BiondVax Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

JERUSALEM, March 28, 2022 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today published its fourth quarter and full year financial results for the year ended December 31, 2021 and provided a business update. At the same time, the Company filed its Annual Report on Form 20-F with the Securities and Exchange Commission.

Business Update

• BiondVax signed an exclusive license agreement for the development and commercialization of a COVID–19 innovative nanosized antibody (NanoAbs) therapy in December 2021 with the Max Planck Institute for Multidisciplinary Sciences (MPG) and University Medical Center Göttingen (UMG), Germany.
• BiondVax signed an additional definitive collaboration agreement in March 2022 with MPG and UMG for development of a pipeline of NanoAb therapies addressing diseases with large unmet medical needs and attractive commercial opportunities such as asthma, psoriasis, psoriatic arthritis, and macular degeneration; BiondVax has the option for an exclusive worldwide license for further development and commercialization of each of these NanoAbs.
• In-house manufacturing: BiondVax has initiated preparations for the manufacturing of NanoAbs at the Company's GMP biologics manufacturing facility in Jerusalem, including acquiring and installing additional equipment and hiring talent highly experienced in the field. Owning a biological GMP manufacturing site provides BiondVax with a competitive edge compared to other development stage biotechnology companies as it reduces its dependency on contract manufacturers, allows direct control over manufacturing of the entire NanoAb pipeline during development and enhances preparedness for seamless clinical supplies and future commercial launch. It also provides the opportunity to create additional intellectual property.
• The European Investment Bank (EIB) has indicated that it supports BiondVax's strategic turnaround plans. In March 2022, the EIB agreed in principle to extend the maturity of its loan until December 2027 with additional terms that provide continued long-term support for BiondVax.
• Jay Green, former Senior Vice President Finance and CFO of GlaxoSmithKline plc (NYSE: GSK) global vaccines business, joined BiondVax's Board of Directors in December 2021.

Amir Reichman, BiondVax's CEO, stated, "I am very happy with our recent strategic developments which launch a new era for BiondVax. These achievements are very much in line with our strategy to build a broad product pipeline which strongly leverages BiondVax's research and clinical development expertise and in-house manufacturing capabilities. We are excited to work with our collaborators at Max Planck and UMG, both considered world class scientific institutions, as we progress the entire NanoAb opportunity."

Mr. Reichman continued, "Our initial goal is to demonstrate proof of concept of inhaled NanoAb therapy in animals in 2022 and conduct human clinical trials in 2023. In parallel, we will begin to generate NanoAbs for the additional indications covered by the new research collaboration agreement, creating a robust pipeline for the Company with multiple opportunities for strategic partnering."

Full Year 2021 Financial Summary

As BiondVax is based in Israel, results are recorded in New Israel Shekels (NIS) and a convenience translation to $US is provided using the exchange rate of 3.11 (NIS/$US), the rate as of the close of business on December 31, 2021.

• Total operating expenses for 2021 were NIS 34.8 million ($11.2 million), compared with NIS 68.8 million in 2020, which were offset by other income of NIS 75.4 million due to the revaluation of the EIB loan.
• R&D expenses for 2021 amounted to NIS 10.3 million ($3.3 million) compared with NIS 51.4 million in 2020.
• Marketing, general and administrative expenses for 2021 were NIS 24.5 million ($7.8 million) compared with NIS 16.7 million in 2020.

Fourth Quarter 2021 Financial Summary

• Total operating expenses for the three months ended December 31, 2021 were NIS 10.9 million ($3.5 million) compared with NIS 12.1 million for the three months ended December 31, 2020. 
• R&D expenses for the three months ended December 31, 2021 decreased to NIS 3.6 million ($1.15 million) from NIS 7.8 million for the three months ended December 31, 2020. This decrease was primarily attributable to expenses related to a Phase 3 clinical trial and related operations at our biologics manufacturing facility that was completed during Q4 2020.
• Marketing, general and administrative expenses for the three months ended December 31, 2021 increased to NIS 7.3 million ($2.3 million) from NIS 4.2 million for the three months ended December 31, 2020. This increase was primarily due to an increase in compensation, consulting and legal services, and other related expenses, in support of changes in corporate strategy and management during 2021.

As of December 31, 2021, BiondVax had cash and cash equivalents of NIS 54 million ($17.4 million) as compared to NIS 9.4 million as of December 31, 2020. The increase in cash was primarily due to secondary offerings of shares in February and December 2021, which resulted in gross proceeds of $13.8 million and $9.8 million, respectively.

The complete audited financial results are available in the Company's Annual Report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission. A summary is included in the tables below.

About BiondVax

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, 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 Details

Company: Joshua E. Phillipson | +972 8 930 2529 | [email protected]  
Investor Relations: Kenny Green | +1 212 378 8040 | [email protected]

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 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 clinical trials, the therapeutic and commercial potential of NanoAbs and execution of a definitive amendment agreement with EIB. 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 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 and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; 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 25, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.  

The notes in the Company's quarterly and annual reports are an integral part of the financial statements. The complete financial results are available in the Form 20-F filed with the Securities and Exchange Commission.

SOURCE BiondVax Pharmaceuticals Ltd.