VBL Therapeutics Announces Second Quarter 2017 Financial Results
August 14 2017 - 7:00AM
VBL Therapeutics (NASDAQ:VBLT), announced financial results for the
three and six months ended June 30, 2017 and provided a corporate
update.
“VBL made significant advances on clinical and operational
fronts during the second quarter of 2017,” said Prof. Dror Harats,
Chief Executive Officer of VBL Therapeutics. “We continue to
progress in our Phase 3 GLOBE study investigating our lead asset
VB-111 in patients with recurrent glioblastoma (rGBM). The trial is
proceeding according to plan, following a second positive review by
the independent Data Safety Monitoring Committee (DSMC) that took
place in April. We expect a final DSMC review in late September,
and top-line data in Q1 2018. Based on our interactions with the
FDA and the SPA for the trial, the GLOBE study should support a
Biologics License Application (BLA)."
“VB-111 continues to generate positive clinical results and we
recently provided follow-up data demonstrating that more than 50%
of patients achieved long-term survival following treatment with
VB-111 in our three completed Phase 2 trials, in rGBM,
platinum-resistant ovarian cancer and radioiodine refractory
differentiated thyroid cancer. VBL is also following up on patients
who remain alive for up to 7 years after enrolling into VB-111
Phase 1 study,” continued Prof. Harats. "We are on track to
initiate a Phase 3 study of VB-111 in ovarian cancer by year-end
2017 and an exploratory clinical study in combination with a
checkpoint inhibitor in lung cancer in Q1 2018.”
“As we are planning for commercialization of VB-111 in rGBM and
preparing to launch our new manufacturing facility, we also made an
important senior management addition during the quarter, with the
appointment of Dr. Corinne Epperly as our US Chief Operating
Officer. Dr. Epperly’s impressive skills and industry track record
will be valuable assets to VBL as we continue to advance VB-111 in
multiple oncology indications. We welcome her to the team and look
forward to the contributions she will make,” concluded Prof.
Harats.
Second Quarter and Recent Corporate
Highlights:
- Long-term survival update on VB-111: In addition to long-term
survival for some Phase 1 patients being followed up to 7 years,
the Company provided an update on long-term survival from VB-111
Phase 2 trials of patients with multiple tumor types, at the BIO
International Convention.• rGBM: In the Phase 2 rGBM study,
12-month survival was 54% in patients who were treated with VB-111
through progression, including an rGBM patient who remains alive
with complete response after 38 months, compared to 23% of patients
who had limited exposure of a therapeutic dose of VB-111. According
to a meta-analysis, the 12-month survival on Avastin® (bevacizumab)
is only 24%.• Ovarian cancer: In the Phase 2 recurrent
platinum-resistant and refractory ovarian cancer study, 53% of
patients treated with a therapeutic dose of VB-111 in combination
with paclitaxel were alive at 15 months. No patients in the
sub-therapeutic dose were alive at the 15-month time
point.• Thyroid cancer: In the Phase 2 radioiodine refractory
differentiated thyroid cancer study, 53% of those who received
multiple therapeutic doses of VB-111 were alive at 24 months,
compared to 33% of those who received a single, sub-therapeutic
dose of VB-111. 35% of patients on the therapeutic dose cohort
remain alive at 39 to 46 months.
- Presented new data at the American Society of Clinical Oncology
(ASCO) annual meeting that strengthen the evidence for the
anti-tumor activity of VB-111 in rGBM.• The data, from
patients in the completed Phase 2 study of VB-111 in rGBM,
demonstrate that longer exposure of VB-111 significantly attenuated
tumor growth kinetics and was associated with more frequent tumor
regression, compared with limited exposure.• Full data
analysis of our Phase 2 study in rGBM shows
statistically-significant benefit of VB-111 not just on Overall
Survival (OS) (p=0.043), but also on Progression-Free Survival
(PFS) (p=0.01).
- Published research on MOSPD2, a novel immune-oncology target at
the annual American Association of Cancer Research (AACR)
meeting.• 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.
- Appointed Corinne Epperly, MD, MPH, as US Chief Operating
Officer.• Dr. Epperly is an oncology expert with industry
background in drug development, strategy, commercialization and
operations. Her experience includes seven years
at Bristol-Myers Squibb, where most recently she was involved
in leading the preparation for the commercial launches of
OPDIVO® (nivolumab) in hepatocellular carcinoma, glioblastoma
and metastatic melanoma.• Dr. Epperly will have key
responsibilities in forming VBL's marketing strategy and
commercialization plans for VB-111.
- Awarded a grant of 8.75 million New Israeli Shekels
(approximately $2.5 million) by the Israel Innovation Authority.
The grant will support clinical trials and development activities
for calendar year 2017 and beyond.
Second Quarter Ended June 30, 2017 Financial
Results:
- Cash Position: At June 30, 2017, we had
cash, cash equivalents and short-term bank deposits totaling $33.8
million and working capital of $31.8 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 on-going Phase 3 clinical trial of VB-111 in rGBM, to
support our planned potential registrational 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 launch of our new Modiin facility.
- R&D Expenses: Research and
development expenses for the quarter ended June 30, 2017 were
approximately $3.2 million, compared to approximately $2.2 million
in the same period of 2016.
- G&A Expenses: General and
administrative expenses for the quarter ended June 30, 2017 were
approximately $1.9 million, compared to approximately $1.1 million
in the same period of 2016. The bulk of this increase is attributed
to a one-time non-cash cost for management share-based compensation
expense.
- Net Loss: The Company reported a net
loss for the quarter ended June 30, 2017 of $4.9 million, or
($0.18) per share, compared to a net loss of $3.3 million, or
($0.14) per share in the quarter ended June 30, 2016.
Six Months Ended June 30, 2017 Financial
Results:
- R&D Expenses: Research and
development expenses (net) were $7.4 million for the six month
period of 2017, compared to $6.2 million for the six month period
of 2016.
- G&A Expenses: General and
administrative expenses for the six month period of 2017 were $3.0
million, compared to $1.9 million in the same period of 2016. See
related comment for second quarter above.
- Net Loss: Net loss for the six months of
2017 was $9.9 million, or ($0.37) per share, compared to a net loss
of $8.0 million, or ($0.35) per share in the first six months of
2016.
Conference CallMonday, August 14th @
8:30am Eastern Time
Domestic: |
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877-280-1254 |
International: |
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646-254-3367 |
Conference ID: |
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1065636 |
Webcast: |
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https://edge.media-server.com/m6/p/m9onohwh |
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Replays, Available through August 27, 2017
Domestic: |
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866-932-5017 |
International: |
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347-366-9565 |
Conference ID: |
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1065636 |
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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
>300 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.
|
VASCULAR BIOGENICS
LTD.CONDENSED INTERIM STATEMENTS OF FINANCIAL
POSITION(UNAUDITED) |
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
2017 |
|
2016 |
|
|
|
U.S. dollars
in thousands |
|
Assets |
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
11,064 |
|
|
$ |
11,585 |
|
|
Short-term bank deposits |
|
|
22,724 |
|
|
|
33,669 |
|
|
Other current assets |
|
|
3,875 |
|
|
|
1,320 |
|
|
TOTAL CURRENT ASSETS |
|
|
37,663 |
|
|
|
46,574 |
|
|
NON-CURRENT ASSETS: |
|
|
|
|
|
|
|
Property and equipment, net |
|
|
3,171 |
|
|
|
687 |
|
|
Long-term prepaid expenses |
|
|
176 |
|
|
|
13 |
|
|
TOTAL NON-CURRENT ASSETS |
|
|
3,347 |
|
|
|
700 |
|
|
TOTAL ASSETS |
|
$ |
41,010 |
|
|
$ |
47,274 |
|
|
Liabilities and equity |
|
|
|
|
|
|
|
CURRENT LIABILITIES— |
|
|
|
|
|
|
|
Accounts payable and accrued expenses: |
|
|
|
|
|
|
|
Trade |
|
$ |
4,087 |
|
|
$ |
2,522 |
|
|
Other |
|
|
1,730 |
|
|
|
2,266 |
|
|
TOTAL CURRENT LIABILITIES |
|
|
5,817 |
|
|
|
4,788 |
|
|
NON-CURRENT LIABILITIES— |
|
|
|
|
|
|
|
Severance pay obligations, net |
|
|
94 |
|
|
|
86 |
|
|
TOTAL LIABILITIES |
|
|
5,911 |
|
|
|
4,874 |
|
|
EQUITY: |
|
|
|
|
|
|
|
Ordinary shares |
|
|
50 |
|
|
|
50 |
|
|
Accumulated other comprehensive income |
|
|
40 |
|
|
|
40 |
|
|
Additional paid in capital |
|
|
200,005 |
|
|
|
197,400 |
|
|
Warrants |
|
|
2,960 |
|
|
|
2,960 |
|
|
Accumulated deficit |
|
|
(167,956 |
) |
|
|
(158,050 |
) |
|
TOTAL EQUITY |
|
|
35,099 |
|
|
|
42,400 |
|
|
TOTAL LIABILITIES AND EQUITY |
|
$ |
41,010 |
|
|
$ |
47,274 |
|
|
|
|
VASCULAR BIOGENICS
LTD.CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE
LOSS(UNAUDITED) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
U.S. dollars in thousands |
|
RESEARCH AND
DEVELOPMENT EXPENSES, net |
|
$ |
3,209 |
|
|
$ |
2,230 |
|
|
$ |
7,353 |
|
|
$ |
6,233 |
|
|
GENERAL AND
ADMINISTRATIVE EXPENSES |
|
|
1,898 |
|
|
|
1,060 |
|
|
|
3,003 |
|
|
|
1,923 |
|
|
OPERATING
LOSS |
|
|
5,107 |
|
|
|
3,290 |
|
|
|
10,356 |
|
|
|
8,156 |
|
|
FINANCIAL
INCOME |
|
|
(239 |
) |
|
|
(22 |
) |
|
|
(458 |
) |
|
|
(159 |
) |
|
FINANCIAL
EXPENSES |
|
|
4 |
|
|
|
6 |
|
|
|
8 |
|
|
|
6 |
|
|
FINANCIAL
EXPENSES, net |
|
|
(235 |
) |
|
|
(16 |
) |
|
|
(450 |
) |
|
|
(153 |
) |
|
COMPREHENSIVE
LOSS |
|
$ |
4,872 |
|
|
$ |
3,274 |
|
|
$ |
9,906 |
|
|
$ |
8,003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS PER
ORDINARY SHARE |
|
U.S. dollars |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
0.18 |
|
|
$ |
0.14 |
|
|
$ |
0.37 |
|
|
$ |
0.35 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares |
|
WEIGHTED
AVERAGE ORDINARY SHARES OUTSTANDING— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
27,009,719 |
|
|
|
23,602,333 |
|
|
|
26,957,719 |
|
|
|
23,033,339 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTOR CONTACT:
Michael Rice
LifeSci Advisors, LLC
(646) 597-6979
MEDIA CONTACT:
Matt Middleman
LifeSci Public Relations
(646) 627-8384
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