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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended June 30, 2023
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 |
|
(I.R.S.
Employer |
incorporation
or organization) |
|
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 |
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, 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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 11, 2023, the registrant had 77,640,467
ordinary shares, par value NIS 0.01 par value
per share, outstanding.
Table
of Contents
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q 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; |
|
|
● |
our
cash runway; |
|
|
● |
exploration
and execution of additional strategic transactions to further maximize shareholder value, including the proposed VB-601 asset
sale; |
|
|
● |
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 a first-in-human Phase 1 trial for
VB-601 and our research and development program, subject to the Merger, and the proposed VB-601 Asset Sale, if at all; |
|
|
● |
our
continued listing on The Nasdaq Capital Market; |
|
|
● |
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; |
|
|
● |
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 and commitments
associated with such grants; and |
|
|
● |
developments
relating to our competitors and our industry. |
All
forward-looking statements involve risks, assumptions and uncertainties. You should not rely upon forward-looking statements as predictors
of future events. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions,
including risks described in the section titled “Risk Factors” contained in our Annual Report on Form 10-K for the year ended
December 31, 2022, filed with the Securities and Exchange Commission, or SEC, on March 14, 2023, including, among other things, the following:
● |
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, the proposed VB-601 asset sale
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 Stock Market LLC, or Nasdaq, 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. |
|
|
● |
Our
ordinary shares may be delisted from the Nasdaq and begin trading in the over-the-counter markets if we are not successful in regaining
compliance with the Nasdaq’s continued listing standards, which may negatively impact the price of our ordinary shares and our
ability to access the capital markets. |
|
|
● |
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 government, EIC, 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
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 through the proposed asset sale or otherwise. 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, and may make it more challenging to complete the successful disposition
of such asset. |
|
|
● |
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 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. |
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 Quarterly Report are based on information available to us on the date of this
Quarterly 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 Quarterly Report might not occur.
PART
I—FINANCIAL INFORMATION
Item
1. Financial Statements.
VASCULAR
BIOGENICS LTD.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
| |
June 30, 2023 | | |
December 31, 2022 | |
| |
U.S. dollars in thousands | |
ASSETS | |
| | |
| |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 24,264 | | |
$ | 17,665 | |
Restricted Cash | |
| - | | |
| 360 | |
Short-term bank deposits | |
| - | | |
| 3,054 | |
Other current assets | |
| 284 | | |
| 1,070 | |
Total current assets | |
| 24,548 | | |
| 22,149 | |
| |
| | | |
| | |
Non-current assets: | |
| | | |
| | |
Funds in respect of employee rights upon retirement | |
| 98 | | |
| 368 | |
Property, plant and equipment, net | |
| - | | |
| 6,601 | |
Operating lease right-of-use assets | |
| - | | |
| 541 | |
Total non-current assets | |
| 98 | | |
| 7,510 | |
Total assets | |
$ | 24,646 | | |
$ | 29,659 | |
| |
| | | |
| | |
LIABILITIES AND SHAREHOLDERS’ EQUITY | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable and accruals: | |
| | | |
| | |
Accounts payable | |
$ | 718 | | |
$ | 808 | |
Accrued expenses | |
| 3,042 | | |
| 2,925 | |
Other current liabilities | |
| 1,541 | | |
| 2,434 | |
Current maturity of operating leases liability | |
| - | | |
| 564 | |
| |
| | | |
| | |
Total current liabilities | |
$ | 5,301 | | |
$ | 6,731 | |
| |
| | | |
| | |
Non-current liabilities: | |
| | | |
| | |
Liability for employee rights upon retirement | |
| 108 | | |
| 477 | |
Total non-current liabilities | |
| 108 | | |
| 477 | |
| |
| | | |
| | |
Total liabilities | |
$ | 5,409 | | |
$ | 7,208 | |
| |
| | | |
| | |
Shareholders’ equity: | |
| | | |
| | |
Ordinary shares, NIS 0.01 par value; 200,000,000 Authorized as of June 30, 2023 and December 31, 2022; 70,500,117 and 69,750,117 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively. | |
| 175 | | |
| 174 | |
Additional paid in capital | |
| 316,952 | | |
| 316,654 | |
Accumulated deficit | |
| (297,890 | ) | |
| (294,377 | ) |
Total equity | |
| 19,237 | | |
| 22,451 | |
| |
| | | |
| | |
Total liabilities and equity | |
$ | 24,646 | | |
$ | 29,659 | |
The
accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
VASCULAR
BIOGENICS LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF NET LOSS AND COMPREHENSIVE LOSS
(UNAUDITED)
| |
| | | |
| | | |
| | | |
| | |
| |
Three Months Ended | | |
Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
U.S. dollars in thousands | | |
| |
Revenues | |
$ | - | | |
$ | 64 | | |
$ | - | | |
$ | 177 | |
Cost of revenues | |
| - | | |
| (34 | ) | |
| (2 | ) | |
| (89 | ) |
Gross profit (loss) | |
| - | | |
| 30 | | |
| (2 | ) | |
| 88 | |
Research and development expenses, net | |
$ | (1,546 | ) | |
$ | 6,721 | | |
$ | (1,490 | ) | |
$ | 14,181 | |
General and administrative expenses | |
| 1,873 | | |
| 2,923 | | |
| 5,112 | | |
| 6,085 | |
Impairment loss of plant, property and equipment | |
| 349 | | |
| - | | |
| 349 | | |
| - | |
Capital (gain) loss | |
| 187 | | |
| - | | |
| (423 | ) | |
| - | |
Operating loss | |
| 863 | | |
| 9,614 | | |
| 3,550 | | |
| 20,178 | |
Financial income | |
| - | | |
| (205 | ) | |
| (67 | ) | |
| (351 | ) |
Financial expenses | |
| 11 | | |
| 25 | | |
| 30 | | |
| 35 | |
Financial loss (income), net | |
| 11 | | |
| (180 | ) | |
| (37 | ) | |
| (316 | ) |
Net loss and comprehensive loss | |
$ | 874 | | |
$ | 9,434 | | |
$ | 3,513 | | |
$ | 19,862 | |
| |
U.S. dollars | |
Loss per ordinary share | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
$ | 0.01 | | |
$ | 0.12 | | |
$ | 0.04 | | |
$ | 0.26 | |
Basic | |
$ | 0.01 | | |
$ | 0.12 | | |
$ | 0.04 | | |
$ | 0.26 | |
| |
Number of shares | |
Weighted average ordinary shares outstanding | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
| 78,393,524 | | |
| 77,398,939 | | |
| 78,098,460 | | |
| 77,392,922 | |
Basic | |
| 78,393,524 | | |
| 77,398,939 | | |
| 78,098,460 | | |
| 77,392,922 | |
The
accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
VASCULAR
BIOGENICS LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN ORDINARY SHARES SUBJECT TO POSSIBLE REDEMPTION AND SHAREHOLDERS’ EQUITY
(UNAUDITED)
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
Ordinary
shares subject | |
| |
| | |
| | |
Additional | | |
| | |
| | |
| | |
to
possible | |
| |
Ordinary
shares in | | |
paid | | |
| | |
Accumulated | | |
Total | | |
redemption | |
| |
shares | | |
Amount | | |
capital | | |
Warrants | | |
deficit | | |
equity | | |
shares | | |
Amount | |
| |
| | |
| | |
U.S. dollars in thousands | | |
| | |
| |
Balance
at April 1, 2022 | |
| 69,337,312 | | |
$ | 173 | | |
$ | 311,999 | | |
$ | 3,127 | | |
$ | (272,501 | ) | |
$ | 42,798 | | |
| - | | |
$ | - | |
Changes
for the three months ended June 30, 2022 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net
loss | |
| | | |
| | | |
| | | |
| | | |
| (9,434 | ) | |
| (9,434 | ) | |
| | | |
| - | |
Expired
warrants | |
| | | |
| | | |
| 3,127 | | |
| (3,127 | ) | |
| | | |
| | | |
| | | |
| | |
Share
based compensation | |
| 11,627 | | |
| -* | | |
| 1,010 | | |
| - | | |
| - | | |
| 1,010 | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance
at June 30, 2022 | |
| 69,348,939 | | |
$ | 173 | | |
$ | 316,136 | | |
$ | - | | |
$ | (281,935 | ) | |
$ | 34,374 | | |
| - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | |
| | |
Additional | | |
| | |
| |
| |
Ordinary shares in | | |
paid | | |
Accumulated | | |
Total | |
| |
shares | | |
Amount | | |
capital | | |
deficit | | |
equity | |
| |
U.S. dollars in thousands | |
Balance
at April 1, 2023 | |
| 69,750,117 | | |
$ | 174 | | |
$ | 316,741 | | |
$ | (297,016 | ) | |
$ | 19,899 | |
Balance | |
| 69,750,117 | | |
$ | 174 | | |
$ | 316,741 | | |
$ | (297,016 | ) | |
$ | 19,899 | |
Changes for the three months ended June 30, 2023 | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| | | |
| | | |
| | | |
| (874 | ) | |
| (874 | ) |
Issuance of ordinary shares | |
| 750,000 | | |
| 1 | | |
| - | | |
| - | | |
| 1 | |
Share based compensation to employees | |
| - | | |
| - | | |
| 211 | | |
| - | | |
| 211 | |
Balance at June 30, 2023 | |
| 70,500,117 | | |
$ | 175 | | |
$ | 316,952 | | |
$ | (297,890 | ) | |
$ | 19,237 | |
Balance | |
| 70,500,117 | | |
$ | 175 | | |
$ | 316,952 | | |
$ | (297,890 | ) | |
$ | 19,237 | |
The
accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
VASCULAR
BIOGENICS LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN ORDINARY SHARES SUBJECT TO POSSIBLE REDEMPTION AND SHAREHOLDERS’ EQUITY
(UNAUDITED)
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
Ordinary shares subject | |
| |
| | |
| | |
Additional | | |
| | |
| | |
| | |
to possible | |
| |
Ordinary shares in | | |
paid | | |
| | |
Accumulated | | |
Total | | |
redemption | |
| |
shares | | |
Amount | | |
capital | | |
Warrants | | |
deficit | | |
equity | | |
shares | | |
Amount | |
| |
| | |
| | |
U.S. dollars in thousands | | |
| | |
| |
Balance at January 1, 2022 | |
| 68,711,584 | | |
$ | 171 | | |
$ | 309,355 | | |
$ | 3,127 | | |
$ | (262,073 | ) | |
$ | 50,580 | | |
| 615,366 | | |
$ | 1,598 | |
Changes for the six months ended June 30, 2022 | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| | | |
| | | |
| | | |
| | | |
| (19,862 | ) | |
| (19,862 | ) | |
| | | |
| | |
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 | |
| 21,989 | | |
| -* | | |
| 2,058 | | |
| - | | |
| - | | |
| 2,058 | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at June 30, 2022 | |
| 69,348,939 | | |
$ | 173 | | |
$ | 316,136 | | |
$ | - | | |
$ | (281,935 | ) | |
$ | 34,374 | | |
| - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | |
| | |
Additional | | |
| | |
| |
| |
Ordinary shares in | | |
paid | | |
Accumulated | | |
Total | |
| |
shares | | |
Amount | | |
capital | | |
deficit | | |
equity | |
| |
U.S. dollars in thousands | |
Balance
at January 1, 2023 | |
| 69,750,117 | | |
$ | 174 | | |
$ | 316,654 | | |
$ | (294,377 | ) | |
$ | 22,451 | |
Balance | |
| 69,750,117 | | |
$ | 174 | | |
$ | 316,654 | | |
$ | (294,377 | ) | |
$ | 22,451 | |
Changes for the six months ended June 30, 2023 | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| | | |
| | | |
| | | |
| (3,513 | ) | |
| (3,513 | ) |
Issuance of ordinary shares | |
| 750,000 | | |
| 1 | | |
| - | | |
| - | | |
| 1 | |
Share based compensation to employees | |
| - | | |
| - | | |
| 298 | | |
| - | | |
| 298 | |
Balance at June 30, 2023 | |
| 70,500,117 | | |
$ | 175 | | |
$ | 316,952 | | |
$ | (297,890 | ) | |
$ | 19,237 | |
Balance | |
| 70,500,117 | | |
$ | 175 | | |
$ | 316,952 | | |
$ | (297,890 | ) | |
$ | 19,237 | |
The
accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
VASCULAR
BIOGENICS LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
| |
| | | |
| | |
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
| |
U.S. dollars in thousands | |
| |
| | |
| |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | | |
| | |
Net loss | |
$ | (3,513 | ) | |
$ | (19,862 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| - | | |
| 701 | |
Impairment | |
| 349 | | |
| - | |
Interest (income) expense | |
| 54 | | |
| (31 | ) |
Net gain on sale of long-term assets | |
| (423 | ) | |
| - | |
Net changes in operating leases | |
| - | | |
| (266 | ) |
Exchange losses (gain) on cash and cash equivalents and restricted cash | |
| (2 | ) | |
| 141 | |
Changes in accrued liability for employee rights upon retirement | |
| (99 | ) | |
| 27 | |
Share-based compensation | |
| 298 | | |
| 2,058 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Decrease in other current assets and long-term prepaid expenses | |
| 786 | | |
| 191 | |
Increase (decrease) in accounts payable: | |
| | | |
| | |
Trade | |
| (254 | ) | |
| (995 | ) |
Other (including other non-current liability) | |
| (1,246 | ) | |
| 160 | |
Decrease in deferred revenue | |
| - | | |
| (176 | ) |
Net cash used in operating activities | |
$ | (4,050 | ) | |
$ | (18,052 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
Purchase of property and equipment | |
$ | - | | |
$ | (843 | ) |
Proceeds from the sale of long-term assets | |
| 7,286 | | |
| - | |
Investment in short-term bank deposits | |
| - | | |
| (3,000 | ) |
Maturity of short-term bank deposits | |
| 3,000 | | |
| 15,108 | |
Net cash provided by investing activities | |
$ | 10,286 | | |
$ | 11,265 | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Proceeds from issuance of ordinary shares | |
$ | 1 | | |
$ | - | |
Net cash provided by financing activities | |
$ | 1 | | |
$ | - | |
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | |
$ | 6,237 | | |
$ | (6,787 | ) |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD | |
| 18,025 | | |
| 22,348 | |
EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | |
| 2 | | |
| (141 | ) |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD | |
$ | 24,264 | | |
$ | 15,420 | |
| |
| | | |
| | |
SUPPLEMENTARY INFORMATION OF INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | |
| | | |
| | |
Purchase of property and equipment in payables | |
| - | | |
| (11 | ) |
RECONCILIATION OF CASH, CASH EQUIVALENTS, AND RESTRICTED CASH REPORTED IN THE STATEMENT OF FINANCIAL POSITION | |
| | | |
| | |
Cash and cash equivalents | |
| 24,264 | | |
| 15,060 | |
Restricted bank deposits included in non-current assets | |
| - | | |
| 360 | |
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | |
$ | 24,264 | | |
$ | 15,420 | |
| |
| | | |
| | |
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS | |
| | | |
| | |
Reclassification of ordinary shares subject to possible redemption into ordinary shares | |
$ | - | | |
$ | 1,598 | |
Interest received | |
$ | 74 | | |
$ | 86 | |
The
accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
VASCULAR
BIOGENICS LTD.
NOTES
TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
NOTE
1 – GENERAL
Vascular
Biogenics Ltd. (“VBL” or the “Company”) is a biopharmaceutical company that has historically focused on developing
targeted therapies for immune-inflammatory diseases and cancer. VBL’s goal has been to provide differentiated targeted therapeutics
to address the underlying cause of diseases where treatment options are limited.
VBL’s
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, non-alcoholic steatohepatitis (“NASH”)
and inflammatory bowel disease. VB-601 was developed using VBL’s monocyte targeting technology (“MTT”) and is designed
to specifically inhibit monocyte migration. VBL plans to monetize this asset prior to or concurrent with the Merger rather than pursue
further clinical development internally. On June 30, 2023, VBL entered into a non-binding term sheet, as amended,
for the proposed sale of the VB-601 Asset. However, as discussed below, there is no guarantee
that VBL will be successful in completing the proposed transaction for VB-601 or that it will be able to otherwise monetize this asset.
In
May 2023, VBL received an additional €1.4
million ($1.5
million) in grant funding from the EIC under the previously awarded ofra-vec grant.
Proposed
Merger with Notable Labs, Inc.
On
February 22, 2023, VBL entered into a Merger Agreement (the “Merger Agreement”) with Notable Labs, Inc., a Delaware corporation
(“Notable”), and Vibrant Merger Sub, Inc., a Delaware corporation and VBL’s direct, wholly-owned subsidiary, 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 (“Effective Time”), with Notable continuing after the merger as the surviving corporation
and VBL’s wholly-owned subsidiary (such transaction, the “Merger”). 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 VBL ordinary shares outstanding 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 outstanding 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 VBL’s net cash at the closing of the Merger, the terms and
net proceeds of Notable’s pre-closing financing, and the capitalization of VBL and Notable. 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 conduct of their respective businesses between the date of signing
the Merger Agreement and the Effective Time.
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 organization
will consist of up to seven directors, with one director designated by VBL. Upon the closing of the transaction, the combined
organization 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 association to: (i) effect an increase of VBL’s registered
share capital and/or effect a reverse split of VBL ordinary shares at a ratio to be determined; (ii) change VBL’s name to “Notable
Labs, Ltd.”; and (iii) make other such changes as mutually agreeable to VBL and Notable.
VBL’s
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 VBL’s current
directors and executive officers who currently collectively beneficially own or control an aggregate of approximately 2.5% of the outstanding
VBL 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 VBL ordinary shares beneficially owned by such shareholder in favor of the issuance of VBL ordinary shares
in the Merger at the VBL shareholder meeting to be held in connection with the Merger.
Although
VBL has entered into the Merger Agreement and intends to consummate the proposed Merger, there is no assurance that VBL 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,
VBL will reconsider its strategic alternatives and could pursue other courses of action.
Asset
Sale- Modi’in Facility
On
February 15, 2023, VBL entered into a purchase agreement providing for the sale of VBL’s rights to the Modi’in manufacturing
facility, along with certain tangible assets and equipment located therein for $7.1 million. In addition, VBL accrued a liability for
a potential payment to the Israeli Innovation Authority (“IIA”) as a result of the sale, which was recorded against the capital
gain. VBL intends 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 VBL will have sufficient funds to satisfy the minimum net cash closing required pursuant
to the Merger Agreement. VBL completed the asset sale on March 9, 2023 and retained the right to use a portion of the space for a nominal
fee until August 31, 2023, with a potential extension of an additional month. During the six months ended June 30, 2023, we recorded a gain on sale (net of fees paid to the IIA) resulting from
the facility sale and other fixed asset sales of approximately $0.4 million.
Proposed
Sale of VB-601 Asset
On
June 30, 2023, VBL entered into a non-binding term sheet with Wellbeing Group Ltd. (“Wellbeing”) (as amended on July 25,
2023, the “VB-601 Offer”) for the proposed sale of the VB-601 Asset to Wellbeing, or one of its assignees, for total
consideration of up to $5 million plus royalties (the “VB-601 Asset Sale”). The
VB-601 Offer consists of a $250,000 upfront
cash payment to be paid upon closing, up to a total of $4.75 million
in clinical and commercial milestones, and a low to mid single digit percentage tiered royalty on annual net sales above $50 million.
The VB-601 Offer includes a 90-day exclusivity period and other reasonable and customary closing conditions for a transaction of
this type and nature. Wellbeing intends to form a new company and recruit Prof. Harats, Dr. Feige, and Mr. Backenroth
(“Interested Parties”) as investors and partners to manage the company and develop VB-601 due to their historical
knowledge of the program. Due to the involvement of the Interested Parties in the entity that will be moving forward with and
developing the VB-601 Asset, the transaction is considered a related party transaction, and requires audit committee and board of
directors approval and execution of definitive documentation. VBL’s board of directors also resolved that the closing of the
VB-601 Asset Sale would be subject to the separate approval of the VBL shareholders at the VBL special meeting. The Interested
Parties recused themselves from negotiations between VBL and Wellbeing regarding the VB-601 Offer. The VB-601 Asset Sale would be
expected to close immediately prior to or concurrent with the Merger, however, it is not a condition to the closing of the
Merger.
Nasdaq
Listing
In
August 2022, VBL received a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC
(“Nasdaq”), notifying VBL 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 the Nasdaq
Capital Market and received an additional 180 day period to regain compliance, or until August 28, 2023. 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. Upon a Staff Delisting Determination, 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. If the Company does not regain compliance with the bid price requirement by the
end of the second compliance period, if its trading price falls below $0.10
for ten consecutive trading days, or if it is not granted an additional extension by the Hearings Panel after the second compliance
period ends on August 28, 2023, VBL’s ordinary shares would be subject to delisting.
As
of June 30, 2023, VBL wrote-off all remaining fixed assets and related accumulated depreciation and recorded an impairment loss of
$0.3
million on the fixed assets.
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 June 30, 2023, VBL had an accumulated deficit of $297.9
million and cash and cash equivalents of approximately $24.3
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 transactions
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 potential future 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.
NOTE
2 – BASIS OF PREPARATION OF THE FINANCIAL STATEMENTS
The
accompanying unaudited condensed consolidated financial statements of VBL have been prepared in accordance with accounting principles
generally accepted in the United States (“GAAP”) for interim financial information. Accordingly, they do not include all
of the information and notes required by GAAP for annual financial statements. In the opinion of management, all adjustments (of a normal
recurring nature) considered necessary for the fair statement of the results for the interim periods presented have been included. Operating
results for the interim period are not necessarily indicative of the results that may be expected for the full year.
The
accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiary, VBL Inc. (U.S.-based
subsidiary).
These
unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements in the Annual
Report on Form 10-K for the year ended December 31, 2022, filed by VBL with the U.S. Securities and Exchange Commission (the “SEC”)
on March 14, 2023. The comparative balance sheet at December 31, 2022 has been derived from the audited financial statements at that
date.
NOTE
3 – SIGNIFICANT ACCOUNTING POLICIES
The
accounting policies and calculation methods applied in the preparation of the condensed consolidated interim financial statements are
consistent with those applied in the preparation of the annual financial statements as of December 31, 2022 and for the year then ended.
Net
Loss Per Share
VBL
complies with accounting and disclosure requirements of FASB Accounting Standards Codification (“ASC”) Topic 260,
“Earnings Per Share.” Basic loss per ordinary share is computed by dividing the net loss by the
weighted average number of ordinary shares outstanding (including fully vested pre-funded
warrants and fully vested restricted stock units (“RSUs”)) during the period.
Potentially
dilutive securities have been excluded from VBL’s computation of net loss per share as such securities would have been anti-dilutive.
There were 5,334,440 ordinary shares underlying outstanding options and RSUs at June 30, 2023, and 10,459,480 ordinary shares underlying
outstanding options and RSUs at June 30, 2022.
NOTE
4 – SHAREHOLDERS’ EQUITY
a.
Ordinary Shares
The
Company has 200 million ordinary shares, NIS 0.01 par value per share, authorized as of June 30, 2023. Each ordinary share is entitled
to one voting right. Ordinary share owners are entitled to dividends when funds are legally available and declared by the Company’s
board of directors.
b.
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 June 30, 2023, none
of the pre-funded warrants have been exercised. See Note 6 below for information on pre-funded warrants exercised subsequent to June 30, 2023.
c.
Restricted Stock Units
During
the six months ended June 30, 2023, 750,000
restricted stock units vested and were exercised into ordinary shares at an exercise price of 0.01
NIS.
NOTE
5 – CONTINGENT LIABILITIES
The
Company is committed to pay royalties to the Government of Israel (the “Government”) on proceeds from sales of products in
the research and development of which the Government participates by way of grants. At the 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,
the Company is not obligated to pay any such royalties. As the Company does not foresee any revenue from these projects, it believes
it is no longer obligated to pay additional royalties, except for a potential repayment of support for assets that are monetized. Under
the terms of the Company’s funding from the 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 June
30, 2023, 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 $1.1 million in royalties.
NOTE
6 – SUBSEQUENT EVENTS
On
July 28, 2023, 7,400,000
pre-funded warrants were exercised via cashless
exercise resulting in the issuance of 7,140,350
ordinary shares.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with the
unaudited condensed consolidated interim financial statements and related notes included in this Form 10-Q. Our audited financial
statements as of and for the year ended December 31, 2022 have been prepared in accordance with U.S. Generally Accepted Accounting
Principles, or U.S. GAAP, and our unaudited condensed consolidated interim financial statements for the three and six months ended
June 30, 2023, or the period, have been prepared in accordance with U.S. GAAP, “Interim Reporting,” or ASC 270 and Article 10 of Regulation S-X. Unless
stated otherwise, comparisons included herein are made to the three and six months period ended on June 30, 2022, or the parallel
period. Unless the context requires otherwise, references in this Report on Form 10-Q to the “Company”,
“VBL,” “we,” “us,” and “our” refer to Vascular Biogenics Ltd. and its consolidated
subsidiary. You should read the “Risk Factors” section of this Quarterly Report on Form 10-Q and the “Risk
Factors” section included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, for a discussion of
important factors that could cause actual results to differ materially from the results described in or implied by the
forward-looking statements contained in the following discussion and analysis.
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, non-alcoholic
steatohepatitis, or NASH, and inflammatory bowel disease. VB-601 was developed using our monocyte targeting technology, or MTT, and
is designed to specifically inhibit monocyte migration. We plan to monetize this asset prior to or concurrent to the Merger (as
defined below), rather than pursue clinical development internally. On June 30, 2023, we entered into a non-binding term sheet, as
amended, for the sale of the VB-601 Asset to Wellbeing Group Ltd., or Wellbeing, or one of its assignees, for total cash
consideration of up to $5 million plus royalties. However, there is no guarantee that we will be successful in consummating the
proposed VB-601 Asset Sale, identifying any alternative strategic transaction for VB-601, or
further develop this asset.
Proposed
Merger with Notable Labs, Inc.
On
February 22, 2023, we entered into a Merger Agreement, or the Merger Agreement, with Notable Labs, Inc., or Notable, and Vibrant Merger
Sub, Inc., 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 is referred to throughout this Quarterly Report as the Merger) at
the effective time, 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,
par value NIS 0.01 per share, or 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
Ordinary Shares outstanding on a fully diluted basis and subject to adjustment, and our securityholders as of immediately prior to the
Effective Time are expected to own approximately 24% of the Ordinary Shares outstanding 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 (as defined in the Merger Agreement) relative to Target Net Cash (as defined in the Merger Agreement)
at the closing of the Merger, the terms and net proceeds of Notable’s pre-closing financing, and our capitalization and that of
Notable. 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 states that, immediately following the Effective Time, the board of directors of the combined organization
will consist of up to seven directors, with one director designated by us. Upon the closing of the transaction, the combined organization
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 association 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 Notable and us.
While
the accounting treatment of the Merger is not yet finalized, it is expected to be a reverse asset acquisition accounted for as a
reverse recapitalization, as our assets at the time of the closing of the Merger are expected to be primarily cash and cash
equivalents, and the historical financial statements of Notable will be our historical financial
statements upon completion of 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
remaining 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. |
Asset Sale- Modi’in Facility
On
February 15, 2023, we entered into an Asset Purchase Agreement, or the Asset Purchase Agreement, providing for the sale of our
rights to our former 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 and retained the right to use a portion of
the space for a nominal fee until August 31, 2023, with a potential extension of an additional month. During the six months ended
June 30, 2023, we recorded a gain on sale (net of fees paid to the IIA) resulting from the facility sale and other fixed asset sales
of approximately $0.4 million.
Proposed Sale
of VB-601 Asset
On
June 30, 2023, we entered into a non-binding term sheet with Wellbeing (as amended on July 25, 2023), or the VB-601 Offer, for the sale
of the VB-601 Asset to Wellbeing, or one of its assignees, for total consideration of up to $5 million plus royalties, or the VB-601
Asset Sale. The VB-601 Offer consists of a $250,000 upfront cash payment to be paid upon closing, up to a total of $4.75 million in clinical
and commercial milestones, and a low to mid single digit percentage tiered royalty on annual net sales above $50 million. The VB-601
Offer includes a 90-day exclusivity period and other reasonable and customary closing conditions for a transaction of this type and nature.
Wellbeing intends to form a new company and recruit Prof. Harats, Dr. Feige, and Mr. Backenroth, or the Interested Parties, as investors
and partners to manage the company and develop VB-601 due to their historical knowledge of the program. Due to the involvement of the
Interested Parties in the entity that will be moving forward with and developing the VB-601 Asset, the transaction is considered a related
party transaction, and requires audit committee and board of directors approval and execution of definitive documentation. Our board
of directors also resolved that the closing of the VB-601 Asset Sale would be subject to the separate approval of our shareholders at
the VBL special meeting. The Interested Parties recused themselves from negotiations between us and Wellbeing regarding the VB-601 Offer.
The VB-601 Asset Sale would be expected to close immediately prior to or concurrent with the Merger, however, it is not a condition to
the closing of the Merger.
Nasdaq
Listing
In
August 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).
The Nasdaq deficiency letter did not result in the immediate delisting of our ordinary shares, and our ordinary shares continue to
trade uninterrupted under the symbol “VBLT.” Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we 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, our ordinary shares had a closing bid price of at least $1.00 for 10 consecutive business days,
Nasdaq would have provided us with a written confirmation of compliance and the matter would have closed. We did not regain
compliance by February 27, 2023, requested the transfer of our listing to the Nasdaq Capital Market and received an additional 180
day period to regain compliance, or until August 28, 2023. Further, under Nasdaq Listing Rules 5810(c)(1) and 5810(c)(3)(A)(iii), if
our trading price falls below $0.10 for ten consecutive trading days, we will receive a Staff Delisting Determination providing for
automatic suspension and delisting. If we do not regain compliance with the bid price requirement by the end of the second
compliance period, or if our trading price falls below $0.10 for ten consecutive trading days, our ordinary shares will be subject
to delisting. Because we do not expect to complete the Merger by the end of the second compliance period, we expect that we will receive a further delisting letter from Nasdaq, following which we expect that we will timely
request a hearing with the Nasdaq Hearings Panel, or the Panel, at which hearing we will request a further extension with which to evidence
compliance with all applicable requirements for continued listing on Nasdaq. Our timely request for a hearing will stay any suspension
or delisting action pending the ultimate outcome of the hearing. Our plan to regain compliance
will include the completion of the proposed Merger and reverse stock split. Notwithstanding, there can be no assurance that the Panel will
grant our request for continued listing or that we will be able to evidence compliance within any extension period that may be
granted by the Panel.
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
Co., Ltd., or 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 in the third quarter of 2022, 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 technologies and product candidates. 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. |
Historically,
research and development activities were the primary focus of our business. Our research and development expenses have decreased significantly
since the termination of the OVAL study and ofra-vec program and embarking on the strategic process that resulted in the proposed Merger
and facility sale.
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 June 30, 2023, 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, 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 June 30, 2023, totaled $38.4 million. On July 19, 2023, the IIA notified us that it has closed all of the grant funded programs.
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 and May 2023, we received $1.1 million and $1.5 million, respectively, 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.
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 ongoing
general and administrative expenses for personnel to decrease; however, we also expect a significant increase in legal, accounting, and
administrative fees related to the Merger.
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.
Results
of Operations
Comparison
of the three and six-month periods ended June 30, 2023 and 2022 (in thousands):
| |
Three Months Ended | | |
Increase | | |
Six Months Ended | | |
Increase | |
| |
June 30, | | |
(decrease) | | |
June 30, | | |
(decrease) | |
| |
2023 | | |
2022 | | |
$ | | |
2023 | | |
2022 | | |
$ | |
| |
in thousands) | | |
(in thousands) | |
| |
(unaudited) | | |
(unaudited) | |
Revenues | |
$ | - | | |
$ | 64 | | |
$ | (64 | ) | |
$ | - | | |
$ | 177 | | |
$ | (177 | ) |
Cost of revenues | |
| - | | |
| (34 | ) | |
| 34 | | |
| (2 | ) | |
| (89 | ) | |
| 87 | |
Gross profit | |
| | | |
| 30 | | |
| (30 | ) | |
| (2 | ) | |
| 88 | | |
| (90 | ) |
Expenses: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Research and development, gross | |
| (58 | ) | |
| 6,709 | | |
| (6,767 | ) | |
| (2 | ) | |
| 14,195 | | |
| (14,197 | ) |
Government grants | |
| (1,488 | ) | |
| 12 | | |
| (1,500 | ) | |
| (1,488 | ) | |
| (14 | ) | |
| (1,474 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Research and development, net | |
| (1,546 | ) | |
| 6,721 | | |
| (8,267 | ) | |
| (1,490 | ) | |
| 14,181 | | |
| (15,671 | ) |
General
and administrative | |
| 1,873 | | |
| 2,923 | | |
| (1,050 | ) | |
| 5,112 | | |
| 6,085 | | |
| (973 | ) |
Impairment loss | |
| 349 | | |
| - | | |
| 349 | | |
| 349 | | |
| - | | |
| 349 | |
Capital (gain) loss | |
| 187 | | |
| - | | |
| 187 | | |
| (423 | ) | |
| - | | |
| (423 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Operating loss | |
| 863 | | |
| 9,614 | | |
| (8,751 | ) | |
| 3,550 | | |
| 20,178 | | |
| (16,628 | ) |
Financial expense (income), net | |
| 11 | | |
| (180 | ) | |
| 191 | | |
| (37 | ) | |
| (316 | ) | |
| 279 | |
Loss | |
$ | 874 | | |
$ | 9,434 | | |
$ | (8,560 | ) | |
$ | 3,513 | | |
$ | 19,862 | | |
$ | (16,349 | ) |
Revenues
Comparison
of three-month periods ending June 30, 2023 and 2022
No
revenues were recorded in the three months ended June 30, 2023, compared to $0.1 million for the parallel period in 2022. The decrease
is due to the termination of the NanoCarrier license agreement.
No
cost of revenues were recorded in the three months ended June 30, 2023, compared to $0.1 million for the parallel period in 2022. 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.
Comparison
of six-month periods ending June 30, 2023 and 2022
No
revenues were recorded in the six months ended June 30, 2023, compared to $0.2 million for the parallel period in 2022. The decrease
is due to the termination of the NanoCarrier license agreement.
Cost
of revenues for the six months ended June 30, 2023 was $0.002 million compared to $0.1 million for the parallel period. Cost of revenues
is attributed to the labor costs and other expenses related to the performance obligations that were delivered during the period.
Research
and development expenses, net
Comparison
of three-month periods ending June 30, 2023 and 2022
Research
and development expenses are shown net of grants. Research and development expenses, net, for the three months ended June 30, 2022 were
approximately $(1.5) million, compared to approximately $6.7 million in the parallel period, a decrease of approximately $8.3 million.
The decrease in research and development expenses, net, in the three-month period was mainly related to the termination of the ofra-vec
clinical trials and related activities as well as termination of the research and development labor workforce and the associated reversal
of share based compensation expense in 2023 in addition to the $1.5 million grant received from the EIC during the second quarter of
2023.
Comparison
of six-month periods ending June 30, 2023 and 2022
Research
and development expenses are shown net of grants. Research and development expenses, net, for the six months ended June 31, 2023 were
approximately $(1.5) million, compared to approximately $14.2 million in the parallel period, a decrease of approximately $15.7 million.
The decrease in research and development expenses, net, was mainly related was mainly related to the termination of the ofra-vec clinical
trials and related activities as well as termination of the research and development labor workforce and the associated reversal of share
based compensation expense in 2023 in addition to the $1.5 million grant received from the EIC during the second quarter of 2023.
General
and administrative expenses
Comparison
of three-month periods ending June 30, 2023 and 2022
General
and administrative expenses for the three months ended June 30, 2023 were $1.9 million, compared to $2.9 million for the parallel period,
a decrease of $1.1 million. This decrease is mainly attributed to reversal of share based compensation expense as well as decrease in
payroll as bonuses were not paid in 2023 compared to the parallel period, offset by an increase in legal costs related to the Merger.
Comparison
of six-month periods ending June 30, 2023 and 2022
General
and administrative expenses for the six months ended June 30, 2023 were $5.1 million, compared to $6.1 million for the parallel period,
a decrease of $1.0 million. This decrease is mainly attributed to reversal of share based compensation expense and a decrease in commercialization
activity as well as decrease in payroll as bonuses were not paid in 2023 compared to the parallel period, offset by an increase in legal
costs related to the Merger.
Impairment
Loss
Comparison
of three-month periods ending June 30, 2023 and 2022
Impairment loss for the three months ended June 30, 2023 was $0.3 million compared to zero in the parallel period. The loss was due to
the write down of the remaining fixed assets in 2023 in preparation for the Merger.
Comparison
of six-month periods ending June 30, 2023 and 2022
Impairment loss for the six months ended June 30, 2023 was $0.3 million compared to zero in the parallel period. The loss was due to the
write down of the remaining fixed assets in 2023 in preparation for the Merger.
Capital
(gain) loss
Comparison
of three-month periods ending June 30, 2023 and 2022
Capital
loss for the three months ended June 30, 2023 was $0.2 million compared to zero in the parallel period. The loss in the three month period
was a result of a capital loss from the sale of certain fixed assets to third parties in the second quarter of 2023.
Comparison
of six-month periods ending June 30, 2023 and 2022
Capital
gain for the six months ended June 30, 2023 was $0.4 million compared to zero in the parallel period. This increase is attributed to
the gain on the sale of certain assets and rights as part of the facility sale offset by a payment to the IIA for those
assets.
Financial
expenses (income), net
Comparison
of three-month periods ending June 30, 2023 and 2022
Financial
expenses, net, was approximately $0.01 million for the three months ended June 30, 2023 compared to $0.2 million of income for the parallel
period. The decrease was primarily attributable to a change in exchange rates and a decrease in deposit income.
Comparison
of six-month periods ending June 30, 2023 and 2022
Financial
income, net, was approximately $0.04 million for the six months ended June 30, 2022 compared to $0.3 million for the parallel period.
The decrease was primarily attributable to a change in exchange rates and a decrease
in deposit income.
Liquidity
and Capital Resources
Since
our inception and through June 30, 2023, we have raised an aggregate of $328.5 million to fund our operations, including $29.4 million
from IIA grants and $2.6 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.
On
June 30, 2023, we had cash, cash equivalents, short-term bank deposits and restricted bank deposits totaling $24.3 million and working
capital of $19.2 million. Based on our current cash resources, and successful implementation of our reduction in workforce, we believe
our current cash as of June 30, 2023 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, the completed sale of our rights to lease the Modi’in facility and certain
related assets, and on the proposed VB-601 Asset Sale) 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 the development of VB-601.
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.
Cash
Flows
The
following table sets forth the primary sources and uses of cash for each of the periods set forth below:
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
| |
(in thousands) | |
| |
(unaudited) | |
Cash used in operating activities | |
$ | (4,050 | ) | |
$ | (18,052 | ) |
Cash provided by (used in) investing activities | |
| 10,286 | | |
| 11,265 | |
Cash provided by financing activities | |
| 1 | | |
| - | |
| |
$ | 6,237 | | |
$ | (6,787 | ) |
Operating
Activities
Net
cash used in operating activities was approximately $4.1 million for the six months ended June 30, 2023 and was primarily the result
of our $3.5 million net loss in addition to a net increase in working capital of $0.7 million, partially offset by an aggregate of $0.2
million in non-cash charges.
Net
cash used in operating activities for the parallel period was $18.1 million and was primarily the result of our $19.9 million net loss
and a net increase in working capital of $0.8 million, partially offset by an aggregate of $2.6 million in non-cash charges.
Investing
Activities
Net
cash used in investing activities was approximately $10.3 million for the six months ended June 30, 2023, and was primarily due to maturation
of short-term bank deposits of $3.0 million and the proceeds of the sale of a long-term assets of $7.3 million.
Net
cash used in investing activities in the parallel period was $11.3 million. This was primarily due to maturation of short-term bank deposits
of $15.1 million, offset by investment in short-term bank deposits of $3.0 million and the purchase of fixed assets of $0.8 million.
Financing
Activities
Cash
provided by financing activities for the six months ended June 30, 2023 was $0.001 million and related to the issuance of shares to
employees.
There
were no financing activities for the six months ended June 30, 2022.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Not
applicable.
Item
4. Controls and Procedures.
Management’s
Evaluation of our Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure
controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange
Act, as of June 30, 2023. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2023,
our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively)
concluded that, as of such date, our disclosure controls and procedures were effective.
Changes
in Internal Control over Financial Reporting
There
was no change 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 quarter ended June 30, 2023 that has materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
PART
II—OTHER INFORMATION
Item
1. Legal Proceedings
As
of the date of this Quarterly Report on Form 10-Q, we are not involved in any material legal proceedings. However, from time to time,
we could be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Regardless
of the outcome, legal proceedings can have an adverse impact on us because of defense and settlement costs, diversion of management resources
and other factors.
Item
1A. Risk Factors.
Not
applicable.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information.
Not
applicable
Item
6. Exhibits.
Exhibit
Number |
|
Description |
|
|
|
2.1+ |
|
Agreement and Plan of Merger, dated February 22, 2023, among Vascular Biogenics, Ltd., Notable Labs, Inc. and Vibrant Merger Sub, Inc. (incorporated by reference to Exhibit 2.1 to the Form 8-K filed with the Securities and Exchange Commission on February 23, 2023). |
|
|
|
3.1 |
|
Articles of Association of the Registrant (incorporated by reference to Exhibit 3.1 to the Form 10-K filed with the Securities and Exchange Commission on March 14, 2023). |
|
|
|
3.2 |
|
Memorandum of Association of the Registrant (incorporated by reference to Exhibit 3.1 to the Form 10-K filed with the Securities and Exchange Commission on March 14, 2023). |
|
|
|
10.1 |
|
Non-Binding Term Sheet between Vascular Biogenics Ltd. and Wellbeing Group Ltd., dated June 30, 2023, as amended July 25, 2023 (incorporated by reference to Annex D to the proxy statement/prospectus/information statement included in the Form S-4 filed with the Securities and Exchange Commission on July 26, 2023). |
|
|
|
31.1* |
|
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2* |
|
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1¥ |
|
Certification of Principal Executive Officer and Principal 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 Interactive Data File because its 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 (embedded within the Inline XBRL document) |
*
Filed herewith.
¥
This exhibit is being furnished and shall not be deemed
to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor
shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities
Act or the Exchange Act, except as otherwise stated in such filing.
+
Schedules have been omitted from this filing pursuant to Item 601(b)(2) of Regulation S-K. VBL
agrees to furnish supplementally a copy of any omitted schedule to the SEC upon its request; provided, however, that VBL may request
confidential treatment pursuant to Rule 24b-2 of the Exchange Act for any schedule so furnished.
SIGNATURES
Pursuant
to the requirements 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:
August 14, 2023 |
By: |
/s/
Dror Harats |
|
Name: |
Dror
Harats |
|
Title: |
Chief
Executive Officer (Principal Executive Officer) |
|
|
|
Date:
August 14, 2023 |
By: |
/s/
Sam Backenroth |
|
Name: |
Sam
Backenroth |
|
Title: |
Chief
Financial Officer (Principal Financial and Accounting Officer) |
Exhibit
31.1
CERTIFICATION
I,
Dror Harats, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q 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 registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an 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:
August 14, 2023 |
|
|
|
/s/
Dror Harats |
|
Dror
Harats |
|
Chief
Executive Officer |
|
Exhibit
31.2
CERTIFICATION
I,
Sam Backenroth, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q 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 registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an 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:
August 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 Quarterly Report on Form 10-Q of Vascular Biogenics Ltd. (the “Company”) for the quarter ended June 30,
2023 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: August 14 , 2023 |
/s/
Dror Harats |
|
/s/
Sam Backenroth |
Dror
Harats |
|
Sam
Backenroth |
Chief
Executive Officer |
|
Chief
Financial Officer |
This
certification accompanies the Quarterly Report on Form 10-Q 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.
v3.23.2
Cover - shares
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Aug. 11, 2023 |
Cover [Abstract] |
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v3.23.2
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 24,264
|
$ 17,665
|
Restricted Cash |
|
360
|
Short-term bank deposits |
|
3,054
|
Other current assets |
284
|
1,070
|
Total current assets |
24,548
|
22,149
|
Non-current assets: |
|
|
Funds in respect of employee rights upon retirement |
98
|
368
|
Property, plant and equipment, net |
|
6,601
|
Operating lease right-of-use assets |
|
541
|
Total non-current assets |
98
|
7,510
|
Total assets |
24,646
|
29,659
|
Accounts payable and accruals: |
|
|
Accounts payable |
718
|
808
|
Accrued expenses |
3,042
|
2,925
|
Other current liabilities |
1,541
|
2,434
|
Current maturity of operating leases liability |
|
564
|
Total current liabilities |
5,301
|
6,731
|
Non-current liabilities: |
|
|
Liability for employee rights upon retirement |
108
|
477
|
Total non-current liabilities |
108
|
477
|
Total liabilities |
5,409
|
7,208
|
Shareholders’ equity: |
|
|
Ordinary shares, NIS 0.01 par value; 200,000,000 Authorized as of June 30, 2023 and December 31, 2022; 70,500,117 and 69,750,117 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively. |
175
|
174
|
Additional paid in capital |
316,952
|
316,654
|
Accumulated deficit |
(297,890)
|
(294,377)
|
Total equity |
19,237
|
22,451
|
Total liabilities and equity |
$ 24,646
|
$ 29,659
|
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v3.23.2
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|
Jun. 30, 2023 |
Dec. 31, 2022 |
Statement of Financial Position [Abstract] |
|
|
Common stock, par value |
₪ 0.01
|
₪ 0.01
|
Common stock, shares authorized |
200,000,000
|
200,000,000
|
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70,500,117
|
69,750,117
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70,500,117
|
69,750,117
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X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.2
Condensed Consolidated Statements of Net Loss and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Revenue from Contract with Customer [Abstract] |
|
|
|
|
Revenues |
|
$ 64
|
|
$ 177
|
Cost of revenues |
|
(34)
|
(2)
|
(89)
|
Gross profit (loss) |
|
30
|
(2)
|
88
|
Research and development expenses, net |
(1,546)
|
6,721
|
(1,490)
|
14,181
|
General and administrative expenses |
1,873
|
2,923
|
5,112
|
6,085
|
Impairment loss of plant, property and equipment |
349
|
|
349
|
|
Capital (gain) loss |
187
|
|
(423)
|
|
Operating loss |
863
|
9,614
|
3,550
|
20,178
|
Financial income |
|
(205)
|
(67)
|
(351)
|
Financial expenses |
11
|
25
|
30
|
35
|
Financial loss (income), net |
11
|
(180)
|
(37)
|
(316)
|
Net loss and comprehensive loss |
$ 874
|
$ 9,434
|
$ 3,513
|
$ 19,862
|
Loss per ordinary share |
|
|
|
|
Basic |
$ 0.01
|
$ 0.12
|
$ 0.04
|
$ 0.26
|
Diluted |
$ 0.01
|
$ 0.12
|
$ 0.04
|
$ 0.26
|
Weighted average ordinary shares outstanding |
|
|
|
|
Basic |
78,393,524
|
77,398,939
|
78,098,460
|
77,392,922
|
Diluted |
78,393,524
|
77,398,939
|
78,098,460
|
77,392,922
|
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v3.23.2
Condensed Consolidated Statements of Changes in Ordinary Shares Subject to Possible Redemption and Shareholders' Equity (Unaudited) - USD ($) $ in Thousands |
Common Stock [Member] |
Common Stock [Member]
Common Stock Subject to Mandatory Redemption [Member]
|
Additional Paid-in Capital [Member] |
Warrant [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2021 |
$ 171
|
|
$ 1,598
|
$ 309,355
|
$ 3,127
|
$ (262,073)
|
$ 50,580
|
Balance, shares at Dec. 31, 2021 |
68,711,584
|
|
615,366
|
|
|
|
|
Net loss |
|
|
|
|
|
(19,862)
|
(19,862)
|
Expired warrants |
|
|
|
3,127
|
(3,127)
|
|
|
Share based compensation to employees |
|
[1] |
|
2,058
|
|
|
2,058
|
Shares Issued, Shares, Share-Based Payment Arrangement, after Forfeiture |
21,989
|
|
|
|
|
|
|
Reclassification of redemption shares into ordinary shares |
$ 2
|
|
$ (1,598)
|
1,596
|
|
|
1,598
|
[custom:ReclassificationOfSharesRedemptionSharesIntoOrdinaryShares] |
615,366
|
|
(615,366)
|
|
|
|
|
Balance at Jun. 30, 2022 |
$ 173
|
|
|
316,136
|
|
(281,935)
|
34,374
|
Balance, shares at Jun. 30, 2022 |
69,348,939
|
|
|
|
|
|
|
Balance at Mar. 31, 2022 |
$ 173
|
|
|
311,999
|
3,127
|
(272,501)
|
42,798
|
Balance, shares at Mar. 31, 2022 |
69,337,312
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
(9,434)
|
(9,434)
|
Expired warrants |
|
|
|
3,127
|
(3,127)
|
|
|
Share based compensation to employees |
|
[2] |
|
1,010
|
|
|
1,010
|
Shares Issued, Shares, Share-Based Payment Arrangement, after Forfeiture |
11,627
|
|
|
|
|
|
|
Balance at Jun. 30, 2022 |
$ 173
|
|
|
316,136
|
|
(281,935)
|
34,374
|
Balance, shares at Jun. 30, 2022 |
69,348,939
|
|
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 174
|
|
|
316,654
|
|
(294,377)
|
22,451
|
Balance, shares at Dec. 31, 2022 |
69,750,117
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
(3,513)
|
(3,513)
|
Share based compensation to employees |
|
|
|
298
|
|
|
298
|
Issuance of ordinary shares |
$ 1
|
|
|
|
|
|
1
|
Issuance of ordinary shares, shares |
750,000
|
|
|
|
|
|
|
Balance at Jun. 30, 2023 |
$ 175
|
|
|
316,952
|
|
(297,890)
|
19,237
|
Balance, shares at Jun. 30, 2023 |
70,500,117
|
|
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 174
|
|
|
316,741
|
|
(297,016)
|
19,899
|
Balance, shares at Mar. 31, 2023 |
69,750,117
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
(874)
|
(874)
|
Share based compensation to employees |
|
|
|
211
|
|
|
211
|
Issuance of ordinary shares |
$ 1
|
|
|
|
|
|
1
|
Issuance of ordinary shares, shares |
750,000
|
|
|
|
|
|
|
Balance at Jun. 30, 2023 |
$ 175
|
|
|
$ 316,952
|
|
$ (297,890)
|
$ 19,237
|
Balance, shares at Jun. 30, 2023 |
70,500,117
|
|
|
|
|
|
|
|
|
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v3.23.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
Net loss |
$ (3,513)
|
$ (19,862)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation |
|
701
|
Impairment |
349
|
|
Interest (income) expense |
54
|
(31)
|
Net gain on sale of long-term assets |
(423)
|
|
Net changes in operating leases |
|
(266)
|
Exchange losses (gain) on cash and cash equivalents and restricted cash |
(2)
|
141
|
Changes in accrued liability for employee rights upon retirement |
(99)
|
27
|
Share-based compensation |
298
|
2,058
|
Changes in operating assets and liabilities: |
|
|
Decrease in other current assets and long-term prepaid expenses |
786
|
191
|
Increase (decrease) in accounts payable: |
|
|
Trade |
(254)
|
(995)
|
Other (including other non-current liability) |
(1,246)
|
160
|
Decrease in deferred revenue |
|
(176)
|
Net cash used in operating activities |
(4,050)
|
(18,052)
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
Purchase of property and equipment |
|
(843)
|
Proceeds from the sale of long-term assets |
7,286
|
|
Investment in short-term bank deposits |
|
(3,000)
|
Maturity of short-term bank deposits |
3,000
|
15,108
|
Net cash provided by investing activities |
10,286
|
11,265
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
Proceeds from issuance of ordinary shares |
1
|
|
Net cash provided by financing activities |
1
|
|
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH |
6,237
|
(6,787)
|
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD |
18,025
|
22,348
|
EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH |
2
|
(141)
|
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD |
24,264
|
15,420
|
SUPPLEMENTARY INFORMATION OF INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: |
|
|
Purchase of property and equipment in payables |
|
(11)
|
RECONCILIATION OF CASH, CASH EQUIVALENTS, AND RESTRICTED CASH REPORTED IN THE STATEMENT OF FINANCIAL POSITION |
|
|
Cash and cash equivalents |
24,264
|
15,060
|
Restricted bank deposits included in non-current assets |
|
360
|
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows |
24,264
|
15,420
|
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS |
|
|
Reclassification of ordinary shares subject to possible redemption into ordinary shares |
|
1,598
|
Interest received |
$ 74
|
$ 86
|
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v3.23.2
GENERAL
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
GENERAL |
NOTE
1 – GENERAL
Vascular
Biogenics Ltd. (“VBL” or the “Company”) is a biopharmaceutical company that has historically focused on developing
targeted therapies for immune-inflammatory diseases and cancer. VBL’s goal has been to provide differentiated targeted therapeutics
to address the underlying cause of diseases where treatment options are limited.
VBL’s
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, non-alcoholic steatohepatitis (“NASH”)
and inflammatory bowel disease. VB-601 was developed using VBL’s monocyte targeting technology (“MTT”) and is designed
to specifically inhibit monocyte migration. VBL plans to monetize this asset prior to or concurrent with the Merger rather than pursue
further clinical development internally. On June 30, 2023, VBL entered into a non-binding term sheet, as amended,
for the proposed sale of the VB-601 Asset. However, as discussed below, there is no guarantee
that VBL will be successful in completing the proposed transaction for VB-601 or that it will be able to otherwise monetize this asset.
In
May 2023, VBL received an additional €1.4
million ($1.5
million) in grant funding from the EIC under the previously awarded ofra-vec grant.
Proposed
Merger with Notable Labs, Inc.
On
February 22, 2023, VBL entered into a Merger Agreement (the “Merger Agreement”) with Notable Labs, Inc., a Delaware corporation
(“Notable”), and Vibrant Merger Sub, Inc., a Delaware corporation and VBL’s direct, wholly-owned subsidiary, 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 (“Effective Time”), with Notable continuing after the merger as the surviving corporation
and VBL’s wholly-owned subsidiary (such transaction, the “Merger”). 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 VBL ordinary shares outstanding 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 outstanding 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 VBL’s net cash at the closing of the Merger, the terms and
net proceeds of Notable’s pre-closing financing, and the capitalization of VBL and Notable. 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 conduct of their respective businesses between the date of signing
the Merger Agreement and the Effective Time.
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 organization
will consist of up to seven directors, with one director designated by VBL. Upon the closing of the transaction, the combined
organization 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 association to: (i) effect an increase of VBL’s registered
share capital and/or effect a reverse split of VBL ordinary shares at a ratio to be determined; (ii) change VBL’s name to “Notable
Labs, Ltd.”; and (iii) make other such changes as mutually agreeable to VBL and Notable.
VBL’s
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 VBL’s current
directors and executive officers who currently collectively beneficially own or control an aggregate of approximately 2.5% of the outstanding
VBL 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 VBL ordinary shares beneficially owned by such shareholder in favor of the issuance of VBL ordinary shares
in the Merger at the VBL shareholder meeting to be held in connection with the Merger.
Although
VBL has entered into the Merger Agreement and intends to consummate the proposed Merger, there is no assurance that VBL 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,
VBL will reconsider its strategic alternatives and could pursue other courses of action.
Asset
Sale- Modi’in Facility
On
February 15, 2023, VBL entered into a purchase agreement providing for the sale of VBL’s rights to the Modi’in manufacturing
facility, along with certain tangible assets and equipment located therein for $7.1 million. In addition, VBL accrued a liability for
a potential payment to the Israeli Innovation Authority (“IIA”) as a result of the sale, which was recorded against the capital
gain. VBL intends 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 VBL will have sufficient funds to satisfy the minimum net cash closing required pursuant
to the Merger Agreement. VBL completed the asset sale on March 9, 2023 and retained the right to use a portion of the space for a nominal
fee until August 31, 2023, with a potential extension of an additional month. During the six months ended June 30, 2023, we recorded a gain on sale (net of fees paid to the IIA) resulting from
the facility sale and other fixed asset sales of approximately $0.4 million.
Proposed
Sale of VB-601 Asset
On
June 30, 2023, VBL entered into a non-binding term sheet with Wellbeing Group Ltd. (“Wellbeing”) (as amended on July 25,
2023, the “VB-601 Offer”) for the proposed sale of the VB-601 Asset to Wellbeing, or one of its assignees, for total
consideration of up to $5 million plus royalties (the “VB-601 Asset Sale”). The
VB-601 Offer consists of a $250,000 upfront
cash payment to be paid upon closing, up to a total of $4.75 million
in clinical and commercial milestones, and a low to mid single digit percentage tiered royalty on annual net sales above $50 million.
The VB-601 Offer includes a 90-day exclusivity period and other reasonable and customary closing conditions for a transaction of
this type and nature. Wellbeing intends to form a new company and recruit Prof. Harats, Dr. Feige, and Mr. Backenroth
(“Interested Parties”) as investors and partners to manage the company and develop VB-601 due to their historical
knowledge of the program. Due to the involvement of the Interested Parties in the entity that will be moving forward with and
developing the VB-601 Asset, the transaction is considered a related party transaction, and requires audit committee and board of
directors approval and execution of definitive documentation. VBL’s board of directors also resolved that the closing of the
VB-601 Asset Sale would be subject to the separate approval of the VBL shareholders at the VBL special meeting. The Interested
Parties recused themselves from negotiations between VBL and Wellbeing regarding the VB-601 Offer. The VB-601 Asset Sale would be
expected to close immediately prior to or concurrent with the Merger, however, it is not a condition to the closing of the
Merger.
Nasdaq
Listing
In
August 2022, VBL received a deficiency letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC
(“Nasdaq”), notifying VBL 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 the Nasdaq
Capital Market and received an additional 180 day period to regain compliance, or until August 28, 2023. 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. Upon a Staff Delisting Determination, 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. If the Company does not regain compliance with the bid price requirement by the
end of the second compliance period, if its trading price falls below $0.10
for ten consecutive trading days, or if it is not granted an additional extension by the Hearings Panel after the second compliance
period ends on August 28, 2023, VBL’s ordinary shares would be subject to delisting.
As
of June 30, 2023, VBL wrote-off all remaining fixed assets and related accumulated depreciation and recorded an impairment loss of
$0.3
million on the fixed assets.
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 June 30, 2023, VBL had an accumulated deficit of $297.9
million and cash and cash equivalents of approximately $24.3
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 transactions
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 potential future 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.
|
X |
- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.23.2
BASIS OF PREPARATION OF THE FINANCIAL STATEMENTS
|
6 Months Ended |
Jun. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
BASIS OF PREPARATION OF THE FINANCIAL STATEMENTS |
NOTE
2 – BASIS OF PREPARATION OF THE FINANCIAL STATEMENTS
The
accompanying unaudited condensed consolidated financial statements of VBL have been prepared in accordance with accounting principles
generally accepted in the United States (“GAAP”) for interim financial information. Accordingly, they do not include all
of the information and notes required by GAAP for annual financial statements. In the opinion of management, all adjustments (of a normal
recurring nature) considered necessary for the fair statement of the results for the interim periods presented have been included. Operating
results for the interim period are not necessarily indicative of the results that may be expected for the full year.
The
accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiary, VBL Inc. (U.S.-based
subsidiary).
These
unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements in the Annual
Report on Form 10-K for the year ended December 31, 2022, filed by VBL with the U.S. Securities and Exchange Commission (the “SEC”)
on March 14, 2023. The comparative balance sheet at December 31, 2022 has been derived from the audited financial statements at that
date.
|
X |
- DefinitionThe entire disclosure for the basis of accounting, or basis of presentation, used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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|
v3.23.2
SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
SIGNIFICANT ACCOUNTING POLICIES |
NOTE
3 – SIGNIFICANT ACCOUNTING POLICIES
The
accounting policies and calculation methods applied in the preparation of the condensed consolidated interim financial statements are
consistent with those applied in the preparation of the annual financial statements as of December 31, 2022 and for the year then ended.
Net
Loss Per Share
VBL
complies with accounting and disclosure requirements of FASB Accounting Standards Codification (“ASC”) Topic 260,
“Earnings Per Share.” Basic loss per ordinary share is computed by dividing the net loss by the
weighted average number of ordinary shares outstanding (including fully vested pre-funded
warrants and fully vested restricted stock units (“RSUs”)) during the period.
Potentially
dilutive securities have been excluded from VBL’s computation of net loss per share as such securities would have been anti-dilutive.
There were 5,334,440 ordinary shares underlying outstanding options and RSUs at June 30, 2023, and 10,459,480 ordinary shares underlying
outstanding options and RSUs at June 30, 2022.
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v3.23.2
SHAREHOLDERS’ EQUITY
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
SHAREHOLDERS’ EQUITY |
NOTE
4 – SHAREHOLDERS’ EQUITY
a.
Ordinary Shares
The
Company has 200 million ordinary shares, NIS 0.01 par value per share, authorized as of June 30, 2023. Each ordinary share is entitled
to one voting right. Ordinary share owners are entitled to dividends when funds are legally available and declared by the Company’s
board of directors.
b.
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 June 30, 2023, none
of the pre-funded warrants have been exercised. See Note 6 below for information on pre-funded warrants exercised subsequent to June 30, 2023.
c.
Restricted Stock Units
During
the six months ended June 30, 2023, 750,000
restricted stock units vested and were exercised into ordinary shares at an exercise price of 0.01
NIS.
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v3.23.2
CONTINGENT LIABILITIES
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
CONTINGENT LIABILITIES |
NOTE
5 – CONTINGENT LIABILITIES
The
Company is committed to pay royalties to the Government of Israel (the “Government”) on proceeds from sales of products in
the research and development of which the Government participates by way of grants. At the 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,
the Company is not obligated to pay any such royalties. As the Company does not foresee any revenue from these projects, it believes
it is no longer obligated to pay additional royalties, except for a potential repayment of support for assets that are monetized. Under
the terms of the Company’s funding from the 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 June
30, 2023, 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 $1.1 million in royalties.
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v3.23.2
SUBSEQUENT EVENTS
|
6 Months Ended |
Jun. 30, 2023 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
6 – SUBSEQUENT EVENTS
On
July 28, 2023, 7,400,000
pre-funded warrants were exercised via cashless
exercise resulting in the issuance of 7,140,350
ordinary shares.
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v3.23.2
SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Net Loss Per Share |
Net
Loss Per Share
VBL
complies with accounting and disclosure requirements of FASB Accounting Standards Codification (“ASC”) Topic 260,
“Earnings Per Share.” Basic loss per ordinary share is computed by dividing the net loss by the
weighted average number of ordinary shares outstanding (including fully vested pre-funded
warrants and fully vested restricted stock units (“RSUs”)) during the period.
Potentially
dilutive securities have been excluded from VBL’s computation of net loss per share as such securities would have been anti-dilutive.
There were 5,334,440 ordinary shares underlying outstanding options and RSUs at June 30, 2023, and 10,459,480 ordinary shares underlying
outstanding options and RSUs at June 30, 2022.
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v3.23.2
GENERAL (Details Narrative) $ / shares in Units, € in Millions |
|
|
1 Months Ended |
6 Months Ended |
|
|
Jun. 30, 2023
USD ($)
|
Feb. 15, 2023
USD ($)
|
May 31, 2023
USD ($)
|
May 31, 2023
EUR (€)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
Aug. 31, 2022
$ / shares
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Proceeds from grant |
|
|
$ 1,500,000
|
€ 1.4
|
|
|
|
|
Specified expenses |
|
|
|
|
$ 5,000,000
|
|
|
|
Net of cash acquired |
|
|
|
|
$ 15,000,000
|
|
|
|
Beneficially ownship percentage |
2.50%
|
|
|
|
2.50%
|
|
|
|
Gain on sale of other fixed assets |
|
|
|
|
$ 400,000
|
|
|
|
Impairment loss |
|
|
|
|
349,000
|
|
|
|
Accumulated deficit |
$ 297,890,000
|
|
|
|
297,890,000
|
|
$ 294,377,000
|
|
Cash, cash equivalents, and short-term investments |
24,300,000
|
|
|
|
24,300,000
|
|
|
|
Nasdaq Stock Market LLC [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Minimum bid price, per share | $ / shares |
|
|
|
|
|
|
|
$ 1.00
|
Closing bid price, per share | $ / shares |
|
|
|
|
|
|
|
1.00
|
Trading price, per share | $ / shares |
|
|
|
|
|
|
|
$ 0.10
|
Wellbeing [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Sale of productive assets |
50,000,000
|
|
|
|
|
|
|
|
Consideration transferred |
|
|
|
|
5,000,000
|
|
|
|
Upfront payment |
250,000
|
|
|
|
|
|
|
|
Equity interest in acquiree |
$ 4,750,000
|
|
|
|
|
|
|
|
Merger Agreement [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Termination fee |
|
|
|
|
2,500,000
|
|
|
|
Out of pocket fees and expense |
|
|
|
|
$ 500,000
|
|
|
|
Sale of productive assets |
|
$ 15,000,000.0
|
|
|
|
|
|
|
Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Tangible assets and equipment |
|
$ 7,100,000
|
|
|
|
|
|
|
Security Holder [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Ownership percentage |
76.00%
|
|
|
|
76.00%
|
|
|
|
Security Holder [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Ownership percentage |
24.00%
|
|
|
|
24.00%
|
|
|
|
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SHAREHOLDERS’ EQUITY (Details Narrative)
|
6 Months Ended |
|
|
Jun. 30, 2023
₪ / shares
shares
|
Dec. 31, 2022
₪ / shares
shares
|
Apr. 30, 2021
$ / shares
shares
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Ordinary shares, shares authorized |
200,000,000
|
200,000,000
|
|
Ordinary shares, par value | ₪ / shares |
₪ 0.01
|
₪ 0.01
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Number of units vested |
750,000
|
|
|
Ordinary shares exercise price | ₪ / shares |
₪ 0.01
|
|
|
Common Stock [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Ordinary shares, shares authorized |
200,000,000
|
|
|
Ordinary shares, par value | ₪ / shares |
₪ 0.01
|
|
|
Common Stock [Member] | Underwriting Agreement [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Ordinary shares, par value | $ / shares |
|
|
$ 0.01
|
Prefunded Warrants [Member] | Underwriting Agreement [Member] |
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
Warrants to purchase shares |
0
|
|
8,050,000
|
Warrants price per share | $ / shares |
|
|
$ 1.89
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