TEL AVIV, Israel, Aug. 14, 2017 (GLOBE NEWSWIRE) -- 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 Call
Monday, August 14th @ 8:30am Eastern
Time
Replays, Available through August 27, 2017
Domestic: |
|
866-932-5017 |
International: |
|
347-366-9565 |
Conference ID: |
|
1065636 |
|
|
|
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 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