NESS ZIONA, Israel, April 28,
2017 /PRNewswire/ -- BiondVax Pharmaceuticals
Ltd. (NASDAQ: BVXV; TASE: BVXV), a clinical stage
biopharmaceutical company focused on developing and commercializing
M-001, a universal flu vaccine candidate, today announced its
fourth quarter and full year financial results for the year ended
December 31, 2016, and provided a
business update.
The Company also filed its annual report for the year ended
December 31, 2016, on Form 20F with
the U.S. Securities and Exchange Commission. This can be downloaded
from BiondVax's website.
Fourth Quarter 2016 Financial Summary
Results are in New Israel Shekels (NIS) and convenience
translation to $US is provided using the exchange rate of 3.845 as
at December 31, 2016.
- Fourth quarter operating expenses, net, were NIS 3.12 million ($811,000) compared with NIS 4.06 million in the fourth quarter of last
year;
- Fourth quarter R&D expenses, net, amounted to NIS 1.83 million ($476,000) compared with NIS 2.87 million in the fourth quarter of last
year;
Full Year 2016 Financial Summary
- Total operating expenses, net, were NIS
11.90 million ($3.10 million)
compared with NIS 11.30 million in
2015;
- R&D expenses, net, amounted to NIS
7.79 million ($2.03 million)
compared with NIS 7.91 million in
2015;
As of December 31, 2016, BiondVax
had cash and cash equivalents, short-term investments and
marketable securities of NIS 27.4
million ($7.1 million) as
compared to NIS 37.5 million as of
December 31, 2015. This decrease was
attributable to utilization of available cash resources to fund
operations.
Recent Corporate Update
- The Company announced positive preliminary safety results from
the Phase 2b clinical trial of M-001, conducted in collaboration
with the European UNISEC consortium[1]. Immunogenicity
results, currently being processed by other UNISEC consortium
entities, are expected by the end of Q2 2017.
- In January 2017, Angels High Tech
Investments Ltd. invested NIS 10.9
million, approximately $2.8
million, in exchange for 33.8 million ordinary BiondVax
shares on the Tel Aviv Stock Exchange (equivalent to 844,000 NASDAQ
listed ADS) at the December 29, 2016,
Tel Aviv closing market price.
Following the transaction, Angels Investments held 19.99% of all
issued and outstanding share capital of the Company.
- The peer-reviewed journal Vaccine published an article
titled, "Back to the future: Immunization with M-001 prior to
trivalent influenza vaccine in 2011/12 enhanced protective immune
responses against 2014/15 epidemic strain." The article reports
that blood plasma samples from people who received M-001 in 2011
(as part of BiondVax's BVX-005 clinical trial in the elderly)
showed a five-fold significant increase of protective antibodies
against a new epidemic 2014/15 flu strain (A/Swiss) – a strain
which did not exist when M-001 was administered to the BVX-005
participants.
- An article by BiondVax-affiliated authors titled,
"Strategy for approving a universal flu vaccine" was
published in the peer-reviewed journal Future
Virology.
- The Company received approval for a grant representing 20% of a
NIS 20 million budget from
Israel's Ministry of Economy and
Industry to build a facility for commercial scale production of
M-001, its universal flu vaccine candidate.
Dr. Ron Babecoff,
BiondVax's President and CEO, commented, "I am pleased we are
progressing and keeping expenses at the planned level. Recent
reports in CNN[2],[3] and The Washington Times[4] indicate flu
pandemic threats like H7N9 are an increasingly urgent concern.
Current solutions are insufficient. These concerns strengthen our
unwavering commitment to bring our universal flu vaccine candidate
to the market to improve pandemic preparedness."
[1] UNISEC research has received funding from the European Union
Seventh Framework Programme (FP7/2007-2013) under grant agreement
n°602012.
[2] The big one is coming, and it's going to be a flu pandemic.
http://edition.cnn.com/2017/04/07/health/flu-pandemic-sanjay-gupta/index.html.
[3] Seven reasons we're at more risk than ever of a global
pandemic.
http://edition.cnn.com/2017/04/03/health/pandemic-risk-virus-bacteria/.
[4] Congress, WHO sound the alarm over pandemic avian flu in
China.
http://www.washingtontimes.com/news/2017/apr/21/congress-who-sound-alarm-over-pandemic-bird-flu-or/.
About BiondVax Pharmaceuticals Ltd
BiondVax is a clinical phase biopharmaceutical company
developing a universal flu vaccine. The vaccine is designed to
provide multi-season protection against most seasonal and pandemic
human influenza virus strains. BiondVax's proprietary technology
utilizes a unique combination of conserved and common peptides from
influenza virus proteins, activating both arms of the immune system
for a cross-protecting and long-lasting effect. BiondVax is traded
on NASDAQ: BVXV and TASE: BVXV. 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 risk
that drug development involves a lengthy and expensive process with
uncertain outcome, the results of the contemplated Phase 2
& 3 trials, delays or obstacles in launching and/or
successfully completing our clinical trials, the impact of
the global economic environment on the Company customer target
base, 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, 2016
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.
* Tables to Follow *
BALANCE
SHEETS
|
In thousands,
except share and per share data
|
|
|
|
|
|
|
|
Convenience
|
|
|
|
|
|
|
translation
|
|
|
December
31,
|
|
December
31,
|
|
|
2015
|
|
2016
|
|
2016
|
|
|
N I
S
|
|
U.S.
dollars
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
33,470
|
|
15,705
|
|
$
4,084
|
Marketable
securities
|
|
2,016
|
|
2,017
|
|
525
|
Short-term
deposits
|
|
-
|
|
7,602
|
|
1,977
|
Other
receivables
|
|
1,442
|
|
815
|
|
212
|
|
|
|
|
|
|
|
|
|
36,928
|
|
26,139
|
|
6,798
|
LONG‑TERM
ASSETS:
|
|
|
|
|
|
|
Marketable
securities
|
|
2,048
|
|
2,050
|
|
533
|
Property, plant
and equipment
|
|
2,044
|
|
1,443
|
|
375
|
Other long term
assets
|
|
287
|
|
478
|
|
124
|
|
|
|
|
|
|
|
|
|
4,379
|
|
3,971
|
|
1,032
|
|
|
|
|
|
|
|
|
|
41,307
|
|
30,110
|
|
$
7,830
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
Trade
payables
|
|
931
|
|
686
|
|
$
178
|
Other
payables
|
|
768
|
|
689
|
|
179
|
|
|
|
|
|
|
|
|
|
1,699
|
|
1,375
|
|
357
|
LONG‑TERM
LIABILITIES:
|
|
|
|
|
|
|
Warrants
|
|
5,994
|
|
3,043
|
|
791
|
Severance pay
liability, net
|
|
69
|
|
76
|
|
20
|
|
|
|
|
|
|
|
|
|
6,063
|
|
3,119
|
|
811
|
|
|
|
|
|
|
|
SHAREHOLDERS'
EQUITY :-
|
|
|
|
|
|
|
Ordinary shares
of NIS 0.0000001 par value:
|
|
|
|
|
|
|
Authorized:
391,000,000 shares as of
December 31, 2015 and 2016; Issued and
Outstanding 135,097,367 shares as of December 31, 2015 and 2016
|
|
*) -
|
|
*) -
|
|
*) -
|
Share
premium
|
|
110,679
|
|
113,041
|
|
29,399
|
Options
|
|
2,536
|
|
1,435
|
|
373
|
Other
comprehensive income
|
|
12
|
|
6
|
|
2
|
Accumulated
deficit
|
|
(79,682)
|
|
(88,866)
|
|
(23,112)
|
|
|
|
|
|
|
|
|
|
33,545
|
|
25,616
|
|
6,662
|
|
|
|
|
|
|
|
|
|
41,307
|
|
30,110
|
|
$
7,830
|
|
|
|
|
|
|
|
|
|
|
*) Represents an
amount lower than NIS 1.
|
STATEMENTS OF
COMPREHENSIVE INCOME
|
In thousands,
except share and per share data
|
|
|
|
|
|
|
|
|
|
Convenience
translation
(Note
2c)
|
|
|
Year
ended
December
31,
|
|
Year
ended
December
31,
|
|
|
2014
|
|
2015
|
|
2016
|
|
2016
|
|
|
N I
S
|
|
U.S.
dollars
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development, net of participations
|
|
5,492
|
|
7,906
|
|
7,794
|
|
$
2,027
|
Marketing, general and
administrative
|
|
2,650
|
|
3,397
|
|
4,106
|
|
1,068
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
8,142
|
|
11,303
|
|
11,900
|
|
3,095
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(8,142)
|
|
(11,303)
|
|
(11,900)
|
|
(3,095)
|
Financial
income
|
|
394
|
|
1,128
|
|
3,019
|
|
785
|
Financial
expense
|
|
(16)
|
|
(24)
|
|
(303)
|
|
(79)
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
(7,764)
|
|
(10,199)
|
|
(9,184)
|
|
(2,389)
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
Items to be
reclassified to profit or loss in subsequent periods:
|
|
|
|
|
|
|
|
|
Gain (loss) from
available-for-sale marketable securities
|
|
(4)
|
|
(5)
|
|
(6)
|
|
(2)
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
(7,768)
|
|
(10,204)
|
|
(9,190)
|
|
$
(2,391)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share
|
|
(0.14)
|
|
(0.10)
|
|
(0.07)
|
|
$
(0.02)
|
|
|
|
|
|
|
|
|
|
Weighted average number
of shares outstanding used to compute basic and diluted loss per
share
|
|
54,286,227
|
|
105,522,642
|
|
135,097,367
|
|
135,097,367
|
|
|
|
|
|
|
|
|
|
|
|
For notes and details, please see the 20F filing with the
SEC.
For further information, please contact:
BiondVax
Joshua Phillipson
Business Development Manager
+972-8-930-2529 x5105
j.phillipson@biondvax.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/biondvax-announces-fourth-quarter-and-full-year-2016-financial-results-and-update-300447893.html
SOURCE BiondVax Pharmaceuticals Ltd.