JERUSALEM, Aug. 22, 2018 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV), a Phase 3 clinical stage
biopharmaceutical company focused on developing and commercializing
M-001, a universal flu vaccine candidate, today announced its
financial results for the quarter ended June
30, 2018.
Second Quarter 2018 Financial Summary
Results are in New Israel Shekels (NIS) and convenience
translation to $US is provided using the exchange rate of 3.65
(NIS/$US) as at June 30,
2018.
- Second quarter operating expenses were NIS 30.6m ($8.4m)
compared with NIS 2.59m for the
second quarter of 2017;
- Second quarter R&D expenses amounted to NIS 29.2m ($8m)
compared with NIS 2m for the second
quarter of 2017;
As of June 30, 2018, BiondVax had
cash and cash equivalents of NIS 37.1
million ($10.1 million) as
compared to NIS 36.6m as of
March 30, 2018. Expenses are related
to execution of planned ongoing operations including
the launch of a pivotal, clinical efficacy, Phase 3 trial
of the Company's M-001 Universal Flu Vaccine candidate, and
construction of a mid-size commercial manufacturing facility.
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-season protection against current and future,
seasonal and pandemic influenza virus strains. BiondVax's
proprietary technology utilizes a unique combination of conserved
and common influenza virus peptides, activating both arms of the
immune system for a cross-protecting and long-lasting effect. In a
total of 6 completed Phase 1/2 and Phase 2 human clinical trials,
covering 698 participants, the vaccine has been shown to be safe,
well-tolerated, and immunogenic. 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
involve certain risks and uncertainties 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, the
prosecution and outcome of the ongoing Phase 2 and Phase 3 trials
and any subsequent trials; timing of receipt of regulatory
approval of the new manufacturing facility its products; 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 United States Food and Drug
Administration or equivalent foreign regulatory agencies; the
adequacy of available cash resource and the ability to raise
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, 2017 filed
with the U.S. Securities and Exchange Commission, or SEC, which is
available on the SEC's website, www.sec.gov, and in the
Company's periodic filings with the SEC and the Tel-Aviv Stock
Exchange. We undertake no obligation to revise or update any
forward-looking statement for any reason.
** Tables to Follow **
BALANCE
SHEETS
|
In thousands,
except per share data
|
|
|
|
|
|
|
|
|
Convenience
translation
|
|
|
December
31,
|
|
June
30,
|
|
June
30,
|
|
|
2017
|
|
2017
|
|
2018
|
|
2018
|
|
|
Audited
|
|
Unaudited
|
|
Unaudited
|
|
|
N I
S
|
|
U.S.
dollars
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
71,382
|
|
31,334
|
|
37,128
|
|
10,172
|
Marketable
securities
|
|
-
|
|
4,067
|
|
|
|
-
|
Short-term
deposits
|
|
-
|
|
1,200
|
|
-
|
|
-
|
Other
receivables
|
|
3,923
|
|
2,812
|
|
4,067
|
|
1,114
|
|
|
|
|
|
|
|
|
|
|
|
75,305
|
|
39,413
|
|
41,195
|
|
11,286
|
LONG‑TERM
ASSETS:
|
|
|
|
|
|
|
|
|
Property, plant and
equipment
|
|
5,510
|
|
1,233
|
|
18,793
|
|
5,149
|
Other long term
assets
|
|
880
|
|
505
|
|
880
|
|
241
|
|
|
|
|
|
|
|
|
|
|
|
6,390
|
|
1,738
|
|
19,673
|
|
5,390
|
|
|
|
|
|
|
|
|
|
|
|
81,695
|
|
41,151
|
|
60,868
|
|
16,676
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
6,223
|
|
1,188
|
|
1,323
|
|
363
|
Other
payables
|
|
660
|
|
664
|
|
780
|
|
214
|
|
|
|
|
|
|
|
|
|
|
|
6,883
|
|
1,852
|
|
2,103
|
|
577
|
LONG‑TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
Liability in respect
of government grants
|
|
10,300
|
|
-
|
|
12,790
|
|
3,504
|
Loan from
others
|
|
-
|
|
-
|
|
20,710
|
|
5,674
|
Warrants
|
|
8,177
|
|
18,231
|
|
8,475
|
|
2,322
|
Severance pay
liability, net
|
|
83
|
|
79
|
|
79
|
|
22
|
|
|
|
|
|
|
|
|
|
|
|
18,560
|
|
18,310
|
|
42,054
|
|
11,522
|
SHAREHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
Ordinary shares of NIS
0.0000001 par value:
|
|
|
|
|
|
|
|
|
Authorized:
391,000,000 shares as of June 30,
2018, 2017 (unaudited) and
December 31,
2017; Issued and Outstanding: 261,419,599,
179,595,199 and 261,419,599 shares respectively
|
|
*) -
|
|
*)
-
|
|
*) -
|
|
*) -
|
Share
premium
|
|
179,669
|
|
132,824
|
|
179,821
|
|
49,265
|
Options
|
|
-
|
|
533
|
|
-
|
|
-
|
Other
comprehensive income
|
|
-
|
|
2
|
|
-
|
|
-
|
Accumulated
deficit
|
|
(123,417)
|
|
(112,370)
|
|
(163,110)
|
|
(44,688)
|
|
|
|
|
|
|
|
|
|
|
|
56,252
|
|
20,989
|
|
16,711
|
|
4,577
|
|
|
|
|
|
|
|
|
|
|
|
81,695
|
|
41,151
|
|
60,868
|
|
16,676
|
|
*)
Represents an amount lower than NIS 1.
|
STATEMENTS OF
COMPREHENSIVE INCOME
|
|
In thousands,
except per share data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convenience
translation
|
|
|
|
Year
ended
December
31,
|
|
Three months
ended
June
30,
|
|
Six months
ended
June
30,
|
|
Six
months
ended
June
30,
|
|
|
|
2017
|
|
2017
|
|
2018
|
|
2017
|
|
2018
|
|
2018
|
|
|
|
|
|
Unaudited
|
|
Unaudited
|
|
|
|
N I
S
|
|
U.S.
dollars
|
|
|
|
(In thousands,
except per share data)
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development, net of participations
|
|
18,777
|
|
2,022
|
|
29,205
|
|
3,896
|
|
40,950
|
|
11,219
|
|
Marketing, general
and administrative
|
|
4879
|
|
569
|
|
1,445
|
|
1,663
|
|
2,329
|
|
638
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
23,656
|
|
2,591
|
|
30,650
|
|
5,559
|
|
43,279
|
|
11,857
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(23,656)
|
|
(2,591)
|
|
(30,650)
|
|
(5,559)
|
|
(43,279)
|
|
(11,857)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
income
|
|
18
|
|
5
|
|
6,386
|
|
13
|
|
6,386
|
|
1,255
|
|
Financial
expense
|
|
(10,913)
|
|
(9,086)
|
|
(1,227)
|
|
(17,958)
|
|
(2,800)
|
|
(273)
|
|
|
|
0
|
|
|
|
|
|
|
|
|
|
|
|
Total finance
(expense) income, net
|
|
(10,895)
|
|
(9,081)
|
|
5,159
|
|
(17,945)
|
|
3,586
|
|
982
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
(34,551)
|
|
(11,672)
|
|
(25,491)
|
|
(23,504)
|
|
(39,693)
|
|
(10,875)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items to be
reclassified to profit or loss in subsequent periods:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
available-for-sale financial assets
|
|
(6)
|
|
(4)
|
|
-
|
|
(4)
|
|
-
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
(34,557)
|
|
(11,676)
|
|
(25,491)
|
|
(23,508)
|
|
(39,693)
|
|
(10,875)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share (NIS)
|
|
(0.17)
|
|
(0.07)
|
|
(0.10)
|
|
(0.14)
|
|
(0.15)
|
|
(0.04)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares
outstanding used to compute basic and
diluted loss per share
|
|
201,030,768
|
|
175,809,413
|
|
261,419,599
|
|
169,182,101
|
|
261,419,599
|
|
261,419,599
|
|
Contact Details
Joshua
Phillipson
+972 8 930 2529
j.phillipson@biondvax.com
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SOURCE BiondVax Pharmaceuticals Ltd.