BiondVax Files FY 2022 Financial Statements and Annual Report on Form 10-K and Provides Business Update
April 17 2023 - 4:25PM
via InvestorWire --
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, today
published its full-year financial results for the year ended
December 31, 2022, and provided a business update. At the same
time, the Company filed its Annual Report on Form 10-K with the
Securities and Exchange Commission.
Business Update &
Recent Highlights
- In late 2021 and early 2022,
BiondVax signed definitive agreements with the Max Planck Society
(MPG) and the University Medical Center Göttingen, Germany (UMG)
aiming to enable BiondVax to build a pipeline of “bio-better”
nanosized VHH antibodies (NanoAbs), which would exhibit significant
advantages over currently approved human monoclonal antibodies
(mAbs) for several therapeutic indications.
- As compared to mAbs, the unique
physicochemical characteristics of NanoAbs being generated by
BiondVax’s scientific partners at the Max Planck Institute for
Multidisciplinary Sciences (MPI-NAT) demonstrate several
competitive attributes, such as greater binding affinity, target
neutralization at lower drug concentrations, stability at high
temperatures, convenient routes of administration and formulation
advantages. The Company believes that if NanoAbs with these
attributes are developed as drug candidates for specific
indications where their attributes present an advantage over
currently marketed mAbs, they would provide an opportunity to
capture a meaningful share of several large and growing markets. At
the same time, upfront costs and risks commonly associated with new
drug development would be reduced (e.g., sparing the need to prove
that neutralizing a specific target molecule with an antibody
generates a beneficial clinical response in humans) and initiation
of clinical development would be accelerated. In addition, having
access to a multi-asset pipeline would hedge BiondVax’s risk and
provide greater opportunity and flexibility in pursuing partnering
deals with other pharma companies.
- In addition to anti-SARS-CoV-2
NanoAbs for which BiondVax signed an exclusive worldwide licensing
agreement with MPG, BiondVax has an exclusive option for an
exclusive worldwide license agreement at pre-agreed financial terms
for additional NanoAbs discovered and characterized under the
BiondVax-MPG-UMG agreement. On September 20, 2022, BiondVax
announced that it will focus on further NanoAb development
beginning with NanoAbs targeting immune system cytokines such as
IL-17 as drug candidates for the potential treatment of psoriasis
and psoriatic arthritis.
- These new NanoAbs are in addition
to BiondVax’s NanoAb program for the treatment and prophylactic
prevention of COVID-19, for which the Company shared positive
preclinical in vivo data indicating that the innovative inhaled
anti-SARS-CoV-2 NanoAb virtually prevented illness when
administered prophylactically. The results also demonstrated that
when administered therapeutically, the inhaled NanoAb virtually
eliminated the virus in lungs, and led to a significantly shorter
and milder illness.
- BiondVax is currently evaluating
plans to commence a Phase 1/2a clinical trial while monitoring the
ongoing evolution of the COVID-19 virus and variants of concern
(“VoCs”) around the world. In the past few months major shifts in
predominant VoCs have occurred rapidly and continuation of this
pace could make it difficult to utilize the results of the Phase
1/2a trial in a subsequent pivotal trial in case the predominant
VoC is different than the VoC predominant during the Phase 1/2a
trial. Although, as previously communicated, BiondVax holds NanoAbs
that cover all VoCs, MPI-NAT and UMG are working as part of the
accompanying Research Collaboration with BiondVax on discovery and
selection of a single NanoAb, aimed at neutralizing all current
VoCs. Given the resources of the Company and the availability of
additional NanoAbs targeting different indications to license from
MPG and UMG, the Company deems it prudent to advance its pipeline
while continuing to monitor the evolution of the COVID-19
virus.
- On December 6, 2022, BiondVax
welcomed Professor Dr. med. Matthias Dobbelstein, Director of
the Institute of Molecular Oncology at UMG and an Associate Member
of the MPI-NAT, as a member of the Company’s Scientific Advisory
Board (SAB).
- BiondVax is offering its cGMP
manufacturing capabilities to interested parties, including aseptic
fill and finish suite, laboratories and experienced professionals
for CDMO services. This may optimize use of BiondVax’s assets and
generate revenues, while enabling the Company to prioritize its
NanoAb pipeline development.
- BiondVax began filing as a US
domestic issuer in 2023. Consequently, the Company is now reporting
in U.S. GAAP. Previously, as a foreign private issuer, the
Company’s financial results were reported under IFRS GAAP.
“BiondVax’s recent achievements leave me very
optimistic about BiondVax’s growth potential and ability to deliver
value to our stakeholders,” commented Amir
Reichman, BiondVax’s CEO. “In late 2021 and early 2022, we
signed exclusive agreements with the Max Planck Institute for
Multidisciplinary Sciences and the University Medical Center
Göttingen, Germany to build a pipeline of ‘biobetter’ nanosized VHH
antibodies (NanoAbs), which exhibit strong potential for several
significant advantages over currently approved human monoclonal
antibodies (mAbs), targeting diseases with attractive commercial
opportunities. This past winter we published exciting data from the
proof-of-concept in vivo trial of an inhaled NanoAb therapy.
Looking forward, I’m excited to exercise our option to obtain an
exclusive license at pre-agreed financial terms to anti-IL-17
NanoAbs targeting safe, effective, and convenient treatment of
psoriatic lesions; scale up in-house NanoAb manufacturing; and
conduct an in vitro proof-of-concept study and potentially also a
preclinical trial of the IL-17 NanoAb as a therapy for
psoriasis.”
“The BiondVax team, in collaboration with our
scientific partners from MPI-NAT and UMG, has worked exceedingly
hard to develop best in class capabilities in NanoAb
technology-based drug development. I want to thank our shareholders
for their continued support as we progress toward building the
Company into a financial success by providing caregivers and
patients with high-quality, innovative, de-risked pharmaceutical
products that help protect and improve human life,” Reichman
added.
Full-Year 2022
Financial Summary
- R&D
expenses for 2022 amounted to $5.7 million compared with
$3.2 million in 2021.
-
Marketing, general and
administrative expenses for 2022 were $5.3 million
compared with $7.6 million in 2021.
- Financial
income for 2022 was $5.2 million compared with
$2.6 million for 2021. The increase in financial income was
primarily due to currency exchange differences and the
restructuring of the EIB loan, partially offset by the fair value
of warrant liabilities.
- Total
operating expenses for 2022 were $11.06 million, compared
with $10.8 million in 2021.
- Net
loss for 2022 was $5.8 million compared to a loss of $8.2
million for 2021.
As of December 31, 2022, BiondVax had cash and
cash equivalents of $14 million as compared to $17.3 million as of
December 31, 2021. The decrease in cash from December 31, 2021, to
December 31, 2022, was primarily due to the operating expenses for
2022 offset by a public secondary offering of shares in December
2022, which resulted in gross proceeds of $8 million.
The complete audited financial results are available in the
Company’s Annual Report on Form 10-K for the year ended December
31, 2022, filed with the Securities and Exchange Commission. A
summary is included in the tables below.
About BiondVaxBiondVax
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.
Contact DetailsInvestor Relations | +972 8 930
2529 | ir@biondvax.com
Forward Looking StatementsThis
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
strategy, future operations, future financial position, future
revenue, projected expenses, prospects, plans and objectives of
management are forward-looking statements. Examples of such
statements include, but are not limited to, statements regarding
the timing of future pre-clinical clinical trials, and the
therapeutic and commercial potential of NanoAbs. 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; 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.
BALANCE SHEETSU.S.
dollars in thousands (except
share and per share data)
|
|
December 31, |
|
|
|
2022 |
|
|
|
2021 |
|
ASSETS |
|
|
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
Cash and cash equivalents |
|
$ |
12,650 |
|
|
$ |
17,241 |
|
Short-term deposit |
|
|
1,425 |
|
|
|
133 |
|
Restricted short-term deposit |
|
|
140 |
|
|
|
143 |
|
Prepaid expenses and other receivables |
|
|
155 |
|
|
|
326 |
|
|
|
|
|
|
Total
current assets |
|
|
14,370 |
|
|
|
17,843 |
|
|
|
|
|
|
NON-CURRENT ASSETS: |
|
|
|
|
Property, plant and equipment, net |
|
|
11,245 |
|
|
|
12,386 |
|
Operating lease right-of-use assets |
|
|
1,452 |
|
|
|
1,807 |
|
|
|
|
|
|
Total
non-current assets |
|
|
12,697 |
|
|
|
14,193 |
|
|
|
|
|
|
Total
assets |
|
$ |
27,067 |
|
|
$ |
32,036 |
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
Trade payables |
|
$ |
716 |
|
|
$ |
999 |
|
Warrants |
|
|
5,329 |
|
|
|
- |
|
Operating lease short-term liabilities |
|
|
382 |
|
|
|
375 |
|
Other payables |
|
|
1,240 |
|
|
|
1,070 |
|
|
|
|
|
|
Total
current liabilities |
|
|
7,667 |
|
|
|
2,444 |
|
|
|
|
|
|
NON-CURRENT LIABILITIES: |
|
|
|
|
Loan from others |
|
|
20,082 |
|
|
|
27,164 |
|
Operating lease long-term liabilities |
|
|
1,078 |
|
|
|
1,446 |
|
|
|
|
|
|
Total
non-current liabilities |
|
|
21,160 |
|
|
|
28,610 |
|
|
|
|
|
|
CONTINGENT LIABILITIES AND COMMITMENTS |
|
|
|
|
|
|
|
|
|
SHAREHOLDERS’ EQUITY: |
|
|
|
|
Ordinary shares of no par value: Authorized: 20,000,000,000 shares
at December 31, 2022, and 1,800,000,000 at December 31, 2021;
Issued 989,290,784 shares at December 31, 2022 and 739,048,544
shares at December 31, 2021. |
|
|
- |
|
|
|
- |
|
Additional paid-in capital |
|
|
116,082 |
|
|
|
113,076 |
|
Accumulated deficit |
|
|
(115,835 |
) |
|
|
(110,039 |
) |
Other comprehensive loss |
|
|
(2,007 |
) |
|
|
(2,055 |
) |
|
|
|
|
|
Total
shareholders’ equity |
|
|
(1,760 |
) |
|
|
982 |
|
|
|
|
|
|
Total
liabilities and shareholders’ equity |
|
$ |
27,067 |
|
|
$ |
32,036 |
|
|
STATEMENTS OF COMPREHENSIVE
LOSSU.S. dollars in
thousands (except share and per share
data)
|
Year ended |
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
Research and development |
$ |
5,765 |
|
|
$ |
3,249 |
|
Marketing, general and
administrative |
|
5,296 |
|
|
|
7,625 |
|
Other income |
|
- |
|
|
|
(12 |
) |
|
|
|
|
Total operating loss |
|
11,061 |
|
|
|
10,862 |
|
|
|
|
|
Financial income, net |
|
(5,265 |
) |
|
|
(2,656 |
) |
|
|
|
|
Net loss |
$ |
5,796 |
|
|
$ |
8,206 |
|
|
|
|
|
Net loss per share
attributable to ordinary shareholders, basic and diluted |
|
(0.01 |
) |
|
|
(0.02 |
) |
|
|
|
|
Weighted average number of
shares used in computing net loss per share attributable to
ordinary shareholders, basic and diluted |
|
754,076,407 |
|
|
|
564,575,967 |
|
|
The notes in the Company's financial report are an integral part
of the financial statements. The complete financial results are
available in the Form 10-K filed with the Securities and Exchange
Commission (SEC).
Corporate Communications:InvestorBrandNetwork
(IBN)Los Angeles,
Californiawww.InvestorBrandNetwork.com310.299.1717
OfficeEditor@InvestorBrandNetwork.com
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