JERUSALEM, Nov. 26, 2019
/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, 2019.
Third Quarter 2019 Financial Summary
Results are in New Israel Shekels (NIS) and convenience
translation to $US is provided using the exchange rate of 3.482
(NIS/$US) as at September 30,
2019.
- Third quarter operating expenses were NIS 18.9m ($5.4m)
compared with NIS 5.8m for the third
quarter of 2018;
- Third quarter R&D expenses amounted to NIS 16.1m ($4.6m)
compared with NIS 4.3m for the third
quarter of 2018;
Expenses were related to execution of planned ongoing
operations, including the ongoing pivotal, clinical efficacy, Phase
3 trial of the Company's M-001 Universal Flu Vaccine candidate and
construction of a mid-size pilot manufacturing facility.
As of September 30, 2019, BiondVax
had cash and cash equivalents of NIS 75.2
million ($21.6 million) as
compared to NIS 33.9 million as of
June 30, 2019.
Recent Business highlights:
- $20 million was raised in a
shareholder rights offering that concluded in July 2019. As a consequence of the offering and
an associated option to purchase ordinary shares that were not
purchased by other shareholders in the offering, Angels Investments
in High Tech Ltd., wholly owned by Marius
Nacht, lead investor of the aMoon Fund, held approximately
42% of outstanding BiondVax shares.
- Mr. Mark Germain was appointed
Chairman of BiondVax's Board of Directors, effective September 30, 2019.
- In October 2019, BiondVax
received €4 million from the European Investment Bank (EIB). These
funds are the final tranche of the previously announced
co-financing agreement signed in June
2017 and extended in April
2019 from €20 million to €24 million.
- Laboratory work for the primary and secondary outcome measures
in the NIAID-sponsored Phase 2 clinical trial in the USA is now complete and the analysis is
ongoing. Results are expected in Q2 2020.
- Enrollment and randomization of 12,463 participants was
successfully completed in the pivotal, clinical efficacy, Phase 3
trial of BiondVax's M-001 Universal Influenza Vaccine
candidate.
** 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 6 completed Phase 1/2 and Phase 2 clinical trials,
covering 698 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. 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 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 publication by
NIAID of the results of the NIH/NIAID conducted Phase 2
clinical trial in the USA;
timing of receipt of regulatory approval of the new manufacturing
facility; 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, 2018 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.
BALANCE
SHEETS
|
In thousands,
except share and per share data
|
|
|
|
|
|
|
Convenience
translation
|
|
|
December
31,
|
|
September
30,
|
|
September
30,
|
|
|
2018
|
|
2018
|
|
2019
|
|
2019
|
|
|
Audited
|
|
Unaudited
|
|
Unaudited
|
|
|
N I
S
|
|
U.S.
dollars
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
75,883
|
|
52,985
|
|
75,247
|
|
21,610
|
Other
receivables
|
|
965
|
|
2,716
|
|
1,887
|
|
542
|
|
|
|
|
|
|
|
|
|
|
|
76,848
|
|
55,701
|
|
77,134
|
|
22,152
|
LONG‑TERM
ASSETS:
|
|
|
|
|
|
|
|
|
Property, plant and
equipment
|
|
28,249
|
|
24,175
|
|
34,324
|
|
9,857
|
Right-of-use
assets
|
|
-
|
|
-
|
|
7,371
|
|
2,117
|
Other long term
assets
|
|
740
|
|
888
|
|
507
|
|
146
|
|
|
|
|
|
|
|
|
|
|
|
28,989
|
|
25,063
|
|
42,202
|
|
12,120
|
|
|
|
|
|
|
|
|
|
|
|
105,837
|
|
80,764
|
|
119,336
|
|
34,272
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
20,723
|
|
1,732
|
|
1,552
|
|
446
|
Operating lease
liability
|
|
-
|
|
-
|
|
697
|
|
200
|
Other
payables
|
|
1,076
|
|
981
|
|
820
|
|
235
|
|
|
|
|
|
|
|
|
|
|
|
21,799
|
|
2,713
|
|
3,069
|
|
881
|
LONG‑TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
Liability in respect
of government grants
|
|
14,643
|
|
12,930
|
|
14,454
|
|
4,151
|
Operating lease
liability
|
|
-
|
|
-
|
|
6,898
|
|
1,981
|
Loan from
others
|
|
94,360
|
|
42,770
|
|
108,353
|
|
31,118
|
Warrants
|
|
6,168
|
|
7,759
|
|
6,908
|
|
1,984
|
Accrued severance pay,
net
|
|
82
|
|
81
|
|
87
|
|
25
|
|
|
|
|
|
|
|
|
|
|
|
115,253
|
|
63,540
|
|
136,700
|
|
39,259
|
SHAREHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
Ordinary shares of NIS
0.0000001 par value:
|
|
|
|
|
|
|
|
|
Authorized:
600,000,000 shares at September 30, 2019, 2018
(unaudited) and December 31, 2018; Issued and outstanding:
402,351,657, 261,419,599 and 261,41,599 shares at
September 30, 2019, 2018 (unaudited) and December 31,
2018,
respectively
|
|
*)
-
|
|
*)
-
|
|
*)
-
|
|
*)
-
|
Share
premium
|
|
179,929
|
|
179,871
|
|
256,889
|
|
73,776
|
Accumulated
deficit
|
|
(211,144)
|
|
(165,360)
|
|
(277,322)
|
|
(79,644)
|
|
|
|
|
|
|
|
|
|
|
|
(31,215)
|
|
14,511
|
|
(20,433)
|
|
(5,868)
|
|
|
|
|
|
|
|
|
|
|
|
105,837
|
|
80,764
|
|
119,336
|
|
34,272
|
*) Represents an
amount lower than NIS 1.
|
STATEMENTS OF
COMPREHENSIVE LOSS
|
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,
|
|
|
2018
|
|
2018
|
|
2019
|
|
2018
|
|
2019
|
|
2019
|
|
|
Audited
|
|
Unaudited
|
|
Unaudited
|
|
|
N I
S
|
|
U.S.
dollars
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development, net of
participations
|
|
71,913
|
|
4,347
|
|
16,133
|
|
45,297
|
|
37,037
|
|
10,637
|
Marketing, general and
administrative
|
|
5,154
|
|
1,475
|
|
2,790
|
|
3,804
|
|
8,741
|
|
2,510
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
77,067
|
|
5,822
|
|
18,923
|
|
49,101
|
|
45,778
|
|
13,147
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(77,067)
|
|
(5,822)
|
|
(18,923)
|
|
(49,101)
|
|
(45,778)
|
|
(13,147)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
income
|
|
2,936
|
|
3,729
|
|
169
|
|
9,817
|
|
193
|
|
55
|
Financial
expense
|
|
(13,596)
|
|
(157)
|
|
(601)
|
|
(2,659)
|
|
(20,593)
|
|
(5,914)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total financial income
(expense), net
|
|
(10,660)
|
|
3,572
|
|
(432)
|
|
7,158
|
|
(20,400)
|
|
(5,859)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss and total
comprehensive loss
|
|
(87,727)
|
|
(2,250)
|
|
(19,355)
|
|
(41,943)
|
|
(66,178)
|
|
(19,006)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share (in
NIS)
|
|
(0.34)
|
|
(0.01)
|
|
(0.05)
|
|
(0.16)
|
|
(0.23)
|
|
(0.07)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of shares
outstanding used to compute basic
and diluted loss per share
|
|
261,419,599
|
|
261,419,599
|
|
377,899,911
|
|
261,419,599
|
|
290,794,601
|
|
290,794,601
|
Contact Details:
Joshua E.
Phillipson
+972-8-930-2529
j.phillipson@biondvax.com
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SOURCE BiondVax Pharmaceuticals Ltd.