BiondVax Announces Financial Plans to Support Ongoing Development of its NanoAb Pipeline
JERUSALEMIsrael , September 30, 2022 /PRNewswire/ — BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) (“BiondVax”), a biotechnology company focused on the development, manufacture and commercialization of innovative products for the prevention and treatment of infectious diseases and other illnesses, announced yesterday the filing of a registration statement (“Form F-1 “) with the United States Securities and Exchange Commission (“SEC”) for a firm underwriting offer of BiondVax American Depositary Shares (“ADSs”). Once declared effective by the SEC, Form F-1 can be used to raise capital.
BiondVax is currently developing, under an exclusive worldwide license, a nanoscale antibody (“NanoAb”) for the treatment of COVID-19, developed by researchers at the Max Planck Institute for Multidisciplinary Sciences (MPG) and University Medical Center Gwhere(UMG). As recently reported, in the coming weeks, BiondVax intends to initiate a proof-of-concept preclinical study of the COVID-19 NanoAb as an inhaled therapy in animals infected with COVID-19. Assuming positive results, a first-in-human Phase 1/2a clinical trial of the COVID-19 NanoAb inhaled therapy will be initiated in 2023.
As part of the five-year BiondVax-MPG-UMG Research Collaborative Agreement (RCA) for additional “biobetter” NanoAbs, Prof. Dirk Gorlich of MPG and his team succeeded in generating, identifying and isolating NanoAbs targeting a number of additional biological target molecules. Professor Görlich and his colleague Professor Matthias Dobbelstein from UMG verified the strong affinity of the new NanoAbs with their biological target molecules and their high thermostability. The research teams also demonstrated strong neutralization by several NanoAb candidates of their respective target molecules. Following the above progress, BiondVax decided earlier this month to initially focus on developing additional pipelines starting with NanoAbs as drug candidates for the potential treatment of psoriasis, psoriatic arthritis and asthma.
These recent successful developments provide BiondVax with the opportunity to not only initiate a Phase 1/2a clinical trial of its inhaled therapeutic NanoAb against COVID-19 next year as planned, but also to significantly expand its portfolio of NanoAbs by development. Accordingly, the proceeds from the F-1’s contemplated firm commitment subscription equity issuance are designed to provide BiondVax with the capital necessary to continue to aggressively execute its strategy.
In addition, BiondVax has 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 equity to maintain the listing. Nasdaq’s notification letter was based on BiondVax’s Form 6-K/A, dated August 29, 2022disclosing financial information for the period ended June 30, 2022which had equity of $1,277,000and noted that BiondVax does not follow the market value alternatives for listed securities or net income from continuing operations.
The letter says that under Nasdaq listing rules, BiondVax has 45 calendar days to submit a plan to Nasdaq to restore compliance with the minimum shareholder listing requirement. If a plan is submitted by BiondVax, and if accepted by Nasdaq, Nasdaq may grant an extension of up to 180 days from the date of Nasdaq’s letter for BiondVax to demonstrate compliance with the requirement. registration in the minimum capital of the shareholders. If BiondVax submits a plan and the plan is not accepted by Nasdaq, BiondVax will have the opportunity to appeal that decision to a Nasdaq Hearing Panel under Nasdaq Listing Rule 5815( has).
The notification letter has no immediate effect on the listing of BiondVax’s ADSs, and its ADSs will at this time continue to trade on the Nasdaq Capital Market under the symbol “BVXV”.
The proposed share offering, if carried out, would correct the shareholders’ equity deficit. In addition, BiondVax will pursue additional definitive steps to regain and maintain compliance with Nasdaq listing rules.
Amir ReichmanCEO of BiondVax, explained, “As we updated last week, in addition to the next steps in COVID-19 NanoAb, following the exciting progress made by our collaborating scientists at the Max Planck Institute for Multidisciplinary Sciences (MPG) and Medical Center University of Göttingen (UMG), we intend to advance the development of additional NanoAbs for the treatment of diseases such as asthma, psoriatic arthritis and psoriasis Although the stock market remains unfavorable, particularly for companies capitalization, we believe that aggressively advancing our programs is the best path to creating shareholder value that will be reflected when the market regains some stability.We consider the registration statement filed yesterday for an equity offering offered as part of a well-designed set of activities to ensure that BiondVax continues to deliver. sion to pursue an offer was made prior to the letter of non-compliance, we are optimistic that the successful conclusion of the offer will remedy the deficiency and put the problem behind us. Out of an abundance of caution, we will pursue additional measures in parallel, consistent with our proactive approach to restructuring our loan with the European Investment Bank, as previously announced.”
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and marketing innovative products for the prevention and treatment of infectious and other diseases. Since its inception, BiondVax has completed eight clinical trials, including a phase 3 trial in seven countries and 12,400 participants of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceuticals. With highly experienced leadership in the pharmaceutical industry, BiondVax aims to develop a pipeline of diverse and commercially viable products and platforms, starting with an innovative nanoscale antibody (NanoAb) pipeline. www.biondvax.com.
Company: Joshua E. Phillipson | +972 8 930 2529 | [email protected]
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 fact, included in this communication regarding strategy, future operations, future funding, future financial condition, future revenues, projected expenditures, 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 nanoscale antibodies (NanoAbs); and the timing of proof-of-concept studies and NanoAb clinical trials. These forward-looking statements reflect management’s current beliefs with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause actual results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. . The risks and uncertainties include, but are not limited to, the risk that the company will not be able to 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 realized; the risk of delay of preclinical and clinical data of the NanoAbs, if any; the risk that BiondVax may not be able to obtain additional capital on attractive terms, if at all; risks related 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 not at all; time of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, as appropriate or required; the risk that the manufacturing facility cannot be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development will involve a long and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company can be found 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.
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SOURCE Biondvax Pharmaceuticals Ltd