VBL Therapeutics Announces First Quarter 2017 Financial Results
May 15 2017 - 7:15AM
VBL Therapeutics (NASDAQ:VBLT), a clinical-stage biotechnology
company focused on the discovery, development and commercialization
of first-in-class treatments for cancer, announced financial
results for the first quarter ended March 31, 2017, as well as a
corporate update.
“We continue to execute on our strategy to develop VB-111, a
targeted anti-cancer gene-therapy agent that is positioned to treat
a wide range of solid tumors,” said Professor Dror Harats, Chief
Executive Officer of VBL Therapeutics. “Our GLOBE pivotal
trial in rGBM has completed enrollment and the DSMB committee
reviewed the GLOBE safety data collected through a cutoff date
in March 2017 and unanimously recommended that the study
continue as planned. Based on the current event rate in this
trial, we now expect the interim analysis to occur in the third
quarter of 2017, with top line data from the full dataset becoming
available in early 2018. Our planned Phase 3 clinical trial of
VB-111 in ovarian cancer is expected to begin in the second half of
2017.”
“We are also exploring the potential of VB-111 in other tumor
types, and recently presented data at the ASGCT conference showing
an enhanced benefit of VB-111 in combination with a checkpoint
inhibitor in preclinical models of lung cancer and melanoma.
Accordingly, we intend to launch an exploratory study of VB-111 in
combination with a checkpoint inhibitor in lung cancer by year-end
2017,” continued Prof. Harats. “Supporting this progress is a
strong balance sheet, with $39.6 million in cash on hand at the end
of the first quarter, which we believe will be sufficient to fund
our operating expenses and capital expenditure requirements into
2019.”
First Quarter and Recent Corporate Updates
- Completed enrollment in the pivotal GLOBE study investigating
VB-111 in rGBM. ° Enrollment in the study, 256 patients
in total, was completed in December 2016, five months ahead of
schedule. ° The DSMB committee reviewed the GLOBE
safety data collected through a cutoff date in March
2017 and unanimously recommended that the study continue as
planned. ° Company expects the GLOBE interim
analysis to occur in the third quarter of 2017, with top-line
results from the full dataset becoming available in early
2018.
- Presented preclinical data on VB-111 in combination with a
checkpoint inhibitor at the 20th Annual American Society of Gene
& Cell Therapy (ASGCT) meeting in Washington DC. °
Combination of VB-111 and anti-PD-L1 resulted in an amplified
antitumor effect in models of lung cancer and melanoma.
- Data from the prior Phase 2 clinical trial that investigated
VB-111 in rGBM have been selected for presentation at the 2017
American Society of Clinical Oncology (ASCO) annual meeting on June
5. ° The poster at ASCO will feature
new data on individual patients who were enrolled in this
trial.
- Announced full results from exploratory Phase 2 study of VB-111
in patients with advanced, differentiated thyroid cancer. °
The study previously met its primary endpoint, defined as
6-month progression-free-survival (PFS-6) of 25%, with a dose
response. An overall survival benefit was seen with a tail of more
than 40% at 3.7 years for the therapeutic-dose cohort.
- Published research on MOSPD2, a potential novel immune-oncology
target at the annual American Association of Cancer Research (AACR)
meeting in Washington DC. ° A paper discussing MOSPD2
was published online in The Journal of Immunology in January
2017. ° Targeting of MOSPD2 may have several
therapeutic applications, including inhibition of monocyte
migration in chronic inflammatory conditions inhibition of tumor
cell metastases and targeting of MOSPD2 tumor cells. °
VBL’s “VB-600 series” of pipeline candidates is being
developed toward these applications.
- Announced new data supporting use of Lecinoxoids in NASH
° In a retrospective analysis of five Phase 1 studies and
three Phase 2 studies, liver enzyme tests were performed for
subjects dosed with VB-201, and identified a statistically
significant time- and dose-dependent reduction of alkaline
phosphatase (ALP) blood levels as well as a reduction in levels of
gamma-glutamyltransferase (GGT), in patients treated orally with
VB-201. Reductions in these biomarkers may indicate
improvement in liver fibrosis.
First Quarter 2017 Financial Results:
- Cash Position: At March 31, 2017, we had
cash, cash equivalents and short-term bank deposits totaling $39.6
million and working capital of $37.2 million. We expect that our
cash, cash equivalents and short-term bank deposits will enable us
to fund our operating expenses and capital expenditure requirements
into 2019 and is expected to be sufficient to enable us to complete
our ongoing Phase 3 clinical trial of VB-111 in rGBM, to support
our planned potential registration trial in ovarian cancer and an
exploratory clinical study of VB-111 in combination with a
checkpoint inhibitor in lung cancer, as well as to support the
investment in the new Modiin facility to which we intend to
relocate in a few months.
- R&D Expenses: Research and development
expenses for the quarter ended March 31, 2017 were approximately
$4.1 million, compared to approximately $4.0 million in the same
period of 2016.
- G&A Expenses: General and
administrative expenses for the quarter ended March 31, 2017 were
approximately $1.1 million, compared to approximately $0.9 million
in the same period of 2016.
- Net Loss: The Company reported a net
loss for the quarter ended March 31, 2017 of $5.0 million, or
($0.19) per share, compared to a net loss of $4.7 million, or
($0.21) per share in the quarter ended March 31, 2016.
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Conference Call, Monday, May 15th @ 8:30am Eastern
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Domestic: |
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866-409-1555 |
International: |
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913-661-9178 |
Conference ID: |
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7109868 |
Webcast: |
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http://edge.media-server.com/m/p/hg84w5hv |
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Replays,
available through May 29, 2017: |
Toll Free: |
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844-512-2921 |
International:
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412-317-6671 |
Conference ID: |
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7109868 |
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About VBLVascular 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 cancer. The Company’s lead oncology
product candidate, ofranergene obadenovec (VB-111), is a
first-in-class biologic agent that uses a dual mechanism to target
solid tumors. It utilizes an angiogenesis-specific sensor (VBL's
PPE-1-3x proprietary promoter) to specifically target the tumor
vasculature, by induction of cell death in angiogenic endothelial
cells in the tumor milieu. Moreover, it is an immune-stimulant that
triggers a local anti-tumor immune response, which is accompanied
by recruitment of CD8 T-cells and apoptosis of tumor cells.
Ofranergene obadenovec is positioned to treat a wide range of solid
tumors and is conveniently administered as an IV infusion once
every two months. It has been observed to be well-tolerated in
>200 cancer patients and we have observed its efficacy signals
in an “all comers” Phase 1 trial as well as in three tumor-specific
Phase 2 studies. Ofranergene obadenovec is currently being studied
in a Phase 3 pivotal trial for recurrent Glioblastoma, conducted
under an FDA Special Protocol Assessment (SPA).
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 include, but are not limited to,
statements regarding the clinical development of ofranergene
obadenovec (VB-111) and its therapeutic potential, ongoing and
planned clinical trials and clinical results, including the timing
thereof, our other pipeline candidates, including the clinical
development and therapeutic potential of our VB-600 series of
pipeline candidates and Lecinoxoids in NASH, our new Modiin
facility and our cash position and financial outlook. 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, and the risk that
historical clinical trial results may not be predictive of future
trial results. In particular, results from our pivotal Phase 3
clinical trial of ofranergene obadenovec (VB-111) in rGBM may not
support approval of ofranergene obadenovec for marketing in the
United States, notwithstanding the positive results seen in prior
clinical experience. A further list and description of these risks,
uncertainties and other risks can be found in the Company’s
regulatory filings with the U.S. Securities and Exchange
Commission. 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.
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VASCULAR BIOGENICS LTD.CONDENSED
INTERIM STATEMENTS OF FINANCIAL POSITION(UNAUDITED) |
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March 31, |
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December 31, |
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|
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2017 |
|
|
2016 |
|
|
|
|
U.S. dollars
in thousands |
|
Assets |
|
|
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|
|
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CURRENT
ASSETS: |
|
|
|
|
|
|
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Cash and
cash equivalents |
|
$ |
5,947 |
|
|
$ |
11,585 |
|
|
Short-term bank deposits |
|
|
33,686 |
|
|
|
33,669 |
|
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Other
current assets |
|
|
2,037 |
|
|
|
1,320 |
|
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TOTAL CURRENT
ASSETS |
|
|
41,670 |
|
|
|
46,574 |
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NON-CURRENT
ASSETS: |
|
|
|
|
|
|
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Property
and equipment, net |
|
|
878 |
|
|
|
687 |
|
|
Long-term
prepaid expenses |
|
|
187 |
|
|
|
13 |
|
|
TOTAL
NON-CURRENT ASSETS |
|
|
1,065 |
|
|
|
700 |
|
|
TOTAL
ASSETS |
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$ |
42,735 |
|
|
$ |
47,274 |
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|
Liabilities and equity |
|
|
|
|
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CURRENT
LIABILITIES— |
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|
|
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Accounts
payable and accrued expenses: |
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|
|
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|
|
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Trade |
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$ |
2,916 |
|
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$ |
2,522 |
|
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Other |
|
|
1,604 |
|
|
|
2,266 |
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TOTAL CURRENT
LIABILITIES |
|
|
4,520 |
|
|
|
4,788 |
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NON-CURRENT
LIABILITIES— |
|
|
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|
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|
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Severance
pay obligations, net |
|
|
91 |
|
|
|
86 |
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TOTAL
LIABILITIES |
|
|
4,611 |
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|
|
4,874 |
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EQUITY: |
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Ordinary
shares |
|
|
50 |
|
|
|
50 |
|
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Accumulated Other comprehensive income |
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|
40 |
|
|
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40 |
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Additional paid in capital |
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|
198,158 |
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|
|
197,400 |
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Warrants |
|
|
2,960 |
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|
|
2,960 |
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Accumulated deficit |
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|
(163,084 |
) |
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|
(158,050 |
) |
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TOTAL
EQUITY |
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|
38,124 |
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|
|
42,400 |
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TOTAL
LIABILITIES AND EQUITY |
|
$ |
42,735 |
|
|
$ |
47,274 |
|
|
|
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VASCULAR BIOGENICS LTD.CONDENSED
INTERIM STATEMENTS OF COMPREHENSIVE LOSS(UNAUDITED) |
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Three Months Ended
March 31, |
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2017 |
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2016 |
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U.S. dollars in thousands |
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RESEARCH AND
DEVELOPMENT EXPENSES, net |
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$ |
4,144 |
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$ |
4,003 |
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GENERAL AND
ADMINISTRATIVE EXPENSES |
|
|
1,105 |
|
|
|
863 |
|
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OPERATING
LOSS |
|
|
5,249 |
|
|
|
4,866 |
|
|
FINANCIAL
INCOME |
|
|
(219 |
) |
|
|
(137 |
) |
|
FINANCIAL
EXPENSES |
|
|
4 |
|
|
|
— |
|
|
FINANCIAL
EXPENSES, net |
|
|
(215 |
) |
|
|
(137 |
) |
|
COMPREHENSIVE
LOSS |
|
$ |
5,034 |
|
|
$ |
4,729 |
|
|
|
|
|
|
|
|
|
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LOSS PER
ORDINARY SHARE |
|
U.S. dollars |
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
0.19 |
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$ |
0.21 |
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Number of shares |
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WEIGHTED
AVERAGE ORDINARY SHARES OUTSTANDING— |
|
|
|
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Basic and
diluted |
|
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26,907,172 |
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|
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22,476,773 |
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INVESTOR CONTACT:
Michael Rice
LifeSci Advisors, LLC
(646) 597-6979
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