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BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) Provides Business Update, Reports FY2022 Financial Results

  • Biotechnology innovator BiondVax Pharmaceuticals recently provided a business update and published full-year financial results for the period ended December 31, 2022
  • Achievements realized to date leave CEO Amir Reichman optimistic about the company’s growth potential and ability to deliver value to shareholders
  • The company enjoys definitive, exclusive agreements including options for exclusive worldwide licenses with the Max Planck Society and the University Medical Center Göttingen, Germany to enable it to build a pipeline of ‘biobetter’ nanosized VHH antibodies (“NanoAbs”)
  • Pipeline to target diseases with attractive commercial opportunities such as psoriasis, psoriatic arthritis, COVID-19, macular degeneration and asthma

Biotechnology innovator BiondVax Pharmaceuticals (NASDAQ: BVXV) recently provided a business update, published its full-year financial results for the period ended December 31, 2022, and filed its annual report on Form 10-K with the Securities and Exchange Commission (“SEC”) (https://nnw.fm/03KoB). The business update reflected recent highlights and achievements that company CEO Amir Reichman says leave him “optimistic about BiondVax’s growth potential and ability to deliver value to our stakeholders.”

A developmental stage biotech company keen on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, BiondVax in late 2021 and early 2022 entered into definitive agreements with the Max Planck Society (“MPG”)’s Max Planck Institute for Multidisciplinary Sciences (“MPI-NAT”) and the University Medical Center Göttingen, Germany (“UMG”) to enable the company build a pipeline of ‘biobetter’ nanosized VHH antibodies (“NanoAbs”).

These alpaca derived NanoAbs not only possess unique physicochemical characteristics – such as target neutralization at lower drug concentrations, convenient routes of administration, formulation advantages, stability at high temperatures, and greater binding affinity – but also exhibit strong potential for a number of significant competitive advantages over currently approved human monoclonal antibodies (“mAbs”) targeting diseases with attractive commercial opportunities.

“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,” the business update reads.

Furthermore, the company believes the focus on NanoAbs with targets already validated by mAbs will help reduce the upfront costs and risks commonly associated with new drug development, especially given that the mechanism of action of antibodies on target molecules has already been established. Thus, the initiation of clinical development would be accelerated. Moreover, the company holds, “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.”

The BiondVax-MPG-UMG agreements include an exclusive worldwide licensing agreement allowing the company to develop and commercialize anti-SARS-CoV-2 NanoAbs. Subsequently, BiondVax developed innovative inhaled anti-SARS-CoV-2 NanoAbs that were the subject of a successful preclinical in vivo study evaluating their therapeutic and prophylactic capabilities. The study unearthed highly positive results showing showed that the NanoAbs not only virtually eliminated the virus in the lungs (https://nnw.fm/r55Bq) and led to a significantly shorter and milder illness (https://nnw.fm/yIJUl) but also prevented illness (https://nnw.fm/EPdTj). Guided by these positive results, the company is currently assessing plans to commence a Phase 1/2a clinical trial.

The company also holds an exclusive option for an exclusive worldwide license agreement at pre-agreed financial terms for additional NanoAbs discovered and characterized under the agreement. Against this backdrop and based on promising results from a research collaboration agreement (“RCA”) with MPI-NAT and UMG, BiondVax last year announced its intention to next focus development on NanoAbs that target immune system cytokines such as IL-17, IL-13, and TSLP as drug candidates for the potential treatment of psoriasis, psoriatic arthritis, and asthma (https://nnw.fm/GYwr2).

“Looking ahead, 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,” CEO Amir Reichman stated.

The company also plans to offer interested parties its cGMP manufacturing capabilities, including experienced professionals for CDMO (Contract Development and Manufacturing Organization) services, laboratories, and aseptic fill and finish suite, with the objective of optimizing the use of its assets and generating revenues. Still, the company will prioritize its NanoAb pipeline development, extending its focus on research and development (“R&D”), which saw the company increase its R&D expenses from $3.2 million in 2021 to $5.7 million in 2022.

“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,” Reichman added. “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.”

As documented in its financial summary, BiondVax also reported cash and cash equivalents of $14 million and working capital of $6.7 million as of December 31, 2022. According to the Form 10-K filing, the company expects its existing capital resources will enable it to fund its operating expenses and capital expenditure requirements for at least the next 12 months (https://nnw.fm/EhJiq).

For more information, visit the company’s website at www.BiondVax.com.

NOTE TO INVESTORS: The latest news and updates relating to BVXV are available in the company’s newsroom at https://nnw.fm/BVXV

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