JERUSALEM, June 30, 2020 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage
biopharmaceutical company focused on developing and commercializing
M-001, a universal influenza vaccine candidate, today announced its
first quarter financial results for the quarter ended March 31, 2020.
First Quarter 2020 Financial Summary
Results are in New Israel Shekels (NIS) and convenience
translation to $US is provided using the exchange rate of
3.57 (NIS/$US) as at March
31, 2020.
Total operating expenses for the first quarter were NIS 20.0 million (approximately $5.6 million) compared with NIS 7.1 million for the first quarter of
2019.
- R&D expenses for the first quarter amounted to NIS 19 million (approximately $5.3 million) compared with
NIS 5.7 million for the first quarter
of 2019.
- Net loss for the first quarter was NIS
3.7 million (approximately $1.0 million)
compared to net income of NIS 566
thousand for the first quarter of 2019.
The increase in total operating expenses compared to the first
quarter of 2019 was primarily due to expenses related to the
ongoing Phase 3 trial and scale-up at our manufacturing
facility.
As of March 31, 2020, BiondVax had
cash and cash equivalents of NIS 42.5
million (approximately $11.9
million) compared to NIS 72.4
million as of December 31,
2019.
*Tables to follow*
About BiondVax
BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage
biopharmaceutical company developing a universal flu vaccine. The
vaccine candidate, called M-001, is designed to provide
multi-strain and multi-season protection against current and
future, seasonal and pandemic influenza. BiondVax's proprietary
technology utilizes a unique combination of conserved and common
influenza virus peptides intended to stimulate both arms of the
immune system for a cross-protecting and long-lasting effect. In a
total of seven completed Phase 1/2 and Phase 2 clinical trials
enrolling 818 participants, the vaccine has been shown to be safe,
well-tolerated, and immunogenic. The ongoing pivotal Phase 3
clinical trial aims to assess safety and effectiveness of M-001 in
reducing flu illness and severity. For more information, please
visit www.biondvax.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Litigation Reform Act of 1995. Words
such as "expect," "believe," "intend," "plan," "continue," "may,"
"will," "anticipate," and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements reflect the management's current views with respect to
certain current and future events and are subject to various risks,
uncertainties and assumptions that could cause the results to
differ materially from those expected by the management of BiondVax
Pharmaceuticals Ltd. Risks and uncertainties include, but are not
limited to, risks relating to the COVID-19 (coronavirus) pandemic,
the prosecution, timing and results of the ongoing Phase 2 and
Phase 3 trials and any subsequent trials; timing of receipt of
regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy
and safety of the vaccine; the timing of clinical trials and
marketing approvals; the risk that drug development involves a
lengthy and expensive process with uncertain outcome; the ability
of the Company to maintain, preserve and defend its intellectual
property and patents granted; whether our vaccine candidate will
successfully advance through the clinical trial process on a timely
basis, or at all, and receive approval from the U.S. Food and Drug
Administration or equivalent foreign regulatory agencies; the
adequacy of available cash resources and the ability to raise
additional capital when needed. More detailed information about the
risks and uncertainties affecting the Company is contained under
the heading "Risk Factors" in our Annual Report on Form 20-F for
the year ended December 31, 2019
filed with the U.S. Securities and Exchange Commission, or SEC,
which is available on the SEC's website, www.sec.gov. We undertake
no obligation to revise or update any forward-looking statement for
any reason.
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BALANCE
SHEETS
|
|
In thousands,
except share and per share data
|
|
|
|
|
|
|
|
|
|
Convenience
|
|
|
|
|
|
|
|
|
Translation
|
|
December
31
|
|
|
March
31,
|
|
March
31,
|
|
2019
|
|
|
2019
|
|
2020
|
|
2020
|
|
Audited
|
|
|
Unaudited
|
|
Unaudited
|
|
|
|
|
N I
S
|
|
U.S.
dollars
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
|
Trade
payables
|
17,062
|
|
|
15,249
|
|
3,278
|
|
919
|
|
Operating lease
liabilities
|
694
|
|
|
676
|
|
684
|
|
192
|
|
Other
payables
|
1,203
|
|
|
1,275
|
|
807
|
|
226
|
|
|
|
|
|
|
|
|
|
|
18,959
|
|
|
17,200
|
|
4,769
|
|
1,337
|
|
LONG–TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
|
Liability in respect
of government grants
|
14,812
|
|
|
14,568
|
|
12,991
|
|
3,644
|
|
Operating lease
liabilities
|
6,809
|
|
|
7,247
|
|
6,641
|
|
1,863
|
|
Loan from
others
|
123,780
|
|
|
88,792
|
|
117,784
|
|
33,039
|
|
Warrants
|
16,354
|
|
|
2,059
|
|
6,861
|
|
1,925
|
|
Severance pay
liability, net
|
89
|
|
|
84
|
|
90
|
|
25
|
|
|
|
|
|
|
|
|
|
|
161,844
|
|
|
112,750
|
|
144,367
|
|
40,496
|
|
SHAREHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
|
Ordinary shares of NIS 0.0000001
par
value: Authorized: 600,000,000
shares at
March 31, 2020 (unaudited) and
at
391,000,000 shares at March 31,
2019
(unaudited) and
December 31, 2019;
Issued and outstanding:
410,213,977
shares at March 31, 2020
(unaudited),
261,419,599 shares at March 31,
2019
(unaudited) and 402,351,657
shares at
December 31, 2019
|
*)
-
|
|
|
*)
-
|
|
*)
-
|
|
*)
-
|
|
Share
premium
|
73,867
|
|
|
179,987
|
|
262,729
|
|
73,697
|
|
Accumulated
deficit
|
(92,690)
|
|
|
(210,578)
|
|
(324,033)
|
|
(90,893)
|
|
|
|
|
|
|
|
|
|
|
(18,823)
|
|
|
(30,591)
|
|
(61,304)
|
|
(17,196)
|
|
|
|
|
|
|
|
|
|
|
33,493
|
|
|
99,359
|
|
87,832
|
|
24,637
|
|
|
|
STATEMENTS OF
COMPREHENSIVE INCOME (LOSS)
|
|
|
In thousands,
except share and per share data
|
|
|
|
|
|
|
|
|
|
|
Convenience
|
|
|
|
|
|
|
|
|
translation
|
|
|
|
|
|
|
|
|
Three
months
|
|
|
Year
ended
|
|
Three months
ended
|
|
ended
|
|
|
December
31,
|
|
March
31,
|
|
March
31,
|
|
|
2019
|
|
2019
|
|
2020
|
|
2020
|
|
|
Audited
|
|
Unaudited
|
|
Unaudited
|
|
|
NIS
|
|
U.S.
dollars
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development, net of
participations
|
68,645
|
|
5,732
|
|
19,068
|
|
5,348
|
|
|
Marketing, general
and administrative
|
9,706
|
|
1,433
|
|
981
|
|
275
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
78,351
|
|
7,165
|
|
20,049
|
|
5,623
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
(78,351)
|
|
(7,165)
|
|
(20,049)
|
|
(5,623)
|
|
|
Financial
income
|
4
|
|
9,754
|
|
16,502
|
|
4,629
|
|
|
Financial
expense
|
(30,847)
|
|
(2,023)
|
|
(148)
|
|
(42)
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) and
total
comprehensive income
(loss)
|
(109,194)
|
|
566
|
|
(3,695)
|
|
(1,036)
|
|
|
Basic and Diluted net
income (loss)
per share
|
(0.33)
|
|
0.002
|
|
(0.01)
|
|
(0.002)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares
outstanding used to compute
basic
and diluted income (loss) per
share
|
326,651,721
|
|
261,419,599
|
|
408,596,752
|
|
408,596,752
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Logo -
http://mma.prnewswire.com/media/615570/BiondVax_Pharmaceuticals_Logo.jpg
Contact Details
Joshua E.
Phillipson | +972 8 930 2529 |
j.phillipson@biondvax.com
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content:http://www.prnewswire.com/news-releases/biondvax-announces-first-quarter-2020-financial-results-301086229.html
SOURCE BiondVax Pharmaceuticals Ltd.