VBL Therapeutics Announces Second Quarter 2020 Financial Results and Provides Corporate Update
August 13 2020 - 7:00AM
VBL Therapeutics (Nasdaq: VBLT) today announced financial results
for the second quarter ended June 30, 2020, and provided a
corporate update.
“We have made excellent progress advancing our
lead candidate VB-111 during 2020,” said Dror Harats, M.D., Chief
Executive Officer of VBL Therapeutics. “The first interim analysis
in our OVAL Phase 3 pivotal study in ovarian cancer demonstrated
the potential benefit of VB-111 over standard-of-care in a
randomized-controlled study, and the recent positive second interim
analysis indicates that the trial continues to be on the right
track. OVAL has shown strong recruitment despite the COVID-19
pandemic. Also, when the Company blindly reviews response rate
data in all trial participants, that is in the treatment and
control groups combined, we are very encouraged by the high
response rate of over 50% of the total evaluable patients, which
has been maintained. The investigator sponsored studies of VB-111
in GBM and colorectal cancer are headed for initiation. Our MOSPD2
programs are gaining momentum, with pre-IND application for our
lead candidate VB-601 for inflammation, and recent scientific
presentations in NASH and colitis at DDW, in rheumatoid arthritis
at EULAR 2020 and in oncology at the AACR meeting.”
Second Quarter and Recent Key Corporate
Highlights:
VB-111
● |
Efficacy data from first interim analysis in the OVAL were reported
in March and presented at the ASCO20 Annual Meeting, showing 58% or
higher objective response rate. |
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OVAL independent DSMC reviewed unblinded data and determined that
the study has met the interim pre-specified criterion of an
absolute percentage advantage of 10% or higher in CA-125 response
in the VB-111 treated arm compared to control. The DSMC recommended
that the study proceed without modification. |
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Overall response rate in the first 60 randomized evaluable patients
was 53%. Assuming a balanced randomization, it can be deduced that
the response rate in the treatment arm (VB-111 in addition to
weekly paclitaxel) was 58% or higher. |
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In patients with post-treatment fever, the response was 69%. Fever
is frequently observed after VB-111 treatment. |
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Successful second pre-planned interim analysis, with a positive
DSMC review of OS data, the primary endpoint of the OVAL Phase 3
potential registration study, was completed on August 11. |
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Independent DSMC reviewed unblinded data of the first 100 patients
with follow-up of at least 3 months and determined that the study
should proceed without modification. |
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Two investigator sponsored VB-111 Phase 2 studies, in rGBM, at Dana
Farber Cancer Center and other leading neuro-oncology centers, and
in metastatic colorectal cancer by the NCI, are on track for
initiation. |
MOSPD2
● |
Pre-IND application for VBL’s VB-601 mAb for immune-inflammatory
indications was submitted to the FDA in June. The application is
currently under review by the agency. |
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Announced new data implicating the potential of its anti-MOSPD2
antibodies for treatment of nonalcoholic steatohepatitis (NASH) and
colitis at DDW 2020. |
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Treatment with anti-MOSPD2 antibodies was shown to decrease
inflammation and fibrosis in a NASH model and significantly reduce
disease activity in a colitis model. VBL’s study was rated in the
top 10% of all abstracts in this category and was selected as
Poster of Distinction. |
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Presented new data at the European League Against Rheumatism
(EULAR) implicating the potential of proprietary anti-MOSPD2
antibodies for treatment of rheumatoid arthritis (RA). |
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Treatment with anti-MOSPD2 antibodies significantly inhibited
arthritis progression in the collagen-induced arthritis model
(p<0.005). The treatment reduced >50% of disease severity and
blocked further disease progression. |
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Anti-MOSPD2 demonstrated higher activity than anti-TNFa in the
advanced phase of the disease. |
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Published a new manuscript demonstrating the potential of MOSPD2
antibodies in multiple sclerosis (MS). The results add to a growing
body of data demonstrated activity of VBL’s antibodies in models of
chronic inflammatory disease. |
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Presented new data demonstrating the potential of anti-MOSPD2
immune-mediated targeting of solid tumors at the Annual American
Association for Cancer Research (AACR) Virtual Annual Meeting
II. |
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MOSPD2 bi-specific antibody candidates induced T-cell activation
and significantly extended the survival of animals carrying
established metastatic cervical and breast cancer. |
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The data presented demonstrated that the bi-specific antibody
candidates mediated killing of tumor cells by CD8 T-cells in a
dose-dependent manner and induced T-cell activation in-vivo. |
VB-201
● |
The world-leading European animal health company partner, that is
evaluating VB-201 for veterinary applications, advised that the
program met a pre-determined milestone. This triggered an
undisclosed cash payment to VBL. |
Corporate:
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Raised $18.1 million of gross proceeds in two registered direct
offerings |
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Awarded a non-dilutive grant of up to 3.175 million New Israeli
Shekels (NIS; approximately $0.9 million) by the Israel Innovation
Authority (IIA). |
Quarter Ended June 30, 2020 Financial
Results:
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Cash Position: At June 30, 2020, VBL had
cash, cash equivalents, short-term bank deposits and restricted
bank deposit totaling $41.3 million and working capital of $36.1
million. VBL expects that its cash and cash equivalents and
short-term bank deposits will be sufficient to fund operating
expenses and capital expenditure requirements into the third
quarter of 2022. |
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Revenue: Revenues for the second quarter, 2020
were $158 thousand, compared to $138 thousand for the comparable
period in 2019. |
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Research and Development Expenses: Research and
Development expenses, net, were approximately $4.9 million for the
second quarter, compared to approximately $3.7 million in the
comparable period of 2019. |
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General and Administrative Expenses: General and
administrative expenses for the second quarter were $1.1 million,
compared to $1.2 million for the same period of 2019. |
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Comprehensive Loss: VBL reported a net loss for
three-month period ended June 30, 2020 of $5.8 million, or ($0.14)
per diluted share, compared to a net loss of $4.7 million, or
($0.13) per diluted share, in the same period of 2019. |
For further details on VBL’s financials, please
refer to Form 6-k filed with the SEC.
Conference Call:
Thursday, August 13 @
8:30amET
From the US: |
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877-407-9208 |
International: |
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201-493-6784 |
Israel local Number: |
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1-809-406-247 |
Conference ID: |
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13707066 |
Webcast: |
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https://edge.media-server.com/mmc/p/y7tts2sv |
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.
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, VB-600, including their clinical development, therapeutic
potential, the impact of the COVID-19 pandemic on VBL's
business, operations, clinical trials, supply chain, strategy,
goals and anticipated timelines 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 market and other conditions,
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. 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, 2019, 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, except as required by law.
INVESTOR CONTACT:
Michael RiceLifeSci Advisors(646) 597-6979
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL
POSITION(UNAUDITED)
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June 30, 2020 |
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December 31, 2019 |
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U.S. dollars in thousands |
|
Assets |
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|
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CURRENT ASSETS: |
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|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
16,702 |
|
|
$ |
9,436 |
|
Short-term bank deposits |
|
|
24,045 |
|
|
|
27,100 |
|
Short-term restricted bank deposits |
|
|
153 |
|
|
|
- |
|
Trade Receivables |
|
|
118 |
|
|
|
- |
|
Other current assets |
|
|
1,703 |
|
|
|
1,242 |
|
TOTAL CURRENT ASSETS |
|
|
42,721 |
|
|
|
37,778 |
|
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|
|
|
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|
|
|
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NON-CURRENT ASSETS: |
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|
|
|
|
|
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Restricted bank deposits |
|
|
358 |
|
|
|
506 |
|
Property and equipment, net |
|
|
6,455 |
|
|
|
6,949 |
|
Right-of-use assets |
|
|
2,840 |
|
|
|
3,088 |
|
Long-term prepaid expenses |
|
|
300 |
|
|
|
300 |
|
TOTAL NON-CURRENT ASSETS |
|
|
9,953 |
|
|
|
10,843 |
|
TOTAL ASSETS |
|
$ |
52,674 |
|
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$ |
48,621 |
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Liabilities and equity |
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CURRENT LIABILITIES- |
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Accounts payable and accruals: |
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Trade |
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$ |
2,241 |
|
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$ |
3,330 |
|
Other |
|
|
3,247 |
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|
|
4,238 |
|
Deferred revenue |
|
|
533 |
|
|
|
386 |
|
Lease liabilities |
|
|
641 |
|
|
|
774 |
|
TOTAL CURRENT LIABILITIES |
|
|
6,662 |
|
|
|
8,728 |
|
|
|
|
|
|
|
|
|
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NON-CURRENT LIABILITIES- |
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|
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Severance pay obligations, net |
|
|
163 |
|
|
|
163 |
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Deferred revenue |
|
|
1,283 |
|
|
|
1,723 |
|
Other non-current liability |
|
|
82 |
|
|
|
- |
|
Lease liabilities |
|
|
1,946 |
|
|
|
2,167 |
|
TOTAL NON-CURRENT
LIABILITIES |
|
|
3,474 |
|
|
|
4,053 |
|
TOTAL LIABILITIES |
|
|
10,136 |
|
|
|
12,781 |
|
|
|
|
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SHAREHOLDERS’ EQUITY: |
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Ordinary shares, NIS 0.01 par value; Authorized as of June 30, 2020
andDecember 31, 2019, 70,000,000 shares; issued and outstanding as
of June30, 2020 and December 31, 2019, 47,896,736 and 35,882,928
shares,respectively |
|
|
108 |
|
|
|
73 |
|
Accumulated other comprehensive income |
|
|
(8 |
) |
|
|
(8 |
) |
Additional paid in capital |
|
|
251,331 |
|
|
|
235,974 |
|
Warrants |
|
|
10,401 |
|
|
|
7,904 |
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Accumulated deficit |
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|
(219,294 |
) |
|
|
(208,103 |
) |
TOTAL SHAREHOLDERS’
EQUITY |
|
|
42,538 |
|
|
|
35,840 |
|
TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
$ |
52,674 |
|
|
$ |
48,621 |
|
The accompanying notes are an integral part of the
financial statements. |
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|
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE
LOSS(UNAUDITED)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
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U.S. dollars in thousands |
|
REVENUES |
|
$ |
158 |
|
|
$ |
138 |
|
|
$ |
524 |
|
|
$ |
357 |
|
COST OF
REVENUES |
|
|
(60 |
) |
|
|
(50 |
) |
|
|
(113 |
) |
|
|
(88 |
) |
GROSS
PROFIT |
|
|
98 |
|
|
|
88 |
|
|
|
411 |
|
|
|
269 |
|
RESEARCH AND
DEVELOPMENT EXPENSES, net |
|
$ |
4,865 |
|
|
$ |
3,729 |
|
|
$ |
9,616 |
|
|
$ |
7,037 |
|
GENERAL AND
ADMINISTRATIVE EXPENSES |
|
|
1,074 |
|
|
|
1,181 |
|
|
|
2,242 |
|
|
|
2,437 |
|
OPERATING
LOSS |
|
|
5,841 |
|
|
|
4,822 |
|
|
|
11,447 |
|
|
|
9,205 |
|
FINANCIAL
INCOME |
|
|
(37 |
) |
|
|
(223 |
) |
|
|
(329 |
) |
|
|
(499 |
) |
FINANCIAL
EXPENSES |
|
|
34 |
|
|
|
91 |
|
|
|
73 |
|
|
|
166 |
|
FINANCIAL INCOME,
net |
|
|
(3 |
) |
|
|
(132 |
) |
|
|
(256 |
) |
|
|
(333 |
) |
COMPREHENSIVE
LOSS |
|
$ |
5,838 |
|
|
$ |
4,690 |
|
|
$ |
11,191 |
|
|
$ |
8,872 |
|
LOSS PER ORDINARY
SHARE |
|
U.S. dollars |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
0.14 |
|
|
$ |
0.13 |
|
|
$ |
0.28 |
|
|
$ |
0.25 |
|
|
|
Number of shares |
|
WEIGHTED AVERAGE
ORDINARY SHARES OUTSTANDING- |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
42,674,526 |
|
|
|
35,881,128 |
|
|
|
39,354,355 |
|
|
|
35,881,128 |
|
The accompanying notes are an integral
part of the condensed financial statements.
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