JERUSALEM, Aug. 26, 2021 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical
company focused on developing, manufacturing and ultimately
commercializing products for the prevention and treatment of
infectious diseases and related illnesses, today published its
second quarter financial results for the quarter ended June 30, 2021.
Financial Summary
Results are in New Israel Shekels (NIS) and convenience
translation to $US is provided using the exchange rate of 3.26
(NIS/$US), the rate as of the close of business on June 30, 2021.
- R&D expenses for the three months ended June 30, 2021 decreased to NIS 1.9 million ($0.6
million) from NIS 11.9 million
for the three months ended June 30,
2020. This decrease was primarily attributable to expenses
related to a Phase 3 clinical trial and related operations at our
manufacturing facility. As previously reported, the trial concluded
in Q4 2020.
- Marketing, general and administrative expenses for the three
months ended June 30, 2021 increased
to NIS 7 million ($2.1 million) from NIS 4.1
million for the three months ended June 30, 2020. This increase of NIS 2.9 million ($0.6
million) was primarily due to salary and salary related
expenses related to the former CEO's termination, an increase in
Board of Directors expenses, the new CEO's salary, share based
compensation expenses, and an increase in professional
services.
- Operating expenses for the three months ended June 30, 2021 were NIS 8.9
million ($2.7 million)
compared with NIS 16.0 million for
the three months ended June 30,
2020.
- Financial expenses for the three months ended June 30, 2021 were NIS 3.1
million ($0.95 million)
compared with NIS 25.9 million for
the three months ended June 30, 2020.
This reduction was attributable primarily due to a decrease in
financial expenses as a result of a $21
million warrants revaluation charge during the three
months ended June 30, 2020 compared
to none in the three months ended June 30,
2021.
As of June 30, 2021, BiondVax had
cash and cash equivalents of NIS 39.9
million ($12.2 million) as
compared to NIS 48.6 million as of
March 31, 2021.
Unaudited Q2 financial results will be submitted to the
Securities and Exchange Commission. A summary is included in the
tables below.
CEO Statement
Chief Executive Officer of BiondVax Mr. Amir Reichman commented, "Since joining the
Company earlier this year, my team and I, with the support of the
Board of Directors, have been identifying and are assessing a
number of promising technologies and potential partners with the
goal of building a diversified pipeline of biological products and
platforms for therapeutic use through in licensing, co-developing,
acquiring or partnering. Our potential partners include top tier
researchers, institutes and/or companies that possess relevant
Intellectual Property that may fit with BiondVax's strategic
aspirations, experience and capabilities. We are currently engaged
in deep-dive evaluations of some particularly intriguing
opportunities. In collaboration with these potential partners and
relevant experts we are assessing these potential avenues from
several perspectives, including scientific merit, complementary
synergies with our manufacturing infrastructure and product
development expertise, as well as their potential for commercial
market success."
Reichman continued, "Last week, I relocated with my
family to Israel from Belgium where I had been serving in a senior
leadership role at GSK Vaccines headquarters. I am pleased to now
be working face-to-face with the highly experienced, motivated and
talented BiondVax team, and I am increasingly optimistic with
regard to our potential to rebuild BiondVax to
become a successful biopharmaceutical company excelling in
identifying, developing, manufacturing and ultimately
commercializing biological therapeutics and vaccines."
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a
biopharmaceutical company focused on developing, manufacturing and
ultimately commercializing products for the prevention and
treatment of infectious diseases and related illnesses. The Company
had been developing M-001, a novel influenza vaccine candidate that
was designed to provide multi-strain and multi-season protection
against current and future seasonal and pandemic influenza. In
seven Phase 1/2 and Phase 2 clinical trials designed to test for
immunogenicity, the Company was able to demonstrate M-001 was
effective in stimulating an immune response to a broad range of
influenza virus strains. In October
2020, the Company completed a Phase 3 clinical trial of
M-001 which did not meet the trial's primary and secondary efficacy
endpoints. The Company is now pursuing the goal of developing a
pipeline of diversified and commercially viable products and
platforms.
Contact Details
Company: Joshua E.
Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Kenny
Green (Israel) | +1 646 201
9246 | kgreen@edisongroup.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, including statements regarding
future business strategies that BiondVax may explore. These
forward-looking statements reflect 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, the risk that BiondVax may not be able to
secure additional capital on attractive terms, if at all; the risk
that the European Investment Bank may accelerate the loans under
its finance contract with BiondVax; the risk that BiondVax may not
execute a strategic alternative to M-001 or implement a strategy
that will diversify BiondVax's risk, and, if executed, may not be
successful; risks relating to the COVID-19 (coronavirus) pandemic;
BiondVax's ability to acquire rights to additional product
opportunities; BiondVax's ability to enter into collaborations on
terms acceptable to BiondVax or at all; timing of receipt of
regulatory approval of BiondVax's manufacturing facility in
Jerusalem, if at all or when
required; the risk that the manufacturing facility will not be able
to be used for a wide variety of applications and other vaccine and
treatment technologies, and the risk that drug development involves
a lengthy and expensive process with uncertain outcomes. More
detailed information about the risks and uncertainties affecting
the Company is contained under the heading "Risk
Factors" in the Company's Annual Report on Form 20-F filed
with the Securities and Exchange Commission on May 13, 2021. BiondVax undertakes no obligation
to revise or update any forward-looking statement for any
reason.
BALANCE
SHEETS
|
In thousands,
except share and per share data
|
|
|
|
|
|
|
|
|
Convenience
Translation
|
|
December
31,
|
|
|
June
30,
|
|
June
30,
|
|
2020
|
|
|
2020
|
|
2021
|
|
2021
|
|
Audited
|
|
|
Unaudited
|
|
Unaudited
|
|
|
|
|
N I
S
|
|
U.S.
dollars
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
9,421
|
|
|
38,752
|
|
39,883
|
|
12,234
|
Other
receivables
|
1,204
|
|
|
2,467
|
|
2,641
|
|
810
|
|
10,625
|
|
|
41,219
|
|
42,524
|
|
13,044
|
LONG–TERM
ASSETS:
|
|
|
|
|
|
|
|
|
Property, plant and
equipment
|
39,607
|
|
|
36,937
|
|
38,979
|
|
11,957
|
Right-of-use
assets
|
6,206
|
|
|
6,662
|
|
6,109
|
|
1,874
|
Other long-term
assets
|
473
|
|
|
891
|
|
437
|
|
134
|
|
|
|
|
|
|
|
|
|
|
46,286
|
|
|
44,490
|
|
45,525
|
|
13,965
|
|
|
|
|
|
|
|
|
|
|
56,911
|
|
|
85,709
|
|
88,049
|
|
27,009
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Trade
payables
|
1,868
|
|
|
4,070
|
|
2,635
|
|
808
|
Operating lease
liabilities
|
654
|
|
|
676
|
|
764
|
|
234
|
Loan from
others
|
60,421
|
|
|
-
|
|
64,248
|
|
19,708
|
Other
payables
|
1,246
|
|
|
1,609
|
|
1,739
|
|
534
|
|
|
|
|
|
|
|
|
|
|
64,189
|
|
|
6,355
|
|
69,386
|
|
21,284
|
LONG–TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
Liability in respect
of government grants
|
-
|
|
|
12,686
|
|
-
|
|
-
|
Operating lease
liabilities
|
6,088
|
|
|
6,457
|
|
6,047
|
|
1,855
|
Loan from
others
|
-
|
|
|
122,041
|
|
-
|
|
-
|
Other
payables
|
1,135
|
|
|
-
|
|
1,135
|
|
348
|
Severance pay
liability, net
|
95
|
|
|
92
|
|
95
|
|
29
|
|
|
|
|
|
|
|
|
|
|
7,318
|
|
|
141,276
|
|
7,277
|
|
2,232
|
SHAREHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
Ordinary shares of no
par value: Authorized:
1,800,000,000 shares at June 30, 2021
(unaudited) and 600,000,000 shares at June
30, 2020 (unaudited) and 700,000 shares at
December 31, 2020, respectively; Issued and
outstanding: 573,285,824 shares at June 30,
2021 (unaudited), 460,822,640 shares at June
30, 2020 (unaudited) and 461,285,824 shares
at December 31, 2020
|
*)
-
|
|
|
*)
-
|
|
*)
-
|
|
*)
-
|
Share
premium
|
310,197
|
|
|
304,089
|
|
356,358
|
|
109,313
|
Accumulated
deficit
|
(324,793)
|
|
|
(366,011)
|
|
(344,972)
|
|
(105,820)
|
|
|
|
|
|
|
|
|
|
|
(14,596)
|
|
|
(61,922)
|
|
11,386
|
|
3,493
|
|
|
|
|
|
|
|
|
|
|
56,911
|
|
|
85,709
|
|
88,049
|
|
27,009
|
*) Represents less
than 1 NISUSD
|
STATEMENTS OF
COMPREHENSIVE LOSS
|
In thousands,
except share and per share data
|
|
|
|
|
|
|
|
|
|
|
|
|
Convenience
translation
|
|
|
|
Year
ended
December
31,
|
|
Three months
ended
June
30,
|
|
Six months
ended
June
30,
|
|
Six
months
ended
June
30,
|
|
|
|
2020
|
|
2020
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
Audited
|
|
Unaudited
|
|
Unaudited
|
|
|
|
N I
S
|
|
U.S.
dollars
|
|
|
|
(In thousands,
except per share data)
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development, net of participations
|
|
51,463
|
|
11,948
|
|
1,900
|
|
31,016
|
|
4,653
|
|
1,427
|
|
Marketing, general
and administrative
|
|
16,687
|
|
4,139
|
|
7,002
|
|
5,120
|
|
11,007
|
|
3,376
|
|
Other
income
|
|
(75,484)
|
|
-
|
|
-
|
|
-
|
|
-
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses (income)
|
|
(7,334)
|
|
16,087
|
|
8,902
|
|
36,136
|
|
15,660
|
|
4,803
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
(loss)
|
|
7,334
|
|
(16,087)
|
|
(8,902)
|
|
(36,136)
|
|
(15,660)
|
|
(4,803)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
income
|
|
3,843
|
|
(11,291)
|
|
(360)
|
|
5,211
|
|
822
|
|
252
|
|
Financial
expense
|
|
(15,632)
|
|
(14,600)
|
|
(2,731)
|
|
(14,748)
|
|
(5,341)
|
|
(1,638)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and total
comprehensive loss
|
|
(4,455)
|
|
(41,978)
|
|
(11,993)
|
|
(46,673)
|
|
(20,179)
|
|
(6,189)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
(0.01)
|
|
(0.10)
|
|
(0.03)
|
|
(0.11)
|
|
(0.04)
|
|
(0.01)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares outstanding used to compute basic and diluted loss
per share
|
|
443,260,878
|
|
433,498,227
|
|
573,205,607
|
|
431,485,801
|
|
552,140,030
|
|
552,140,030
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The notes in the
Company's quarterly report are an integral part of the financial
statements. The complete financial results are available in the
Form 6-K to be filed with the Securities and Exchange
Commission.
|
View original
content:https://www.prnewswire.com/news-releases/biondvax-announces-second-quarter-2021-financial-results-and-provides-business-update-301363895.html
SOURCE BiondVax Pharmaceuticals Ltd.