JERUSALEM, Nov. 13, 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 September 30, 2018.
Third Quarter 2018 Financial Summary
Results are in New Israel Shekels (NIS) and convenience
translation to $US is provided using the exchange rate of 3.627
(NIS/$US) as at September 30,
2018.
- Third quarter operating expenses were NIS 49.1m ($13.5m)
compared with NIS 3.21m for the third
quarter of 2017;
- Third quarter R&D expenses amounted to NIS 45.3m ($12.5m)
compared with NIS 1.17m for the third
quarter of 2017;
As of September 30, 2018, BiondVax
had cash and cash equivalents of NIS 53.0
million ($14.6 million) as
compared to NIS 37.1 million as of
June 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.
Of note, during this third quarter a €6 million tranche was
received by the Company as part of the previously announced €20
million co-financing agreement with the European Investment Bank
(EIB). On October 21, 2018, after
this third quarter reporting period, an additional €8 million
representing the third and final tranche of the EIB agreement was
received by BiondVax, and will be included in the Company's fourth
quarter financial results.
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 resources 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. We undertake no obligation
to revise or update any forward-looking statement for any
reason.
** Tables to Follow **
BALANCE
SHEETS
|
|
In thousands,
except share and per share data
|
|
|
|
|
|
|
|
|
|
Convenience
translation
|
|
|
December
31,
|
|
September
30,
|
|
September
30,
|
|
|
2017
|
|
2017
|
|
2018
|
|
2018
|
|
|
Audited
|
|
Unaudited
|
|
Unaudited
|
|
|
N I
S
|
|
U.S.
dollars
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
71,382
|
|
76,892
|
|
52,985
|
|
14,608
|
Short-term
deposits
|
|
-
|
|
1,200
|
|
*)
-
|
|
*)
-
|
Other
receivables
|
|
3,923
|
|
3,779
|
|
2,716
|
|
749
|
|
|
|
|
|
|
|
|
|
|
|
75,305
|
|
81,871
|
|
55,701
|
|
15,357
|
LONG‑TERM
ASSETS:
|
|
|
|
|
|
|
|
|
Property, plant and
equipment
|
|
5,510
|
|
1,308
|
|
24,175
|
|
6,665
|
Other long term
assets
|
|
880
|
|
515
|
|
888
|
|
245
|
|
|
|
|
|
|
|
|
|
|
|
6,390
|
|
1,823
|
|
25,063
|
|
6,910
|
|
|
|
|
|
|
|
|
|
|
|
81,695
|
|
83,694
|
|
80,764
|
|
22,267
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
6,223
|
|
792
|
|
1,732
|
|
477
|
Other
payables
|
|
660
|
|
2,344
|
|
981
|
|
270
|
|
|
|
|
|
|
|
|
|
|
|
6,883
|
|
3,136
|
|
2,713
|
|
747
|
LONG‑TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
Liability in respect
of government grants
|
|
10,300
|
|
-
|
|
12,930
|
|
3,565
|
Loan from
others
|
|
-
|
|
-
|
|
42,770
|
|
11,792
|
Warrants
|
|
8,177
|
|
11,829
|
|
7,759
|
|
2,139
|
Severance pay
liability, net
|
|
83
|
|
81
|
|
81
|
|
22
|
|
|
|
|
|
|
|
|
|
|
|
18,560
|
|
11,910
|
|
63,540
|
|
17,518
|
SHAREHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
Ordinary
shares
|
|
|
|
|
|
|
|
|
Authorized:
600,000,000 shares as of September
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
|
|
179,182
|
|
179,871
|
|
49,592
|
Options
|
|
-
|
|
533
|
|
-
|
|
-
|
Other
comprehensive income
|
|
-
|
|
-
|
|
|
|
-
|
Accumulated
deficit
|
|
(123,417)
|
|
(111,067)
|
|
(165,360)
|
|
(45,590)
|
|
|
|
|
|
|
|
|
|
|
|
56,252
|
|
68,648
|
|
14,511
|
|
4,002
|
|
|
|
|
|
|
|
|
|
|
|
81,695
|
|
83,694
|
|
80,764
|
|
22,267
|
*)
Represents an amount lower than NIS 1.
|
|
|
|
|
|
|
|
|
STATEMENTS OF
COMPREHENSIVE INCOME
|
|
In thousands,
except share and per share data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convenience
translation
|
|
|
Year
ended
December
31,
|
Three months
ended
September
30,
|
|
Nine months
ended
September
30,
|
|
Nine
months
ended
September
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
|
|
1,174
|
|
4,347
|
|
5,070
|
|
45,297
|
|
12,488
|
Marketing, general
and administrative
|
|
4,879
|
|
2,036
|
|
1,475
|
|
3,699
|
|
3,804
|
|
1,049
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
23,656
|
|
3,210
|
|
5,822
|
|
8,769
|
|
49,101
|
|
13,537
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(23,656)
|
|
(3,210)
|
|
(5,822)
|
|
(8,769)
|
|
(49,101)
|
|
(13,537)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
income
|
|
18
|
|
4,558
|
|
3,729
|
|
17
|
|
9,817
|
|
2,707
|
Financial
expense
|
|
(10,913)
|
|
(45)
|
|
(157)
|
|
(13,449)
|
|
(2,659)
|
|
(733)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total financial
income (expense), net
|
|
(10,895)
|
|
4,513
|
|
3,572
|
|
(13,432)
|
|
7,158
|
|
1,974
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
|
(34,551)
|
|
1,303
|
|
(2,250)
|
|
(22,201)
|
|
(41,943)
|
|
(11,564)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
available-for-sale financial
assets
|
|
(6)
|
|
(2)
|
|
-
|
|
(6)
|
|
-
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
income (loss)
|
|
(34,557)
|
|
1,301
|
|
(2,250)
|
|
(22,207)
|
|
(41,943)
|
|
(11,564)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per
share
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
(NIS)
|
|
(0.17)
|
|
0.01
|
|
(0.01)
|
|
(0.12)
|
|
(0.16)
|
|
(0.04)
|
Diluted
(NIS)
|
|
(0.17)
|
|
(0.01)
|
|
(0.01)
|
|
(0.12)
|
|
(0.16)
|
|
(0.04)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares used in
compute earnings (loss) per
share
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
201,030,768
|
|
191,521,484
|
|
261,419,599
|
|
180,680,089
|
|
261,419,599
|
|
261,419,599
|
Diluted
|
|
201,030,768
|
|
201,302,584
|
|
261,419,599
|
|
180,680,089
|
|
261,419,599
|
|
261,419,599
|
Contact Details
Joshua E.
Phillipson
+972 8 930 2529
j.phillipson@biondvax.com
View original
content:http://www.prnewswire.com/news-releases/biondvax-announces-third-quarter-2018-financial-results-300749499.html
SOURCE BiondVax Pharmaceuticals Ltd.