VBL Therapeutics Announces Year End 2017 Financial Results
March 15 2018 - 7:15AM
Conference Call and Webcast at 8:30am Eastern
Time
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 quarter and year-ended December 31, 2017 and
provided a corporate update.
"VBL has more than $50 million in cash, which will enable us to
continue the development of VB-111 and our promising pipeline
through 2020," said Dror Harats, M.D., Chief Executive Officer of
VBL Therapeutics. "We intend to continue the ongoing OVAL trial,
our Phase 3 potential registration trial in platinum-resistant
ovarian cancer, in collaboration with the GOG Foundation. We
intend to add an interim analysis for evidence of efficacy signal
in our OVAL trial, sooner than in our original plan. We expect that
the interim readout may be available during the first half of
2019."
"Beyond VB-111, we have a strong pipeline,
including our exciting MOSPD2 program for oncology and inflammatory
indications. We intend to present new data from this program in
oncology as a late-breaking news at the forthcoming American
Academy of Cancer Research (AACR) meeting in April 2018."
Fourth Quarter and Recent Corporate
Highlights:
- Reported top-line results from its pivotal Phase 3 GLOBE study
in patients with rGBM which was designed to evaluate VB-111 in
combination with bevacizumab (Avastin®), compared with bevacizumab
alone.
- The study did not meet its pre-specified primary endpoint of
overall survival (OS) or secondary endpoint
progression-free-survival (PFS).
- Announced the initiation of the Phase 3 potential registration
trial, OVAL, studying VB-111 in platinum-resistant ovarian cancer.
- The OVAL study has been designed to enroll up to 350 adult
patients at approximately 70 clinical sites in the
U.S. and Israel. Patients are being randomized 1:1 to
VB-111 in combination with chemotherapy, or chemotherapy alone. The
primary endpoint is overall survival.
- The study is being conducted in collaboration with the
Gynecologic Oncology Group (GOG) Foundation, Inc., a leading
organization for research excellence in the field of gynecology
malignancies.
- The European Medicines Agency (EMA) designated VB-111 as an
“orphan medicinal product” for the treatment of ovarian cancer in
October 2017.
- Signed an exclusive license agreement with NanoCarrier Co.,
Ltd. (TSE Mothers:4571) for the development, commercialization and
supply of VB-111 in Japan.
- In February 2018, VBL received a milestone payment in relation
to this agreement.
- Opened new gene therapy manufacturing plant in Modiin, Israel.
- 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.).
- The facility was constructed with the support of
the Israel Innovation Authority of the Ministry of
Economy.
- Appointed David Hastings and Susan Kelley, M.D. to its Board of
Directors.
- In November 2017, raised $18.75 million in gross proceeds,
before deducting the underwriting discounts and commissions and
other estimated expenses, in a public offering of common
stock.
Year Ended December 31, 2017 Financial
Results
- Revenues: In 2017 we recognized revenues of
$13.8 million, generated from the licensing and development
agreement with NanoCarrier.
- Cash Position: At December 31, 2017, we had
cash, cash equivalents and short-term bank deposits of $54.7
million and working capital of $50.9 million. We expect that our
cash and cash equivalents and short-term bank deposits will enable
us to fund our operating expenses and capital expenditure
requirements through 2020.
- R&D Expenses: Research and development
expenses for the year ended December 31, 2017 were approximately
$17.8 million, compared to approximately $12.4 million in the year
ended December 31, 2016.
- G&A Expenses: General and administrative
expenses for the year ended December 31, 2017 were approximately
$5.8 million, compared to approximately $3.8 million in the year
ended December 31, 2016.
- Comprehensive Loss: The Company reported a
comprehensive loss for the year ended December 31, 2017 of $10.2
million, or ($0.37) per share, compared to a net loss of $16.0
million, or ($0.64) per share in the year ended December 31,
2016.
Conference Call
Thursday, March 15th @ 8:30am Eastern
Time |
Domestic: |
877-222-6394 |
International: |
703-925-2702 |
Conference ID: |
7392936 |
Webcast: |
https://edge.media-server.com/m6/p/y3srj89d |
|
|
Replays, Available
through March 29th: |
|
Domestic: |
855-859-2056 |
International: |
404-537-3406 |
Conference ID: |
7392936 |
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 demonstrated 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
trial for platinum-resistant ovarian cancer.
Forward Looking StatementsThis
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 projected cash resources and cash runway, the
clinical development of ofranergene obadenovec (VB-111) and our
other pipeline candidates, including our expectations for their
therapeutic potential in the conditions in which they are being or
may in the future be evaluated. 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, the
risk that historical clinical trial results may not be predictive
of future trial results, and that our product candidates that we
are developing may not demonstrate success in clinical trials. 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, including in our
annual report on Form 20-F for the year ended December 31, 2017.
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.
INVESTOR CONTACT:Michael RiceLifeSci Advisors,
LLC(646) 597-6979
MEDIA CONTACT:Matt Middleman, M.D.LifeSci
Public Relationsmatt@lifescipublicrelations.com(646) 627-8384
|
|
VASCULAR BIOGENICS LTD. |
|
STATEMENTS OF FINANCIAL POSITION |
|
|
|
|
|
December 31 |
|
|
|
2017 |
|
|
2016 |
|
|
|
U.S. dollars in thousands |
|
Assets |
|
|
|
|
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
6,694 |
|
|
$ |
11,585 |
|
Short-term bank deposits |
|
|
48,035 |
|
|
|
33,669 |
|
Trade
receivables |
|
|
2,000 |
|
|
|
— |
|
Other
current assets |
|
|
1,729 |
|
|
|
1,320 |
|
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
ASSETS |
|
|
58,458 |
|
|
|
46,574 |
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
ASSETS: |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
|
7,128 |
|
|
|
687 |
|
Long-term
prepaid expenses |
|
|
103 |
|
|
|
13 |
|
|
|
|
|
|
|
|
|
|
TOTAL
NON-CURRENT ASSETS |
|
|
7,231 |
|
|
|
700 |
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS |
|
$ |
65,689 |
|
|
$ |
47,274 |
|
|
|
|
|
|
|
|
|
|
Liabilities and equity |
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES— |
|
|
|
|
|
|
|
|
Accounts
payable: |
|
|
|
|
|
|
|
|
Trade |
|
$ |
3,058 |
|
|
$ |
2,522 |
|
Other |
|
|
3,465 |
|
|
|
2,266 |
|
Deferred
revenue |
|
|
1,046 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES |
|
|
7,569 |
|
|
|
4,788 |
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
LIABILITIES— |
|
|
|
|
|
|
|
|
Severance
pay obligations, net |
|
|
128 |
|
|
|
86 |
|
Deferred
revenue |
|
|
2,092 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
TOTAL NON-CURRENT LIABILITIES |
|
|
2,220 |
|
|
|
86 |
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES |
|
|
9,789 |
|
|
|
4,874 |
|
|
|
|
|
|
|
|
|
|
COMMITMENTS |
|
|
|
|
|
|
|
|
EQUITY: |
|
|
|
|
|
|
|
|
Ordinary
shares, NIS 0.01 par value; Authorized as of December 31, 2017 and
2016, 70,000,000 shares; issued and outstanding as of December 31,
2017 and 2016, 29,879,323 and 26,902,285 shares, respectively |
|
|
57 |
|
|
|
50 |
|
Accumulated other comprehensive income |
|
|
16 |
|
|
|
40 |
|
Additional paid in capital |
|
|
221,055 |
|
|
|
197,400 |
|
Warrants |
|
|
2,960 |
|
|
|
2,960 |
|
Accumulated deficit |
|
|
(168,188 |
) |
|
|
(158,050 |
) |
|
|
|
|
|
|
|
|
|
TOTAL
EQUITY |
|
|
55,900 |
|
|
|
42,400 |
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND EQUITY |
|
$ |
65,689 |
|
|
$ |
47,274 |
|
|
|
|
|
|
|
|
|
|
|
|
VASCULAR BIOGENICS LTD. |
|
STATEMENTS OF COMPREHENSIVE LOSS |
|
|
|
|
|
Year ended December 31 |
|
|
|
2017 |
|
|
2016 |
|
|
2015 |
|
|
|
U.S. dollars in thousands |
|
REVENUES |
|
|
13,864 |
|
|
|
— |
|
|
|
— |
|
COST OF
REVENUES |
|
|
(340 |
) |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS
PROFIT |
|
|
13,524 |
|
|
|
— |
|
|
|
— |
|
RESEARCH AND
DEVELOPMENT EXPENSES, net |
|
$ |
17,770 |
|
|
$ |
12,447 |
|
|
$ |
11,198 |
|
MARKETING
EXPENSES |
|
|
562 |
|
|
|
— |
|
|
|
— |
|
GENERAL AND
ADMINISTRATIVE EXPENSES |
|
|
5,847 |
|
|
|
3,828 |
|
|
|
3,673 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING
LOSS |
|
|
10,655 |
|
|
|
16,275 |
|
|
|
14,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCIAL
INCOME |
|
|
(544 |
) |
|
|
(285 |
) |
|
|
(100 |
) |
FINANCIAL
EXPENSES |
|
|
27 |
|
|
|
12 |
|
|
|
117 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCIAL
EXPENSES (INCOME), net |
|
|
(517 |
) |
|
|
(273 |
) |
|
|
17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS FOR THE
YEAR |
|
|
10,138 |
|
|
|
16,002 |
|
|
|
14,888 |
|
OTHER
COMPREHENSIVE LOSS (INCOME)— |
|
|
|
|
|
|
|
|
|
|
|
|
Items
that will not be reclassified to profit or loss— |
|
|
|
|
|
|
|
|
|
|
|
|
Re-measurements of post-employment benefit obligation |
|
|
24 |
|
|
|
5 |
|
|
|
(6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE
LOSS |
|
$ |
10,162 |
|
|
$ |
16,007 |
|
|
$ |
14,882 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. dollars |
|
LOSS PER
ORDINARY SHARE |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
0.37 |
|
|
$ |
0.64 |
|
|
$ |
0.73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares |
|
WEIGHTED
AVERAGE ORDINARY SHARES OUTSTANDING— |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
27,398,169 |
|
|
|
24,970,585 |
|
|
|
20,309,596 |
|
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