JERUSALEM, Aug. 20, 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
second quarter financial results for the quarter ended June 30, 2020.
Second Quarter 2020 Financial Summary
Results are in New Israel Shekels (NIS) and convenience
translation to $US is provided using the exchange rate of
3.466 (NIS/$US) as at June 30,
2020.
Total operating expenses for the second quarter were NIS
16.0 million (approximately
$4.61 million) compared with NIS
19.7 million for the second quarter of 2019.
- R&D expenses for the second quarter amounted to NIS
11.9 million (approximately $3.4 million) compared
with NIS 15.2 million for the second
quarter of 2019.
- Net loss for the second quarter was NIS
42 million (approximately $12.1 million) compared to net
loss of NIS 47.4 million for the
second quarter of 2019.
The decrease in total operating expenses compared to the second
quarter of 2019 was primarily due to fewer costs associated with
the nearly complete pivotal Phase 3 trial and completion of
construction of the manufacturing facility.
As of June 30, 2020, BiondVax had
cash and cash equivalents of NIS 38.7
million (approximately $11.2
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.
Contact Details
Joshua E.
Phillipson | +972 8 930 2529 |
j.phillipson@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.
BALANCE
SHEETS
|
In thousands, except
share and per share data
|
|
|
|
|
|
|
|
|
|
Convenience
|
|
|
|
|
|
|
|
|
Translation
|
|
December
31
|
|
|
June 30,
|
|
June
30,
|
|
2019
|
|
|
2019
|
|
2020
|
|
2020
|
|
Audited
|
|
|
Unaudited
|
|
Unaudited
|
|
|
|
|
N I
S
|
|
U.S.
dollars
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
72,467
|
|
|
33,916
|
|
38,752
|
|
11,181
|
Other
receivables
|
656
|
|
|
1,258
|
|
2,467
|
|
712
|
|
|
|
|
|
|
|
|
|
|
73,123
|
|
|
35,174
|
|
41,219
|
|
11,893
|
LONG–TERM
ASSETS:
|
|
|
|
|
|
|
|
|
Property, plant and
equipment
|
34,981
|
|
|
32,475
|
|
36,937
|
|
10,658
|
Right-of-use
assets
|
7,136
|
|
|
7,610
|
|
6,662
|
|
1,922
|
Other long-term
assets
|
510
|
|
|
510
|
|
891
|
|
257
|
|
|
|
|
|
|
|
|
|
|
42,627
|
|
|
40,595
|
|
44,490
|
|
12,837
|
|
|
|
|
|
|
|
|
-
|
|
115,750
|
|
|
75,769
|
|
85,709
|
|
24,730
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Trade
payables
|
17,062
|
|
|
7,977
|
|
4,070
|
|
1,174
|
Operating lease
liabilities
|
694
|
|
|
686
|
|
676
|
|
195
|
Other
payables
|
1,203
|
|
|
1,348
|
|
1,609
|
|
464
|
|
|
|
|
|
|
|
|
|
|
18,959
|
|
|
10,011
|
|
6,355
|
|
1,835
|
LONG–TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
Liability in respect
of government grants
|
14,812
|
|
|
14,621
|
|
12,686
|
|
3,660
|
Operating lease
liabilities
|
6,809
|
|
|
7,076
|
|
6,457
|
|
1,863
|
Loan from
others
|
123,780
|
|
|
110,971
|
|
122,041
|
|
35,211
|
Warrants
|
16,354
|
|
|
5,517
|
|
-
|
|
-
|
Severance pay
liability, net
|
89
|
|
|
86
|
|
92
|
|
26
|
|
|
|
|
|
|
|
|
|
|
161,844
|
|
|
138,271
|
|
141,276
|
|
40,760
|
SHAREHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
Ordinary shares of no
par value: Authorized:
600,000,000, 391,000,000
and
600,000,000 shares at June 30,
2020 and
2019 (unaudited) and December
31, 2019,
respectively; Issued and
outstanding:
460,822,640, 261,419,599
and
402,351,657 shares at June 30,
2020 and
2019 (unaudited) and December
31, 2019,
respectively
|
*)
-
|
|
|
*)
-
|
|
*)
-
|
|
*)
-
|
Share
premium
|
255,285
|
|
|
185,454
|
|
304,089
|
|
87,735
|
Accumulated
deficit
|
(320,338)
|
|
|
(257,967)
|
|
(366,011)
|
|
(105,600)
|
|
|
|
|
|
|
|
|
|
|
(65,053)
|
|
|
(72,513)
|
|
(61,922)
|
|
(17,865)
|
|
|
|
|
|
|
|
|
|
|
115,750
|
|
|
75,769
|
|
85,709
|
|
24,730
|
|
*)
Represents less than NISUSD 1.
|
STATEMENTS OF
COMPREHENSIVE INCOME (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,
|
|
|
|
2019
|
|
2019
|
|
2020
|
|
2019
|
2020
|
|
2020
|
|
|
|
Audited
|
|
Unaudited
|
|
Unaudited
|
|
|
|
N I
S
|
|
U.S.
dollars
|
|
|
|
(In thousands,
except per share data)
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development, net of
participations
|
|
68,645
|
|
15,172
|
|
11,948
|
|
20,904
|
|
31,016
|
|
8,949
|
|
Marketing, general
and administrative
|
|
9,706
|
|
4,518
|
|
4,139
|
|
5,951
|
|
5,120
|
|
1,477
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
78,351
|
|
19,690
|
|
16,087
|
|
26,855
|
|
36,136
|
|
10,426
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
|
|
Operating
loss
|
|
(78,351)
|
|
(19,690)
|
|
(16,087)
|
|
(26,855)
|
|
(36,136)
|
|
(10,426)
|
|
Financial
income
|
|
4
|
|
-
|
|
(11,291)
|
|
24
|
|
5,211
|
|
1,503
|
|
Financial
expense
|
|
(30,847)
|
|
(27,699)
|
|
(14,600)
|
|
(19,992)
|
|
(14,748)
|
|
(4,255)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
(109,194)
|
|
(47,389)
|
|
(41,978)
|
|
(46,823)
|
|
(46,673)
|
|
(13,177)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
(NIS)
|
|
(0.33)
|
|
(0.18)
|
|
(0.10)
|
|
(0.18)
|
|
(0.11)
|
|
(0.03)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares
outstanding used to compute basic
and diluted loss per share
|
|
326,651,721
|
|
261,482,786
|
|
433,498,227
|
|
261,435,179
|
|
431,485,801
|
|
431,485,801
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE BiondVax Pharmaceuticals Ltd.