JERUSALEM, April 30, 2019 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company
focused on developing and commercializing M-001, a universal flu
vaccine candidate currently undergoing a pivotal clinical
efficacy Phase 3 trial, today announced its fourth quarter and
full year financial results for the year ended December 31, 2018 and provided a business
update.
Fourth Quarter 2018 Financial Summary
Results are in New Israel Shekels (NIS) and convenience
translation to $US is provided using the exchange rate of
3.748(NIS/$US) as at December 31,
2018.
- Fourth quarter operating expenses were NIS 27.9 million (approximately $7.5 million) compared with NIS 14.9 million for the fourth quarter of
2017;
- Fourth quarter R&D expenses amounted to NIS 26.6 million ($7.1
million) compared with NIS 13.7
million for the fourth quarter of 2017;
Full Year 2018 Financial Summary
- Total operating expenses, net, were NIS
77.06 million ($20.5 million)
compared with NIS 23.66 million in
2017;
- R&D expenses, net, amounted to NIS
71.9 million ($19.18 million)
compared with NIS 18.78 million in
2017;
As of December 31, 2018, BiondVax
had cash and cash equivalents and short-term investments of
NIS 75.8 million ($20.24m) as compared to NIS 71.38 million as of December 31, 2017.
2018 Highlights and Recent Corporate Update
- Pivotal clinical efficacy Phase 3 trial: In the first
cohort of BiondVax's ongoing pivotal, clinical efficacy, Phase
3 trial of M-001, 4,094 participants were recruited prior to the
2018/19 flu season. Approximately 8,000 additional participants are
expected to be recruited in the trial's second cohort beginning in
Q3 2019. The placebo-controlled trial will assess safety and
effectiveness of M-001 alone in reducing flu illness and severity
in adults aged 50 years and older. Results are expected by the end
of 2020.
- Mid-size commercial manufacturing facility: In
August 2018, BiondVax relocated to a
newly constructed mid-size commercial scale manufacturing facility
in Jerusalem, Israel. Based in the
Jerusalem Bio Park, a biotech hub on the Hadassah Medical Center
Hebrew University Ein Kerem campus, the
new approximately 20,000 square foot (1850m2) facility includes offices,
laboratories, and GMP manufacturing suites with planned annual
capacity of 20 million doses of M-001 in bulk with up to 10 million
single dose syringes.
- €24 million non-dilutive co-funding: In
April 2019, the Management Committee
of the European Investment Bank (EIB) agreed to extend the €20
million EIB-BiondVax non-dilutive co-financing agreement, signed in
2017, by an additional €4 million. The funds will be used in
support of the ongoing pivotal, clinical efficacy, Phase 3 trial of
BiondVax's M-001 Universal Flu Vaccine candidate in Europe.
- NIH-sponsored Phase 2 clinical trial: All
participants have completed their final visit in a Phase 2 clinical
trial of BiondVax's M-001 universal flu vaccine, conducted by
several Vaccine Treatment and Evaluation Units
(VTEUs) sponsored by the National Institute of Allergy and
Infectious Diseases (NIAID), part of the U.S. Department of Health
& Human Services (HHS)'s National Institutes of Health
(NIH).
Complete financial results are available in the Company's annual
report on Form 20-F for the year ended December 31, 2018, which was filed with the
Securities and Exchange Commission on April
30, 2019.
About BiondVax
BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage
biopharmaceutical company developing a universal flu vaccine. The
proprietary technology of the vaccine candidate, called M-001,
utilizes a unique combination of conserved and common influenza
virus peptides designed to provide multi-season and multi-strain
protection against current and future, seasonal and pandemic
influenza. 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. An additional Phase 2 trial
is being conducted by the NIH/NIAID is the US. As well, BiondVax is
currently conducting a large pivotal clinical efficacy Phase 3
trial in Europe. 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
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,
|
|
December
31,
|
|
|
2017
|
|
2018
|
|
2018
|
|
|
N I
S
|
|
U.S.
dollars
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
71,382
|
|
75,883
|
|
20,246
|
Other
receivables
|
|
3,923
|
|
965
|
|
258
|
|
|
|
|
|
|
|
|
|
75,305
|
|
76,848
|
|
20,504
|
LONG‑TERM
ASSETS:
|
|
|
|
|
|
|
Property, plant
and equipment
|
|
5,510
|
|
28,249
|
|
7,537
|
Other long term
assets
|
|
880
|
|
740
|
|
197
|
|
|
|
|
|
|
|
|
|
6,390
|
|
28,989
|
|
7,734
|
|
|
|
|
|
|
|
|
|
81,695
|
|
105,837
|
|
28,238
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
Trade
payables
|
|
6,223
|
|
20,723
|
|
5,529
|
Other
payables
|
|
660
|
|
1,076
|
|
287
|
|
|
|
|
|
|
|
|
|
6,883
|
|
21,799
|
|
5,816
|
LONG‑TERM
LIABILITIES:
|
|
|
|
|
|
|
Liability in respect
of government grants
|
|
10,300
|
|
14,643
|
|
3,907
|
Loan from
others
|
|
-
|
|
94,360
|
|
25,176
|
Warrants
|
|
8,177
|
|
6,168
|
|
1,645
|
Severance pay
liability, net
|
|
83
|
|
82
|
|
22
|
|
|
|
|
|
|
|
|
|
18,560
|
|
115,253
|
|
30,750
|
|
|
|
|
|
|
|
SHAREHOLDERS'
EQUITY:
|
|
|
|
|
|
|
Ordinary shares
of NIS 0.0000001 par
value:
|
|
|
|
|
|
|
Authorized:
391,000,000 shares as of
December 31, 2018 and 2017; Issued and
Outstanding: 261,419,599, shares as of
December 31, 2018 and 2017
|
|
*) -
|
|
*) -
|
|
*) -
|
Share
premium
|
|
179,669
|
|
179,929
|
|
48,007
|
Accumulated
deficit
|
|
(123,417)
|
|
(211,144)
|
|
(56,335)
|
|
|
|
|
|
|
|
|
|
56,252
|
|
(31,215)
|
|
(8,328)
|
|
|
|
|
|
|
|
|
|
81,695
|
|
105,837
|
|
28,238
|
|
*)
Represents an amount lower than NIS 1.
|
STATEMENTS OF
COMPREHENSIVE INCOME
|
In thousands,
except per share data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convenience
translation
|
|
|
Year
ended
December
31,
|
|
Year
ended
December
31,
|
|
|
2016
|
|
2017
|
|
2018
|
|
2018
|
|
|
N I
S
|
|
U.S.
dollars
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development, net of
participations
|
|
7,794
|
|
18,777
|
|
71,913
|
|
19,187
|
Marketing, general
and
administrative
|
|
4,106
|
|
4,879
|
|
5,154
|
|
1,375
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
11,900
|
|
23,656
|
|
77,067
|
|
20,562
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(11,900)
|
|
(23,656)
|
|
(77,067)
|
|
(20,562)
|
Financial
income
|
|
3,019
|
|
18
|
|
2,936
|
|
783
|
Financial
expense
|
|
(303)
|
|
(10,913)
|
|
(13,596)
|
|
(3,628)
|
|
|
|
|
|
|
|
|
|
Loss
|
|
(9,184)
|
|
(34,551)
|
|
(87,727)
|
|
(23,407)
|
|
|
|
|
|
|
|
|
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
|
Items to be
reclassified to profit or
loss in subsequent
periods:
|
|
|
|
|
|
|
|
|
Loss from
available-for-sale
marketable securities
|
|
(6)
|
|
(6)
|
|
-
|
|
-
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
(9,190)
|
|
(34,557)
|
|
(87,727)
|
|
(23,407)
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share
|
|
(0.07)
|
|
(0.17)
|
|
(0.34)
|
|
(0.09)
|
|
|
|
|
|
|
|
|
|
Weighted average number
of shares
outstanding used to compute
basic
and diluted loss per share
|
|
135,097,367
|
|
201,030,768
|
|
261,419,599
|
|
261,419,599
|
|
|
|
|
|
|
|
|
|
|
Contact Details
Joshua E.
Phillipson, +972-8-930-2529, j.phillipson@biondvax.com
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SOURCE Biondvax Pharmaceuticals Ltd