NESS ZIONA, Israel, May 30,
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 financial results for the
quarter ended March 31, 2017 and
provided a business update.
First Quarter 2017 Financial Summary
Results are in New Israel Shekels (NIS) and convenience
translation to $US is provided using the exchange rate of 3.63
(NIS/$US) as at March 31,
2017.
- First quarter operating expenses were NIS 2.97m ($817,000) compared with NIS 2.83m for the first quarter of 2016;
- First quarter R&D expenses amounted to NIS 1.87m ($516,000) compared with NIS 2.06m for the first quarter of 2016;
As of March 31, 2017, BiondVax had
cash and cash equivalents, short-term investments and marketable
securities of NIS 35 million
($9.6 million) as compared to
NIS 27 million as of December 31, 2016. The increase is attributable
to a private placement of NIS 10.9
million.
Recent Corporate Update
- The European UNISEC consortium sponsored Phase 2b processed the
final participant in September. Preliminary safety results were
reported in November.[1] Immunogenicity results and statistical
analysis are currently being processed by other UNISEC consortium
entities.
- In January, 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.[2]
- In January, 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.[3]
- An article by BiondVax-affiliated authors titled,
"Strategy for approving a universal flu vaccine" was
published in March in the peer-reviewed journal Future
Virology.[4]
- Also in March, 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 its universal flu vaccine candidate.[5]
- In April, the company presented at the Influenza Vaccines for
the World (IVW2017) conference in Switzerland.
[1]
http://www.biondvax.com/2016/11/biondvax-phase-2b-trial-preliminary-safety-results-the-universal-flu-vaccine-candidate-is-safe-and-well-tolerated/
[2]
http://www.biondvax.com/2017/01/biondvax-receives-us-2-8-million-investment-from-angels-high-tech-investments-ltd/
[3]
http://www.biondvax.com/2017/01/back-to-the-future-study-published-in-vaccine-journal-indicates-biondvaxs-universal-flu-vaccine-candidate-may-cover-strains-which-dont-yet-exist/
[4]
http://www.biondvax.com/2017/03/biondvax-publishes-regulatory-approval-strategy-for-novel-universal-flu-vaccines-in-future-virology-journal/
[5]
http://www.biondvax.com/2017/03/biondvax-approved-for-grant-from-israels-ministry-of-economy-and-industry-to-build-facility-for-commercial-scale-production-of-its-universal-flu-vaccine/
About BiondVax
BiondVax is a 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. For more information, 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 per share data
|
|
|
|
|
|
|
|
|
|
Convenience
translation
|
|
|
December
31,
|
|
March
31,
|
|
March
31,
|
|
|
2016
|
|
2016
|
|
2017
|
|
2017
|
|
|
|
|
Unaudited
|
|
Unaudited
|
|
|
N I
S
|
|
U.S.
dollars
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
15,705
|
|
29,817
|
|
24,020
|
|
6,613
|
Marketable
securities
|
|
4,067
|
|
4,065
|
|
4,068
|
|
1,120
|
Short-term
deposits
|
|
7,602
|
|
-
|
|
6,751
|
|
1,859
|
Other
receivables
|
|
815
|
|
2,282
|
|
4,979
|
|
1,371
|
|
|
|
|
|
|
|
|
|
|
|
28,189
|
|
36,164
|
|
39,818
|
|
10,963
|
LONG‑TERM
ASSETS:
|
|
|
|
|
|
|
|
|
Property, plant and
equipment
|
|
1,443
|
|
1,903
|
|
1,297
|
|
357
|
Other long term
assets
|
|
478
|
|
290
|
|
478
|
|
132
|
|
|
|
|
|
|
|
|
|
|
|
1,921
|
|
2,193
|
|
1,775
|
|
489
|
|
|
|
|
|
|
|
|
|
|
|
30,110
|
|
38,357
|
|
41,593
|
|
11,452
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
686
|
|
836
|
|
752
|
|
207
|
Other
payables
|
|
689
|
|
735
|
|
526
|
|
145
|
|
|
|
|
|
|
|
|
|
|
|
1,375
|
|
1,571
|
|
1,278
|
|
352
|
LONG‑TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
Options
|
|
3,043
|
|
4,540
|
|
10,848
|
|
2,987
|
Severance pay
liability, net
|
|
76
|
|
71
|
|
76
|
|
21
|
|
|
|
|
|
|
|
|
|
|
|
3,119
|
|
4,611
|
|
10,924
|
|
3,008
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS' EQUITY
(DEFICIT):
|
|
|
|
|
|
|
|
|
Ordinary shares of NIS
0.0000001 par value:
|
|
|
|
|
|
|
|
|
Authorized:
391,000,000 shares as of
March 31, 2017, 2016 (unaudited) and
December 31, 2016; Issued and
Outstanding: 162,481,153 ,
135,097,367 and 135,097,367
shares respectively
|
|
*) -
|
|
*)
-
|
|
*)
-
|
|
*)
-
|
Share
premium
|
|
113,041
|
|
111,083
|
|
129,550
|
|
35,668
|
Options
|
|
1,435
|
|
2,536
|
|
533
|
|
147
|
Other
comprehensive income
|
|
6
|
|
14
|
|
6
|
|
2
|
Accumulated
deficit
|
|
(88,866)
|
|
(81,458)
|
|
(100,698)
|
|
(27,725)
|
|
|
|
|
|
|
|
|
|
|
|
25,616
|
|
32,175
|
|
29,391
|
|
8,092
|
|
|
30,110
|
|
38,357
|
|
41,593
|
|
11,452
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*) 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
March
31,
|
|
Three
months
ended
March
31,
|
|
|
|
2016
|
|
2016
|
|
2017
|
|
2017
|
|
|
|
|
|
Unaudited
|
|
Unaudited
|
|
|
|
NIS
|
|
U.S.
dollars
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development, net of participations
|
|
|
7,794
|
|
2,063
|
|
1,874
|
|
516
|
Marketing, general
and administrative
|
|
|
4,106
|
|
771
|
|
1,094
|
|
301
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
11,900
|
|
2,834
|
|
2,968
|
|
817
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(11,900)
|
|
(2,834)
|
|
(2,968)
|
|
(817)
|
|
|
|
|
|
|
|
|
|
|
Financial
income
|
|
|
3,019
|
|
1,481
|
|
8
|
|
2
|
Financial
expense
|
|
|
(303)
|
|
(423)
|
|
(8,872)
|
|
(2,443)
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
(9,184)
|
|
(1,776)
|
|
(11,832)
|
|
(3,258)
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) from
available-for-sale financial assets
|
|
|
(6)
|
|
2
|
|
-
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
|
(9,190)
|
|
(1,774)
|
|
(11,832)
|
|
(3,258)
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted net
loss per share
|
|
|
(0.07)
|
|
(0.01)
|
|
(0.07)
|
|
(0.02)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares
outstanding used to compute basic
and diluted loss per share
|
|
|
135,097
|
|
135,097
|
|
162,481
|
|
162,481
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact Details
Joshua
Phillipson
Business Development Manager
+972 8 930 2529
j.phillipson@biondvax.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/biondvax-announces-first-quarter-2017-financial-results-and-update-300465204.html
SOURCE BiondVax Pharmaceuticals Ltd.