Full Press Release Details
BiondVax announces financial plans to support
its ongoing NanoAb pipeline development
Jerusalem, Israel - September 30,
2022 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) ("BiondVax"), a biotechnology company focused on developing,
manufacturing, and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, announced
the filing yesterday of a Registration Statement ("Form F-1") with the US Securities and Exchange Commission ("SEC")
for a firm commitment underwritten offering of BiondVax American Depositary Shares ("ADSs"). Once declared effective by the
SEC the Form F-1 can be used to raise capital.
BiondVax is currently developing, under an exclusive
worldwide license, a nanosized antibody ("NanoAb") for the treatment of COVID-19, developed by researchers at the Max Planck
Institute for Multidisciplinary Sciences (MPG) and the University Medical Center G ttingen (UMG). As recently reported, in the coming
weeks BiondVax intends to initiate a preclinical proof-of-concept study of the COVID-19 NanoAb as an inhaled therapy in COVID-19 infected
animals. Assuming successful results, a first-in-human Phase 1/2a clinical trial of the COVID-19 NanoAb inhaled therapy will be initiated
Under the five-year BiondVax-MPG-UMG research
collaboration agreement (RCA) for additional "biobetter" NanoAbs, Professor Dirk G rlich of MPG and his team have successfully
generated, identified and isolated NanoAbs addressing a number of additional biological target molecules. Professor G rlich and his
colleague Professor Matthias Dobbelstein of UMG verified strong affinity by the new NanoAbs to their biological target molecules and high
thermostability. The research teams have also demonstrated strong neutralization by several NanoAb candidates of their respective target
molecules. As a result of the above progress, BiondVax decided earlier this month to initially focus additional pipeline development beginning
with NanoAbs as drug candidates for the potential treatment of psoriasis, psoriatic arthritis, and asthma.
These recent successful developments present
BiondVax with an opportunity to not only initiate a Phase 1/2a clinical trial of its inhaled COVID-19 therapeutic NanoAb next year as
planned, but also to significantly expand its portfolio of NanoAbs in development. Consequently, the proceeds of the firm commitment
underwriting share issuance contemplated by the F-1 are designed to provide BiondVax with the capital necessary to continue to aggressively
execute its strategy.
In addition, BiondVax received a notification
letter from The Nasdaq Stock Market ("Nasdaq") dated September 28, 2022 advising BiondVax that it is not in compliance with
Listing Rule 5550(b)(1) requiring companies listed on the Nasdaq Capital Market to maintain a minimum of $2,500,000 in stockholders'
equity for continued listing. The notification letter from Nasdaq was based on BiondVax's Form 6-K/A, dated August 29, 2022, disclosing
financial information for the period ended June 30, 2022, which reported shareholders' equity of $1,277,000, and noted that BiondVax
does not meet the alternatives of market value of listed securities or net income from continued operations.
The letter states that under Nasdaq's Listing
Rules, BiondVax has 45 calendar days to submit a plan to Nasdaq to regain compliance with the minimum stockholders' equity listing
requirement. If a plan is submitted by BiondVax, and if it is accepted by Nasdaq, Nasdaq can grant an extension of up to 180 days from
the date of the Nasdaq letter for BiondVax to evidence compliance with the minimum stockholders' equity listing requirement. If
BiondVax submits a plan and the plan is not accepted by Nasdaq, BiondVax will have the opportunity to appeal such decision to a Nasdaq
Hearings Panel under Nasdaq Listing Rule 5815(a).
The notification letter has no immediate effect
on the listing of BiondVax's ADSs, and its ADSs will continue at this time to trade on the Nasdaq Capital Market under the symbol
The contemplated equity offering, if consummated,
would rectify the stockholders' equity deficiency. Furthermore, BiondVax will pursue additional definitive steps to regain and maintain
compliance with Nasdaq listing rules.
Amir Reichman, BiondVax's CEO, explained,
"As we updated last week, in addition to the upcoming COVID-19 NanoAb milestones, following exciting progress made by our scientific
collaborators at the Max Planck Institute for Multidisciplinary Sciences (MPG), and the University Medical Center G ttingen (UMG)
we intend to advance development of additional NanoAbs for the treatment of diseases such as asthma, psoriatic arthritis and psoriasis.
While the stock market remains unfavorable, particularly for small cap companies, we believe aggressively advancing our programs is the
best path to create shareholder value to be reflected when the market regains some stability. We view the registration statement filed
yesterday for a proposed equity offering as one piece of a well-crafted set of activities to ensure BiondVax continues to deliver. While
the decision to pursue an offering was made in advance of the letter of non-compliance, we are optimistic that the offering's successful
conclusion will address the deficiency and put the issue behind us. To be prudent we will pursue additional measures in parallel, consistent
with our proactive approach to restructuring our loan from the European Investment Bank, as previously announced."
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is
a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment
of infectious diseases and other illnesses. Since its inception, BiondVax 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: 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 communication regarding strategy, future operations, future financings, 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, the therapeutic and commercial potential of nanosized antibodies (NanoAbs); and the timing of NanoAb proof-of-concept studies and
clinical trials. 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 the company
may not raise capital on acceptable terms or at all, the risk that the company will not submit a compliance plan acceptable to Nasdaq,
the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical
data for NanoAbs, if any; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; risks relating
to the COVID-19 (coronavirus) pandemic; 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 20-F filed with the Securities and Exchange Commission
on March 28, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.