JERUSALEM, June 12, 2020 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage
biopharmaceutical company focused on developing and commercializing
M-001, a universal influenza vaccine candidate, today announced its
fourth quarter and full year financial results for the year ended
December 31, 2019 and provided a
business update.
Fourth Quarter 2019 Financial Summary
Results are in New Israel Shekels (NIS) and convenience
translation to $US is provided using the exchange rate of 3.456
(NIS/$US) as at December 31,
2019.
- Total operating expenses were NIS 32.5
million (approximately $9.4
million) compared with NIS
27.9 million for the fourth quarter of 2018.
- R&D expenses for the fourth quarter amounted to
NIS 31.6 million ($9.1 million) compared with NIS 26.6 million for the fourth quarter of
2018.
Full Year 2019 Financial Summary
- Total operating expenses for 2019 were NIS 78.3 million ($22.6 million) compared with NIS
77 million in 2018.
- R&D expenses for 2019 amounted to NIS 68.6 million ($19.8 million) compared with NIS 71.9 million in 2018.
As of December 31, 2019, BiondVax
had cash and cash equivalents of NIS
72.4 million ($20.9
million) compared to NIS 75.8
million as of December 31,
2018. Complete financial results are available in the
Company's annual report on Form 20-F for the year ended
December 31, 2019, which is being
filed with the Securities and Exchange Commission today.
*Tables to follow*
2019 Highlights and Recent Corporate Update
- Pivotal clinical efficacy Phase 3 trial: The
pivotal Phase 3 clinical trial aims to compare the safety and
clinical efficacy of M-001 versus a placebo in preventing flu
illness (as primary endpoints), and in reducing flu illness
severity (as a secondary endpoint) from circulating influenza
strains. Prior to both the 2018/19 and 2019/20 flu seasons, a
total of over 12,400 adult volunteers aged 50+ (with half aged 65+)
in seven European countries were enrolled. To date, no serious
treatment related adverse events have been identified. Monitoring
of the trial's second cohort (enrolled for the 2019/20 flu season)
is nearly complete, and the Phase 3 clinical trial results are
expected by the end of 2020.
- NIH-supported Phase 2 clinical trial: The clinical
study report (CSR) of the NIH-supported Phase 2 clinical trial
was completed earlier this week. The CSR concludes that "M-001
was safe in this study" and that "M-001 induced significant
polyfunctional T cell responses," indicating that both primary
endpoints of the trial were achieved. The trial in 120 adult
volunteers, supported by the U.S. National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of
Health (NIH), was conducted by several of NIAID's Vaccine Treatment
and Evaluation Units (VTEUs) in the U.S.
- Pilot manufacturing facility: Equipment
installation and scale-up in BiondVax's pilot manufacturing
facility in Jerusalem are in
progress. The facility has planned annual capacity of up to between
10 and 20 million doses in bulk.
- €24 million non-dilutive co-funding: The European
Investment Bank (EIB) extended the 2017 co-financing agreement from
€20 million to €24 million to support construction of BiondVax's
pilot manufacturing facility in Israel and Phase 3 trial. BiondVax was honored
to host Mr. Ambroise Fayolle, EIB
Vice-President, during his visit to BiondVax in June 2019 for a signature event celebrating the
extension of the financing agreement.
- $20 million rights
offering: In June and July
2019, BiondVax raised approximately US$20 million in a rights offering to existing
shareholders.
- Warrant expiration: BiondVax received proceeds of
approximately $4.2 million through
exercises of BiondVax warrants between January 1, 2020 and expiration of the warrants in
May 2020.
- New Board members: In September
2019, Mr. Mark Germain was
appointed Chairman of the Board of Directors. In March 2020, Mr. Samuel Moed, Dr. Yael Margolin, and Mr. Adi Raviv were elected to the board. Mr. Moed
recently served as Senior Vice President, Corporate Strategy at
Bristol Myers Squibb (NYSE: BMY).
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 seven completed Phase 1/2 and Phase 2 clinical trials
enrolling 818 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. 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 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, risks relating to the COVID-19 (coronavirus) pandemic,
the prosecution, timing and results of the ongoing Phase 2 and
Phase 3 trials and any subsequent trials; timing of receipt of
regulatory approval of our manufacturing facility in Jerusalem; 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 U.S. Food
and Drug Administration or equivalent foreign regulatory agencies;
the adequacy of available cash resources and the ability to raise
additional 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, 2019
filed with the U.S. Securities and Exchange Commission, or SEC,
which is available on the SEC's website, www.sec.gov. We undertake
no obligation to revise or update any forward-looking statement for
any reason.
Contact Details
Joshua E.
Phillipson | +972 8 930 2529 |
j.phillipson@biondvax.com
BALANCE
SHEETS
|
In thousands,
except share and per share data
|
|
|
|
|
|
|
|
|
Convenience
|
|
|
|
|
|
|
|
Translation
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
2018
|
|
2019
|
|
2019
|
|
|
|
N I
S
|
|
U.S.
dollars
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
75,883
|
|
72,467
|
|
20,968
|
Other
receivables
|
|
|
965
|
|
656
|
|
190
|
|
|
|
|
|
|
|
|
|
|
|
76,848
|
|
73,123
|
|
21,158
|
LONG–TERM
ASSETS:
|
|
|
|
|
|
|
|
Property, plant and
equipment
|
|
|
28,249
|
|
34,981
|
|
10,122
|
Right-of-use
assets
|
|
|
-
|
|
7,136
|
|
2,065
|
Other long-term
assets
|
|
|
740
|
|
510
|
|
148
|
|
|
|
|
|
|
|
|
|
|
|
28,989
|
|
42,627
|
|
12,335
|
|
|
|
|
|
|
|
|
|
|
|
105,837
|
|
115,750
|
|
33,493
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
Trade
payables
|
|
|
20,723
|
|
17,062
|
|
4,937
|
Current maturities of
lease liabilities
|
|
|
-
|
|
694
|
|
201
|
Other
payables
|
|
|
1,076
|
|
1,203
|
|
348
|
|
|
|
|
|
|
|
|
|
|
|
21,799
|
|
18,959
|
|
5,486
|
LONG–TERM
LIABILITIES:
|
|
|
|
|
|
|
|
Liability in respect
of government grants
|
|
|
14,643
|
|
14,812
|
|
4,286
|
Lease
Liabilities
|
|
|
-
|
|
6,809
|
|
1,970
|
Loan from
others
|
|
|
94,360
|
|
123,780
|
|
35,816
|
Warrants
|
|
|
6,168
|
|
16,354
|
|
4,732
|
Severance pay
liability, net
|
|
|
82
|
|
89
|
|
26
|
|
|
|
|
|
|
|
|
|
|
|
115,253
|
|
161,844
|
|
46,830
|
SHAREHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
Ordinary shares of NIS
0.0000001 par value: Authorized:
391,000,000 shares at December 31, 2019 and 2018;
Issued and outstanding: 402,351,657 and 261,419,599,
shares at of December 31, 2019 and 2018, respectively
|
|
|
*)
-
|
|
*)
-
|
|
*)
-
|
Share
premium
|
|
|
179,929
|
|
255,285
|
|
73,867
|
Accumulated
deficit
|
|
|
(211,144)
|
|
(320,338)
|
|
(92,690)
|
|
|
|
|
|
|
|
|
|
|
|
(31,215)
|
|
(65,053)
|
|
(18,823)
|
|
|
|
|
|
|
|
|
|
|
|
105,837
|
|
115,750
|
|
33,493
|
*)
Represents amounts less than NISUSD 1.
STATEMENTS OF
COMPREHENSIVE LOSS
|
In thousands,
except share and per share data
|
|
|
|
|
|
|
Convenience
translation
|
|
|
|
Year
ended
December
31,
|
|
Year
ended
December
31,
|
|
|
|
2017
|
|
2018
|
|
2019
|
|
2019
|
|
|
|
N I
S
|
|
U.S.
dollars
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development, net of participations
|
|
|
18,777
|
|
71,913
|
|
68,645
|
|
19,863
|
Marketing, general and
administrative
|
|
|
4,879
|
|
5,154
|
|
9,706
|
|
2,808
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
23,656
|
|
77,067
|
|
78,351
|
|
22,671
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(23,656)
|
|
(77,067)
|
|
(78,351)
|
|
(22,671)
|
Financial
income
|
|
|
18
|
|
2,936
|
|
4
|
|
1
|
Financial
expense
|
|
|
(10,913)
|
|
(13,596)
|
|
(30,847)
|
|
(8,926)
|
|
|
|
|
|
|
|
|
|
|
Loss
|
|
|
(34,551)
|
|
(87,727)
|
|
(109,194)
|
|
(31,596)
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items to be
reclassified to profit or loss in subsequent periods:
|
|
|
|
|
|
|
|
|
|
Loss from
available-for-sale marketable
securities
|
|
|
(6)
|
|
-
|
|
-
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
|
(34,557)
|
|
(87,727)
|
|
(109,194)
|
|
(31,596)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share
|
|
|
(0.17)
|
|
(0.34)
|
|
(0.33)
|
|
(0.09)
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of shares outstanding used to compute basic and diluted loss per
share
|
|
|
201,030,768
|
|
261,419,599
|
|
326,651,721
|
|
326,651,721
|
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SOURCE BiondVax Pharmaceuticals Ltd.