BiondVax Reports Second Quarter Financial Results and Provides Business Update
11 August 2023 - 3:00PM
via IBN -
BiondVax Pharmaceuticals Ltd. (Nasdaq:
BVXV), a biotechnology company focused on developing,
manufacturing, and commercializing innovative immunotherapeutic
products primarily for the treatment of infectious and autoimmune
diseases, announced the publication today of its financial results
for the second quarter ended June 30, 2023, and provided a business
update.
Second Quarter 2023 Financial
Summary
- R&D expenses for the three months ended
June 30, 2023, amounted to $1.45 million compared with $1.97
million for the three months ended June 30, 2022.
- Marketing, general and administrative expenses
for the three months ended June 30, 2023, amounted to $1.14 million
compared with $1.29 million for the three months ended June 30,
2022.
- Total operating expenses for the three months
ended June 30, 2023, amounted to $2.56 million compared with $3.26
million for the three months ended June 30, 2022.
- Financial (loss) income for the three months
ended June 30, 2023, amounted to $1.16 million loss compared with
$0.28 million income for the three months ended June 30, 2022.
- Net loss for the three months ended June 30,
2023, amounted to $3.76 million compared with $2.98 million for the
three months ended June 30, 2022.
As of June 30, 2023, BiondVax had cash and cash
equivalents of $7.6 million as compared to $14.2 million as of
December 31, 2022. In the six months ended June 30, 2023, BiondVax
had an operating loss of $7.3 million and negative cash flows from
operating activities of $5.9 million. BiondVax’s current operating
budget includes various assumptions concerning the level and timing
of cash receipts and cash outlays for operating expenses and
capital expenditures, including a cost-savings plan. BiondVax is
planning to finance its operations from its existing working
capital resources and additional sources of capital and financing
with respect to which the Company has initiated actions. However,
there is no assurance that additional capital and/or financing will
be available to BiondVax, and even if available, whether it will be
on terms acceptable to BiondVax or in amounts required.
Accordingly, BiondVax’s board of directors approved the
cost-savings plan mentioned above, to be implemented if and as
required, in whole or in part, at its discretion, to allow BiondVax
to continue its operations and meet its cash obligations. The
cost-savings plan consists of cutting expenditures by means of
further efficiencies and synergies, which include mainly the
reduction in headcount and postponing or cancelling capital
expenditures that would not be required for the implementation of
the revised business plan. BiondVax’s Board of Directors believes
that BiondVax’s existing financial resources, potential successful
capital raisings and its current operating plans (including the
possible disposition of assets outside the ordinary course of
business) and restructuring of debt, along with the effects of the
cost-savings plan, may be adequate to satisfy its expected
liquidity requirements for a period of at least twelve months from
the date hereof, although there is no guarantee.
BiondVax’s unaudited financial results will be
submitted to the Securities and Exchange Commission on Form 6‑K. A
summary of such results is included in the tables below.
Business Update
- CDMO:
- As announced previously, BiondVax has decided to leverage its
aseptic manufacturing site and laboratories by creating a CDMO
business unit in parallel to its innovative R&D business unit.
The CDMO business unit offers biological drug development services
with a focus on preclinical and small clinical stage
biopharmaceutical companies. These companies tend to have limited
capital and require cost effective drug development services that
can be executed in very short timelines. These companies also
typically lack the resources required to build their own
laboratories and production lines for biological drug development.
They also often encounter challenges working with large CDMOs due
to the relatively high costs, long timelines and lack of agility in
their processes. To overcome these challenges, preclinical and
small clinical stage companies may outsource product development to
a boutique CDMO such as the one owned by BiondVax. In particular,
BiondVax’s CDMO business unit allows clients to leverage BiondVax’s
expertise in process development, optimization, scale-up, GMP
manufacturing for clinical trials, and navigating complex
regulatory frameworks. Additional information is available
at www.biondvax.com/cdmo.
- Pipeline Development:
- In June 2023, BiondVax signed an exclusive license agreement
with Max Planck Innovation for development and commercialization of
a novel anti-IL-17 NanoAb (VHH antibody) for treatment of
autoimmune and inflammatory diseases including psoriasis. We are
aggressively advancing the NanoAb preclinical development and
expect the IL-17 NanoAb to enter clinical testing in 2024.
- BiondVax is pursuing a strategic partnership for its COVID-19
self-administered inhaled NanoAb therapeutic/prophylactic which
demonstrated highly promising in vivo results in animals.
- NanoAbs for treatment of additional autoimmune diseases such as
asthma and wet AMD are being developed at Max Planck and University
Medical Center Göttingen as part of their research collaboration
agreement with BiondVax. BiondVax holds exclusive options for
exclusive licenses at pre agreed financial terms for each of the
resulting NanoAbs.
About BiondVax BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biotechnology company
focused on developing, manufacturing, and commercializing
innovative immunotherapeutic products primarily for the treatment
of infectious and autoimmune diseases. Since its inception, the
company has executed eight clinical trials including a
seven-country, 12,400-participant Phase 3 trial of its vaccine
candidate and has built a state-of-the-art manufacturing facility
for biopharmaceutical products. With highly experienced
pharmaceutical industry leadership, BiondVax is aiming to
develop a pipeline of diversified and commercially viable products
and platforms beginning with an innovative nanosized antibody
(NanoAb) pipeline. www.biondvax.com.
Company Contact Details Joshua E.
Phillipson | +972 8 930 2529 | j.phillipson@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. All statements, other than statements
of historical facts, included in this press release regarding cash
liquidity, strategy, future operations, future financial position,
future revenue, projected expenses, prospects, plans and objectives
of management are forward-looking statements. These forward-looking
statements reflect 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 BiondVax may not be able to secure
additional capital on attractive terms, if at all, and the risk
that BiondVax may not be able to execute its operating plan; the
risk that the therapeutic and commercial potential of NanoAbs will
not be met; the risk of a delay in the preclinical and clinical
trials data for NanoAbs, if any; the risk that our business
strategy may not be successful; the risk that the European
Investment Bank (EIB) may accelerate the loans under its finance
contract with BiondVax; risks relating to the SARS-CoV-2 (COVID-19)
virus; BiondVax's ability to acquire rights to additional product
opportunities; BiondVax's ability to enter into collaborations on
terms acceptable to BiondVax or at all; timing of receipt of
regulatory approval of BiondVax's manufacturing facility in
Jerusalem, if at all or when required; the risk that the
manufacturing facility will not be able to be used for a wide
variety of applications and other vaccine and treatment
technologies; and the risk that drug development involves a lengthy
and expensive process with uncertain outcomes. More detailed
information about the risks and uncertainties affecting the Company
is contained under the heading "Risk Factors" in the Company's
Annual Report on Form 10-K filed with the Securities and Exchange
Commission on April 17, 2023. BiondVax undertakes no obligation to
revise or update any forward-looking statement for any
reason.
Wire Service Contact: IBN Los
Angeles, California www.InvestorBrandNetwork.com 310.299.1717
Office Editor@InvestorBrandNetwork.com
|
CONDENSED BALANCE SHEETS (Unaudited) |
U.S. dollars in thousands (except share
and per share data) |
|
|
June 30, |
|
|
December 31, |
|
|
2023 |
|
|
|
|
2022 |
|
|
Unaudited |
|
|
Audited |
ASSETS |
|
|
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
Cash and cash equivalents |
$ |
7,506 |
|
|
|
$ |
14,075 |
|
Restricted cash |
|
126 |
|
|
|
|
140 |
|
Prepaid expenses and other receivables |
|
138 |
|
|
|
|
155 |
|
|
|
|
|
|
Total current assets |
|
7,770 |
|
|
|
|
14,370 |
|
|
|
|
|
|
NON-CURRENT ASSETS: |
|
|
|
|
Property, plant and equipment, net |
|
10,802 |
|
|
|
|
11,245 |
|
Operating lease right-of-use assets |
|
1,325 |
|
|
|
|
1,452 |
|
|
|
|
|
|
Total non-current assets |
|
12,127 |
|
|
|
|
12,697 |
|
|
|
|
|
|
Total assets |
$ |
19,897 |
|
|
|
$ |
27,067 |
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
Trade payables |
$ |
651 |
|
|
|
$ |
716 |
|
Operating lease liabilities |
|
394 |
|
|
|
|
382 |
|
Other payables |
|
843 |
|
|
|
|
1,240 |
|
|
|
|
|
|
Total current liabilities |
|
1,888 |
|
|
|
|
2,338 |
|
|
|
|
|
|
NON-CURRENT LIABILITIES: |
|
|
|
|
Warrants liability |
|
902 |
|
|
|
|
5,329 |
|
Loan from others |
|
23,292 |
|
|
|
|
20,082 |
|
Non-current operating lease liabilities |
|
927 |
|
|
|
|
1,078 |
|
|
|
|
|
|
Total non-current liabilities |
|
25,121 |
|
|
|
|
26,489 |
|
|
|
|
|
|
CONTINGENT LIABILITIES AND COMMITMENTS |
|
|
|
|
|
|
|
|
|
SHAREHOLDERS’ EQUITY (DEFICIT): |
|
|
|
|
Ordinary shares of no par value: Authorized: 20,000,000,000 shares
at June 30, 2023 and at December 31, 2022; Issued and outstanding
1,453,970,784 shares at June 30, 2023 and 989,290,784 shares at
December 31, 2022 |
|
- |
|
|
|
|
- |
|
Additional paid-in capital |
|
117,740 |
|
|
|
|
116,082 |
|
Accumulated deficit |
|
(123,112 |
) |
|
|
|
(115,835 |
) |
Accumulated other comprehensive loss |
|
(1,740 |
) |
|
|
|
(2,007 |
) |
|
|
|
|
|
Total shareholders’ deficit |
|
(7,112 |
) |
|
|
|
(1,760 |
) |
|
|
|
|
|
Total liabilities and shareholders’ deficit |
$ |
19,897 |
|
|
|
$ |
27,067 |
|
|
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited) |
U.S. dollars
in thousands (except share and per share data) |
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
expenses, net |
$ |
1,454 |
|
|
$ |
1,974 |
|
|
$ |
3,449 |
|
|
$ |
3,137 |
|
Marketing, general and
administrative |
|
1,141 |
|
|
|
1,289 |
|
|
|
2,332 |
|
|
|
2,741 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating loss |
|
2,595 |
|
|
|
3,263 |
|
|
|
5,781 |
|
|
|
5,878 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial loss (income),
net |
|
1,167 |
|
|
|
(280 |
) |
|
|
1,496 |
|
|
|
(420 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
3,762 |
|
|
$ |
2,983 |
|
|
$ |
7,277 |
|
|
$ |
5,458 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to ordinary shareholders, basic and diluted |
|
(0.003 |
) |
|
|
(0.004 |
) |
|
|
(0.006 |
) |
|
|
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares used for computing basic and diluted net loss per share |
|
1,351,850,046 |
|
|
|
746,898,671 |
|
|
|
1,322,019,241 |
|
|
|
745,817,220 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED STATEMENTS OF
COMPREHENSIVE LOSS
(Unaudited) |
U.S. dollars in thousands (except share and per share
data) |
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(3,762 |
) |
|
|
(2,983 |
) |
|
|
(7,277 |
) |
|
|
(5,458 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive (income) loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments |
|
|
151 |
|
|
|
(13 |
) |
|
|
267 |
|
|
|
(47 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
3,611 |
|
|
$ |
(2,996 |
) |
|
$ |
7,010 |
|
|
$ |
(5,505 |
) |
The notes in BiondVax’s quarterly report are an
integral part of the financial statements. The notes to the
financial results will be available in the Form 6-K to be filed by
BiondVax with the Securities and Exchange Commission.
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