VBL Therapeutics Announces First Quarter 2018 Financial Results
May 17 2018 - 07:00AM
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 first quarter ended March 31, 2018 and provided a
corporate update.
“We continue to advance the OVAL trial, our
Phase 3 potential registration trial in platinum-resistant ovarian
cancer, in collaboration with the GOG Foundation,” said Yael Cohen
M.D., VP Clinical Development of VBL Therapeutic. “We are in the
process of amending the protocol to include an interim analysis for
evidence of an early efficacy signal with a potential readout from
this analysis in the fourth quarter of 2019.”
“We are also advancing our MOSPD2 program for
oncology and inflammatory indications and, at the recent American
Academy of Cancer Research (AACR) meeting, presented new
proof-of-concept on the use of a bispecific antibody to kill
MOSPD2-expressing cancer cells,” said Dror Harats M.D., Chief
Executive Officer of VBL Therapeutics. “VBL is well capitalized,
with approximately $50 million in cash, which will enable us to
continue the development of VB-111 and our deep pipeline through
2020.’
First Quarter and Recent Corporate
Highlights:
- Continued to treat patients in the ongoing Phase 3 OVAL trial,
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.-- The
Company is modifying the OVAL protocol to incorporate an efficacy
interim readout, which is expected to occur in the fourth quarter
of 2019.
- The Company is conducting an in-depth analysis of the GLOBE
study, including analysis of patient subgroups, in order to better
understand the outcome of the study, the major difference between
the Phase II and the GLOBE trial and the potential activity of
VB-111 in rGBM.
- Presented late breaking research on the Company’s MOSPD2
oncology program at the American Association for Cancer Research
(AACR) 2018 annual meeting.-- The data provide proof-of-concept on
the use of a bispecific antibody to kill MOSPD2-expressing cancer
cells, with potential applicability to solid tumors and myeloid
malignancies.-- The MOSPD2 program was also featured in a
presentation at the 17th MIXiii-BIOMED 2018 Conference and
Exhibition, May 15-17 in Tel Aviv, Israel.-- VBL is developing
its VB-600 series of antibodies targeting MOSPD2 for oncology and
inflammatory applications.
- Awarded 8.9 million New Israeli Shekels (approximately US$2.5
million) non-dilutive grant by the Israel Innovation Authority
(IIA).-- The funds will support the development of VB-111 as
well as the Company’s Vascular Targeting System (VTS™) platform for
therapeutic gene therapy.
- Appointed two senior pharmaceutical executives, Susan Kelley,
M.D., and David Hastings, to its Board of Directors.
First Quarter Ended March 31, 2018 Financial
Results:
- Revenues: In 2017 the Company entered into an
exclusive license agreement with NanoCarrier Co., Ltd. and received
an up-front and a milestone payment of $17.0 million in aggregate,
of which $0.2 million was recognized as of March 2018.
- Cash Position: Cash, cash equivalents and
short-term bank deposits at March 31, 2018, were $49.9 million.
Working capital at March 31 was $44.3 million. The Company expects
that the current cash, cash equivalents and short-term bank
deposits will be sufficient to fund operating expenses and capital
expenditure requirements through 2020.
- R&D Expenses: Research and development
expenses for the quarter ended March 31, 2018, were approximately
$5.8 million, compared to approximately $4.1 million in the
comparable period in 2017. R&D expenses are shown net of IIA
grants.
- G&A Expenses: General and administrative
expenses for the quarter ended March 31, 2018 were $1.4 million,
compared to $1.1 million for the comparable period in 2017.
- Comprehensive Loss: The Company reported a
comprehensive loss for first quarter ended March 31, 2018 of $7.2
million, or ($0.24) per share, compared to a net loss of $5.0
million, or ($0.19) per share in first quarter ended March 31,
2017.
Conference Call:
Thursday, May 17th @ 8:30am Eastern Time
US Domestic: |
|
877-222-6394 |
International: |
|
1-703-925-2702 |
Conference ID: |
|
9993639 |
Webcast: |
|
https://edge.media-server.com/m6/p/zja7xger |
Replays, Available through May 31, 2018
US Domestic: |
|
855-859-2056 |
International: |
|
1-404-537-3406 |
Conference ID: |
|
9993639 |
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, 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 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 VB-111, including its clinical
development, therapeutic potential and clinical results. 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. 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
|
|
VASCULAR BIOGENICS LTD. |
|
|
|
CONDENSED INTERIM STATEMENTS OF FINANCIAL
POSITION |
|
(UNAUDITED) |
|
|
|
|
|
|
|
March, 31 |
|
|
December, 31 |
|
|
|
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. dollars in thousands |
|
Assets |
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
|
|
$ |
8,583 |
|
|
$ |
6,694 |
|
Short-term bank deposits |
|
|
|
|
41,306 |
|
|
|
48,035 |
|
Trade
receivables |
|
|
|
|
— |
|
|
|
2,000 |
|
Other
current assets |
|
|
|
|
2,307 |
|
|
|
1,729 |
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
ASSETS |
|
|
|
|
52,196 |
|
|
|
58,458 |
|
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
ASSETS: |
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
|
|
|
8,222 |
|
|
|
7,128 |
|
Long-term
prepaid expenses |
|
|
|
|
64 |
|
|
|
103 |
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
NON-CURRENT ASSETS |
|
|
|
|
8,286 |
|
|
|
7,231 |
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS |
|
|
|
$ |
60,482 |
|
|
$ |
65,689 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and equity |
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES- |
|
|
|
|
|
|
|
|
|
|
Accounts
payable: |
|
|
|
|
|
|
|
|
|
|
Trade |
|
|
|
$ |
3,612 |
|
|
$ |
3,058 |
|
Other |
|
|
|
|
3,426 |
|
|
|
3,465 |
|
Deferred
revenue |
|
|
|
|
883 |
|
|
|
1,046 |
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES |
|
|
|
|
7,921 |
|
|
|
7,569 |
|
|
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
LIABILITIES- |
|
|
|
|
|
|
|
|
|
|
Severance
pay obligations, net |
|
|
|
|
128 |
|
|
|
128 |
|
Deferred
revenue |
|
|
|
|
2,092 |
|
|
|
2,092 |
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL NON-CURRENT LIABILITIES |
|
|
|
|
2,220 |
|
|
|
2,220 |
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES |
|
|
|
|
10,141 |
|
|
|
9,789 |
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY: |
|
|
|
|
|
|
|
|
|
|
Ordinary
shares |
|
|
|
|
57 |
|
|
|
57 |
|
Accumulated other comprehensive income |
|
|
|
|
16 |
|
|
|
16 |
|
Additional paid in capital |
|
|
|
|
222,675 |
|
|
|
221,055 |
|
Warrants |
|
|
|
|
2,960 |
|
|
|
2,960 |
|
Accumulated deficit |
|
|
|
|
(175,367 |
) |
|
|
(168,188 |
) |
|
|
|
|
|
|
|
|
|
|
|
TOTAL
EQUITY |
|
|
|
|
50,341 |
|
|
|
55,900 |
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND EQUITY |
|
|
|
$ |
60,482 |
|
|
$ |
65,689 |
|
VASCULAR BIOGENICS LTD. |
|
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE
LOSS |
|
(UNAUDITED) |
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. dollars in thousands |
|
REVENUES |
|
|
|
|
163 |
|
|
|
- |
|
COST OF REVENUES |
|
|
|
|
(67 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT |
|
|
|
|
96 |
|
|
|
- |
|
RESEARCH AND DEVELOPMENT EXPENSES, net |
|
|
|
$ |
5,760 |
|
|
$ |
4,144 |
|
MARKETING EXPENSES |
|
|
|
|
235 |
|
|
|
- |
|
GENERAL AND ADMINISTRATIVE EXPENSES |
|
|
|
|
1,395 |
|
|
|
1,105 |
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING LOSS |
|
|
|
|
7,294 |
|
|
|
5,249 |
|
|
|
|
|
|
|
|
|
|
|
|
FINANCIAL INCOME |
|
|
|
|
(145 |
) |
|
|
(219 |
) |
FINANCIAL EXPENSES |
|
|
|
|
30 |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
FINANCIAL EXPENSES (INCOME), net |
|
|
|
|
(115 |
) |
|
|
(215 |
) |
|
|
|
|
|
|
|
|
|
|
|
COMPREHENSIVE LOSS |
|
|
|
|
7,179 |
|
|
|
5,034 |
|
|
|
|
|
|
|
|
|
|
|
|
LOSS PER ORDINARY SHARE |
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
|
$ |
0.24 |
|
|
$ |
0.19 |
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares |
|
WEIGHTED AVERAGE ORDINARY SHARES OUTSTANDING- |
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
|
|
29,887,254 |
|
|
|
26,907,172 |
|
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