JERUSALEM, April 17, 2023 (GLOBE NEWSWIRE) -- 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.
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.
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 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.
U.S. dollars in thousands (except share and per share data)
|Cash and cash equivalents||$||12,650||$||17,241|
|Restricted short-term deposit||140||143|
|Prepaid expenses and other receivables||155||326|
|Total current assets||14,370||17,843|
|Property, plant and equipment, net||11,245||12,386|
|Operating lease right-of-use assets||1,452||1,807|
|Total non-current assets||12,697||14,193|
|LIABILITIES AND SHAREHOLDERS’ EQUITY|
|Operating lease short-term liabilities||382||375|
|Total current liabilities||7,667||2,444|
|Loan from others||20,082||27,164|
|Operating lease long-term liabilities||1,078||1,446|
|Total non-current liabilities||21,160||28,610|
|CONTINGENT LIABILITIES AND COMMITMENTS|
|Ordinary shares of no par value: Authorized: 20,000,000,000 shares at December 31, 2022, and 1,800,000,000 at December 31, 2021; Issued 989,290,784 shares at December 31, 2022 and 739,048,544 shares at December 31, 2021.||-||-|
|Additional paid-in capital||116,082||113,076|
|Other comprehensive loss||(2,007||)||(2,055||)|
|Total shareholders’ equity||(1,760||)||982|
|Total liabilities and shareholders’ equity||$||27,067||$||32,036|
STATEMENTS OF COMPREHENSIVE LOSS
U.S. dollars in thousands (except share and per share data)
|Research and development||$||5,765||$||3,249|
|Marketing, general and administrative||5,296||7,625|
|Total operating loss||11,061||10,862|
|Financial income, net||(5,265||)||(2,656||)|
|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).