuneration of the auditor(s), the
Shareholders in an annual General Meeting may, by a Resolution, act (and in the absence of
any action in connection therewith shall be
deemed to have so acted) to authorize the Board
of Directors to fix such remuneration subject to such criteria or standards, if any, as may
be provided in such Resolution, and
if no such criteria or standards are so provided, such
remuneration shall be fixed in an amount commensurate with both the volume and nature of
the services rendered by the
auditor(s). By an act appointing such auditors, the Company
may appoint the auditor(s) to serve for a period of up to the end of completion of the audit
of the yearly financial
statements for the three (3) year period then ended.
 
 
 
 

 
 
125.
The
auditors shall be entitled to receive notices of every General Meeting of the Company and
to attend such meetings and to express their opinions on all matters pertaining
to their
function as the auditors of the Company.
 
126.
Subject
to the provisions of the Companies Law and the U.S. Rules, any act carried out by the auditors
of the Company shall be valid as against any person doing business in
good faith with the
Company, notwithstanding any defect in the appointment or qualification of the auditors.
 
127.
For
as long as the Company is a Public Company, as defined in the Companies Law, it shall appoint
an internal auditor possessing the authorities set forth in the Companies
Law. The internal
auditor of the Company shall present all of its proposed work plans to the Audit Committee
of the Board of Directors, which shall have the authority to
approve them, subject to any
modifications in its discretion.
 
NOTICES
 
128.
 
128.1.
The
Company may serve any written notice or other document on a Shareholder by way of delivery
by hand, by facsimile transmission or by dispatch by prepaid
registered mail to his address
as recorded in the Register, or if there is no such recorded address, to the address given
by him to the Company for the sending of
notices to him. Notwithstanding the foregoing or
any other provision to the contrary contained herein, notices or any other information or
documents required to be
delivered to a Shareholder shall be deemed to have been duly delivered
if submitted, published, filed or lodged in any manner prescribed by applicable law. With
respect to the manner of providing such notices or other disclosures, the Company may distinguish
between the Shareholders listed on its regular Registry and those
listed in any “additional
registry”, as defined in Section 138(a) of the Companies Law, administered by a transfer
agent or stock exchange registration company.
 
128.2.
Any
Shareholder may serve any written notice or other document on the Company by way of delivery
by hand at the Office, by facsimile or email transmission to the
Company or by dispatch by
prepaid registered mail to the Company at the Office.
 
128.3.
Any
notice or document which is delivered or sent to a Shareholder in accordance with these Articles
shall be deemed to have been duly delivered and sent in respect
of the shares held by him
(whether in respect of shares held by him alone or jointly with others), notwithstanding
the fact that such Shareholder has died or been
declared bankrupt at such time (whether or
not the Company knew of his death or bankruptcy), and shall be deemed to be sufficient delivery
or dispatch to heirs,
trustees, administrators or transferees and any other persons (if any)
who have a right in the shares.
 
128.4.
Any
such notice or other document shall be deemed to have been served:
 
128.4.1. in
the case of mailing, 48 hours after it has been posted, or when actually received by the
addressee if sooner than 48 hours after it has been posted;
 
128.4.2. in
the case of overnight air courier, on the next day following the day sent, with receipt confirmed
by the courier, or when actually received by the addressee if
sooner;
 
128.4.3. in
the case of personal delivery, when actually tendered in person to such Shareholder;
 
 
 
 

 
 
128.4.4. in
the case of facsimile or other electronic transmission (including email), the next day following
the date on which the sender receives automatic electronic
confirmation by the recipient’s
facsimile machine or computer or other device that such notice was received by the addressee;
or
 
128.4.5. in
the case a notice is, in fact, received by the addressee, when received, notwithstanding
that it was defectively addressed or failed, in some other respect, to
comply with the provisions
of this Article 128.
 
129.
Any
Shareholder whose address is not described in the Register, and who shall not have designated
in writing an address for the receipt of notices, shall not be entitled to
receive any notice
from the Company. In the case of joint holders of a share, the Company shall be entitled
to deliver a notice by dispatch to the joint holder whose name
stands first in the Register
in respect of such share.
 
130.
Whenever
it is necessary to give notice of a particular number of days or a notice for another period,
the day of delivery shall be counted in the number of calendar days or the
period, unless
otherwise specified.
 
131.
Notwithstanding
anything to the contrary contained herein, notice by the Company of a General Meeting, containing
the information required to be set forth in such notice
under these Articles, which is published,
within the time otherwise required for giving notice of such meeting, in:
 
131.1.
at
least two daily newspapers in the State of Israel shall be deemed to be notice of such meeting
duly given, for the purposes of these Articles, to any Shareholder
whose address as registered
in the Register (or as designated in writing for the receipt of notices and other documents)
is located in the State of Israel; and
 
131.2.
one
daily newspaper in New York, NY, United States, and in one international wire service shall
be deemed to be notice of such meeting duly given, for the purposes
of these Articles, to
any shareholder whose address as registered in the Register (or as designated in writing
for the receipt of notices and other documents) is located
outside the State of Israel.
 
INSURANCE,
INDEMNITY AND EXCULPATION
 
132.
Subject
to the provisions of the Companies Law, the Company shall be entitled to enter into a contract
to insure all or part of the liability of an Office Holder of the Company,
imposed on him
in consequence of an act which he has performed by virtue of being an Office Holder, in respect
of any of the following:
 
132.1.
The
breach of a duty of care to the Company or to any other Person;
 
132.2.
The
breach of a fiduciary duty to the Company, provided that the Office Holder acted in good
faith and had reasonable grounds for believing that the action would
not adversely affect
the best interests of the Company;
 
132.3.
A
pecuniary liability imposed on him in favor of any other person in respect of an act done
in his capacity as an Office Holder.
 
132.4.
Any
other circumstances arising under the law with respect to which the Company may, or will
be able to, insure an Office Holder.
 
133.
Subject
to the provisions of the Companies Law, the Company shall be entitled to indemnify an Office
Holder of the Company, to the fullest extent permitted by applicable
law. Subject to the
provisions of the Companies Law, including the receipt of all approvals as required therein
or under any applicable law, the Company may resolve
retroactively to indemnify an Office
Holder with respect to the following liabilities and expenses, provided, in each of the below
cases, that such liabilities or expenses were
incurred by such Office Holder in such Office
Holder’s capacity as an Office Holder of the Company:
 
 
 
 

 
 
133.1.
a
monetary liability imposed on him in favor of a third party in any judgment, including any
settlement confirmed as judgment and an arbitrator’s award which has
been confirmed
by the court, in respect of an act performed by the Office Holder by virtue of the Office
Holder being an Office Holder of the Company; provided,
however, that: (a) any indemnification
undertaking with respect to the foregoing shall be limited (i) to events which, in the opinion
of the Board of Directors, are
foreseeable in light of the Company’s actual operations
at the time of the granting of the indemnification undertaking, and (ii) to an amount or
by criteria determined
by the Board of Directors to be reasonable in the given circumstances;
and (b) the events that in the opinion of the Board of Directors are foreseeable in light
of the
Company’s actual operations at the time of the granting of the indemnification
undertaking are listed in the indemnification undertaking together with the amount or
criteria
determined by the Board of Directors to be reasonable in the given circumstances;
 
133.2.
reasonable
litigation expenses, including legal fees, paid for by the Office Holder, in an investigation
or proceeding conducted against such Office Holder by an
agency authorized to conduct such
investigation or proceeding, and which investigation or proceeding: (i) concluded without
the filing of an indictment (as defined in
the Companies Law) against such Office Holder
 and without there having been a monetary liability imposed against such Office Holder in
 lieu of a criminal
proceeding (as defined in the Companies Law); (ii) concluded without the
filing of an indictment against such Office Holder but with there having been a monetary
liability imposed against such Office Holder in lieu of a criminal proceeding for an offense
that does not require proof of criminal intent; or (iii) involves financial
sanction;
 
133.3.
reasonable
litigation expenses, including legal fees, paid for by the Office Holder, or which the Office
Holder is obligated to pay under a court order, in a proceeding
brought against the Office
Holder by the Company, or on its behalf, or by a third party, or in a criminal proceeding
in which the Office Holder is found innocent, or in
a criminal proceeding in which the Office
Holder was convicted of an offense that does not require proof of criminal intent; and
 
133.4.
any
other event, occurrence or circumstances in respect of which the Company may lawfully indemnify
an Office Holder of the Company (including, without
limitation, indemnification with respect
to the matters referred to under Section 56h(b)(1) of the Israeli Securities Law 5728-1968,
as amended.
 
133.5.
The
Company may undertake to indemnify an Office Holder as aforesaid:
(i) prospectively, provided that the undertaking is limited to categories of events which
in the
opinion of the Board of Directors can be foreseen when the undertaking to indemnify
is given, and to an amount set by the Board of Directors as reasonable under the
circumstances,
and (ii) retroactively.
 
134.
Subject
to the provisions of the Companies Law including the receipt of all approvals as required
therein or under any applicable law, the Company may, to the maximum
extent permitted by
the Companies Law, exempt and release, in advance, any Office Holder from any liability for
damages arising out of a breach of a duty of care towards the
Company.
 
135.
 
135.1.
Any
amendment to the Companies Law adversely affecting the right of any Office Holder to be indemnified
or insured pursuant to Articles 132, 133 and 134 and any
amendments to Articles 132, 133
and 134 shall be prospective in effect, and shall not affect the Company’s obligation
or ability to indemnify or insure an Office
Holder for any act or omission occurring prior
to such amendment, unless otherwise provided by applicable law.
 
 
 
 

 
 
135.2.
The
provisions of Articles 132, 133 and 134 are not intended, and shall not be interpreted so
as to restrict the Company, in any manner, in respect of the procurement
of insurance and/or
in respect of indemnification and/or exculpation, in favor of any person who is not an Office
Holder, including, without limitation, any employee,
agent, consultant or contractor of the
Company who is not an Office Holder; and/or any Office Holder to the extent that such insurance
and/or indemnification is not
specifically prohibited under law.
 
WINDING-UP
AND REORGANIZATION
 
136.
Should
the Company be wound up and the assets of the Company made available for distribution among
Shareholders be insufficient to repay all of the Company’s paid-up
capital, such assets
shall be divided in a manner whereby the losses shall, as far as possible, be borne by the
Shareholders pro rata to the nominal value of the paid-up capital
on the shares held by each
of them, and, if at the time of the winding-up, the property of the Company available for
distribution among the Shareholders should exceed the
amount sufficient for the repayment
of the full nominal value of the paid-up capital at the time of commencement of the winding-up,
the surplus shall be distributed to the
Shareholders pro rata to the paid-up capital held
by each of them.
 
137.
Upon
the sale of the Company’s assets, the Board of Directors may, or in the case of a liquidation,
the liquidators may, if authorized to do so by a Resolution of the Company,
accept fully
or partly paid-up shares, or securities of another company, Israeli or non-Israeli, whether
in existence at such time or about to be formed, in order to purchase the
property of the
Company, or part thereof, and to the extent permitted under the Companies Law, the Board
of Directors may (or in the case of a liquidation, the liquidators
may) distribute the aforesaid
shares or securities or any other property of the Company among the Shareholders without
realizing the same, or may deposit the same in the
hands of trustees for the Shareholders,
and the General Meeting by a Resolution may decide, subject to the provisions of the Companies
Law, on the distribution or allotment
of cash, shares or other securities, or the property
of the Company and on the valuation of the aforesaid securities or property at such price
and in such manner as the
Shareholders at such General Meeting shall decide, and all of the
Shareholders shall be obliged to accept any valuation or distribution determined as aforesaid
and to waive
their rights in this regard, except, in a case in which the Company is about
to be wound-up and is in the process of liquidation, for those legal rights (if any) which,
according
to the provisions of the Companies Law, may not be changed or modified.
 
*           *           *
 
 

 
 
Changes to the Articles
of Association, approved by the shareholders on July 29, 2020
 
AMENDMENTS
TO CURRENT ARTICLES OF ASSOCIATION
 
Article
6 of the Company’s Articles of Association will read as follows:
 
The
Company’s share capital shall be NIS 1,500,000 divided as follows:
 
The
share capital of the Company shall consist of NIS 1,500,000 divided into 150,000,000 Ordinary Shares, of a nominal value of NIS 0.01
each (the “Ordinary Shares”).
 
 
 
 

 
 
Changes
to the Articles of Association, approved by the shareholders on July 7, 2022
 
AMENDMENTS
TO CURRENT ARTICLES OF ASSOCIATION
 
Article
6 of the Company’s Articles of Association will read as follows:
 
The Company’s share capital shall be NIS 2,000,000
divided as follows:
 
The
share capital of the Company shall consist of NIS 2,000,000 divided into 200,000,000 Ordinary Shares, of a nominal value of NIS 0.01
each (the “Ordinary Shares”).
 
 
 
 

 
Exhibit
3.2
 
THE
COMPANIES ORDINANCE
A
COMPANY LIMITED BY SHARES
 
MEMORANDUM
OF ASSOCIATION
OF
MEDICARD
LTD.
 
1.
The
name of the Company is:
 
In
Hebrew : 
 
In
English : Medicard Ltd.
 
2.
The principal
objects for which the Company was founded are:
 
 
(a) To conduct
research and development activities in all aspects of Bio-technology and medical devices; and
(b) To establish,
found, invest, participate in establishing or founding, to enter a partnership or otherwise join any body corporate or legal entity
in accordance with law; and
(c) In general
to engage in any other business commercial, industry or other activity of any kind which is not legally prohibited or restricted
by law.
 
 
3.
The liability
of the members is limited.
 
 
4.
The initial
share capital of the Company is:
 
NIS
38,000 divided into 38,000 Ordinary Shares of NIS 1.00 (One New Israel Shekel) each.
 
5.
We, the
several persons whose names and addresses are subscribed, desire to incorporate a company in accordance with this Memorandum of Association,
 and we hereby
respectively agree to subscribe to the number of shares in the Company’s share capital as written next to our
names below:
 
 
 
Name
and Addresses of
Subscribers
 
identification
Numbers
 
Number
of Shares Subscribed to by
each
Subscriber
 
Signatures
1.
 
Eager-Bio
Ltd. Sitrya 7 Israel 76834
 
51-239553-4
 
99
Ordinary Shares
 
[Eager-Bio
Ltd.]
2.
 
Pro.
Max Herzberg Sitrya 7 Israel 76834
 
02-607808-9
 
1
Ordinary Share
 
[Prof.
Max Herzberg]
Total
number of shares subscribed to: 100
 
Date: January 27, 2000
 
 
 
 
Witness
to above signatures:
[/s/
Yuval Horn]
 
 
 

 
 
Companies
Registrar
 
Ministry
of Justice
 
State
of Israel
Companies
Law 5759-1999
 
Change
of Company Name Certificate
 
I
hereby approve that based on a resolution and in accordance with provision 31(b) to the Companies Law, 5759-1999
 
 
MEDICARD
LTD
 
Changed
its name and shall now be named
 
 
VASCULAR
BIOGENICS LTD
 
Given
in my signature in Jerusalem
 
1
of Shvat 5762
14/01/02
 
Company’s
number 512899766
 
 
Yehuda
Kats, Advocate
 
 
 
Registrar
of Companies
 
 

 
 
Changes
to the Memorandum of Association, approved by the shareholders on April 23, 2014
 
AMENDMENTS
TO CURRENT MEMORANDUM OF ASSOCIATION
 
Effective
as of the Closing and subject thereto to replace Article 4 of the Company’s Memorandum of Association, so that it will read, in
its entirety, as follows:
 
“4.
The Company’s share capital shall be NIS 50,000, divided as follows:
 
(a)
1,419,005 Ordinary Shares, NIS 0.01 par value each;
(b)
132,586 Series A Preferred Shares, NIS 0.01 par value each;
(c)
570,217 Series B Preferred Shares, NIS 0.01 par value each;
(d)
342,778 Series C Preferred Shares, NIS 0.01 par value each;
(e)
1,585,414 Series D Preferred Shares, NIS 0.01 par value each;
(f)
325,000 Series D-1 Preferred Shares, NIS 0.01 par value each; and
(g)
625,000 Series E Preferred Shares, par value NIS 0.01 per share.”
 
 

 
 
Changes
to the Memorandum of Association, approved by the shareholders on June 18, 2014
 
AMENDMENTS
TO CURRENT MEMORANDUM OF ASSOCIATION
 
1.
Effective
immediately prior to the closing of the Public Offering and subject thereto to replace Article
4 of the Company’s Memorandum of Association, in its entirety, so that
it will read
as follows:
 
“4.
The Company’s share capital shall be NIS 70,000 consisting of Seventy Million Ordinary Shares of the Company of nominal value NIS
0.01 each,”
 
2.
Any
future amendment of the articles of association of the Company, as shall be in effect from
time to time, shall automatically amend any applicable corresponding provision
of the Memorandum
of Association without any further need to specifically amend the Memorandum of Association
and that such amendment shall enter into effect according
to and by the requisite majority
for amending the articles of association.
 
 

 
 
Changes
to the Memorandum of Association, approved by the shareholders on July 10, 2014
 
AMENDMENTS
TO CURRENT MEMORANDUM OF ASSOCIATION
 
Article
4 of the Company’s Memorandum of Association will read as follows:
 
The
Company’s share capital shall be NIS 700,000 divided as follows:
 
 
(a) 49,200,000
Ordinary Shares, NIS 0.01 par value each;
 
(b) 1,100,000
Series A Preferred Shares, NIS 0.01 par value each;
 
(c) 4,600,000
Series B Preferred Shares, NIS 0.01 par value each;
 
(d) 2,400,000
Series C Preferred Shares, NIS 0.01 par value each;
 
(e) 10,000,000
Series D Preferred Shares, NIS 0.01 par value each; and
 
(f)
2,700,000
Series E Preferred Shares, NIS 0.01 par value each.
 
The
foregoing does not derogate from the Shareholders resolutions dated June 18, 2014.
 
 

 
 
Changes
to the Memorandum of Association, approved by the shareholders on July 29, 2020
 
AMENDMENTS
TO CURRENT MEMORANDUM OF ASSOCIATION
 
Article
4 of the Company’s Memorandum of Association will read as follows:
 
The
Company’s share capital shall be NIS 1,500,000 divided as follows:
 
The
share capital of the Company shall consist of NIS 1,500,000 divided into 150,000,000 Ordinary Shares, of a nominal value of NIS 0.01
each (the “Ordinary Shares”).
 
 

 
 
Changes
to the Memorandum of Association, approved by the shareholders on July 7, 2022
 
AMENDMENTS
TO CURRENT MEMORANDUM OF ASSOCIATION
 
Article
4 of the Company’s Memorandum of Association will read as follows:
 
The
Company’s share capital shall be NIS 2,000,000 divided as follows:
 
The
share capital of the Company shall consist of NIS 2,000,000 divided into 200,000,000 Ordinary Shares, of a nominal value of NIS 0.01
each (the “Ordinary Shares”).
 
 

 
Exhibit
4.1
 
DESCRIPTION
OF SECURITIES
 
The
following description of the capital stock of Vascular Biogenics Ltd. (“us,” “our,” “we” or the “Company”)
is a summary of the rights of our ordinary shares and certain provisions
of our articles of association currently in effect. This summary
does not purport to be complete and is qualified in its entirety by the provisions of our articles of association previously
filed with
the Securities and Exchange Commission and incorporated by reference as an exhibit to the Annual Report on Form 10-K of which this Exhibit
4.1 is a part, as well as to the
applicable provisions of the Israeli Companies Law. We encourage you to read our articles of associations
and applicable portions of the Israeli Companies Law carefully.
 
Authorized
Capital
 
General
 
Our
authorized share capital consists solely of 200,000,000 ordinary shares, par value NIS 0.01 per share. All of our outstanding ordinary
shares are validly issued, fully paid and non-
assessable. Our ordinary shares are not redeemable and do not have any preemptive rights.
 
Registration
Number and Purpose of the Company
 
Our
registration number with the Israeli Registrar of Companies is 51-289976-6. Our purpose as set forth in our amended and restated articles
of association is to engage in any lawful
activity.
 
Voting
Rights and Conversion
 
All
ordinary shares will have identical voting and other rights in all respects.
 
Transfer
of Shares
 
Our
fully paid ordinary shares are issued in registered form and may be freely transferred under our amended and restated articles of association,
unless the transfer is restricted or
prohibited by another instrument, applicable law or the rules of a stock exchange on which the shares
are listed for trade. The ownership or voting of our ordinary shares by non-
residents of Israel is not restricted in any way by our amended
and restated articles of association or the laws of the State of Israel, except for ownership by nationals of some countries
that are,
or have been, in a state of war with Israel.
 
Election
of Directors
 
Our
ordinary shares do not have cumulative voting rights for the election of directors. As a result, the holders of a majority of the voting
power represented at a shareholders meeting
have the power to elect all of our directors, subject to the special approval requirements
for external directors.
 
Under
our amended and restated articles of association, our board of directors must consist of not less than three, not including two external
directors, but no more than nine directors
(including the external directors). Pursuant to our amended and restated articles of association,
other than the external directors, for whom special election requirements apply under the
Companies Law, the vote required to appoint
a director is a simple majority vote of holders of our voting shares, participating and voting at the relevant meeting. Each director
will
serve until his or her successor is duly elected and qualified or until his or her earlier death, resignation or removal by a vote
of the majority voting power of our shareholders at a
general meeting of our shareholders or until his or her office expires by operation
of law, in accordance with the Companies Law. In addition, our amended and restated articles of
association allow our board of directors
to appoint directors to fill vacancies on the board of directors to serve for a term of office equal to the remaining period of the term
of office of
the directors(s) whose office(s) have been vacated. External directors are elected for an initial term of three years, may
be elected for additional terms of three years each under certain
circumstances, and may be removed from office pursuant to the terms
of the Companies Law. Following the adoption by the Company of certain reliefs provided under the Companies
Law, the Company is exempt
from the requirement to appoint external directors.
 
 

 
 
Dividend
and Liquidation Rights
 
We
may declare a dividend to be paid to the holders of our ordinary shares in proportion to their respective shareholdings. Under the Companies
Law, dividend distributions are
determined by the board of directors and do not require the approval of the shareholders of a company
unless the company’s articles of association provide otherwise. Our amended and
restated articles of association do not require
shareholder approval of a dividend distribution and provide that dividend distributions may be determined by our board of directors.
 
Pursuant
to the Companies Law, the distribution amount is limited to the greater of retained earnings or earnings generated over the previous
two years, according to our then last
reviewed or audited financial statements, provided that the date of the financial statements is
not more than six months prior to the date of the distribution, or we may otherwise only
distribute dividends that do not meet such criteria
only with court approval. In each case, we are only permitted to distribute a dividend if our board of directors and the court, if
applicable,
determines that there is no reasonable concern that payment of the dividend will prevent us from satisfying our existing and foreseeable
obligations as they become due.
 
In
the event of our liquidation, after satisfaction of liabilities to creditors, our assets will be distributed to the holders of our ordinary
shares in proportion to their shareholdings. This
right, as well as the right to receive dividends, may be affected by the grant of preferential
dividend or distribution rights to the holders of a class of shares with preferential rights that
may be authorized in the future.
 
Exchange
Controls
 
There
are currently no Israeli currency control restrictions on remittances of dividends on our ordinary shares, proceeds from the sale of
the shares or interest or other payments to non-
residents of Israel, except for shareholders who are subjects of countries that are,
or have been, in a state of war with Israel.
 
Shareholder
Meetings
 
Under
Israeli law, we are required to hold an annual general meeting of our shareholders once every calendar year that must be held no later
than 15 months after the date of the
previous annual general meeting. All meetings other than the annual general meeting of shareholders
are referred to in our amended and restated articles of association as extraordinary
general meetings. Our board of directors may call
extraordinary general meetings whenever it sees fit, at such time and place, within or outside of Israel, as it may determine. In
addition,
the Companies Law provides that our board of directors is required to convene an extraordinary general meeting upon the written request
of (i) any two of our directors or
one- quarter of the members of our board of directors or (ii) one or more shareholders holding, in
the aggregate, either (a) 5% or more of our outstanding issued shares and 1% of our
outstanding voting power or (b) 5% or more of our
outstanding voting power. One or more shareholders, holding 1% or more of the outstanding voting power, may ask the board to add
an item
to the agenda of a prospective meeting, if the proposal merits discussion at the general meeting.
 
Subject
to the provisions of the Companies Law and the regulations promulgated thereunder, shareholders entitled to participate and vote at general
meetings are the shareholders of
record on a date to be decided by the board of directors, which may be between four and 40 days prior
to the date of the meeting. Furthermore, the Companies Law requires that
resolutions regarding the following matters must be passed at
a general meeting of our shareholders:
 
●
amendments
to our articles of association;
●
appointment
or termination of our auditors;
●
appointment
of external directors;
●
approval
of certain related party transactions;
●
increases
or reductions of our authorized share capital;
●
a
merger; and
●
the
exercise of our board of directors’ powers by a general meeting, if our board of directors
is unable to exercise its powers and the exercise of any of its powers is required
for our
proper management.
 
The
 Companies Law and our amended and restated articles of association require that a notice of any annual general meeting or extraordinary
 general meeting be provided to
shareholders at least 21 days prior to the meeting and if the agenda of the meeting includes the appointment
or removal of directors, the approval of transactions with office holders or
interested or related parties, or an approval of a merger,
notice must be provided at least 35 days prior to the meeting.
 
 

 
 
Under
the Companies Law and our amended and restated articles of association, shareholders are not permitted to take action via written consent
in lieu of a meeting.
 
Voting
Rights
 
Quorum
Requirements
 
Pursuant
to our amended and restated articles of association, holders of our ordinary shares have one vote for each ordinary share held on all
matters submitted to a vote before the
shareholders at a general meeting. As a foreign private issuer, the quorum required for our general
meetings of shareholders consists of at least two shareholders present in person, by
proxy or written ballot who hold or represent between
them at least 25% of the total outstanding voting rights. A meeting adjourned for lack of a quorum is generally adjourned to the
same
day in the following week at the same time and place or to a later time or date if so specified in the notice of the meeting. At the
reconvened meeting, any two or more
shareholders present in person or by proxy shall constitute a lawful quorum.
 
Vote
Requirements
 
Our
amended and restated articles of association provide that all resolutions of our shareholders require a simple majority vote, unless
otherwise required by the Companies Law or by
our amended and restated articles of association. Under the Companies Law, each of (i)
the approval of an extraordinary transaction with a controlling shareholder and (ii) the terms of
employment or other engagement of the
controlling shareholder of the company or such controlling shareholder’s relative (even if not extraordinary) requires, the approval
of our audit
committee, our board of directors and a Special Majority, in that order. Under our amended and restated articles of association,
the alteration of the rights, privileges, preferences or
obligations of any class of our shares requires a simple majority vote of the
class so affected (or such other percentage of the relevant class that may be set forth in the governing
documents relevant to such class),
in addition to the ordinary majority vote of all classes of shares voting together as a single class at a shareholder meeting. An exception
to the simple
majority vote requirement is a resolution for the voluntary winding up, or an approval of a scheme of arrangement or reorganization,
of the company pursuant to Section 350 of the
Companies Law, which requires the approval of holders of 75% of the voting rights represented
at the meeting, in person, by proxy or by voting deed and voting on the resolution.
 
Access
to Corporate Records
 
Under
the Companies Law, shareholders are provided access to: minutes of our general meetings; our shareholders register and principal shareholders
register, articles of association
and financial statements; and any document that we are required by law to file publicly with the Israeli
Companies Registrar or the Israel Securities Authority. In addition, shareholders
may request to be provided with any document related
to an action or transaction requiring shareholder approval under the related party transaction provisions of the Companies Law.
We may
deny this request if we believe it has not been made in good faith or if such denial is necessary to protect our interest or protect
a trade secret or patent.
 
Modification
of Class Rights
 
Under
the Companies Law and our amended and restated articles of association, the rights attached to any class of share, such as voting, liquidation
and dividend rights, may be
amended by adoption of a resolution by the holders of a majority of the shares of that class present at a
separate class meeting, or otherwise in accordance with the rights attached to
such class of shares, as set forth in our amended and
restated articles of association.
 
Acquisitions
under Israeli Law
 
Full
Tender Offer
 
A
person wishing to acquire shares of an Israeli public company and who would as a result hold over 90% of the target company’s issued
and outstanding share capital is required by
the Companies Law to make a tender offer to all of the company’s shareholders for
the purchase of all of the issued and outstanding shares of the company. A person wishing to acquire
shares of a public Israeli company
and who would as a result hold over 90% of the issued and outstanding share capital of a certain class of shares is required to make
a tender offer to
all of the shareholders who hold shares of the relevant class for the purchase of all of the issued and outstanding
shares of that class. If the shareholders who do not accept the offer
hold less than 5% of the issued and outstanding share capital of
the company or of the applicable class, and more than half of the shareholders who do not have a personal interest in
the offer accept
the offer, all of the shares that the acquirer offered to purchase will be transferred to the acquirer by operation of law. However,
a tender offer will also be accepted if
the shareholders who do not accept the offer hold less than 2% of the issued and outstanding
share capital of the company or of the applicable class of shares.
 
 

 
 
Upon
a successful completion of such a full tender offer, any shareholder that was an offeree in such tender offer, whether such shareholder
accepted the tender offer or not, may,
within six months from the date of acceptance of the tender offer, petition an Israeli court to
determine whether the tender offer was for less than fair value and that the fair value
should be paid as determined by the court. However,
under certain conditions, the offeror may include in the terms of the tender offer that an offeree who accepted the offer will not be
entitled to petition the Israeli court as described above.
 
If
(a) the shareholders who did not respond or accept the tender offer hold at least 5% of the issued and outstanding share capital of the
company or of the applicable class or the
shareholders who accept the offer constitute less than a majority of the offerees that do not
have a personal interest in the acceptance of the tender offer, or (b) the shareholders who did
not accept the tender offer hold 2% or
more of the issued and outstanding share capital of the company (or of the applicable class), the acquirer may not acquire shares of
the company
that will increase its holdings to more than 90% of the company’s issued and outstanding share capital or of the applicable
class from shareholders who accepted the tender offer.
 
Special
Tender Offer
 
The
Companies Law provides that an acquisition of shares of an Israeli public company must be made by means of a special tender offer if
as a result of the acquisition the purchaser
would become a holder of 25% or more of the voting rights in the company. This requirement
does not apply if there is already another holder of at least 25% of the voting rights in the
company. Similarly, the Companies Law provides
that an acquisition of shares in a public company must be made by means of a special tender offer if, as a result of the acquisition,
the
purchaser would become a holder of more than 45% of the voting rights in the company, provided that there is no other shareholder
of the company who holds more than 45% of the
voting rights in the company, subject to certain exceptions.
 
The
Companies Law provides that an acquisition of shares of an Israeli public company must be made by means of a special tender offer if
as a result of the acquisition the purchaser
would become a holder of 25% or more of the voting rights in the company. This requirement
does not apply if there is already another holder of at least 25% of the voting rights in the
company. Similarly, the Companies Law provides
that an acquisition of shares in a public company must be made by means of a special tender offer if, as a result of the acquisition,
the
purchaser would become a holder of more than 45% of the voting rights in the company, provided that there is no other shareholder
of the company who holds more than 45% of the
voting rights in the company, subject to certain exceptions.
 
A
special tender offer must be extended to all shareholders of a company but the offeror is not required to purchase shares representing
more than 5% of the voting power attached to
the company’s outstanding shares, regardless of how many shares are tendered by shareholders.
A special tender offer may be consummated only if (i) outstanding shares representing
at least 5% of the voting power of the company
will be acquired by the offeror and (ii) the number of shares tendered in the offer exceeds the number of shares whose holders objected
to the offer (excluding the purchaser, controlling shareholders, holders of 25% or more of the voting rights in the company or any person
having a personal interest in the acceptance of
the tender offer). If a special tender offer is accepted, then the purchaser or any person
or entity controlling it or under common control with the purchaser or such controlling person or
entity may not make a subsequent tender
offer for the purchase of shares of the target company and may not enter into a merger with the target company for a period of one year
from
the date of the offer, unless the purchaser or such person or entity undertook to effect such an offer or merger in the initial
special tender offer.
 
Merger
 
The
Companies Law permits merger transactions if approved by each party’s board of directors and, unless certain requirements described
under the Companies Law are met, by a
majority vote of each party’s shareholders, and, in the case of the target company, a majority
vote of each class of its shares, voted on the proposed merger at a shareholders meeting.
 
 

 
 
For
purposes of the shareholder vote, unless a court rules otherwise, the merger will not be deemed approved if a majority of the votes of
shares represented at the shareholders meeting
that are held by parties other than the other party to the merger, or by any person (or
group of persons acting in concert) who holds (or hold, as the case may be) 25% or more of the
voting rights or the right to appoint
25% or more of the directors of the other party, vote against the merger. If, however, the merger involves a merger with a company’s
own
controlling shareholder or if the controlling shareholder has a personal interest in the merger, then the merger is instead subject
to the same Special Majority approval that governs all
extraordinary transactions with controlling shareholders. A Special Majority approval
constitutes shareholder approval by a majority vote of the shares present and voting at a meeting
of shareholders called for such purpose,
provided that either: (a) such majority includes at least a majority of the shares held by all shareholders who are not controlling shareholders
and do not have a personal interest in such compensation arrangement; or (b) the total number of shares of non-controlling shareholders
and shareholders who do not have a personal
interest in the compensation arrangement and who vote against the arrangement does not exceed
2% of the company’s aggregate voting rights.
 
If
the transaction would have been approved by the shareholders of a merging company but for the separate approval of each class or the
exclusion of the votes of certain shareholders
as provided above, a court may still approve the merger upon the request of holders of
at least 25% of the voting rights of a company, if the court holds that the merger is fair and
reasonable, taking into account the value
of the parties to the merger and the consideration offered to the shareholders of the target company.
 
Upon
the request of a creditor of either party to the proposed merger, the court may delay or prevent the merger if it concludes that there
exists a reasonable concern that, as a result of
the merger, the surviving company will be unable to satisfy the obligations of the merging
entities, and may further give instructions to secure the rights of creditors.
 
In
addition, a merger may not be consummated unless at least 50 days have passed from the date on which a proposal for approval of the merger
was filed by each party with the Israeli
Registrar of Companies and at least 30 days have passed from the date on which the merger was
approved by the shareholders of each party.
 
Anti-Takeover
Measures under Israeli Law
 
The
Companies Law allow us to create and issue shares having rights different from those attached to our ordinary shares, including shares
providing certain preferred rights with
respect to voting, distributions or other matters and shares having preemptive rights. No preferred
 shares are currently authorized under our amended and restated articles of
association. In the future, if we do authorize, create and
issue a specific class of preferred shares, such class of shares, depending on the specific rights that may be attached to it, may
have
the ability to frustrate or prevent a takeover or otherwise prevent our shareholders from realizing a potential premium over the market
value of their ordinary shares. The
authorization and designation of a class of preferred shares will require an amendment to our amended
and restated articles of association, which requires the prior approval of the
holders of a majority of the voting power attaching to
our issued and outstanding shares at a general meeting. The convening of the meeting, the shareholders entitled to participate and
the
majority vote required to be obtained at such a meeting will be subject to the requirements set forth in the Companies Law as described
above in “Voting Rights.”
 
Borrowing
Powers
 
Pursuant
to the Companies Law and our amended and restated articles of association, our board of directors may exercise all powers and take all
actions that are not required under law
or under our amended and restated articles of association to be exercised or taken by our shareholders,
including the power to borrow money for company purposes.
 
Changes
in Capital
 
Our
amended and restated articles of association enable us to increase or reduce our share capital. Any such changes are subject to the provisions
of the Companies Law and must be
approved by a resolution duly passed by our shareholders at a general meeting by voting on such change
in the capital. In addition, transactions that have the effect of reducing capital,
such as the declaration and payment of dividends
in the absence of sufficient retained earnings or profits, require the approval of both our board of directors and an Israeli court.
 
 

 
Exhibit
10.5
 
RESTATED
EXECUTIVE EMPLOYMENT AGREEMENT
 
THIS
 RESTATED EMPLOYMENT AGREEMENT is made and entered into on January 20, 2022 (the “Effective Date”), by and between
 Vascular Biogenetics Ltd. (the
“Company”) and Prof. Dror Harats, Israeli I.D No.                       (the “Executive”).
The Company and Executive shall be sometimes referred to each as a “Party” and collectively as
the “Parties”).
 
WHEREAS,
the
Parties have entered into an employment agreement dated January 15, 2001, as amended on December
26, 2001, January 9, 2003, December 31, 2006, March
13, 2008, September 16, 2008, April 29,
2013, May 19, 2016 and October 19, 2021 (collectively, the “Previous Agreement”)
pursuant to which the Executive
has been serving as the Company’s Chief Executive Officer;
and
 
 
WHEREAS,
the
Parties have decided to replace the Previous Agreement it in its entirety with this Restated
Employment Agreement (the “Agreement”), such that this
Agreement shall,
commencing as of the Effective Date (defined below), replace any previous agreement, whether
oral or written, between the Parties or anyone
on their behalf in connection with the subject
matter, including the Previous Agreement.
 
NOW,
THEREFORE, in consideration of the mutual undertakings of the Parties, it is hereby agreed as follows:
 
1.
Duties
and Responsibilities
 
1.1. Commencing
as of January 15, 2001 (the “Commencement Date”), Executive shall be employed
by the Company as Chief Executive Officer (CEO) (the “Position”) and
shall
perform such duties and activities as are customarily performed by a CEO of a company and
as shall be assigned to Executive from time to time by the Board of
Directors of the Company
(the “Supervising Officer”).
 
1.2. Executive
shall devote approximately on a 20% of a full-employment basis to the business and affairs
of the Company and the performance of Executive’s duties hereunder.
The Executive shall
be permitted to continue his engagement at the Tel Hashomer, Sheba Hospital, for pay.
 
1.3. The
parties agree that nothing in the Agreement shall be constructed to bar the Executive from
being engaged on other academic related activities that are not competitive with
the business
or technologies of the Company and its affiliates. See Section 5 below. The Executive agrees
to notify the Company of any such engagement or activity, but no
consent by the Company will
be required for this activity or engagement.
 
1.4. The
Position, duties and responsibilities hereunder shall be in the nature of management duties
that demand a special degree of personal loyalty and the terms of employment
hereunder shall
not permit application to this Agreement of the Law of Work Hours and Rest 5711-1951. Accordingly,
the statutory limitations of such law shall not apply to
this Agreement. The Executive shall
not be entitled to additional compensation from the Company for working additional hours
or working on any day of the week, as
required by the Company.
 
1.5. Executive’s
liability towards the Company shall be that of an office holder under the Companies Law 5759-1999
and any other applicable law.
 
1.6. Executive
shall be employed at the Company’s facilities as shall be decided by the Board of Directors
 of the Company. Executive acknowledges and agrees that the
performance of Executive’s
duties may also require domestic and international travel, at the Company’s request
and expense.
 
2.
Term
and Termination
 
2.1. This
Agreement and the employer-employee relationship created hereunder shall remain in force
and effect unless terminated under any of the following circumstances:
 
2.1.1.
Either
Party may terminate this Agreement by providing the other Party with 9 months prior written
 notice (the “Notice Period”). During the Notice Period,
Executive shall
continue working and shall cooperate with the Company and use his best efforts to assist
the integration of the person or persons who will assume
Executive’s responsibilities,
all as shall be requested by the Company at its sole discretion.
 
1

 
 
 
 
Notwithstanding,
the Company shall have the right, at any time during the Notice Period, to terminate the employment relationship immediately, in which
case the
Company shall pay Executive the Salary due for the remaining period of the Notice Period, and the benefits set forth in Sections
3.2 and 3.3 below.
 
 
 
2.1.2.
The
Company may terminate this Agreement and the employer-employee relationship hereunder at
any time, and without derogating from any other remedy to which
the Company may be entitled,
for Cause (as hereinafter defined), by providing Executive written notice thereof. In such
event, this Agreement and the employer-
employee relationship hereunder shall be deemed effectively
terminated as of the date of delivery of such notice.
 
 
 
 
 
The
term “Cause” will include matters such as: (i) a breach by Executive of any of the material terms or conditions of
this Agreement; (ii) willful refusal to perform
the lawful instructions of the Company’s Board of Directors pertaining to the Executive’s
employment under this Agreement provided, however, that if such refusal
to perform is susceptible to cure, the Executive shall
not have cured such refusal within five days of having been given written notice thereof; (iii) Executive’s willful
misconduct,
or action of personal dishonesty, bad faith or breach of trust towards the Company or any of its subsidiaries or affiliates; (iv) conviction
of any crime
involving moral turpitude or dishonesty or the commission by Executive of a criminal offense, or fraud against the Company
or any of its subsidiaries or affiliates; (v)
any breach of the Executive’s fiduciary duties or duties of care to the Company or
any of its subsidiaries or affiliates (except for conduct taken in good faith) (vi) any
conduct (other than conduct in good faith) materially
detrimental to the Company or any of its subsidiaries or affiliates; or (vii) circumstances that deny Executive to
severance payment
under any applicable law or under any judicial decision of a competent tribunal authority.
 
2.1.3.
The
Executive may terminate this Agreement and the employer-employee relationship hereunder at
any time, with immediate effect for Good Reason (as hereinafter
defined), by providing the
Company written notice thereof. In such event, this Agreement and the employer- employee
relationship hereunder shall be deemed
effectively terminated as of the date of delivery
of such notice.
 
 
 
 
 
The
term “Good Reason” shall mean (a) if the Company takes any of the following actions, and fails to cure same within
fifteen (15) days of receipt of written notice
from the Executive: (i) materially reduces the Executive’s overall compensation
package (without Executive’s consent), provided that, any such reduction is not part
of a Company policy pursuant to which the
salary of all other senior officers of the Company is reduced in a comparable manner; or (ii) materially reduces, without
the Executive’s
prior written consent, the Executive’s duties, responsibilities or authority (but not title) relative to the Executive’s
duties, responsibilities and authority
immediately prior to such reduction; or (iii) materially breaches this Agreement; or (b) if the
Executive resigns when such resignation is considered as a discharge or
constructive dismissal which entitles him to severance payment
under Section 11 of the Severance Payment law, 1963 – 5723.
 
2.2. Upon
the earlier of (a) the date of termination of the Notice Period; (b) the date of actual termination
of employment, or (c) Company’s request, Executive shall return to the
Company any
and all Company equipment, property and documents in Executive’s possession or control.
 
2.3. Any
outstanding payment due by Executive to the Company in connection with Executive’s
employment shall be repaid by Executive by the earlier of (a) the date of
termination of
the Notice Period or (b) the date of actual termination of employment for any reason other
than for Cause (or in the event of termination for Cause, then
immediately upon termination
of employment). Notwithstanding, the Company may set-off any such outstanding amounts due
to it against any payment due by the Company
to Executive, subject to applicable law.
 
2.4. If
the Executive’s employment is terminated (i) not for cause or (ii) not due to the Executive’s
termination of his employment with the Company unless such termination is for
Good Reason,
the Executive shall be entitled to a severance pay of 6 months’ Salary (Salary plus
benefits) as well as all funds accrued for the Company as employer of the
Executive in the
Policy (as defined below). In addition, the Executive shall be entitled to payment of his
Salary plus benefits earned up to the date of actual termination.
 
2.5. The
provisions of Sections 2.3, 4, 5, 6, 7 and 8.6 below and the provisions relating to the policies,
will survive the after termination or expiration of this Agreement.
 
2

 
 
3.
Salary
and benefits
 
 
 
In
full consideration for Executive’s employment hereunder, Executive shall be entitled to the following payments and benefits, effective
as of the Commencement Date:
 
3.1. Salary.
The Executive shall be entitled to a gross monthly salary of NIS 20,000 (the “Salary”).
The Salary may be adjusted from time to time according to government
directives and other
adjustments as may be required by applicable law. The Salary shall be payable monthly in
arrears, in accordance with the Company’s usual practice, by
the 9th day
of the following calendar month, in accordance with the Company’s payroll practices.
 
3.2. Manager’s
Insurance; Pension Fund
 
3.2.1.
According
to the Executive’s choice, the Company shall affect a Manager’s Insurance Policy
or Pension Fund or a combination thereof, (the “Policy”) in the name of
the Executive, and shall pay a sum of 8.33% of the Deducted Salary for severance pay. The
Company shall deduct 6% from the Deducted Salary to be paid as
benefits (Tagmulim)
on behalf of the Executive towards such Policy. The Company’s contribution for the
Policy shall be 6.5% of the Deducted Salary as employer’s
share for benefits (Tagmulim).
Such rates shall be adjusted as required by applicable law.
 
3.2.2.
In
the event that the Executive shall elect to be insured in a Manager’s Insurance Policy
 or a provident fund which is not a Pension Fund - the Company’s
contributions for benefits
(Tagmulim) shall include payment for disability insurance in an amount which will
ensure 75% of the Deducted Salary, provided however,
that in any event the contributions
of the Company for benefits shall be equal to at least 5% of the Deducted Salary, and the
total cost of the Company for disability
insurance and benefits shall not exceed 7.5% of
the Deducted Salary. Such rates shall be adjusted as required by applicable law.
 
3.2.3.
The
Parties hereby declare and agree that the pension arrangement in accordance with this clause
constitutes a “beneficial arrangement” for the purpose of the
Extension
Order (Combined Version) for Mandatory Pension under the Collective Agreements Law, 5717-1957
(the “Pension Extension Order”), and the Company
shall not be under any
obligation to provide any pension arrangement as provided in the Pension Extension Order
other than as provided in this Section.
 
3.2.4.
Without
derogating from the generality of the aforesaid, all payments made by the Company to the
Policy shall be in lieu of severance pay due to the Executive or his
heirs from the Company,
and the Company shall not have any additional or other obligations to pay the Executive severance
payments, and the Executive hereby
consents to this arrangement in accordance with Section
14 of the Severance Pay Law 5723-1963 and the “General Approval Regarding Payments
by Employers to a
Pension Fund and Insurance Fund in Lieu of Severance Pay”, a copy
of which is attached to this Agreement as Exhibit A and executed by the Parties (the
“General
Approval”), and the provisions of the General Approval shall
apply to the Executive and this Agreement.
 
3.2.5.
As
of the date indicated herein, the General Approval has not yet been updated to reflect the
percentages of contributions/deductions indicated above. In the event of
discrepancy between
the updated General Approval and the percentages stated herein, the updated General Approval
shall prevail.
 
3

 
 
3.2.6.
The
Company hereby waives any entitlement and/or right for reimbursement with respect to the
severance compensation and acknowledges, that upon termination of
the Executive’s employment
in the Company, including inter alia, in the event of the Executive’s resignation,
the Company shall release the severance compensation
and shall transfer the severance compensation
 to the Executive, except in the event that: (i) the Company has terminated the Executive’s
 employment due to
circumstances under which his/her entitlement for severance payment is
denied pursuant to Articles 16 or 17 of the Severance Law; or (ii) the Executive has already
withdrawn funds from the Policy and not because of “Eiroa Mezake” according
to Section 2(b) of the General Approval.
 
3.3. Annual
Recreation Allowance. Executive shall be entitled to annual recreation allowance (Dmei
Havra’a) according to applicable law.
 
3.4. Vacation.
 
3.4.1.
Executive
shall be entitled to paid vacation days (the “Vacation Days”) of 20 working
days per year (pro-rata for each calendar year), subject to Company’s policy,
provided
that Executive shall not be permitted to accrue more than twelve (12) days’ vacation
in any given year. If not used during the specified period, the value of
unused vacation
time shall be paid to Executive within 90 days following each relevant period. Each leave
shall be coordinated with adequate regard to the needs of
the Company. Notwithstanding the
foregoing, Company shall be entitled to set uniform dates for a vacation to all or part of
its employees, as it deems fit.
 
3.4.2.
Executive
shall be entitled to redeem any unused vacation days carried forward in accordance with this
 Sub-Section, upon the termination of employment in
accordance with the terms set out in the
Vacation Law and the Company’s policy, as may be updated from time to time. If the
employment commences or terminates
part way through any year, the Executive entitlement to
vacation days during that year will be assessed on a pro-rata basis. Any amounts exceeding
the maximum
accumulation of days, shall be cancelled by the Company and shall not be paid
to the Executive upon termination.
 
3.5. Sick
Leave. Executive shall be entitled to paid sick leave pursuant to applicable law, however
sick pay shall be fully paid from the first day of Executive’s absence due to
illness
subject to the presentation of duly medical certificates. Accumulated sick leave cannot be
redeemed at any time.
 
3.6. Expenses.
 
3.6.1.
During
the term of this Agreement, Company shall reimburse Executive for any expenses borne by Executive
in performing the services for the Company, provided
that any expense in excess of $500 shall
be pre-approved by the Board of Directors of the Company. The expenses will be reimbursed
at the end of each month based
on submitted receipts.
 
3.6.2.
The
Salary further includes any and all travel expenses payments to which Executive is entitled
from the Company in connection with transportation to and from the
workplace.
 
3.7. Further
Education Fund (“Keren Hishtalmut”)
 
 
 
 
 
The
Company and the Executive shall maintain a further education fund in the name of the Executive. The Company shall contribute to such
Fund an amount equal to 7.5% of
the Salary, and the Executive shall contribute to such fund an amount equal to 2.5% of the Deducted Salary.
Such contributions to be made in accordance with the relevant
fund and tax rules. The Executive hereby instructs the Company to transfer
to such fund the amount of the Company’s contribution and the Executive’s contribution from each
monthly Salary payment.
 
3.8. Company
Car
 
The
Company will provide the Executive with a company car for his use during the term of his employment with the Company. The Company will
gross up the value of the
car for tax purposes.
 
3.9. Company
Cell Phone
 
The
Company shall provide the Executive with a cellular telephone and shall reimburse the Executive for costs relating to the Executive’s
work use of cellular phone, incurred
by the Executive in carrying out his duties and responsibilities under this Agreement, in accordance
with the regular practices of the Company regarding the reimbursement of
such expenses.
 
4

 
 
3.10.Except
as set forth herein, Executive will bear any and all income and other taxes applicable to
Executive in connection with amounts paid pursuant to this Section 3. The
Company shall legally
deduct and withhold income tax payments and other obligatory payments, such as social security
and mandatory health insurance, from all of the
payments which shall be paid to Executive
hereunder and pursuant to applicable law, including all taxes imposed on any benefits granted
to Executive and on any part of the
benefits which exceeds maximum exemption(s) provided
by law.
 
3.11.It
is hereby agreed that Executive’s determining pay for the purpose of the Insurance
funds, Further Education Fund and severance pay is the Salary, and payments and/or
benefits
and/or bonuses and/or refunds that are not included in the pay, such as a vehicle, reimbursement
of expenses and the like, if applicable, shall not be considered part of
Executive’s
pay for all respects and purposes (the “Deducted Salary”).
 
4.
Confidentiality;
Proprietary Rights
 
4.1. Confidentiality;
Proprietary Information
 
The
Executive represents and warrants that he will keep the terms and conditions of this Agreement strictly confidential and will not disclose
it nor provide a copy of it or any
part thereof to any third party unless and to the extent required by applicable law.
 
4.1.1.
The
Executive acknowledges and agrees that he will have access to confidential and proprietary
information concerning the business and financial activities of the
Company, its parent company(ies)
and their affiliates (together, and solely for the purpose of Sections 4, 5 and 6, the “Company”)
and information and technology
regarding the Company’s products, services, research
and development including without limitation, the Company’s banking, investments, investors,
properties,
employees, marketing plans, customers, suppliers, trade secrets, inventions,
ideas, processes, formulas, source and object codes, data, programs, other works of
authorship,
know-how, improvements, discoveries, developments, designs and techniques and test results,
 inventions, and products (actual or planned). Such
information, whether documentary, written,
oral or computer generated, shall be deemed to be and referred to as “Proprietary
Information”.
 
4.1.2.
Proprietary
Information shall exclude information that (i) was known to the Executive prior to his association
with the Company and can be so proven; (ii) shall have
have become a part of the public knowledge
except as a result of a breach of this Agreement by the Executive; (iii) shall have been
received by the Executive from a
third party having no obligation to the Company; (iv) reflects
general skills and experience gained during the Executive’s engagement by the Company;
or (v) reflects
information and data generally known within the industries in which the Company
transacts business.
 
4.1.3.
The
Executive agrees and declares that all Proprietary Information, patents and other rights
in connection therewith shall be the sole property of the Company and its
assigns. At all
times, both during his engagement by the Company and after termination, the Executive will
keep in confidence and trust all Proprietary Information,
and the Executive will not use
or disclose any Proprietary Information or anything relating to it without the written consent
of the Company, except as may be
necessary for the ordinary course of performing the Executive’s
duties hereunder and in the best interests of the Company.
 
4.1.4.
The
Executive recognizes that the Company received and will receive confidential or proprietary
information from third parties subject to a duty on the Company’s
part to maintain
the confidentiality of such information and to use it only for certain limited purposes.
Such information shall be deemed “Proprietary Information”
for all purposes hereunder,
and shall, without limitation of the foregoing, be returned to the Company upon termination
of the Executive’s employment with the
Company.
 
4.1.5.
The
Executive’s undertakings in this Section 4 shall remain in full force and effect after
termination of this Agreement or any renewal thereof.
 
5

 
 
4.2. Inventions
 
4.2.1.
The
Executive understands that the Company is engaged in a continuous program of research, development,
production and marketing in connection with its business
and that, as an essential part of
his employment with the Company, the Executive is expected to make new contributions to,
and create inventions of value for, the
Company. The Executive agrees to share with the Company
all the Executive’s knowledge and experience, provided however that the Executive shall
not disclose to
the Company, or use for the advancement of the business of the Company, any
information which the Executive has any interest (“Prior Inventions”),
nor any Work
Product (as hereinafter defined) in which any third party has an interest, undertaken
to third parties to keep confidential or in which third parties have any rights.
 
4.2.2.
Executive
warrants and represents (i) to have carefully scrutinized the business of the Company as
well as the various aspects, responsibilities, expectations and
requirements entailed in
the Position and his duties; and (ii) to have no interest to any Work Product of the Company
nor anticipation of any use of Prior Inventions.
 
4.2.3.
Without
derogating from the above, in any event that the Prior Inventions are incorporated by Executive
into an Invention or utilized in performing the Duties,
Company shall be granted a nonexclusive,
royalty-free, perpetual, irrevocable, transferable, worldwide license (with the right to
grant and authorize sublicenses) to
reproduce, utilize, commercialize, develop upon and exploit
such Prior Invention, including, without limitation, in connection with the Prior Invention.
 
4.2.4.
The
Executive acknowledges that all Work Product is “work made for hire”,
will be the sole and exclusive property of the Company and the Executive will not have
any
right or title therein whatsoever.
 
“Work
 Product” shall include all inventions, improvements, designs, concepts, techniques, methods, systems, processes, know-how,
 customer lists, computer
software programs, databases, materials, mask works and trade secrets, trade names and moral rights created,
 in whole or in part, by the Executive during the
Executive’s employment with the Company, or developed using equipment, supplies,
facilities or trade secrets of the Company, or resulted from work performed by
or for the Company or related to the Company’s Business
(which may be changed at the Company’s sole discretion), whether or not copyrightable or otherwise
protectable according to law.
 
4.2.5.
To
the extent not owned exclusively by the Company, the Executive hereby irrevocably transfers
and assigns to the Company all the Executive’s right, title and
interest now and hereafter
acquired in and to all Work Product (and all proprietary rights with respect thereto) and,
when not otherwise assignable herein, agrees to
assign in the future to the Company, all
the Executive’s right, title and interest in and to any and all such Work Product (and
all proprietary rights with respect
thereto), and further undertakes to execute all necessary
documentation and take all further action as may be required in order to perform such assignment.
The
Executive will promptly disclose to the Company fully and in writing all Work Product
authored, conceived or reduced to practice by the Executive, either alone or
jointly with
others.
 
4.2.6.
The
Executive hereby forever waives and agrees never to assert any rights of paternity or integrity,
any right to claim authorship of any Work Product, to object to
any distortion, mutilation
or other modification of, or other derogatory action in relation to any Work Product, whether
or not such would be prejudicial to his honor
or reputation, and any similar right, existing
under judicial or statutory law of any country in the world, or under any treaty, even after
termination of the Executive’s
work on behalf of the Company.
 
6

 
 
4.2.7.
The
Executive agrees to assist the Company in every proper way to obtain for the Company and
enforce patents, copyrights, mask work rights, and other legal
protections for the Company’s
Work Product in any and all countries. The Executive will execute any documents that the
Company may reasonably request for use in
obtaining or enforcing such patents, copyrights,
mask work rights, trade secrets and other legal protections. The Executive’s obligations
under this Section 4.2.7 will
continue beyond the termination of employment with the Company.
The Executive hereby irrevocably appoints any of the Company’s officers as the Executive’s
attorney-in-fact to execute documents on the Executive’s behalf for this purpose.
 
4.2.8.
Without
limitation of any of the other provisions of this Agreement, Executive acknowledges and agrees
that the Salary and other benefits to which Executive is
entitled to receive from the Company
by virtue of Executive’s employment with the Company constitute the sole and exclusive
consideration to which the Executive
is entitled, by virtue of any contract or law, including
but not limited to the Israeli Patent Law 5727-1967 (the “Patent Law”),
in respect of any and all Work Product,
and Executive waives all past, present and future
demands, contentions, allegations or other claims, of any kind, in respect thereof, including
the right to receive any
additional royalties, consideration or other payments. Without derogating
from the aforesaid, Executive acknowledges and agrees that the level of the compensation
and consideration to which Executive is entitled has been established based upon the aforementioned
waiver of rights to receive any such additional royalties,
consideration or other payment.
The foregoing will apply to any “Service Inventions” as defined in the
Patent Law and under no circumstances will Executive be
deemed to have any proprietary right
in any such Service Invention, notwithstanding the provision or non-provision of any notice
of an invention and/or Company
response to any such notice, under Section 132(b) of the Patent
Law. This Agreement expressly intended to be an agreement with regard to the terms and conditions
of consideration for Service Inventions in accordance with Section 134 of the Patent Law.
 
5.
Non-Competition;
Non-Solicitation
 
5.1. The
Executive agrees and undertakes that he will not, for so long as this Agreement is in
effect and for a period of twenty four (24) months thereafter (the “Non-Competition
Period”), compete or assist others to compete with Company’s business as
currently conducted and/or proposed to be conducted during the Non-Competition Period.
 
5.2. The
Executive further agrees and undertakes that for so long as this Agreement is in effect and
for a period of twenty four (24) months thereafter (the “Non-Solicitation
Period”),
he will not: (i) employ, offer to employ, or in any way directly or indirectly solicit or
seek to obtain or achieve the employment by any business or entity of any
person employed
by the Company, or (ii) solicit any business which is similar to the Company’s business
 from individuals or entities that are customers, suppliers or
contractors of the Company.
 
5.3. To
avoid any doubt, the Executive may serve as an academic related consultant to, or an investor
 in, any entity or business in the medical or biotech industry not in
competition with the
Company or its affiliates, provided that adequate notice of the activity or investment is
given to the Board of Directors of the Company. Also, the
Executive may own securities of
any corporation which is engaged in, or competes with the business of the Company and is
publicly owned and traded but in an amount not to
exceed at any one time one percent (1%)
of any class of stock or securities of such company, and provided further that he has no
active role in the publicly owned and traded
corporation as director, employee or otherwise.
 
5.4. The
Parties hereto agree that the duration and area for which the covenants set forth in this
Section 5 are necessary to protect the legitimate interests of the Company and its
business
efforts and accordingly are reasonable, in terms of their geographical and temporal scope.
If any of the terms contained in this Section 5 shall, for any reason, be held
to be excessively
broad with regard to time, geographic scope or activity, the term shall be construed in a
manner to enable it to be enforced to the extent compatible with
applicable law. A breach
of Section 5 hereof, shall cause irreparable harm to the Company and that the Company shall
be entitled to any remedy available to it under
applicable law, including specific performance
of this Agreement or an injunction relief, together with the costs and reasonable attorney’s
fees and disbursements incurred by
the Company in enforcing its rights under Section 5. The
Executive acknowledges that the compensation and benefits he/she receives hereunder includes
special consideration
for the Executive’s undertakings contained in Section 5.
 
7

 
 
6.
Company’s
Property and Personal Information
 
6.1. Company’s
Property
 
6.1.1.
Company
Property. As part of the Position the Company may provide Executive with different equipment
such as cellular phone, computer or portable computer or
other equipment as may be needed
for the performance of the Position (the “Company Property”). Executive
shall use the Company Property for his employment
and reasonable personal use, if applicable.
 Executive acknowledges that the Company is the sole and only owner of the Company Property
 and its contents,
including, any Proprietary Information which shall be subject to the terms
of Section 4 above.
 
6.1.2.
Company
Email. As part of the Position the Company shall provide Executive with a Company email
address (the “Professional Mailbox”), which the Executive
shall use solely
in the framework of his Position and for performing his/her duties, in accordance with Company’s
policies and instructions. The Executive confirms
and acknowledges that the Professional
 Mailbox is provided to him for professional use and the Company may monitor the Professional
 Mailbox and/or any
communications to and from the Company without prior notice, from time
to time, and Executive hereby agrees that such actions shall not be regarded as an invasion
of privacy.
 
6.1.3.
Executive
shall take good care of the Company Property, shall use it carefully and in accordance with
the Company’s instructions and policies and shall notify the
Company immediately with
respect to any damages or failures of the Company Property. Executive shall bear all expenses
relating to any negligent use of the
Company Property. Executive is strictly obligated to
coordinate the installation and configuration of any programs on the computer provided by
the Company, and
must receive specific approval to install any hardware, software or files
on the Company’s computer, including without limitation, the downloading of software
and
files from the internet and privately-owned disks.
 
6.1.4.
Executive
shall return to the Company all Company Property, including without limitations, Company’s
computer, Company’s phone and access to the Professional
Mailbox, no later than the
day of receipt of notice of termination of employment or within 7 days of the Company’s
demand. Executive shall have no right for a lien,
pledge, encumbrance and the like on the
Company’s Property.
 
6.2. Personal
Information
 
6.2.1.
The
Executive grants consent to the Company, its employees and consultants, wherever they may
be located, to utilize and process the Personal Information (as such
term is hereinafter
defined), for purposes related to the Executive’s employment and this Agreement. The
Executive is aware, understands and hereby consents that
the Personal Information which shall
 be collected, will be kept in the Company’s database, held in Israel and/or abroad,
 and further consents that Personal
Information, may, in whole or in part, be transferred,
and further transferred, to databases owned by Company or any entity affiliated with the
Company, or a third
party retained by the Company for assisting in human resources administration,
whether in Israel or abroad, and may be used by such entities for purposes of human
resources
management and administration. In addition, the Company may share personnel records as needed
internally and with third parties in connection with
purposes related to the Executive’s
 employment, audit and compliance activities and as reasonably required in connection with
 the internal operations of the
Company and the Company’s business activities, including
 with respect to due-diligence requests of potential affiliates. Notwithstanding anything
 herein, all
personnel records included in the Personal Information are considered confidential
and access will be limited and restricted to individuals with a need to know or
process basis,
and solely to the extent required. By signing this Agreement, the Executive declares that
he was given the opportunity to ask and request details
regarding the Personal Information
transfer, as aforesaid, and the Executive understood and accepted this Section. The Executive
further acknowledges that he was
made aware that he is entitled to contact the Company with
any question or concern with respect to the Personal Information.
 
8

 
 
“Personal
Information” shall mean Executive’s personal information, including data collected by the Company, such as information
regarding the Executive’s
salary, social benefits, evaluation and training.
 
6.2.2.
Notwithstanding
the above, the Executive confirms that he is aware and agrees that the Company may conduct
audits and inspections at the Company’s offices, at
employees work environment and
in the Company’s computers, which were placed in favor of the Executive for conducting
his Position and performing his duties,
including e-mail messages and internet applications
and their contents. It is hereby clarified and agreed that all materials and findings resulting
from such audits and
inspections shall be the sole property of the Company.
 
7.
Executive
Representations and Warranties
 
Executive
hereby represents and warrants to the Company as follows:
 
7.1. Executive
has the necessary skills, knowledge, ability, expertise and experience to fulfill his
obligations hereunder, shall do so diligently, professionally and conscientiously, in
furtherance
of the Company’s best interests and shall comply with the regulations, policies and
procedures of the Company.
 
7.2. The
execution and delivery of this Agreement and the fulfillment of the terms hereof will constitute
the valid, binding and enforceable obligations of Executive and will not
violate, conflict
with or constitute a default under or breach of any agreement and/or undertaking and/or instrument,
judgment or order to which the Executive is a party or by
which he is bound, or any provision
of law, rule or regulation applicable to the Executive, and do not require the consent of
any person or entity. In the performance of
Executive’s obligations hereunder, Executive
will not make use of (i) any confidential or proprietary information belonging to any third
party, or (ii) any information to which
Executive is restricted from disclosing or using
due to contractual undertakings or by law.
 
7.3. Executive
will not accept, whether during the term of this Agreement or at any time thereafter, directly
or indirectly, any payment, benefit and/or other consideration, from any
third party in connection
with Executive’s employment with the Company, without the Company’s prior written
authorization.
 
7.4. Sexual
Harassments. The Company disapproves of sexual harassments, and will not accept any violations
of the Sexual Harassment Prevention Law 5758-1998 (the “Law”).
Executive
hereby confirms and acknowledges that the Law and the Company’s policies with respect
to preventing sexual harassment have been brought to his attention.
 
8.
Miscellaneous
 
8.1. The
Company shall be entitled to set-off any amount owed to the Company by Executive under the
terms and provisions of this Agreement from any amount owed by the
Company to Executive under
this Agreement or from any other source whatsoever.
 
8.2. Preamble;
Exhibits; Headings; Interpretation. The preamble to this Agreement, and the Exhibits
attached hereto constitute an integral part hereof. Section headings are for
reference and
convenience purposes only and shall not in any way be used for the interpretation of this
Agreement.
 
8.3. Entire
Agreement. The Parties confirm that this is a personal employment contract and that the
relationship between them shall not be subject to any general or special
collective employment
agreement or any custom or practice of the Company in respect of any of its other employees
or contractors. This Agreement, together with the
Exhibits hereto, constitute the entire
agreement between the Parties with respect to the subject matters hereof and thereof and
supersede all prior agreements, understandings
and arrangements, oral or written, between
the Parties with respect to the subject matters hereof, including the Previous Agreement.
It is clarified that Executive shall not be
entitled to any payment, right or benefit which
were not explicitly detailed in this Agreement.
 
9

 
 
8.4. Amendment;
Waiver. No provision of this Agreement may be modified, waived or discharged unless such
waiver, modification or discharge is agreed to in writing and signed
by the Executive and
the Company. No waiver by either Party hereto at any time of any breach by the other Party
hereto of, or compliance with, any condition or provision of
this Agreement to be performed
by such other Party shall be deemed a waiver of similar or dissimilar provisions or conditions
at the same or at any prior or subsequent time.
 
8.5. Successors
and Assign; Assignment. This Agreement shall be binding upon and shall inure to the benefit
of the Company, its successors and assigns. Neither this Agreement
or any of the Executive’s
rights, privileges, or obligations set forth in, arising under, or created by this Agreement
may be assigned or transferred by Executive without the
prior written consent of the Company,
except by will or by the laws of descent and distribution. The Company may freely assign
and/or transfer this Agreement and any of its
rights, privileges, or obligations hereunder.
 
8.6. Governing
Law; Jurisdiction. This Agreement shall be governed by, construed and enforced in accordance
with the laws of the State of Israel, without giving effect to the rules
with respect to
conflicts-of-law. Any dispute arising out of, or relating to this Agreement, its interpretation
or performance hereunder shall be resolved exclusively by the
competent court of the Tel
Aviv-Jaffa district, and each of the parties hereby submits exclusively and irrevocably to
the jurisdiction of such court.
 
8.7. Severability.
If any term or provision of this Agreement shall be declared invalid, illegal or unenforceable,
then such term or provision shall be enforceable to the extent that a
court shall deem it
reasonable to enforce such term or provision and, if any such term or provision shall be
held by any competent court to be unreasonable to enforce to any
extent, such term or provision
shall be severed and all remaining terms and provisions shall be unaffected and shall continue
in full force and effect.
 
8.8. Notices.
Each notice or demand given by a Party pursuant to this Agreement shall be in writing and
sent by registered mail or electronic mail to the other Party at the address
provided by
such Party, and such notice or demand shall be deemed given at the expiration of seven (7)
days from the date of mailing by registered mail or immediately if
delivered by hand or electronic
mail.
 
8.9. The
parties agree that this Agreement and its exhibits constitute, among others, notification
in accordance with the Notice to Employees (Employment Terms) Law, 2002.
 
[THE
REMAINDER OF THIS PAGE WAS INTENTIONALLY LEFT BLANK]
 
10

 
 
[Signature
Page to Prof. Dror Harats Restated Employment Agreement]
 
IN
WITNESS WHEREOF, the parties have executed this Employment Agreement as the date hereof:
 
Company:
 
Executive:
 
 
 
/s/
Marc Kozin
 
/s/
Dror Harats
Vascular Biogenetics Ltd
 
Signature
 
By:
Marc Kozin
 
Name of Executive:
Prof. Dror Harats
 
Title:
Chairman of the Board
 
11

 
 
 
 

 
 
 
 

 
Exhibit
10.6
 
RESTATED
CONSULTING AND SERVICES AGREEMENT
 
THIS
RESTATED CONSULTING AND SERVICES AGREEMENT is made as of January 20, 2022 (the “Effective Date”), by and between Vascular
Biogenetics Ltd, a
company registered under the laws of the State of Israel (the “Company”) and Grand H Services Ltd.
(the “Consultant”). The Company and the Consultant shall sometimes
be referred to, each as a “Party”
and collectively as the “Parties”.
 
WHEREAS,the
Parties have entered into a Consulting and Services Agreement dated January 2003, as amended
on March 26, 2007, March 13, 2008, September 16, 2008, September
10, 2009, January 1, 2016,
January 1, 2018 and October 19, 2021 (collectively, the “Previous Agreement”);
and
 
 
WHEREAS,the
Parties have decided to replace the Previous Agreement it in its entirety with this Restated
Consulting and Services Agreement (the “Agreement”), such that this
Agreement
shall, commencing as of the Effective Date, replace any previous agreement, whether oral
 or written, between the Parties or anyone on their behalf in
connection with the subject
matter, including the Previous Agreement.
 
NOW,
THEREFORE, based on the representations contained herein and in consideration of the mutual promises and covenants set forth herein,
the Parties agree as follows:
 
1.
Appointment;
the Services
 
1.1
The
Company hereby retains the Consultant to consult the Company on management and technological
matters regarding the Company’s business, technologies and affiliates
(the “Services”).
 
 
 
The
Services shall at all times be provided personally and solely by Prof. Dror Hararts (“Prof.
 Harats”), who shall serve as the Company’s Chief Executive Officer.
Accordingly,
Prof. Harats shall assume and undertake all of Consultant’s representations, warranties
and undertakings hereunder.
 
 
1.2
Consultant
shall devote approximately 80% of full-time employment for the performance of the Services.
 
1.3
The
Consultant shall provide the Services at such places and locations to be agreed upon with
the Company.
 
1.4
The
Parties agree that the Consultant shall be an independent contractor of the Company and in
no event shall an employer-employee or principal-agent relationship be
established between
the Company and the Consultant under this agreement. Without derogating from the above, in
the event that, notwithstanding the Parties’ undertakings
hereunder, the Consultant
shall claim, or a court of competent jurisdiction shall determine, the existence of employer-employee
relationship between the Consultant and the
Company under this agreement, then the following
provisions shall apply: (i) the Consultant’s monthly salary for such claimed or determined
period of employer-employee
relationship shall be equal to 60% (sixty percent) of the sum
of the Consulting Fee due to the Consultant as consideration for the Services hereunder;
and (ii) such monthly
salary shall be deemed to constitute all of the Company’s liabilities
and obligations towards the Consultant, of any source or origin, with respect to and in connection
with said
employer-employee relationship, except for such rights with respect to which global
compensation may not be determined pursuant to applicable law; The Company shall be
entitled
to set-off any amount due to it pursuant to this Section 1.4 from any amount due to Consultant
pursuant to this Agreement.
 
1

 
 
2.
The
Consultant’s Representations, Warranties and Covenants
 
The
Consultant hereby represents, warrants and covenants to the Company, and acknowledges that the Company is entering into this Agreement
in reliance thereon, as follows:
 
2.1.
The
Consultant has the necessary skills, knowledge and experience to fulfill Consultant’s
obligations hereunder, shall do so diligently, professionally and conscientiously and
shall
use Consultant’s best efforts in the performance thereof.
 
2.2.
The
execution and delivery of this Agreement and the fulfillment of the terms hereof will constitute
the valid, binding and enforceable obligations of the Consultant and will
not violate, conflict
with or constitute a default under or breach of any agreement and/or undertaking and/or instrument,
 judgment, order, writ or decree to which the
Consultant is a party or by which either is
bound, or any provision of law, rule or regulation applicable to the Consultant, including
without limitation, any confidentiality or
non competition agreement, and do not require
the consent of any person or entity. In the performance of the Consultant’s obligations
hereunder, the Consultant will not make
use of (i) any confidential or proprietary information
belonging to any third party, or (ii) any information to which the Consultant is restricted
from disclosing or using due to
contractual undertakings or by law. Without derogating from
the foregoing, the Consultant represents and warrants that the consent of any entity the
Consultant is employed
by or engaged with, to the extent required in connection with this
Agreement, has been obtained.
 
2.3.
In
the performance of the Consultant’s duties hereunder, the Consultant shall comply with
all applicable laws and regulations.
 
2.4.
The
Consultant will refrain from engaging in any business or other activity which may be of conflict
of interest with the Consultant’s duties and obligations hereunder and
shall promptly
notify the Company of any such matter or activity. The Consultant shall promptly provide
the Company with information regarding the Consultant’s additional
business and activities,
as may be requested by the Company from time to time. The Consultant acknowledges that the
Company may be required to share such information
with third parties and hereby agree thereto,
subject to the prior notification in writing to the Consultant and standard confidentiality
undertakings.
 
 
 
The
Parties agree that nothing contained in this Agreement shall be construed to bar the Consultant
 from being engaged in its private practice and from consulting to
pharmaceutical companies
and to other related activities that are not competitive with the business or technologies
of the Company and its affiliates solely. The Consultant
acknowledges that the activities
specified in this Section 2.4 shall not prevent it from devoting its time, attention and
efforts as set forth in Section 1.2 above, and further
agrees to notify the Company of any
such engagement or activity, but no consent by the Company will be required for this activity
or engagement.
 
2.5.
The
Consultant agrees and undertakes to indemnify, defend, and hold harmless the Company (including
its directors, officers, agents, employees, representatives, successors
and assigns) against
any and all claim, suit, demand, action or procedure, liability, loss, damage, cost and expense
(including reasonable attorney’s fees), based upon, arising
out of or otherwise with
respect to any tax liability, payment or withholding, employee benefits or similar items
in connection with the compensation of the Consultant
pursuant to this Agreement.
 
2

 
 
3.
Consideration
 
3.1.
In
full consideration for the Services rendered in accordance with this Agreement, the Consultant
shall be entitled to a monthly consulting fee equal to NIS 99,196 plus VAT, if
applicable
(the “Consulting Fee”). The Consultant shall be entitled to receive an
 annual bonus equal to one-half of his annual compensation, to be paid according to
milestones
to be determined by the Board of Directors, and in accordance with the Company’s 2019
Compensation Policy for Company Office Holders.
 
3.2.
The
Consulting Fee shall be paid at the first business day of each month.
 
3.3.
All
payments made by the Company to the Consultant hereunder include all taxes levied or imposed
upon on or in connection with the Services and said payments shall be
solely made against
proper invoices in accordance with applicable law.
 
3.4.
The
Consultant shall be solely responsible to pay all taxes, levies, social benefits and any
other payments required by law due in connection with this Agreement, whether in
Israel or
 abroad, provided, however, that the Company may withhold all
 amounts as required by applicable law from payments hereunder or in connection with this
Agreement.
 
3.5.
The
Consultant shall not be entitled to receive any other right, compensation or payment from
the Company, other than as expressly stated in this Section 3.
 
4.
Proprietary
Rights; Ownership of Work Product
 
4.1.
The
Consultant agrees and declares that any and all inventions, ideas, concepts, data, discoveries,
designs, technology, improvements, derivations, techniques and products,
works of authorship,
reports, know-how and proceeds, related to the technology or business of the Company as currently
 conducted and/or proposed to be conducted,
conceived, conducted, designed, developed, reduced
to practice, compiled, created, written, authored, made and/or produced by the Consultant,
alone or jointly with others,
pursuant to, in connection with, resulting or arising from
this Agreement, the provision of services to the Company and/or Confidential Information
(as defined below) or
using equipment, supplies, facilities or trade secrets of the Company,
prior thereto or thereafter (the “Inventions”) and any and all right,
title and interest in and to the
Inventions, including without limitation, all intellectual,
industrial and/or proprietary rights (together with the Inventions, the “Proprietary
Rights”), shall be the sole and
exclusive property of the Company, its successors
and assigns (for the purpose of this Section 4, collectively, the “Company”),
free and clear of any third party right, claim or
demand.
 
4.2.
The
Proprietary Rights shall be promptly reported to the Company but otherwise maintained in
confidence by the Consultant. The Consultant further agrees and undertakes to
take all necessary
measures and to fully cooperate with the Company, during and after the term of this engagement,
in order to perfect, enforce, and/or defend the Proprietary
Rights, and effectuate the Company’s
title and interest therein, including without limitation as follows: (i) to keep accurate
records relating to the conception and reduction to
practice of all Proprietary Rights, which
records shall be the sole and exclusive property of the Company and shall be surrendered
 to the possession of the Company,
immediately upon their creation; and (ii) to provide
the Company with all information, documentation, and assistance, including the preparation
or execution, as applicable, of
documents, declarations, assignments, drawings and other
data. Without derogating from any of the Consultant’s obligations hereunder, The Consultant
hereby appoints any
officer of the Company as the Consultant’s duly authorized agent
to execute, file, prosecute and protect the same before any government agency, court or authority.
 
3

 
 
4.3.
Without
derogating from the above, any and all material (including, without limitation, software,
designs, documentation, memoranda, notes, reports, manuals, patterns,
programs, specifications,
prototypes, formulas, drawings, records, data or other technical or proprietary information),
and any copies or abstracts thereof, whether or not of a
secret or confidential nature, furnished
to the Consultant by the Company or written, authored, created, compiled, composed or developed
by the Consultant in connection
with the Proprietary Rights, is and shall remain the sole
 and exclusive property of the Company. Such property while in the Consultant’s custody
 or control shall be
maintained in good condition.
 
4.4.
In
the event of the expiration or other termination of this Agreement for any reason, or upon
the Company’s earlier request, the Consultant will promptly deliver to the
Company
all materials referred to herein and the Consultant shall not retain or take any materials,
or any reproduction thereof containing or pertaining to Confidential
Information or Proprietary
Rights.
 
5.
Confidentiality
 
5.1.
The
Consultant represents and warrants that it will keep the terms and conditions of this Agreement
strictly confidential and will not disclose it or provide a copy of this
Agreement or any
part thereof to any third person unless and to the extent required by applicable law.
 
5.2.
Any
and all information and data of a proprietary or confidential nature concerning the business
or financial activities of the Company or its technology, whether in oral,
written, graphic,
machine-readable form, or in any other form, including, without limitation, proprietary,
business, financial, technical, development, product, marketing, sales,
price, operating,
performance, cost, know-how and process information, trade secrets, patents, patent applications,
copyrights, ideas and inventions (whether patentable or
not), and all record bearing media
containing or disclosing such information and techniques, disclosed to or otherwise acquired
by the Consultant in connection with this
Agreement and any and all Proprietary Rights (collectively,
“Confidential Information”) is and shall remain the sole and exclusive
property of the Company.
 
5.3.
At
all times, both during the term of this Agreement and thereafter, the Consultant: (i) will
keep the Confidential Information strictly confidential and will not disclose it, or
any
part thereof, provide any documentation with respect thereto, or any part thereof, directly
 or indirectly, to any third party, without the prior written consent of the
Company or unless
and to the extent required by applicable law; and (ii) will not use any Confidential Information
or anything relating to it without the prior written consent
of the Company, except and to
the extent as may be necessary in the ordinary course of performing the Consultant’s
duties and obligations hereunder and in the best interests
of the Company. Notwithstanding
the foregoing, the Consultant shall not be obligated to maintain the confidentiality of the
Confidential Information which: (i) is or becomes a
matter of public knowledge through no
fault of the Consultant or (ii) is authorized, in writing, by the Company for release.
 
5.4.
At
all times, both during the term of this Agreement and thereafter, the Consultant will keep
in trust all Confidential Information. In the event of the termination of this
Agreement
for any reason, or upon the Company’s earlier request, the Consultant will promptly
deliver to the Company all materials referred to herein and the Consultant
shall not retain
or take any materials, or any reproduction thereof containing or pertaining to Confidential
Information.
 
5.5.
The
Consultant recognizes that the Company received and will receive confidential or proprietary
information from third parties, subject to a duty on the Company’s part to
maintain
the confidentiality of such information and to use it only for certain limited purposes.
At all times, both during the term of this Agreement and after its termination,
the Consultant
undertakes to keep any and all such information in strict confidence and trust, and it will
not use or disclose any of such information without the prior written
consent of the Company,
except as may be necessary to perform the Consultant’s duties hereunder and consistent
with the Company’s agreement with such third party. Upon
termination of this Agreement,
the Consultant shall act with respect to such information as set forth in Section 5.4.
 
4

 
 
6.
Non-Compete;
Non-Solicitation
 
6.1.
During
the term of this Agreement and for twenty four (24) months following termination or expiration
thereof, the Consultant agrees that it will not (i) perform any services
for any third party
that, or otherwise engage in, any activity which competes with the Company or the Company’s
business; (ii) entice or solicit to employ or engage (or
employ or otherwise engage), any
individual employed or otherwise engaged, directly or indirectly, by the Company; or (iii)
entice, solicit or encourage any of the Company’s
customers, suppliers or service providers
to either engage with the Consultant in any way that shall compete with the Company, or terminate
or otherwise modify adversely
their business relationship with the Company.
 
6.2.
To
avoid any doubt, Prof. Harats may serve as an academic related consultant to, or an investor
in, any entity or business in the medical or biotech industry not in competition
with the
Company or its affiliates, provided that adequate notice of the activity or investment is
given to the Board of Directors of the Company. Also, Prof. Harats may own
securities of
any corporation which is engaged in, or competes with the business of the Company and is
publicly owned and traded but in an amount not to exceed at any one
time one percent (1%)
of any class of stock or securities of such company, and provided further that he has no
active role in the publicly owned and traded corporation as
director, employee or otherwise.
 
6.3.
The
above provisions shall apply to the Consultant directly and indirectly, alone or jointly
with others, whether as an employee, advisor, service provider, founder, partner,
holder
of equity interest or otherwise (except from the holding of equity securities not greater
than 5% in a publicly traded company). The Consultant hereby acknowledges
that the provisions
of this Section 6 are reasonable to legitimately protect Confidential Information, Proprietary
Rights and Company property (including intellectual property
and goodwill) to which the Consultant,
in its position in the Company, will be exposed, and that the Consultant’s compensation
under this Agreement incorporates special
consideration with respect for these undertakings.
 
7.
Personal
Information
 
Consultant
hereby grants its consent to the Company, its affiliates, and its employees, wherever they may be located, to utilize and process its
Personal Information (as such
term is hereinafter defined), solely for purposes directly related to the performance of the Services.
Consultant is aware, understands and hereby consents that the Personal
Information which shall be collected, will be kept in the Company
databases, held in Israel and/or abroad, and further consents that Personal Information, may, in whole or in
part, be transferred, and
further transferred, to databases owned by a parent or any other entity affiliated with the Company, or a third party retained by the
Company, parent of
affiliates for assisting in administration, whether in Israel or abroad, and may be used by such entities for purposes
of management and administration. The Company may
share personnel records as needed internally and with third parties in connection with
purposes related to the Consultant’s engagement, audit and compliance activities and as
reasonably required in connection with
the internal operations of the Company. Notwithstanding anything herein, all personnel records included in the Personal Information
are
considered confidential and access will be limited and restricted to individuals with need to know or process that Personal Information,
such as management teams and
human resources personnel solely to the extent required in order for them to fulfill their position with
the Company (including due diligence by potential investors and
partners). Consultant declares that it was given the opportunity to ask
 and request details regarding the Personal Information transfer, as aforesaid, and understood and
accepted this section. Consultant further
acknowledges that it was made aware that it is entitled to contact the Company with any question or concern with respect to the
Personal
Information.
 
5

 
 
“Personal
Information” shall mean Consultant’s personal information, including data collected by the Company, such as information
regarding the Consideration, evaluation
and training.
 
Notwithstanding
 the above, the Consultant confirms that he is aware and agrees that the Company may conduct audits and inspections at the Company’s
 offices, at
Consultant’s work environment in the facilities of the Company and in the Company’s computers, which were placed
in favor of the Consultant for conducting the Services
and performing its duties, including e-mail messages and internet applications
and their contents. It is hereby clarified and agreed that all materials and findings resulting from
such audits and inspections shall
be the sole property of the Company.
 
8.
Company’s
Property
 
8.1.
Company
Property. The Company may provide Consultant with different equipment such as cellular
phone, computer or portable computer or other equipment as may be
needed for the performance
of the Services (the “Company Property”). Consultant shall use the Company
Property for the performance of the Services and reasonable
personal use, if applicable.
Consultant acknowledges that the Company is the sole and only owner of the Company Property
and its contents, including, any Proprietary
Information which shall be subject to the terms
of Section 4 above.
 
8.2.
Consultant
shall take good care of the Company Property, shall use it carefully and in accordance with
the Company’s instructions and policies and shall notify the Company
immediately with
respect to any damages or failures of the Company Property. Consultant shall bear all expenses
relating to any negligent use of the Company Property.
Consultant is strictly obligated to
coordinate the installation and configuration of any programs on the computer provided by
the Company, and must receive specific approval
to install any hardware, software or files
on the Company’s computer, including without limitation, the downloading of software
and files from the internet and privately-
owned disks.
 
8.3.
Company
Email. The Company shall provide Consultant with a Company email address (the “Company
Email”) for the performance of the Services. Any use of the
Company Email including
internet use shall be in accordance with the Company’s policies and instructions. Consultant
confirms and acknowledges that the Company Email is
provided to it for professional use and
the Company may monitor the Company Email and/or any communications to and from the Company
without prior notice, and from
time to time, and Consultant hereby agrees that such actions
shall not be regarded as invasion of privacy.
 
 
8.4.
Consultant
shall return to the Company all Company Property, including without limitations, the computer
and phone, if provided, and access to Company Email, no later than
the day of receipt of
notice of termination of termination of this Agreement or within 7 days of the Company’s
demand. Consultant shall have no right for a lien, pledge,
encumbrance and the like on the
Company’s Property
 
9.
Sexual
Harassment
 
The
Company disapproves of sexual harassments, and will not accept any violations of the Sexual Harassment Prevention Law -1998 (the “Law”).
Consultant hereby confirms
and acknowledges that the Law and the Company’s policies with respect to prevention sexual harassment
have been brought to his attention.
 
6

 
 
10.
Term
and Termination
 
10.1.
The
term of this Agreement shall commence as of the Effective Date and shall continue in full
force and effect for twelve (12) months or until earlier terminated by either of
the Parties
by a nine (9) months prior written notice to the other Party. The Term of this Agreement
shall be automatically renewed for successive twelve (12)-month periods.
 
10.2.
The
Company may further terminate this Agreement by written notice to the Consultant having immediate
effect upon: (i) the Consultant’s refusal or inability to perform the
Services hereunder;
or (ii) the material breach of any provision of this Agreement by the Consultant or the Consultant’s
involvement in an act that constitutes breach of trust
between the Consultant and the Company.
 
10.3.
If
the Consultant’s Services are terminated (i) not pursuant to Section 10.2 hereunder,
or (ii) not due to the Consultant’s termination of the Agreement unless such termination
is for Good Reason, the Consultant shall be entitled to a consideration of 6 months Consulting
Fees. “Good Reason” shall mean the occurrence of any of the following
events
and conditions: (a) a change in the Consultant’s status, title, position or
responsibilities which represent a material reduction of the status, title, position or responsibilities
as in
effect immediately prior thereto; (b) a reduction in the Consultant’s Consulting
Fees which is not part of a general reduction in salary with respect to all employees and/or
consultants of the Company; (c) the failure by the Company to continue in effect any material
compensation or benefit plan, program or practice in which the Consultant was
participating;
or (d) any material breach by the Company of any provision of this Agreement .
 
10.4.
The
provisions of Sections 1.4, 2.5, 4, 5, 6, 7 and 12.6 shall survive the termination or expiration
of this Agreement for any reason whatsoever.
 
11.
Notices
 
All
notices and other communications required or permitted to be given or sent hereunder shall be given in writing and shall be deemed to
have been delivered for all purposes upon the
earlier of: (i) within three (3) days following the date upon which it was deposited for
registered mail; (ii) within one (1) business day after it was transmitted by fax or e-mail and
confirmation of transmission has been
obtained; and (iii) upon personal delivery.
 
12.
Miscellaneous
 
12.1.
Further
Assurances. The Parties hereby undertake to execute all necessary documentation and take
all further action as may be required in order to fulfill the purposes of this
Agreement.
 
12.2.
Headings;
Interpretation. The headings of the sections and subsections of this Agreement are for
convenience of reference only and are not to be considered in interpreting this
Agreement
or for any other purpose.
 
12.3.
Entire
Agreement. This Agreement, including all schedules and exhibits attached thereto, constitutes
the entire agreement between the Parties with respect to the subject
matter hereof and thereof,
and supersedes all prior understandings, agreements and discussions between them, oral or
written including the Previous Agreement.
 
12.4.
Amendment;
Waiver. No provision of this Agreement may be amended or modified unless agreed to in
writing and signed by both Parties. The observance of any term hereof
may be waived (either
prospectively or retroactively and either generally or in a particular instance) only with
the written consent of the Party against such waiver is sought.
No waiver by either Party
at any time to act with respect to any breach or default by the other Party of, or compliance
with, any condition or provision of this Agreement to be
performed by such other Party shall
be deemed a waiver of similar or dissimilar provisions or conditions at the same or at any
prior or subsequent time.
 
7

 
 
12.5.
Successors
and Assigns; Assignment. Subject to the provisions hereof, this Agreement shall be binding
upon and shall inure to the benefit of the successors, assigns, heirs,
executors and administrators
of the Parties. Neither this Agreement or any of the Consultant’s rights, privileges,
or obligations hereunder may be assigned or transferred by the
Consultant without the prior
consent in writing of the Company, except by will or by the laws of descent and distribution.
The Company may assign and/or transfer this
Agreement and any of its rights, privileges or
obligations hereunder Agreement, at its discretion, to an affiliate and/or a successor in
interest, which shall be bound by the
provisions hereof.
 
12.6.
Governing
Law. This Agreement shall be governed by and construed and enforced in accordance with
the laws of the State of Israel, without giving effect to the rules with
respect to conflicts-of-law.
Any dispute arising out of, or relating to this Agreement, its interpretation or performance
hereunder shall be resolved exclusively by the competent
court of the Tel Aviv- Jaffa district,
and each of the Parties hereby submits exclusively and irrevocably to the jurisdiction of
such court.
 
12.7.
Severability.
The provisions of this Agreement shall be deemed severable and the invalidity or unenforceability
of any provision shall not affect the validity or enforceability
of the other provisions
hereof. If any part of this Agreement is determined to be invalid, illegal or unenforceable,
such determined shall not affect the validity, legality or
enforceability of any other part
of this Agreement; and the remaining parts shall be enforced as if such invalid, illegal,
or unenforceable part were not contained herein,
provided, however,
that in such event this Agreement shall be interpreted so as to give effect, to the greatest
extent consistent with and permitted by applicable law, to the
meaning and intention of the
excluded provision as determined by such court of competent jurisdiction.
 
12.8.
Counterparts.
This Agreement may be executed in any number of counterparts, each of which shall be an original.
 
[THE
REMAINDER OF THIS PAGE WAS INTENTIONALLY LEFT BLANK]
 
8

 
 
IN
WITNESS WHEREOF, the parties hereto have executed this Consulting and Services Agreement as of the date first above-mentioned.
 
/s/
Marc Kozin
 
/s/
Dror Harats
VASCULAR BIOGENETICS LTD.
 
GRAND H SERVICES LTD.
 
By:
Marc Kozin
By: Dror Harats
Title:Chairman of the Board
Title: 
 
 
Agreed and Accepted:
 
 
 
/s/ Dror
Harats
 
Prof. Dror Harats
 
 

 
 
AMENDMENT
OF RESTATED CONSULTING AGREEMENT
 
This
Amendment (the “Amendment”) by and between Vascular Biogenic Ltd. (the “Company”),
and Grand H Services Ltd. (the “Consultant”).
 
WHEREAS the
Company and the Consultant have entered into a Restated Consulting Agreement, dated January 20, 2022 (the “Agreement”);
and
 
WHEREAS
the parties desire to amend the Agreement as further set forth herein.
 
NOW
THEREFORE, in consideration of the mutual promises contained herein, and intending to be legally bound, the parties hereby declare
and agree as follows:
 
1.
Capitalized
terms used and not otherwise defined herein shall bear the respective meanings ascribed to
them in the Agreement.
 
 
2.
The
following sections shall be amended as follows:
 
2.1
Section
3.1 of the Agreement shall be amended such that the Consultant shall be entitled to a monthly
consulting fee equal to NIS 107,130 plus VAT.
 
 
 
2.2
The
following sub-section (e) shall be added to the definition of “Good Reason” in
Section 10.3 of the Agreement:
 
 
 
 
 
“(e)
retirement to be deemed resignation under Section 2.1.3(b) of the Restated Employment Agreement between the Company and Prof. Dror Harats
dated January 20, 2022.”
 
3.
The
Agreement, as amended hereby, shall continue in full force and effect as originally constituted
and is hereby ratified and affirmed by the Parties.
 
IN
WITNESS WHEREOF, the parties have duly executed this Amendment as of the date below.
 
/s/
Sam Backenroth
 
/s/
Dror Harats
Vascular
Biogenics Ltd.
 
Grand
H Services Ltd.
Date:
8/23/2022
 
Date:
8/23/2022
 
Agreed
and accepted
 
 
 
/s/
Dror Harats
 
Prof.
Dror Harats
 
 
 

 
Exhibit
10.7
 
October
4, 2021
 
Sam Backenroth
 
Re:
Employment Offer
 
Dear
Sam:
 
I
am pleased to offer you employment with Vascular Biogenics Ltd. d/b/a VBL Therapeutics (or its applicable affiliate, the “Company”).
The initial terms of your employment, should
you accept this offer, are set forth below (the “Agreement”).
 
1. Position.
Your position will be Chief Financial Officer reporting to the Chief Executive Officer (“CEO”) of the Company. You will
have such duties, authorities and responsibilities
as the CEO determines, which duties, authority, and responsibilities shall be consistent
with your position. This is a full-time position. While you render services to the Company, you
will not engage in any other employment,
consulting or other business activities (whether full-time or part-time) without the prior, written consent of the CEO or the Board of
Directors
of Company including any applicable committee thereof (“Board”); provided that you may engage in religious, charitable
or other community activities as long as such services and
activities are disclosed to the Board and do not interfere with the performance
of your duties to the Company. For the avoidance of doubt, the Company acknowledges that it shall not
be a violation of this provision
for you to continue, from time to time, engaging in services for Orphion Therapeutics, Inc. (the “Oprhion Services”),
provided that the Orphion Services
do not compete, conflict or interfere with the performance of your services to the Company
or otherwise violate your Restrictive Covenant Obligations (as defined below).
 
2. Start
Date. The first day of your employment for purposes of this Agreement will be October 4, 2021 unless another date is mutually agreed
to by you and the Company (such
actual first day of employment, the “Start Date”).
 
3. Salary.
Initially, the Company will pay you a base salary at the rate of US $410,000 annually. Your base salary will be reviewed annually
and subject to upward adjustment at the
Company’s discretion. However, your base salary may not be decreased other than as part
of an across-the-board salary reduction that applies in the same manner to all senior
executives. Your base salary in effect from time
to time is referred to herein as the “Base Salary.” The Base Salary shall be payable in accordance with the Company’s
standard payroll
schedule and shall be subject to applicable deductions and withholdings.
 
4. Annual
Bonus. You will be eligible for an annual cash bonus of up to 40% of your Base Salary (the “Target Bonus”) based
on the achievement by Company and you of performance
goals established annually by the Board; provided that, depending on results, your
actual bonus may be higher or lower than the Target Bonus, as determined by the Board. The criteria
for any bonus, whether a bonus is
awarded, and the amount of any bonus each shall be determined by the Company in its sole discretion. The Target Bonus is subject to change.
To
earn any bonus, you must be employed with the Company on the date the bonus is paid.
 
5. Equity.
Subject to the approval of the Board (including any applicable committee thereof), and as a material, express condition of any and
all of the terms and conditions of this
Agreement, you will be granted an option (the “Option”) to purchase such number
of common shares of Vascular Biogenics Ltd. as is equal to 0.35% of the fully diluted shares
outstanding, subject in all respects to
 the applicable option plan and the associated option agreement (the “Equity Documents”). As of the date hereof, that
 would amount to
approximately 305,537 shares. The exact amount of shares subject to the Option will be determined by the Board in good
faith as of October 4, 2021. In addition, you will be entitled to
be considered, along with other members of management, for additional
annual grants, ordinarily allocated by the Compensation Committee of the Board in December of each year.
With respect to the first such
annual grant, you will be allocated an additional option covering shares equivalent to 0.15% of the fully diluted shares outstanding
of the Company.
 
 

 
 
6.
Signing Bonus. At the first regular pay period after your Start Date, the Company will pay you a signing bonus of US$100,000.00
(the “Signing Bonus”). If your employment is
terminated by the Company for Cause (as defined in Section 10) or by
you without Good Reason, in either event within the 9 month period immediately following the Start Date, you
agree to repay the
Signing Bonus in full to the Company by no later than 10 days following the last day of your employment with the Company.
“Good Reason” means (i) a diminution
in your base salary except for across-the-board salary reductions based on
 the Company’s financial performance similarly affecting all or substantially all senior management
employees of the Company or
(ii) a change of more than 50 miles in the geographic location of the principal Company office to which you report (not including
any change from
remote to in-person work, or vice versa, in connection with the COVID-19 pandemic) , (iii) any material breach by
the Company of any material provision of this Agreement or any
other material agreement between you and the Company; (iv) a
material, adverse change in your title, duties, or responsibilities (other than temporarily while you are physically or
mentally
incapacitated or as required by applicable law), in any such case (with respect to (iv)) or (v) a material adverse change in the
reporting structure applicable to you, so long as
(in each case, (i) through (v)) you provide written notice to the Chief Executive
Officer of the event constituting Good Reason within thirty (30) days following the initial occurrence of
any such event and the
Company fails to cure such event within 30 days after the date you provide such notice.
 
7. Benefits.
You will be eligible for the employee benefits the Company provides to employees from time to time, subject to the terms and conditions
of the Company’s benefit plans
and other applicable policies. Paid holidays and paid time off shall be made available to you in
accordance with, and subject to the conditions of, Company policies applicable to
officers of the Company, as in effect from time to
time as determined by the Company. You understand that the Company has not previously had employees in the United States and as
a result
has no benefit plans currently designed for US employees. The Company intends to institute benefits as soon as practicable, at a level
commensurate for executives at similarly
situated biotechnology companies in the US. The Company anticipates that such benefits shall
include a 401(k) plan, health insurance and other benefits. Until such time as the
Company institutes a group health insurance plan in
connection with which the Company pays at least eighty percent (80%) of the monthly premiums (at which time the Health
Stipend (as defined
below) shall immediately expire), the Company will pay eighty percent (80%) of the monthly insurance premiums for industry standard and
documented health
insurance coverage approved by the Company (such approval not to be unreasonably withheld) (the “Health Stipend”).
You will be responsible for the remaining portion of such
premiums. You and the Company agree to work collaboratively to obtain such
coverage. You acknowledge that the Health Stipend may constitute taxable income to you, subject to
applicable law.
 
8. Termination
of Employment; Accrued Obligations; Resignation(s) in Connection with Termination. Either you or the Company may terminate your employment
at any time
and for any reason, and with or without cause, provided that the terminating party must provide the non-terminating party
with at least sixty (60) days’ written notice (the “Notice
Period”). The terms and conditions of your employment,
 including without limitation your compensation, benefits and job duties, are subject to change by the Company in its
discretion. In the
event of the ending of your employment for any reason, the Company shall pay you (i) your Base Salary through your last day of employment
(the “Date of
Termination”), and (ii) the amount of any documented expenses properly incurred by you on behalf of
the Company prior to any such termination and not yet reimbursed and (iii) the
value based on your then current salary of any accrued
but unused paid time off, if the Company has an accrual paid time off policy as of the Date of Termination (the “Accrued
Obligations”).
In connection with the termination of your employment for any reason, you agree to resign from any officer position or other position
you have with the Company or
any Company affiliate, effective as of the Date of Termination, and execute any document reasonably requested
by the Company to effectuate such resignation(s).
 
 

 
 
9. Severance.
In the event the Company terminates your employment without Cause (as defined below) or you resign your employment with Good Reason
(as defined above) and in
either case provided you (i) enter into, do not revoke and comply with the terms of a separation agreement
and release in the form provided by the Company which shall include,
without limitation, a general release of claims against the Company
and related persons and entities and mutual (which means that you will agree not to disparage the Company and
related persons and entities,
and the Company will agree to instruct its C- Suite executes not to disparage you) nondisparagement obligations (the “Release”)
within the time period
provided in the Release but in no event later than 60 days after the Date of Termination (the “Release
Requirement”); (ii) resign from any and all positions, including, without
implication of limitation, as a director, trustee
or officer, that you then hold with the Company and any affiliate of the Company; and (iii) comply with the Restrictive Covenant
Agreement
(as defined below), then in addition to the Accrued Obligations and in lieu of the Notice Period, the Company will provide you with the
following “Severance Benefits”:
 
(a) continuation
of your Base Salary as of the Date of Termination for the twelve month period that immediately follows the Date of Termination (the “Salary
Continuation
Payments,” and such period, the “Severance Period”); provided in the event you breach any of
the Restrictive Covenant Obligations (as defined below), all payments of the
Salary Continuation Payments shall immediately cease; and
 
(b) if
elected, continuation of group health plan benefits to the extent authorized by and consistent with 29 U.S.C. § 1161 et seq. (commonly
known as “COBRA”), with the
cost of the regular premium for such benefits shared in the same relative proportion by
the Company and you as in effect on the Date of Termination until the earliest of (i) the
end of the Severance Period; (ii) the date
you become eligible for health benefits through another employer or (iii) the date you otherwise become ineligible for COBRA. You
authorize
the deduction of the employee portion of the COBRA payments from the Salary Continuation Payments. You agree to promptly notify the Company
of your
eligibility for health benefits from another employer and to respond promptly to any COBRA-related requests from the Company;
and
 
(c) any
vested equity rights and vested retirement benefits if any, to which you may be entitled under the Company’s employee benefit plans
as of the Termination Date;
provided that, in no event shall you be entitled to any payments in the nature of severance or termination
payments except as specifically provided herein..
 
The
Salary Continuation Payments shall commence within 60 days after the Date of Termination and shall be made on the Company’s regular
payroll dates; provided, however, that if
the 60-day period begins in one calendar year and ends in a second calendar year, the Salary
Continuation Payments shall begin to be paid in the second calendar year. In the event you
miss a regular payroll period between the
Date of Termination and first Salary Continuation Payment date, the first Salary Continuation Payment shall include a “catch up”
payment.
Solely for purposes of Section 409A of the Internal Revenue Code of 1986, as amended (“Section 409A”), each
Salary Continuation Payment is considered a separate payment.
 
For
the avoidance of doubt, in the event your employment is terminated by the Company for Cause, by you without Good Reason, or due to your
death or Disability , you will be
entitled to the Accrued Obligations but not to the Severance Benefits. For purposes of this Agreement,
“Disability” shall mean a condition for which benefits are payable under any
long-term disability coverage (without regard
to the application of any elimination period requirement) then provided to you by Company or, if no such coverage is then being
provided,
the inability of you to perform the essential functions of your position under this Agreement, even with Company’s reasonable accommodation,
for a period of at least 100
consecutive days as certified by a physician chosen by the Company and reasonably acceptable to you. For
the avoidance of doubt, nothing in this Agreement alters the Company’s or
your obligations under applicable law. .
 
 

 
 
10. Cause.
“Cause” means: (i) your engagement in material misconduct with respect to any of your duties or responsibilities,
including without limitation unlawful harassment and
misappropriation of material funds or material property of the Company or any of
 its affiliates; (ii) your commission of, indictment for, conviction of or plea of guilty or nolo
contendere with respect to (A) any felony
or (B) a misdemeanor involving moral turpitude, deceit, dishonesty or fraud; (iii) any conduct by you that would reasonably be expected
to
result in material injury or reputational harm to the Company or its affiliates if you were retained in your position; (iv) continued
intentional refusal to perform any of your material
responsibilities hereunder that are typical of those assigned to a CFO of a business
of similar size in the same industry as the Company (other than by reason of your physical or mental
illness, incapacity or disability);
(v) a breach by you of the Restrictive Covenant Agreement or any other confidentiality or restrictive covenant obligation you have to
the Company or
any Company affiliate; or (vi) a material violation by you of any of the Company’s written employment policies.
Termination for Cause must be effected, if at all, within 90 days of the
discovery by Company of any event constituting Cause or else
such event shall be waived by the Company as a basis for Cause. Termination for Cause shall only exist under subparts
(iv) and (vi) of
this Section 10 if the Company provides you written notice of the event constituting Cause within thirty (30) days following the date
of the initial occurrence of any
such event and you fail to cure such event within 30 days after the date Company provides such notice.
 
11. Confidential
 Information and Other Restricted Activities. As a condition of the commencement of your employment, you are required to enter into
 the Employee
Confidentiality, Assignment, Nonsolicitation and Noncompetition Agreement (the “Restrictive Covenant Agreement”)
attached hereto. The Restrictive Covenant Agreement, along
with any other confidentiality and restrictive covenant obligation you have
to the Company or any of its affiliates, are referred to as the “Restrictive Covenant Obligations.” You agree
without
reservation that these restraints are necessary for the reasonable and proper protection of the Company and its affiliates, and that
each and every one of the restraints is
reasonable in respect to subject matter, length of time and geographic area.
 
12. Obligations
to Third Parties. By signing this Agreement, you represent to the Company that you have no contractual commitments or other legal
obligations (including with
respect to noncompetition, nonsolicitation, invention assignment and the nondisclosure of confidential information)
 that would or may prohibit or materially inhibit you from
performing your duties for the Company. You agree to disclose to the Company
prior to the Start Date any confidentiality or restrictive covenant agreement you have to any prior
employer. You further agree that
you will not disclose or use confidential information of any former employer or other third party and that you will respect any other
restrictive
covenant obligation you have to any former employer or other third party.
 
13. Section
409A; Taxes. It is intended that the benefits provided under this letter and the Restrictive Covenant Agreement shall comply with
the provisions of Section 409A or qualify
for an exemption to Section 409A, and this letter and the Restrictive Covenant Agreement shall
be construed and interpreted in accordance with such intent. Any payments that qualify
for the “short term deferral” exception
or another exception under Section 409A shall be paid under the applicable exception. Each payment provided under this letter or the
Restrictive
Covenant Agreement shall be treated as a separate payment for Section 409A purposes. Neither the Company (or its affiliates),
the Board, or any employee, officer or director of the
Company (or its affiliates) shall be held liable for any taxes, interest, penalties
or other monetary amounts owed by you as a result of this letter or the Restrictive Covenant Agreement.
All forms of compensation referred
to in this Agreement are subject to reduction to reflect applicable withholding and payroll taxes and other deductions required by law.
You hereby
acknowledge that the Company does not have a duty to design its compensation policies in a manner that minimizes your tax
liabilities, and you will not make any claim against the
Company or the Board related to tax liabilities arising from your compensation.
 
 

 
 
14.
Interpretation and Enforcement. This Agreement, including the Restrictive Covenant Obligations and the Equity Documents,
constitutes the complete agreement between you
and the Company, contains all of the terms of your employment with the Company and
supersedes any prior agreements, representations or understandings (whether written, oral or
implied) between you and the Company.
In entering into this Agreement, you agree that you are not relying on any promises or representations of the Company or any Company
affiliate, except as are expressly contained herein. Except as may otherwise be expressly provided in the Restrictive Covenant
Obligations or the Equity Documents, (i) the terms of
this Agreement and the resolution of any disputes as to the meaning, effect,
performance or validity of this Agreement or arising out of, related to, or in any way connected with this
Agreement, your
employment with the Company or any other relationship between you and the Company (the “Disputes”) will be
governed by New York law, excluding laws relating
to conflicts or choice of law; (ii) you and the Company submit to the exclusive
personal jurisdiction of the federal and state courts located in New York in connection with any Dispute
or any claim related to any
Dispute, and (iii) you and the Company waive any right to trial by jury with respect to such Dispute.
 
15. Assignment.
You may not make any assignment of this Agreement or any interest in it. The Company may assign its rights and obligations under this
Agreement (including the
Restrictive Covenant Obligations) without your consent to any subsidiary, affiliate or to any other person or
entity. This Agreement shall inure to the benefit of and be binding upon
you and the Company, and each of your and its respective successors,
executors, administrators, heirs and permitted assigns.
 
16. Miscellaneous.
This Agreement may not be modified or amended by either you or the Company, and no breach or provision shall be deemed to be waived by
the Company, unless
agreed to in writing by you and the Chief Executive Officer or the Chairperson of the Board. This Agreement may be
executed in two or more counterparts, including by the use of
PDFs, each of which shall be an original and all of which together shall
constitute one and the same instrument.
 
17. Legal
Fees for Negotiation of the Agreement. You shall be reimbursed for Executive’s reasonable legal fees incurred in negotiating
and drafting this Agreement up to a maximum
of $7,500.00, provided that, any such payment shall be made on or before December 31, 2021.
 
Please
indicate your acceptance of this offer by signing below and returning a copy of this letter and the signed Restrictive Covenant Agreement
by September 30, 2021.
 
 

 
 
 
VASCULAR
BIOGENICS LTD. d/b/a VBL THERAPEUTICS
 
 
 
 
By: /s/
Dror Harats
 
 
Dror
Harats, M.D.
 
 
President
and CEO
 
I
have read and accept this employment offer:
 
 
 
/s/
Sam Backenroth
 
Sam
Backenroth
 
 
 
Date:
10/4/2021
 
 
Enclosure:
Restrictive
Covenant Agreement
 
 

 
 
FORM
OF
 
Employee
Confidentiality, Assignment, Nonsolicitation and Noncompetition Agreement
 
In
 consideration and as a condition of the commencement of my employment by Vascular Biogenics Ltd. d/b/a VBL Therapeutics (including its
 subsidiaries and other
affiliates and its and their successors and assigns, the “Company”), I enter into this Employee
Confidentiality, Assignment and Noncompetition Agreement (the “Agreement”) and
agree as follows:
 
1.
Proprietary Information. I agree that all information, whether or not in writing, concerning the Company’s business,
technology, business relationships or financial affairs that the
Company has not released to the general public (collectively, “Proprietary
Information”) and all tangible embodiments thereof are and will be the exclusive property of the Company.
By way of illustration,
Proprietary Information may include information or material that has not been made generally available to the public, such as: (a) corporate
 information,
including plans, strategies, methods, policies, resolutions, negotiations or litigation; (b) marketing information,
including strategies, methods, customer or business partner identities or
other information about customers, business partners, prospect
identities or other information about prospects, or market analyses or projections; (c) financial information, including
cost
and performance data, debt arrangements, equity structure, investors and holdings, purchasing and sales data and price lists; (d) operational,
technological scientific information,
including plans, specifications, manuals, forms, templates, software, pre- clinical and clinical
 testing data and strategies, research and development strategies, designs, methods,
procedures, formulae, data, reports, discoveries,
inventions, improvements, concepts, ideas, and other Developments (as defined below), know-how and trade secrets; and (e) personnel
information, including personnel lists, reporting or organizational structure, resumes, personnel data, performance evaluations and
termination arrangements or documents. Proprietary
Information also includes information identified to me as received under a contractual
obligation to maintain its confidence by the Company from its customers, suppliers or other third
parties. For purposes hereof, a “business
partner” of the Company means any entity that has a contractual relationship with the Company or with whom the Company is negotiating
a
contractual relationship.
 
2.
 Recognition of Company’s Rights. I will not, at any time, without the Company’s prior written permission, either
 during or after my employment, disclose any Proprietary
Information to anyone outside of the Company, or use or permit to be used any
Proprietary Information for any purpose other than the performance of my duties as an employee of the
Company. I will cooperate with
the Company and use my best efforts to prevent the unauthorized disclosure of all Proprietary Information. I will deliver to the Company
all copies and
other tangible embodiments of Proprietary Information in my possession or control upon the earlier of a request by the
Company or termination of my employment.
 
3.
Rights of Others. I understand that the Company is now and may hereafter be subject to nondisclosure or confidentiality agreements
with third persons that require the Company to
protect or refrain from use or disclosure of proprietary information. I agree to be bound
by the terms of such agreements made available to me in the event I have access to such
proprietary information. I understand that the
Company strictly prohibits me from using or disclosing confidential or proprietary information belonging to any other person or entity
(including any employer or former employer), in connection with my employment. In addition, I agree not to bring any confidential information
belonging to any other person or entity
onto Company premises or into Company workspaces.
 
4.
Developments. I will make full and prompt disclosure to the Company of all inventions, discoveries, designs, developments,
methods, modifications, improvements, processes,
algorithms, data, databases, computer programs, research, formulae, techniques, trade
secrets, graphics or images, and audio or visual works and other works of authorship, and other
intellectual property, including works-in-process
(collectively “Developments”) whether or not patentable or copyrightable, that are created, made, conceived or reduced
to practice by
me (alone or jointly with others) or under my direction during the period of my employment which meet the definition of
Company Developments below. I acknowledge that all work
performed by me is on a “work for hire” basis, and I hereby do assign
and transfer and, to the extent any such assignment cannot be made at present, will assign and transfer, to the
Company and its successors
and assigns all my right, title and interest in and to all Developments that (a) relate to the business of the Company or any customer
of, supplier to or
business partner of the Company or any of the products or services being researched, developed, manufactured or sold
by the Company or which may be used with such products or
services; or (b) result from tasks assigned to me by the Company; or (c) result
from the use of premises or personal property (whether tangible or intangible) owned, leased or
contracted for by the Company (“Company-Related
Developments”), and all related patents, patent applications, trademarks and trademark applications, copyrights and copyright
applications, sui generis database rights and other intellectual property rights in all countries and territories worldwide and
under any international conventions (“Intellectual Property
Rights”).
 
 

 
 
To
preclude any possible uncertainty, if there are any inventions or improvements relevant to the subject matter of my employment by the
Company that I have, alone or jointly with
others, conceived, developed or reduced to practice prior to the commencement of my employment
with the Company that I consider to be my property or the property of third parties
and that I wish to have excluded from the scope of
this Agreement (“Prior Inventions”), I have set forth on Exhibit A attached hereto a complete list of those Prior
Inventions. If
disclosure of any such Prior Invention would cause me to violate any prior confidentiality agreement, I understand that
I am not to list such Prior Inventions in Exhibit A but am only to
disclose a cursory name for each such invention, a listing
of the party(ies) to whom it belongs and the fact that full disclosure as to such inventions has not been made for that reason. If
there
are any patents or patent applications in which I am named as an inventor, other than those that have been assigned to the Company (“Other
Patent Rights”), I have also listed
those Other Patent Rights on Exhibit A. If no such disclosure is attached, I represent
that there are no Prior Inventions or Other Patent Rights. If, in the course of my employment with
the Company, I incorporate a Prior
Invention into a Company product, process or machine, research or development program, or other work done for the Company, I hereby grant
to
the Company a nonexclusive, royalty-free, fully paid-up, irrevocable, worldwide license (with the full right to sublicense through
multiple tiers) to make, have made, modify, use, sell,
offer for sale and import such Prior Invention. Notwithstanding the foregoing,
 I will not incorporate, or permit to be incorporated, Prior Inventions in any Company-Related
Development without the Company’s
prior written consent. I will not, without the Company’s prior written consent, incorporate into any Company product or otherwise
deliver to the
Company any software code that is subject to any license that by its terms requires, or conditions the use or distribution
of such code on, the disclosure, licensing or distribution of such
Company product or any source code owned or licensed by the Company
(e.g., software code licensed under the GNU GPL, LGPL or AGPL).
 
This
Agreement does not obligate me to assign to the Company any Development that is developed entirely on my own time and does not relate
to the business efforts or research and
development efforts in which, during the period of my employment, the Company actually is engagedor
is actively planning to be engaged, and does not result from the use of premises
or equipment owned or leased by the Company. I understand
that to the extent this Agreement is required to be construed in accordance with the laws of any state which precludes a
requirement
in an employee agreement to assign certain classes of inventions made by an employee (including, without limitation, pursuant to the
applicable statutory provision for my
state of employment set forth in Exhibit B, if any), this Section 5 will be interpreted not to
apply to any invention that a court rules and/or the Company agrees falls within such classes.
I also hereby waive all claims to any
moral rights or other special rights that I may have or accrue in any Company-Related Developments.
 
5.
Documents and Other Materials. I will keep and maintain adequate and current records of all Proprietary Information and Company-Related
Developments developed by me
during my employment, which records will be available to and remain the sole property of the Company at
all times.
 
All
files, letters, notes, memoranda, reports, records, data, sketches, drawings, notebooks, layouts, charts, quotations and proposals, specification
sheets, blueprints, models, prototypes,
or other written, photographic or other tangible material containing Proprietary Information,
whether created by me or others, which come into my custody or possession, are the
exclusive property of the Company to be used by me
only in the performance of my duties for the Company. Any property situated on the Company’s premises and owned by the
Company,
including without limitation computers, disks and other storage media, filing cabinets or other work areas, is subject to inspection
by the Company at any time with or
without notice. In the event of the termination of my employment for any reason, I will deliver to
the Company all Company property and equipment in my possession, custody or
control, including all files, letters, notes, memoranda,
reports, records, data, sketches, drawings, notebooks, layouts, charts, quotations and proposals, specification sheets, blueprints,
models,
 prototypes, or other written, photographic or other tangible material containing Proprietary Information, and other materials of any
 nature pertaining to the Proprietary
Information of the Company and to my work, and will not take or keep in my possession any of the
foregoing or any copies.
 
6.
Enforcement of Intellectual Property Rights. I will cooperate fully with the Company, both during and after my employment
with the Company, with respect to the procurement,
maintenance and enforcement of Intellectual Property Rights in Company-Related Developments.
I will sign, both during and after my employment, all papers, including without
limitation copyright applications, patent applications,
declarations, oaths, assignments of priority rights, and powers of attorney, which the Company may deem necessary or desirable
in order
to protect its rights and interests in any Company-Related Development or Intellectual Property Rights therein. If the Company is unable,
after reasonable effort, to secure my
signature on any such papers, I hereby irrevocably designate and appoint each officer of the Company
as my agent and attorney-in-fact to execute any such papers on my behalf, and to
take any and all actions as the Company may deem necessary
or desirable in order to protect its rights and interests in any Company-Related Development, including any Intellectual
Property Rights
therein.
 
7.
Nonsolicitation and Noncompetition.
 
In
order to protect the Company’s Proprietary Information and goodwill, during my employment and for a period of: (i) one (1) year
following the date of the cessation of my
employment with the Company (the “Last Date of Employment”), ( “Restricted
Period”):
 
(a)
I shall not, directly or indirectly, in any manner, other than for the benefit of the Company, solicit or transact any Competitive Services
(as defined below) with (i) any
customers of the Company or (ii) any of its vendors which would result in its material decrease in products
or services to Company. For purposes of this Agreement, (i) customers shall
include then current customers to which the Company provided
products or services during the twelve months prior to the Last Date of Employment (the “One Year Lookback”) and
customer
 prospects that the Company solicited during the One Year Lookback, and (ii) vendors shall include then current vendors and vendors that
 provided services to or in
connection with the Company during the One Year Lookback provided that, for purposes of this Section,
customers and vendors shall be limited to those which, in the course of the last
three (3) years of my employment, I had significant
contact with or learned confidential information about.
 
2

 
 
(b)
I shall not, directly or indirectly, in any manner, solicit, entice or attempt to persuade any employee or consultant of the Company
to leave the Company for any reason or
otherwise participate in or facilitate the hire, directly or through another entity, of any person
who is then employed or engaged by the Company.
 
(c)
I shall not directly or indirectly, whether as owner, partner, shareholder, director, manager, consultant, agent, employee, co-venturer
or otherwise, anywhere in the United
States or in any other country in which the Company does business, perform services which are the
same as or similar to those types of services which I conducted or provided to the
Company within the last 24 months of my employment.
for any business that engages in Competitive Services. Competitive Services shall mean develops, manufactures or markets
any products,
or performs any services, that are competitive with the products or services of the Company, or products or services that the Company
or its affiliates, has under
development or that were the subject of active planning at any time during my employment and which remain
 in active planning or development after my employment ends
(“Competitive Services”).
 
8.
Government Contracts. I acknowledge that the Company may have from time to time agreements with other persons or with the
United States Government or its agencies that
impose obligations or restrictions on the Company regarding inventions made during the
course of work under such agreements or regarding the confidential nature of such work. I
agree to comply with any such obligations or
restrictions upon the direction of the Company. In addition to the rights assigned under Section 4, I also assign to the Company (or
any of
its nominees) all rights that I have or acquired in any Developments, full title to which is required to be in the United States
under any contract between the Company and the United
States or any of its agencies at the time of my creation of such Development.
 
9.
Prior Agreements. I hereby represent that, except as I have fully disclosed previously in writing to the Company, I am not
bound by the terms of any agreement with any previous
or current employer or other party to refrain from using or disclosing any trade
secret or confidential or proprietary information in the course of my employment with the Company or
to refrain from competing, directly
or indirectly, with the business of such employer or any other party. I further represent that my performance of all the terms of this
Agreement as an
employee of the Company does not and will not breach any agreement to keep in confidence proprietary information, knowledge
or data acquired by me in confidence or in trust prior
to my employment with the Company. I will not disclose to the Company or induce
the Company to use any confidential or proprietary information or material belonging to any
previous employer or others.
 
10.
Remedies Upon Breach. I understand that the restrictions contained in this Agreement are necessary for the protection of the
business and goodwill of the Company and I consider
them to be reasonable for such purpose. Any breach of this Agreement is likely to
cause the Company substantial and irrevocable damage and therefore, in the event of such breach, the
Company, in addition to such other
remedies which may be available, will be entitled to specific performance and other injunctive relief, without the posting of a bond.
I further
acknowledge that a court may render an award extending the Restricted Period as one of the remedies in the event of my violation
of this Agreement.
 
11.
Use of Voice, Image and Likeness. I give the Company permission to use any and all of my voice, image and likeness, with or
without using my name, in connection with the
products and/or services of the Company, for the purposes of advertising and promoting
 such products and/or services and/or the Company, and/or for other purposes deemed
appropriate by the Company in its reasonable discretion,
except to the extent prohibited by law.
 
12.
No Employment Obligation. I understand that this Agreement does not create an obligation on the Company or any other person
to continue my employment. I acknowledge that,
subject to the terms and conditions of that certain letter agreement between Company and
me extending an offer of employment to me with Company, and unless otherwise agreed in a
formal written employment agreement signed on
behalf of the Company by an authorized officer, my employment with the Company is at will and therefore may be terminated by the
Company
or me at any time and for any reason, with or without cause.
 
13.
Survival and Assignment by the Company. I understand that my obligations under this Agreement will continue in accordance
with its express terms regardless of any changes
in my title, position, duties, salary, compensation or benefits or other terms and conditions
of employment. I further understand that my obligations under this Agreement will continue
following the termination of my employment
regardless of the manner of such termination and will be binding upon my heirs, executors and administrators. The Company will have
the
right to assign this Agreement to its affiliates, successors and assigns. I expressly consent to be bound by the provisions of this Agreement
for the benefit of the Company or any
parent, subsidiary or affiliate to whose employ I may be transferred without the necessity that
this Agreement be resigned at the time of such transfer.
 
14.
Notice of Resignation. If I elect to resign from my employment with the Company, I agree to provide the Company with written
notification of my resignation at least two (2)
weeks prior to my intended resignation date. Such notice shall include information in
reasonable detail about my post-employment job duties and other business activities, including
the name and address of any subsequent
employer and/or person or entity with whom or which I intend to engage in business activities during the Restricted Period and the nature
of
my job duties and other business activities. The Company may elect to waive all or part of the two (2) week notice period in its sole
discretion.
 
3

 
 
15.
Post-Employment Notifications. During the Restricted Period, I will notify the Company of any change in my address and of
each subsequent employment or business activity,
including the name and address of my employer or other post-Company employment plans
and the nature of my activities.
 
16.
Disclosures During Restricted Period. I will provide a copy of this Agreement to any person or entity with whom I may enter
into a business relationship, whether as an
employee, consultant, partner, coventurer or otherwise, prior to entering into such business
relationship during the Restricted Period.
 
17.
Waiver. No waiver of any of my obligations under this Agreement shall be effective unless made in writing by the Company.
 The failure of the Company to require my
performance of any term or obligation of this Agreement, or the waiver of any breach of this
Agreement, shall not prevent the Company’s subsequent enforcement of such term or
obligation or be deemed a waiver of any subsequent
breach.
 
18.
Severability. In case any provisions (or portions thereof) contained in this Agreement shall, for any reason, be held invalid,
illegal or unenforceable in any respect, such invalidity,
illegality or unenforceability shall not affect the other provisions of this
Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision had
never been contained herein.
 If, moreover, any one or more of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to
 duration,
geographical scope, activity or subject, it shall be construed by limiting and reducing it, so as to be enforceable to the
extent compatible with the applicable law as it shall then appear.
 
19.
Choice of Law and Jurisdiction. This Agreement will be deemed to be made and entered into in the State of New York, and will
in all respects be interpreted, enforced and
governed under the laws of such state. I hereby consent to personal jurisdiction of the
state and federal courts situated within such state for purposes of enforcing this Agreement, and
waive any objection that I might have
to personal jurisdiction or venue in those courts.
 
20.
Independence of Obligations. My obligations under this Agreement are independent of any obligation, contractual or otherwise,
the Company has to me. The Company’s breach
of any such obligation shall not be a defense against the enforcement of this Agreement
or otherwise limit my obligations under this Agreement.
 
21.
Protected Disclosures. The Company agrees that nothing contained in this Agreement shall be construed to limit my right to
 communicate with any federal, state or local
governmental agency or commission, including to provide documents or other information,
without notice to the Company. I also understand that nothing in this Agreement shall be
construed to limit my right to share compensation
information concerning myself or others, except that this does not permit me to disclose compensation information concerning others
that
I obtain because my job responsibilities require or allow access to such information.
 
22.
Defend Trade Secrets Act of 2016. The Company agrees that, pursuant to the federal Defend Trade Secrets Act of 2016, I shall
not be held criminally or civilly liable under any
federal or state trade secret law for the disclosure of a trade secret that (a) is
made (i) in confidence to a federal, state, or local government official, either directly or indirectly, or to an
attorney; and (ii)
solely for the purpose of reporting or investigating a suspected violation of law; or (b) is made in a complaint or other document filed
in a lawsuit or other proceeding,
if such filing is made under seal.
 
23.
Entire Agreement; Amendment. This Agreement constitutes the entire agreement between the Company and me with respect to the
subject matter hereof, and supersedes all prior
agreements or understandings, both written and oral, between the Company and me with
respect to the subject matter hereof, but does not in any way merge with or supersede any
other confidentiality, assignment of inventions
or other restrictive covenant agreement or obligation entered into by the Company and me, which agreements and obligations shall
supplement,
and shall not limit or be limited by, this Agreement. This Agreement may be amended only in a written agreement executed by a duly authorized
officer of the Company
and me.
 
IN
WITNESS WHEREOF, the undersigned has executed this agreement as a sealed instrument.
 
EMPLOYEE
 
 
 
 
Signed:         
 
 
Type
or print name:
 
 
 
Date:
 
 
 
4

 
 
EXHIBIT
A
 
To:
COMPANY
 
 
 
 
From:
 
 
 
 
 
Date:
 
 
 
SUBJECT:
Prior
Inventions
 
The
following is a complete list of all inventions or improvements relevant to the subject matter of my employment by the Company that have
been made or conceived or first
reduced to practice by me alone or jointly with others prior to my engagement by the Company:
 
 
☐
No
inventions or improvements
 
 
 
 
 
 
☐
See
below:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
☐
Additional
sheets attached
 
 
 
 
The
following is a list of all patents and patent applications in which I have been named as an inventor:
 
 
 
 
☐
None
 
 
 
 
☐
See
below:
 
“
 
5

 
Exhibit
21.1
 
Subsidiaries
of Vascular Biogenics Ltd.
 
Name
 
Jurisdiction
of Incorporation or Organization
VBL
Inc.
 
Delaware
 
 

 
Exhibit
23.1
 
 
CONSENT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
 
We
hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (Nos. 333-202463, 333-210583, 333-219969,
333-223232, 333-232391 ,333-240995
and 333-265325) of Vascular Biogenics Ltd. of our report dated March 14, 2023 relating to the financial
statements, which appears in this Form 10-K.
 
Tel-Aviv,
Israel
/s/
Kesselman & Kesselman
March
14, 2023
Certified
Public Accountants (Isr.)
 
A
member firm of PricewaterhouseCoopers International Limited
 
Kesselman
& Kesselman, Derech Menachem Begin 146, Tel-Aviv 6492103, Israel,
P.O
Box 7187 Tel-Aviv 6107120, Telephone: +972 -3- 7954555, Fax:+972 -3- 7954556, www.pwc.com/il
 
Kesselman
& Kesselman is a member firm of PricewaterhouseCoopers International Limited, each member firm of which is a separate legal entity
 
 

 
Exhibit 31.1
 
CERTIFICATION
 
I,
Dror Harats, certify that:
 
1.
I
have reviewed this Annual Report on Form 10-K of Vascular Biogenics Ltd.;
 
 
2.
Based
on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the
circumstances
under which such statements were made, not misleading with respect to the period covered
by this report;
 
 
3.
Based
on my knowledge, the financial statements, and other financial information included in this
report, fairly present in all material respects the financial condition, results of
operations
and cash flows of the registrant as of, and for, the periods presented in this report;
 
 
4.
The
registrant’s other certifying officer(s) and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
(a) Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures
to be designed under our supervision, to ensure that material information
relating to the
registrant, including its consolidated subsidiaries, is made known to us by others within
those entities, particularly during the period in which this report is being
prepared;
 
 
 
(b) Designed
such internal control over financial reporting, or caused such internal control over financial
reporting to be designed under our supervision, 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;
 
 
 
(c) Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented
in this report our conclusions about the effectiveness of the disclosure controls
and procedures,
as of the end of the period covered by this report based on such evaluation; and
 
 
 
(d) Disclosed
in this report any change in the registrant’s internal control over financial reporting
that occurred during the period covered by the annual report  that has materially
affected,
or is reasonably likely to materially affect, the registrant’s internal control over
financial reporting; and
 
5.
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrant’s auditors
and the
audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
 
(a) All
significant deficiencies and material weaknesses in the design or operation of internal control
over financial reporting which are reasonably likely to adversely affect the
registrant’s
ability to record, process, summarize and report financial information; and
 
 
 
(b) Any
fraud, whether or not material, that involves management or other employees who have a significant
role in the registrant’s internal control over financial reporting.
 
Date:
March 14, 2023
 
 
 
/s/
Dror Harats
 
Dror
Harats
 
Chief
Executive Officer
 
 
 
 
 

 
Exhibit
31.2
 
CERTIFICATION
 
I,
Sam Backenroth, certify that:
 
1.
I
have reviewed this Annual Report on Form 10-K of Vascular Biogenics Ltd.;
 
2.
Based
on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the
circumstances
under which such statements were made, not misleading with respect to the period covered
by this report;
 
3.
Based
on my knowledge, the financial statements, and other financial information included in this
report, fairly present in all material respects the financial condition, results of
operations
and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.
The
registrant’s other certifying officer(s) and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
(a) Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures
to be designed under our supervision, to ensure that material information
relating to the
registrant, including its consolidated subsidiaries, is made known to us by others within
those entities, particularly during the period in which this report is being
prepared;
 
(b) Designed
such internal control over financial reporting, or caused such internal control over financial
reporting to be designed under our supervision, 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;
 
(c) Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented
in this report our conclusions about the effectiveness of the disclosure controls
and procedures,
as of the end of the period covered by this report based on such evaluation; and
 
(d) Disclosed
in this report any change in the registrant’s internal control over financial reporting
that occurred during the period covered by the annual report that has materially
affected,
or is reasonably likely to materially affect, the registrant’s internal control over
financial reporting; and
 
5.
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrant’s auditors
and the
audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
 
(a) All
significant deficiencies and material weaknesses in the design or operation of internal control
over financial reporting which are reasonably likely to adversely affect the
registrant’s
ability to record, process, summarize and report financial information; and
 
(b) Any
fraud, whether or not material, that involves management or other employees who have a significant
role in the registrant’s internal control over financial reporting.
 
Date:
March 14, 2023
 
 
 
/s/
Sam Backenroth
 
Sam
Backenroth
 
Chief
Financial Officer
 
 
 
 
 

 
Exhibit
32.1
 
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER PURSUANT
TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-
OXLEY ACT OF 2002
 
In
connection with the Annual Report on Form 10-K of Vascular Biogenics Ltd. (the “Company”) for the year ended December 31,
2022 as filed with the Securities and Exchange
Commission (the “Report”), each of the undersigned officers hereby certifies
in such capacity, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-
Oxley Act of 2002, that, to
the best of such officer’s knowledge:
 
(1) the
Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange
Act of 1934; and
 
(2) the
information contained in the Report fairly presents, in all material respects, the financial
condition and results of operations of the Company.
 
Date:
March 14, 2023
 
/s/
Dror Harats
/s/
Sam Backenroth
Dror
Harats
 
Sam
Backenroth
Chief
Executive Officer
Chief
Financial Officer
 
This
certification accompanies the Annual Report on Form 10-K to which it relates and is not deemed “filed” for purposes of Section
18 of the Securities Exchange Act of 1934, as
amended, nor incorporated by reference into any filings under the Securities Act of 1933,
as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the
Registrant specifically incorporates it
by reference.