VBL Therapeutics Announces Third Quarter 2017 Financial Results
November 14 2017 - 7:00AM
Conference Call and Webcast at 8:30am Eastern
Time Today
VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology
company focused on the discovery, development and commercialization
of first-in-class treatments for cancer, today announced financial
results for the three and nine months ended September 30, 2017 and
provided a corporate update.
“We were pleased to announce last week the
signing of an exclusive license agreement with NanoCarrier Co.,
Ltd. (NanoCarrier) for the development, commercialization and
supply of VB-111 in Japan. The license agreement with NanoCarrier
provided for an upfront payment of $15 million on November 7, 2017,
which strengthens our cash position with non-dilutive money and
provides external validation of the Company and VB-111. Our Phase 3
GLOBE Trial investigating VB-111 in recurrent glioblastoma
multiforme (rGBM) is moving according to plan, and the Data Safety
Monitoring Committee, in their last and final safety review,
recommended that the study continue to completion,” said Prof. Dror
Harats, Chief Executive Officer of VBL Therapeutics. “We currently
expect top line results in the first quarter of 2018. As we advance
towards our planned Biologics License Application (BLA) filing for
VB-111, we continue to make preparations for launch and
commercialization. We were pleased to open our state of the art
gene therapy manufacturing facility in Modiin, Israel, which is
designed to produce commercial quantities of the drug.”
“Beyond rGBM, we remain on-track to initiate a
Phase 3 study of VB-111 in ovarian cancer by year-end 2017,”
continued Harats. “We are also planning an exploratory clinical
study in combination with a checkpoint inhibitor in lung cancer in
the first quarter of 2018.”
Third Quarter and Recent Corporate
Highlights:
- The independent Data Safety Monitoring Committee (DSMC)
overseeing the ongoing Phase 3 GLOBE Study investigating
ofranergene obadenovec (VB-111) in recurrent glioblastoma (rGBM)
met on September 28, 2017 to conduct its third and final safety
review. ○ The DSMC reviewed the GLOBE safety data, including
mortality data, collected through a cutoff date in August 2017 and
unanimously recommended that the study continue as planned, to
completion. ○ No additional interim analyses are planned, and
top-line results from the study are expected to be available in the
first quarter of 2018.
- VBL opened its new company headquarters and gene therapy
manufacturing plant in Modiin, Israel. ○ This plant will be
the commercial facility for production of the Company’s lead
product candidate VB-111, if approved. ○ The Modiin facility
is the first commercial-scale gene therapy manufacturing facility
in Israel and currently one of the largest gene-therapy designated
ones in the world (20,000 sq. ft.).
- Signed an exclusive license agreement with NanoCarrier Co.,
Ltd. for the development, commercialization, and supply of VB-111
in Japan. ○ VBL received an up-front payment of $15 million,
and is entitled to receive greater than $100 million in development
and commercial milestone payments, as well as tiered royalties in
the high-teens on net sales.
- VBL’s cash position is strengthened to fund operations through
2019.
- The European Medicines Agency (EMA) designated VB-111 as an
“orphan medicinal product” for the treatment of ovarian cancer,
adding to the orphan status already granted for glioblastoma in US
and Europe.
Third Quarter Ended September 30, 2017
Financial Results:
- Cash Position: At September 30, 2017, we had
cash, cash equivalents and short-term bank deposits totaling $28.2
million and working capital of $24.4 million. In November we
received an additional $15 million in cash as an upfront payment
from NanoCarrier Co., Ltd., under the exclusive license agreement
to develop, commercialize and supply VB-111 in Japan. We expect
that our cash, cash equivalents and short-term bank deposits will
enable us to fund our operating expenses and capital expenditure
requirements through 2019, and expect such cash, cash equivalents
and short-term bank deposits to be sufficient to enable us to
complete our on-going Phase 3 clinical trial of VB-111 in rGBM, to
prepare for the commercialization of VB-111 for rGBM in the US, to
support our planned 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.
- R&D Expenses: Research and development
expenses for the quarter ended September 30, 2017 were
approximately $4.8 million, compared to approximately $2.2 million
in the same period of 2016.
- G&A Expenses: General and administrative
expenses for the quarter ended September 30, 2017 were
approximately $1.7 million, compared to approximately $1.1 million
in the same period of 2016.
- Comprehensive Loss: The Company reported a
comprehensive loss for the quarter ended September 30, 2017 of $6.5
million, or ($0.24) per share, compared to a net loss of $3.2
million, or ($0.12) per share in the quarter ended September 30,
2016.
Nine Months Ended September 30, 2017
Financial Results:
- R&D Expenses: Research and development
expenses (net) were $12.1 million for the nine-month period of
2017, compared to $8.5 million for the nine-month period of
2016.
- G&A Expenses: General and administrative
expenses for the nine-month period of 2017 were $4.7 million,
compared to $3.0 million in the same period of 2016.
- Comprehensive Loss: Comprehensive loss for the
nine months of 2017 was $16.4 million, or ($0.61) per share,
compared to a net loss of $11.2 million, or ($0.46) per share in
the nine months of 2016.
Conference CallTuesday,
November 14 @ 8:30am Eastern Time
Domestic: |
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877-280-1254 |
International: |
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646-254-3366 |
Conference ID: |
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1013162 |
Webcast: |
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https://edge.media-server.com/m6/p/avv5bjwq |
Replays, Available through November 28th:
Domestic: |
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888-203-1112 |
International: |
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719-457-0820 |
Replay Passcode: |
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1013162 |
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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, targeted anti-cancer gene-therapy
agent that is positioned to treat a wide range of solid tumors. It
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) |
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
|
U.S. dollars in thousands |
|
Assets |
|
|
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
11,667 |
|
|
$ |
11,585 |
|
Short-term bank deposits |
|
|
16,497 |
|
|
|
33,669 |
|
Other
current assets |
|
|
1,201 |
|
|
|
1,320 |
|
TOTAL CURRENT
ASSETS |
|
|
29,365 |
|
|
|
46,574 |
|
NON-CURRENT
ASSETS: |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
|
5,644 |
|
|
|
687 |
|
Long-term
prepaid expenses |
|
|
134 |
|
|
|
13 |
|
TOTAL
NON-CURRENT ASSETS |
|
|
5,778 |
|
|
|
700 |
|
TOTAL
ASSETS |
|
$ |
35,143 |
|
|
$ |
47,274 |
|
Liabilities and equity |
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES— |
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses: |
|
|
|
|
|
|
|
|
Trade |
|
$ |
3,253 |
|
|
$ |
2,522 |
|
Other |
|
|
1,754 |
|
|
|
2,266 |
|
TOTAL CURRENT
LIABILITIES |
|
|
5,007 |
|
|
|
4,788 |
|
NON-CURRENT
LIABILITIES— |
|
|
|
|
|
|
|
|
Severance
pay obligations, net |
|
|
93 |
|
|
|
86 |
|
TOTAL
LIABILITIES |
|
|
5,100 |
|
|
|
4,874 |
|
EQUITY: |
|
|
|
|
|
|
|
|
Ordinary
shares |
|
|
50 |
|
|
|
50 |
|
Accumulated other comprehensive income |
|
|
40 |
|
|
|
40 |
|
Additional paid in capital |
|
|
201,489 |
|
|
|
197,400 |
|
Warrants |
|
|
2,960 |
|
|
|
2,960 |
|
Accumulated deficit |
|
|
(174,496 |
) |
|
|
(158,050 |
) |
TOTAL
EQUITY |
|
|
30,043 |
|
|
|
42,400 |
|
TOTAL
LIABILITIES AND EQUITY |
|
$ |
35,143 |
|
|
$ |
47,274 |
|
|
|
|
|
|
|
|
|
|
|
VASCULAR BIOGENICS LTD. |
|
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE
LOSS |
|
(UNAUDITED) |
|
|
|
Three Months EndedSeptember 30, |
|
|
Nine Months EndedSeptember 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
U.S. dollars in thousands |
|
RESEARCH AND
DEVELOPMENT EXPENSES, net |
|
$ |
4,753 |
|
|
$ |
2,235 |
|
|
$ |
12,106 |
|
|
$ |
8,468 |
|
GENERAL AND
ADMINISTRATIVE EXPENSES |
|
|
1,724 |
|
|
|
1,068 |
|
|
|
4,727 |
|
|
|
2,991 |
|
OPERATING
LOSS |
|
|
6,477 |
|
|
|
3,303 |
|
|
|
16,833 |
|
|
|
11,459 |
|
FINANCIAL
EXPENSES |
|
|
35 |
|
|
|
3 |
|
|
|
43 |
|
|
|
9 |
|
OTHER FINANCIAL
(INCOME) EXPENSES |
|
|
28 |
|
|
|
(112 |
) |
|
|
(430 |
) |
|
|
(271 |
) |
FINANCIAL
(INCOME) EXPENSES, net |
|
|
63 |
|
|
|
(109 |
) |
|
|
(387 |
) |
|
|
(262 |
) |
COMPREHENSIVE
LOSS |
|
$ |
6,540 |
|
|
$ |
3,194 |
|
|
$ |
16,446 |
|
|
$ |
11,197 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS PER
ORDINARY SHARE |
|
|
U.S. dollars |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
0.24 |
|
|
$ |
0.12 |
|
|
$ |
0.61 |
|
|
$ |
0.46 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares |
|
WEIGHTED
AVERAGE ORDINARY SHARES OUTSTANDING— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
27,100,213 |
|
|
|
26,875,818 |
|
|
|
27,005,550 |
|
|
|
24,323,508 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTOR CONTACT: Michael Rice LifeSci Advisors, LLC (646)
597-6979
MEDIA CONTACT:Matt MiddlemanLifeSci Public
Relations(646) 627-8384
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