VBL Therapeutics Reports First Quarter 2021 Financial Results and Provides Corporate Update
May 11 2021 - 7:00AM
VBL Therapeutics (Nasdaq: VBLT) today announced financial results
for the first quarter ended March 31, 2021 and provided a corporate
update.
“Our OVAL Phase 3 clinical trial remains on
track and passed its most recent safety review, with the next one
coming in the third quarter,” said Dror Harats, M.D., Chief
Executive Officer of VBL Therapeutics. “During the first quarter
and in early April, we strengthened our balance sheet, raising a
total of approximately $40 million in additional capital, $12.3
million primarily through the exercise of outstanding warrants and
gross proceeds of $28.3 million through a public financing. The
additional capital extends our cash runway until year-end 2023. We
have a number of important milestones anticipated through the rest
of 2021 and look forward to keeping investors apprised of our
progress.”
First Quarter and Recent Corporate
Highlights
- In February, a successful pre-planned DSMC review of the OVAL
study found no safety issues with the trial and recommended its
continuation as planned.
- In March, the Company announced the initiation of randomized,
controlled and blinded trial of VB-111 in patients with recurrent
Glioblastoma Multiforme (rGBM).
- In March, the Company announced the publication of positive
results in peer-reviewed journal Gynecologic Oncology of the
pre-specified interim analysis of the OVAL Phase 3 Registration
Enabling Study of VB-111 in Ovarian Cancer. The analysis showed a
CA-125 response of at least 58% in the VB-111 treatment arm.
- Development of VB-111 in rGBM and colorectal cancer, as well as
of pipeline assets, continues as planned.
Corporate
- In January, the Company entered into an ordinary share purchase
agreement of up to $20 million with Aspire Capital Fund LLC
- During the first quarter, the Company raised an additional
$12.3 million through a combination of sales under the Aspire share
purchase agreement, sales through its At-the-Market (ATM) facility
and the exercise of outstanding warrants
- In April, the Company closed a public offering raising gross
proceeds of $28.3 million
Financial Results for the First Quarter
2021
- As of March 31, 2021, VBL had cash, cash equivalents,
short-term bank deposits and restricted bank deposits totaling
$36.6 million. After the end of the first quarter, VBL raised gross
proceeds of $28.3 million in a public offering of shares and
pre-funded warrants. VBL expects that its cash and cash equivalents
and short-term bank deposits will be sufficient to fund operating
expenses and capital expenditure requirements until year-end
2023.
- Revenues for the first quarter 2021 were $185 thousand, as
compared to $366 thousand in the comparable period in 2020.
- R&D expenses, net were $4.8 million for the first quarter
compared to $4.5 million in the comparable period in 2020.
- G&A expenses were $1.7 million for the fiscal year,
compared to $1.3 million in the comparable period in 2020.
- VBL reported a net loss for the quarter ended March 31, 2021,
of $6.3 million, or ($0.12) per basic share, compared to a net loss
of $5.4 million, or ($0.15) per basic share, in the comparable
period in 2020.
Conference Call:
Tuesday, May 11 at 8:30 a.m.
EDTConference ID: 13719410From the US: 1 877 407
9208Israel Local: 1 809 406 247 International: 1 201 493
6784Webcast: https://edge.media-server.com/mmc/p/w794ban7
The live webcast will be available online and
may be accessed from the “Events and Presentation” page of the
company website. A replay of the webcast will be available
beginning approximately one hour after the conclusion of the call
and will remain available for at least 30 days thereafter.
About VBL
Vascular Biogenics Ltd., operating as VBL
Therapeutics, is a clinical stage biopharmaceutical company focused
on the discovery, development and commercialization of
first-in-class treatments for areas of unmet need in cancer and
immune/inflammatory indications. VBL has developed three platform
technologies: a gene-therapy based technology for targeting newly
formed blood vessels with focus on cancer, an antibody-based
technology targeting MOSPD2 for anti-inflammatory and
immuno-oncology applications, and the Lecinoxoids, a family of
small-molecules for immune-related indications. VBL’s lead oncology
product candidate, ofranergene obadenovec (VB-111), is an
investigational, first-in-class, targeted anti-cancer gene-therapy
agent that is being developed to treat a wide range of solid
tumors. VB-111 is currently being studied in a VBL-sponsored Phase
3 registration enabling trial for platinum-resistant ovarian
cancer.
Forward Looking Statements
This press release contains forward-looking
statements. All statements other than statements of historical fact
are forward-looking statements, which are often indicated by terms
such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“goal,” “intend,” “look forward to,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “will,” “would” and similar
expressions. These forward-looking statements may include, but are
not limited to, statements regarding our programs, including
VB-111, including their clinical development, therapeutic potential
and clinical results. These forward-looking statements are not
promises or guarantees and involve substantial risks and
uncertainties. Among the factors that could cause actual results to
differ materially from those described or projected herein include
uncertainties associated generally with research and development,
clinical trials and related regulatory reviews and approvals, the
risk that historical clinical trial results may not be predictive
of future trial results, that our financial resources do not last
for as long as anticipated, and that we may not realize the
expected benefits of our intellectual property protection. In
particular, the DSMC recommendation that the OVAL trial proceed is
not assurance that the trial will meet its primary endpoint of
overall survival once completed, or that we will obtain positive
results to support further development of this candidate. A further
list and description of these risks, uncertainties and other risks
can be found in our regulatory filings with the U.S. Securities and
Exchange Commission, including in our annual report on Form 20-F
for the year ended December 31, 2020, and subsequent filings with
the SEC. Existing and prospective investors are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. VBL Therapeutics undertakes no
obligation to update or revise the information contained in this
press release, whether as a result of new information, future
events or circumstances or otherwise.
CONTACT:Burns McClellan
for VBL TherapeuticsLee Roth (investors) / Ryo Imai
(media)lroth@burnsmc.com /
rimai@burnsmc.com+1-212-213-0006
VASCULAR BIOGENICS
LTD.CONDENSED INTERIM STATEMENTS OF FINANCIAL
POSITION(UNAUDITED)
|
|
March 31, 2021 |
|
|
December 31, 2020 |
|
|
|
|
|
|
|
|
|
|
U.S. dollars in thousands |
|
ASSETS |
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
24,231 |
|
|
$ |
13,184 |
|
Restricted bank deposits |
|
|
- |
|
|
|
151 |
|
Short-term bank deposits |
|
|
12,021 |
|
|
|
17,110 |
|
Trade receivables |
|
|
- |
|
|
|
129 |
|
Other current assets |
|
|
1,156 |
|
|
|
1,419 |
|
Total current
assets |
|
|
37,408 |
|
|
|
31,993 |
|
|
|
|
|
|
|
|
|
|
Non-current
assets: |
|
|
|
|
|
|
|
|
Restricted bank deposits |
|
|
361 |
|
|
|
362 |
|
Long-term prepaid expenses |
|
|
219 |
|
|
|
241 |
|
Funds in respect of employee rights upon retirement |
|
|
330 |
|
|
|
354 |
|
Property, plant and equipment, net |
|
|
6,547 |
|
|
|
6,632 |
|
Operating lease right-of-use assets |
|
|
2,212 |
|
|
|
2,124 |
|
Total non-current
assets |
|
|
9,669 |
|
|
|
9,713 |
|
Total
assets |
|
$ |
47,077 |
|
|
$ |
41,706 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES, ORDINARY
SHARES SUBJECT TO POSSIBLE REDEMPTION AND SHAREHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts payable: |
|
|
|
|
|
|
|
|
Trade |
|
$ |
1,600 |
|
|
$ |
1,960 |
|
Other |
|
|
3,987 |
|
|
|
4,275 |
|
Deferred revenue |
|
|
713 |
|
|
|
725 |
|
Current maturity of operating leases liability |
|
|
438 |
|
|
|
393 |
|
Current maturity of finance lease liability |
|
|
- |
|
|
|
106 |
|
Total current
liabilities |
|
$ |
6,738 |
|
|
$ |
7,459 |
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities: |
|
|
|
|
|
|
|
|
Liability for employee rights upon retirement |
|
|
442 |
|
|
|
474 |
|
Deferred revenue |
|
|
528 |
|
|
|
704 |
|
Operating lease liability |
|
|
1,974 |
|
|
|
2,029 |
|
Other non-current liability |
|
|
143 |
|
|
|
123 |
|
Total non-current
liabilities |
|
|
3,087 |
|
|
|
3,330 |
|
|
|
|
|
|
|
|
|
|
Commitments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities |
|
$ |
9,825 |
|
|
$ |
10,789 |
|
|
|
|
|
|
|
|
|
|
Ordinary shares
subject to possible redemption, 615,366 shares at redemption value
(see note 4b) |
|
|
1,598 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Shareholders’
equity: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares, NIS 0.01 par value; Authorized as of March 31,
2021 and December 31, 2020, 150,000,000 shares; issued and
outstanding as of March 31, 2021 and December 31, 2020 54,519,369
and 48,187,463 shares, respectively (excluding 615,366 and -0-
shares subject to possible redemption, as of March 31, 2021 and
December 31, 2020, respectively) |
|
|
127 |
|
|
|
108 |
|
Additional paid in capital |
|
|
265,407 |
|
|
|
252,561 |
|
Warrants |
|
|
8,556 |
|
|
|
10,401 |
|
Accumulated deficit |
|
|
(238,436 |
) |
|
|
(232,153 |
) |
Total
equity |
|
|
35,654 |
|
|
|
30,917 |
|
Total liabilities,
ordinary shares subject to possible redemption and shareholders’
equity |
|
$ |
47,077 |
|
|
$ |
41,706 |
|
The accompanying notes are an integral
part of the financial statements.
VASCULAR BIOGENICS LTD.CONDENSED
INTERIM STATEMENTS OF NET LOSS AND COMPREHENSIVE
LOSS(UNAUDITED)
|
|
Three Months Ended March 31 |
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
U.S. dollars in thousands |
|
Revenues |
|
$ |
185 |
|
|
$ |
366 |
|
Cost of revenues |
|
|
(90 |
) |
|
|
(145 |
) |
Gross profit |
|
|
95 |
|
|
|
221 |
|
|
|
|
|
|
|
|
|
|
Research and development
expenses, net |
|
|
4,769 |
|
|
|
4,509 |
|
General and administrative
expenses |
|
|
1,673 |
|
|
|
1,339 |
|
Operating loss |
|
|
6,347 |
|
|
|
5,627 |
|
|
|
|
|
|
|
|
|
|
Financial income |
|
|
(84 |
) |
|
|
(290 |
) |
Interest expense |
|
|
20 |
|
|
|
15 |
|
Financial (income), net |
|
|
(64 |
) |
|
|
(275 |
) |
|
|
|
|
|
|
|
|
|
Net loss and comprehensive
loss |
|
$ |
6,283 |
|
|
$ |
5,352 |
|
|
|
|
|
|
|
|
|
|
Loss per share (see
note 3) |
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
0.12 |
|
|
$ |
0.15 |
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
52,113,675 |
|
|
|
36,103,500 |
|
The accompanying notes are an integral
part of the financial statements.
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