VBL Therapeutics Announces First Quarter 2020 Financial Results and Provides Corporate Update
May 14 2020 - 7:00AM
VBL Therapeutics (Nasdaq: VBLT) today announced financial results
for the first quarter ended March 31, 2020, and provided a
corporate update.
“We reached an important milestone in our
development of VB-111 in ovarian cancer with the recent positive
outcome of the interim analysis of the ongoing Phase 3 OVAL study,
which demonstrated the potential benefit of VB-111 over
standard-of-care in a randomized-controlled study,” said Dror
Harats, M.D., Chief Executive Officer of VBL Therapeutics. “A
second planned interim analysis which will assess overall survival
in the two treatment arms, is expected in the third quarter this
year. We are pleased to be making progress also in our MOSPD2
antibody programs. We recently presented promising new data in NASH
and colitis models in a Poster of Distinction at Digestive Disease
Week, and also published a peer review manuscript on the potential
of MOSPD2 antibodies to treat multiple sclerosis (MS). New data on
our MOSPD2 bi-specific antibodies will be presented in a late
breaking session at the upcoming American Association for Cancer
Research (AACR) annual meeting in June. Based on these
positive developments, we successfully raised additional $18.1
million in gross proceeds, in spite of the COVID-19 pandemic
complexities. Our current cash position is expected to fund our
operations into the third quarter of 2022.”
First Quarter and Key Corporate Highlights:
VB-111:
● |
The independent Data Safety Monitoring Committee (DSMC) reviewed
un-blinded data from the ongoing OVAL study in ovarian cancer and
determined that the study has met the interim pre-specified
criterion, of an absolute percentage advantage of 10% or higher in
CA-125 response in the VB-111 treated arm compared to control. The
DSMC recommended that the study proceed without modification. |
● |
The overall CA-125 response rate in the first 60 randomized
evaluable patients is 53%. Assuming a balanced randomization, the
response rate in the treatment arm (VB-111 in addition to weekly
paclitaxel) is 58% or higher. In patients who had post-dosing
fever, which is a marker for VB-111 treatment, the response rate is
69%. |
● |
The CA-125 response rate observed in the Phase 3 interim analysis
is at least as good as the response rate seen in Phase 2, which
enrolled similar population of patients with platinum-resistant
ovarian cancer. The results will be presented at ASCO20 Virtual
Scientific Program. |
● |
The OVAL interim analysis results were discussed by Dr. Bradley J.
Monk of Arizona Oncology on a KOL call hosted by the Company
on March 26. |
● |
NanoCarrier Co., Ltd., the Japanese licensee for VB-111, announced
its intention to extend the ongoing global Phase 3 OVAL clinical
trial in ovarian cancer to patients in Japan. |
● |
The Israel Innovation Authority (IIA) awarded a
non-dilutive grant of up to 3.175 million New Israeli Shekels (NIS)
(approximately $0.9 million) to fund development of
VB-111. |
● |
The planned studies of VB-111 in metastatic colorectal cancer and
GBM are expected to start patient recruitment as soon as the
COVID-19 situation allows. |
MOSPD2:
● |
Published a new peer review manuscript demonstrating the potential
of MOSPD2 antibodies for multiple sclerosis (MS). |
|
○ |
VBL's data offer a differentiated approach to potential treatment
of relapsing as well as progressive MS disease |
● |
New preclinical data on MOSPD2 antibodies for treatment of NASH and
colitis were presented at Digestive Disease Week (DDW). |
|
○ |
Data demonstrate the potential of VBL's proprietary MOSPD2 mAbs for
chronic inflammatory indications, via a novel and distinct
mechanism targeting monocyte migration |
|
○ |
The study was rated in the top 10% of all abstracts in this
category and was selected as Poster of Distinction |
VB-201:
● |
A milestone event was reached under VBL’s collaborative agreement
with a world-leading European animal health company, evaluating use
of VB-201 for veterinary applications. |
Quarter Ended March 31, 2020 Financial
Results:
● |
Cash Position: At March 31, 2020, VBL had cash,
cash equivalents, short-term bank deposits and restricted bank
deposits totaling $31.6 million and working capital of $24.6
million. VBL expects that its cash and cash equivalents and
short-term bank deposits with the addition approximately $16.7
million from the net proceeds of the Registered Direct Offerings of
which we have announced on May 7, 2020 and on May 11, 2020, will be
sufficient to fund operating expenses and capital expenditure
requirements into the third quarter of 2022. |
● |
Revenues: Revenues for the three-month period
ended March 31, 2020 were $366 thousand, compared to $219 thousand
in the same period of 2019. |
● |
R&D Expenses: Research and development
expenses, net, after government grants, in the three-month period
ended March 31, 2020, were $4.8 million, compared to $3.3 million
in the same period in 2019. |
● |
G&A Expenses: General, administrative and
marketing expenses for the three-month period ended March 31, 2020,
were $1.2 million, compared to the $1.3 million in the same period
in 2019. |
● |
Comprehensive Loss: VBL reported a net loss for
three-month period ended March 31, 2020 of $5.4 million, or ($0.15)
per diluted share, compared to a net loss of $4.2 million, or
($0.12) per diluted share, in the same period of 2019. |
For further details on VBL’s financials, please refer to Form
6-k filed with the SEC.
Conference Call:
Thursday May 14th @ 8:30amET
From the US: |
877-407-9208 |
International: |
201-493-6784 |
Israel: |
1 809 406 247 |
Conference ID: |
13703295 |
Webcast: |
https://edge.media-server.com/mmc/p/ubiyng5a |
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 areas of unmet need in cancer and
immune/inflammatory indications.
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 may include, but are
not limited to, statements regarding our programs, including
VB-111, VB-600, including their clinical development, therapeutic
potential, the impact of the COVID-19 pandemic on our business,
operations, clinical trials, supply chain, strategy, goals and
anticipated timelines 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 market and other conditions, 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, that our financial resources do not last for as long
as anticipated, and that we may not realize the expected benefits
of our intellectual property protection. In particular, the DSMC
recommendation that the OVAL trial proceed is not assurance that
the trial will meet its primary endpoint of overall survival once
completed. A further list and description of these risks,
uncertainties and other risks can be found in our 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, 2019, 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,
except as required by law.
INVESTOR CONTACT:
Michael RiceLifeSci Advisors(646) 597-6979
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF FINANCIAL
POSITION(UNAUDITED)
|
|
March 31, 2020 |
|
|
December 31, 2019 |
|
|
|
|
|
|
|
U.S. dollars in thousands |
|
Assets |
|
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
12,935 |
|
|
$ |
9,436 |
|
Short-term bank deposits |
|
|
18,139 |
|
|
|
27,100 |
|
Trade Receivables |
|
|
230 |
|
|
|
- |
|
Other current assets |
|
|
1,248 |
|
|
|
1,242 |
|
TOTAL CURRENT ASSETS |
|
|
32,552 |
|
|
|
37,778 |
|
|
|
|
|
|
|
|
|
|
NON-CURRENT ASSETS: |
|
|
|
|
|
|
|
|
Restricted bank deposits |
|
|
508 |
|
|
|
506 |
|
Property and equipment, net |
|
|
6,701 |
|
|
|
6,949 |
|
Right-of-use assets |
|
|
2,994 |
|
|
|
3,088 |
|
Long-term prepaid expenses |
|
|
300 |
|
|
|
300 |
|
TOTAL NON-CURRENT ASSETS |
|
|
10,503 |
|
|
|
10,843 |
|
TOTAL ASSETS |
|
$ |
43,055 |
|
|
$ |
48,621 |
|
|
|
|
|
|
|
|
|
|
Liabilities and equity |
|
|
|
|
|
|
|
|
CURRENT LIABILITIES- |
|
|
|
|
|
|
|
|
Accounts payable and accruals: |
|
|
|
|
|
|
|
|
Trade |
|
$ |
2,292 |
|
|
$ |
3,330 |
|
Other |
|
|
4,423 |
|
|
|
4,238 |
|
Deferred revenue |
|
|
451 |
|
|
|
386 |
|
Lease liabilities |
|
|
747 |
|
|
|
774 |
|
TOTAL CURRENT LIABILITIES |
|
|
7,913 |
|
|
|
8,728 |
|
|
|
|
|
|
|
|
|
|
NON-CURRENT LIABILITIES- |
|
|
|
|
|
|
|
|
Severance pay obligations, net |
|
|
158 |
|
|
|
163 |
|
Deferred revenue |
|
|
1,521 |
|
|
|
1,723 |
|
Other non-current liability |
|
|
62 |
|
|
|
- |
|
Lease liabilities |
|
|
1,965 |
|
|
|
2,167 |
|
TOTAL NON-CURRENT
LIABILITIES |
|
|
3,706 |
|
|
|
4,053 |
|
TOTAL LIABILITIES |
|
|
11,619 |
|
|
|
12,781 |
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS’ EQUITY: |
|
|
|
|
|
|
|
|
Ordinary shares |
|
|
75 |
|
|
|
73 |
|
Accumulated other comprehensive income |
|
|
(8 |
) |
|
|
(8 |
) |
Additional paid in capital |
|
|
238,737 |
|
|
|
235,974 |
|
Warrants |
|
|
6,088 |
|
|
|
7,904 |
|
Accumulated deficit |
|
|
(213,456 |
) |
|
|
(208,103 |
) |
TOTAL SHAREHOLDERS’
EQUITY |
|
|
31,436 |
|
|
|
35,840 |
|
TOTAL LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
$ |
43,055 |
|
|
$ |
48,621 |
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral
part of the financial statements.
VASCULAR BIOGENICS LTD.
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE
LOSS
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
U.S. dollars in thousands |
|
REVENUES |
|
$ |
366 |
|
|
$ |
219 |
|
COST OF
REVENUES |
|
|
(53 |
) |
|
|
(38 |
) |
GROSS
PROFIT |
|
|
313 |
|
|
|
181 |
|
RESEARCH AND
DEVELOPMENT EXPENSES, net |
|
$ |
4,751 |
|
|
$ |
3,308 |
|
|
|
|
|
|
|
|
|
|
GENERAL AND
ADMINISTRATIVE EXPENSES |
|
|
1,168 |
|
|
|
1,256 |
|
OPERATING
LOSS |
|
|
5,606 |
|
|
|
4,383 |
|
FINANCIAL
INCOME |
|
|
(292 |
) |
|
|
(276 |
) |
FINANCIAL
EXPENSES |
|
|
39 |
|
|
|
75 |
|
FINANCIAL
INCOME, net |
|
|
(253 |
) |
|
|
(201 |
) |
COMPREHENSIVE LOSS |
|
$ |
5,353 |
|
|
$ |
4,182 |
|
|
|
|
|
|
|
|
|
|
LOSS PER
ORDINARY SHARE |
|
U.S. dollars |
|
|
|
|
|
Basic and diluted |
|
$ |
0.15 |
|
|
$ |
0.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares |
|
WEIGHTED
AVERAGE ORDINARY SHARES OUTSTANDING- |
|
|
|
|
|
|
Basic and diluted |
|
|
36,103,500 |
|
|
|
35,881,128 |
|
|
|
|
|
|
|
|
|
|
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