VBL Therapeutics Announces Second Quarter 2018 Financial Results
16 August 2018 - 9:00PM
Conference Call and Webcast at 8:30am Eastern
Time Today
VBL Therapeutics (Nasdaq: VBLT) today announced financial results
for the second quarter ended June 30, 2018 and provided a corporate
update.
“VBL is well capitalized, with more than $58
million in cash, which will enable us to continue the development
of VB-111 in ovarian cancer, and to advance our innovative
pipeline, including our exciting VB-600 platform targeting MOSPD2,
for more than the next three years," said Dror Harats M.D., Chief
Executive Officer of VBL Therapeutics.
"We continue to have high conviction in the
promise of VB-111 and are focused on executing the ongoing Phase 3
OVAL trial, evaluating VB-111 in platinum-resistant ovarian
cancer. We plan to conduct an interim efficacy analysis of
this trial in the fourth quarter of 2019.”
“We are excited about our MOSPD2 platform and are very
encouraged by the emerging data which highlights the potential of
this novel target in the treatment of both cancer and inflammatory
disease such as multiple sclerosis. Our goal is to file the
first IND from this program by year-end 2019,” continued Prof.
Harats.
VBL will present more data on MOSPD2 at the European Committee
for Treatment and Research in Multiple Sclerosis (or ECTRIMS)
conference on October 11th in Berlin.
Second Quarter and Recent Corporate
Highlights:
- Closed a $15.5 million registered direct offering, which will
enable the Company to continue the development of VB-111 in ovarian
cancer, and to advance the pipeline, including the VB-600 platform
targeting MOSPD2, for the next three years.
- Continued to treat patients in the ongoing Phase 3 OVAL trial,
evaluating VB-111 in platinum-resistant ovarian cancer. An efficacy
interim readout is expected to occur in the fourth quarter of
2019.
- Conducted analyses of the VB-111 Phase 3 GLOBE trial in
recurrent glioblastoma (rGBM). We are particularly investigating
the possibility that the treatment regimen of the GLOBE trial,
which was performed under a pre-agreed Special Protocol Assessment
(SPA), may have impaired the activity of VB-111. Our analyses
have not revealed any other risk factor that can explain the
difference in outcome compared with the prior Phase 2 trial. The
Company plans to present additional data on GLOBE at the Society
for Neuro-Oncology, or SNO meeting, in November 2018.
- Presented positive new data on the Company’s MOSPD2 platform
technology in oncology and inflammation in international
conferences, and published a paper highlighting MOSPD2 as a
potential new target for therapy of solid tumors such as breast
cancer.° Presented a late-breaking study demonstrating a novel
bi-specific antibody that induces immune-cell mediated killing of
cancer cells through binding to a tumor membrane receptor, MOSPD2,
at the American Association for Cancer Research (AACR)
2018 annual meeting. ° Presented data on the role of MOSPD2 in
oncology and inflammation at the 2018 BIO international
convention. VBL research has shown that knocking out the
MOSPD2 gene in mice can protect the animals from developing certain
inflammatory diseases. The Company has generated antibodies that
block immune cell migration and show efficacy in a model of
multiple sclerosis.° A paper published in the International Journal
of Cancer featured VBL data showing that MOSPD2 can play a major
role in breast cancer cell migration and metastasis, and that
targeting MOSPD2 may be a viable therapeutic strategy to prevent
the spreading of breast cancer cells. VBL's data indicate that
knock-out of MOSPD2 in tumor cells may reduce metastasis by up to
95% in certain settings.° VBL is developing the VB-600-MOSPD2
platform of biologic drug candidates for oncology and inflammatory
indications. The Company plans to file the first IND in this
program by year-end
2019.
Second Quarter Ended June 30, 2018
Financial Results:
- Revenues: revenues related to our collaboration in Japan in the
amount of $0.2 million were recognized in the period.
- Cash Position: Cash, cash equivalents and short-term bank
deposits at June 30, 2018, were $58.5 million. Working capital at
June 30 was $54.7 million. The Company estimates that, based on
current projections, the current cash, cash equivalents and
short-term bank deposits will be sufficient to fund operating
expenses and capital expenditure requirements for more than 3
years.
- R&D Expenses: Research and development expenses for the
quarter ended June 30, 2018, were approximately $2.9 million,
compared to approximately $3.2 million in the comparable period in
2017. R&D expenses are shown net of grants from the Israel
Innovation Authority (IIA).
- G&A Expenses: General and administrative expenses for the
quarter ended June 30, 2018 were $1.2 million, compared to $1.9
million for the comparable period in 2017.
- Comprehensive Loss: The Company reported a comprehensive loss
for second quarter ended June 30, 2018 of $4.1 million, or ($0.13)
per share, compared to a net loss of $4.9 million, or ($0.18) per
share in second quarter ended June 30,
2017.
Conference Call:
Thursday, August 16th @ 8:30am Eastern TimeUS
Domestic:
877-222-6394
International:
703-925-2702
Conference ID: 3572709
Webcast: https://edge.media-server.com/m6/p/9dz8zzo9
Replays, Available through August 30, 2018US Domestic:
855-859-2056
International: 404-537-3406Conference ID: 3572709
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, and subsequent filings with the SEC.
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) |
|
|
|
|
|
June 30,
2018 |
|
December 31, 2017 |
|
|
|
U.S. dollars in thousands |
|
Assets |
|
|
|
|
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
58,530 |
|
|
$ |
6,694 |
|
Short-term bank deposits |
|
|
- |
|
|
|
48,035 |
|
Trade
receivables |
|
|
- |
|
|
|
2,000 |
|
Other
current assets |
|
|
2,002 |
|
|
|
1,729 |
|
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
ASSETS |
|
|
60,532 |
|
|
|
58,458 |
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
ASSETS: |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
|
9,143 |
|
|
|
7,128 |
|
Long-term
prepaid expenses |
|
|
39 |
|
|
|
103 |
|
|
|
|
|
|
|
|
|
|
TOTAL
NON-CURRENT ASSETS |
|
|
9,182 |
|
|
|
7,231 |
|
|
|
|
|
|
|
|
|
|
TOTAL
ASSETS |
|
$ |
69,714 |
|
|
$ |
65,689 |
|
|
|
|
|
|
|
|
|
|
Liabilities and equity |
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES- |
|
|
|
|
|
|
|
|
Accounts
payable: |
|
|
|
|
|
|
|
|
Trade |
|
$ |
2,050 |
|
|
$ |
3,058 |
|
Other |
|
|
2,694 |
|
|
|
3,465 |
|
Deferred
revenue |
|
|
703 |
|
|
|
1,046 |
|
Lease
liability |
|
|
351 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
TOTAL CURRENT
LIABILITIES |
|
|
5,798 |
|
|
|
7,569 |
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
LIABILITIES- |
|
|
|
|
|
|
|
|
Severance
pay obligations, net |
|
|
121 |
|
|
|
128 |
|
Deferred
revenue |
|
|
2,092 |
|
|
|
2,092 |
|
Lease
liability |
|
|
641 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
TOTAL NON-CURRENT LIABILITIES |
|
|
2,854 |
|
|
|
2,220 |
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES |
|
|
8,652 |
|
|
|
9,789 |
|
|
|
|
|
|
|
|
|
|
EQUITY: |
|
|
|
|
|
|
|
|
Ordinary
shares |
|
|
73 |
|
|
|
57 |
|
Accumulated other comprehensive income |
|
|
16 |
|
|
|
16 |
|
Additional paid in capital |
|
|
232,490 |
|
|
|
221,055 |
|
Warrants |
|
|
7,904 |
|
|
|
2,960 |
|
Accumulated deficit |
|
|
(179,421 |
) |
|
|
(168,188 |
) |
|
|
|
|
|
|
|
|
|
TOTAL
EQUITY |
|
|
61,062 |
|
|
|
55,900 |
|
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND EQUITY |
|
$ |
69,714 |
|
|
$ |
65,689 |
|
|
|
|
|
|
|
|
|
|
|
|
VASCULAR BIOGENICS LTD. |
|
|
|
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE
LOSS |
|
|
|
(UNAUDITED) |
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
|
U.S. dollars in thousands |
|
REVENUES |
|
$ |
180 |
|
|
$ |
- |
|
|
$ |
343 |
|
|
$ |
- |
|
COST OF
REVENUES |
|
|
(77 |
) |
|
|
- |
|
|
|
(144 |
) |
|
|
- |
|
GROSS
PROFIT |
|
|
103 |
|
|
|
- |
|
|
|
199 |
|
|
|
- |
|
RESEARCH AND
DEVELOPMENT EXPENSES, net |
|
$ |
2,895 |
|
|
$ |
3,209 |
|
|
$ |
8,655 |
|
|
$ |
7,353 |
|
MARKETING
EXPENSES |
|
|
189 |
|
|
|
- |
|
|
|
424 |
|
|
|
- |
|
GENERAL AND
ADMINISTRATIVE EXPENSES |
|
|
1,171 |
|
|
|
1,898 |
|
|
|
2,566 |
|
|
|
3,003 |
|
OPERATING
LOSS |
|
|
4,152 |
|
|
|
5,107 |
|
|
|
11,446 |
|
|
|
10,356 |
|
FINANCIAL
INCOME |
|
|
(108 |
) |
|
|
(239 |
) |
|
|
(253 |
) |
|
|
(458 |
) |
FINANCIAL
EXPENSES |
|
|
10 |
|
|
|
4 |
|
|
|
40 |
|
|
|
8 |
|
FINANCIAL
INCOME, net |
|
|
(98 |
) |
|
|
(235 |
) |
|
|
(213 |
) |
|
|
(450 |
) |
COMPREHENSIVE
LOSS |
|
$ |
4,054 |
|
|
$ |
4,872 |
|
|
$ |
11,233 |
|
|
$ |
9,906 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS PER
ORDINARY SHARE |
|
U.S. dollars |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
$ |
0.13 |
|
|
$ |
0.18 |
|
|
$ |
0.37 |
|
|
$ |
0.37 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares |
WEIGHTED
AVERAGE ORDINARY SHARES OUTSTANDING-- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
30,147,505 |
|
|
|
27,009,719 |
|
|
|
30,017,020 |
|
|
|
26,957,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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