Press Releases

Josh Phillipson Josh Phillipson

BiondVax Reports Second Quarter Financial Results and Provides Business Update

Jerusalem, Israel – Aug. 11, 2023 – 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, announced the publication today of its financial results for the second quarter ended June 30, 2023, and provided a business update.

Second Quarter 2023 Financial Summary

  • R&D expenses for the three months ended June 30, 2023, amounted to $1.45 million compared with $1.97 million for the three months ended June 30, 2022.

  • Marketing, general and administrative expenses for the three months ended June 30, 2023, amounted to $1.14 million compared with $1.29 million for the three months ended June 30, 2022.

  • Total operating expenses for the three months ended June 30, 2023, amounted to $2.56 million compared with $3.26 million for the three months ended June 30, 2022.

  • Financial (loss) income for the three months ended June 30, 2023, amounted to $1.16 million loss compared with $0.28 million income for the three months ended June 30, 2022.

  • Net loss for the three months ended June 30, 2023, amounted to $3.76 million compared with $2.98 million for the three months ended June 30, 2022.

As of June 30, 2023, BiondVax had cash and cash equivalents of $7.6 million as compared to $14.2 million as of December 31, 2022. In the six months ended June 30, 2023, BiondVax had an operating loss of $7.3 million and negative cash flows from operating activities of $5.9 million. BiondVax’s current operating budget includes various assumptions concerning the level and timing of cash receipts and cash outlays for operating expenses and capital expenditures, including a cost-savings plan. BiondVax is planning to finance its operations from its existing working capital resources and additional sources of capital and financing with respect to which the Company has initiated actions. However, there is no assurance that additional capital and/or financing will be available to BiondVax, and even if available, whether it will be on terms acceptable to BiondVax or in amounts required. Accordingly, BiondVax’s board of directors approved the cost-savings plan mentioned above, to be implemented if and as required, in whole or in part, at its discretion, to allow BiondVax to continue its operations and meet its cash obligations. The cost-savings plan consists of cutting expenditures by means of further efficiencies and synergies, which include mainly the reduction in headcount and postponing or cancelling capital expenditures that would not be required for the implementation of the revised business plan. BiondVax’s board of directors believes that BiondVax’s existing financial resources, potential successful capital raisings and its current operating plans (including the possible disposition of assets outside the ordinary course of business) and restructuring of debt, along with the effects of the cost-savings plan, may be adequate to satisfy its expected liquidity requirements for a period of at least twelve months from the date hereof, although there is no guarantee.

BiondVax’s unaudited financial results will be submitted to the Securities and Exchange Commission on Form 6‑K. 

Business Update

  • CDMO

    • As announced previously, BiondVax has decided to leverage its aseptic manufacturing site and laboratories by creating a CDMO business unit in parallel to its innovative R&D business unit. The CDMO business unit offers biological drug development services with a focus on preclinical and small clinical stage biopharmaceutical companies. These companies tend to have limited capital and require cost effective drug development services that can be executed in very short timelines. These companies also typically lack the resources required to build their own laboratories and production lines for biological drug development. They also often encounter challenges working with large CDMOs due to the relatively high costs, long timelines and lack of agility in their processes. To overcome these challenges, preclinical and small clinical stage companies may outsource product development to a boutique CDMO such as the one owned by BiondVax. In particular, BiondVax’s CDMO business unit allows clients to leverage BiondVax’s expertise in process development, optimization, scale-up, GMP manufacturing for clinical trials, and navigating complex regulatory frameworks. Additional information is available at www.biondvax.com/cdmo

  • Pipeline Development

    • In June 2023, BiondVax signed an exclusive license agreement with Max Planck Innovation for development and commercialization of a novel anti-IL-17 NanoAb (VHH antibody) for treatment of autoimmune and inflammatory diseases including psoriasis. We are aggressively advancing the NanoAb preclinical development and expect the IL-17 NanoAb to enter clinical testing in 2024.

    • BiondVax is pursuing a strategic partnership for its COVID-19 self-administered inhaled NanoAb therapeutic/prophylactic which demonstrated highly promising in vivo results in animals.

    • NanoAbs for treatment of additional autoimmune diseases such as asthma and wet AMD are being developed at Max Planck and University Medical Center Göttingen as part of their research collaboration agreement with BiondVax. BiondVax holds exclusive options for exclusive licenses at pre agreed financial terms for each of the resulting nanoAbs.

About BiondVax: 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.

Company Contact Details: 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 press release regarding cash liquidity, strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements.  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, and the risk that BiondVax may not be able to execute its operating plan; 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. 

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Josh Phillipson Josh Phillipson

Nasdaq Grants BiondVax Extension to Regain Compliance with Listing Rules

Jerusalem, Israel – Aug. 1, 2023 – 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 announced that Nasdaq reviewed BiondVax’s multi-faceted plan to regain compliance with Nasdaq’s Listing Rule 5550(b) and provided it an extension until October 30, 2023, to demonstrate compliance.

As previously disclosed, BiondVax received a deficiency letter dated May 1, 2023, from Nasdaq notifying the Company that it is not in compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market.

“We are very pleased that NASDAQ has reviewed our plan and provided us the time to proceed with various initiatives already underway that alone or together will allow us to regain compliance with the shareholders’ equity listing requirement,” said Mr. Amir Reichman, BiondVax’s CEO.  “Among other things we are pursuing a strategic partnership for our COVID-19 self-administered inhaled therapeutic/prophylactic product and advancing ahead of schedule our IL-17 NanoAb inhibitor for the treatment of autoimmune diseases such as psoriasis. This is expected to enter the clinic in 2024.”

“In addition, we decided to leverage our state-of-the-art biologics pilot manufacturing plant by commencing a new contract manufacturing and development services business unit (CDMO),” Reichman continued. “The need for CDMO services by small biotech companies is high and growing and the current offerings by large, multi-national CDMO companies are expensive and with limited available capacity. Our site is a perfect match for a small biotech in that it is well equipped, staffed with highly trained personnel, and its business and quality processes are in place. We see quite a lot of demand for our services and are aggressively pursuing clients. If successful, this business unit could generate meaningful income in the relatively short term.”

BiondVax has provided Nasdaq with its business plan, which includes the pursuit of several non-dilutive grants, potential capital-raising transactions, and development of the company’s new CDMO business. Based on BiondVax’s plans, Nasdaq has provided an extension of time until October 30, 2023, for the company to demonstrate it has regained compliance. In the event the Company fails to show compliance upon filing its annual report on Form 20-F for the year ended December 31, 2023, it may receive notification from Nasdaq that its securities will be delisted; should this occur, the Company may appeal Nasdaq’s determination to a Hearings Panel.

 

About BiondVax: 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.

Company Contact Details: 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 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 preclinical 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.

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Josh Phillipson Josh Phillipson

BiondVax signs exclusive license agreement for development and commercialization of a novel anti-IL-17 antibody for treatment of autoimmune and inflammatory diseases including psoriasis

  • Broad-based collaboration with Max Planck and University Medical Center Gottingen yields attractive anti-IL-17 VHH antibodies (NanoAbs); includes exclusive worldwide license for all potential indications, beginning with psoriasis.

  • BiondVax to lead development and commercialization of NanoAbs with potential to neutralize IL-17A, IL-17F and IL-17A/F isoforms with high potency; ex vivo proof-of-concept expected this year, in vivo early next year.

  • Psoriasis affects over 3% of U.S. population, with global biologics treatment market over $9B annually and growing with 7% CAGR.

  • Adds to BiondVax’s pipeline of bio-better antibodies targeting diseases with large unmet medical needs, attractive commercial opportunities, and that exhibit significant competitive advantages over existing therapies; recent preclinical in vivo data indicated that BiondVax’s anti‑SARS‑CoV‑2 NanoAb virtually prevented illness when inhaled prophylactically and led to a significantly shorter and milder illness when inhaled therapeutically.

Jerusalem, Israel – June 5, 2023 – 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 announces that as part of its ongoing broad-based collaboration with the Max Planck Society and the University Medical Center Gottingen (UMG), it has signed an exclusive worldwide license agreement to develop and commercialize VHH antibodies (NanoAbs) targeting Interleukin-17 (IL-17) as treatments for all potential indications, starting with psoriasis and psoriatic arthritis.

“The license of the IL-17 NanoAb from Max Planck is not only an exciting opportunity to develop a unique treatment for psoriasis and other autoimmune diseases, but another validation of the productivity of our collaboration with Max Planck and UMG and portends additional significant developments to follow,” said Mr. Amir Reichman, BiondVax’s CEO. “Psoriasis affects millions of people worldwide, and we believe our NanoAbs have the potential to provide a much-needed and vastly improved treatment option.”

I wish to thank Professor Dirk Görlich of the Max Planck Institute for Multidisciplinary Sciences and Professor Matthias Dobbelstein of the University Medical Center Göttingen for their valued research collaboration, and Dr. Dieter Link of Max Planck Innovation and his team for their continued support. Our recent experience with tech-transfer, in-house process development, scale-up and manufacturing of the COVID NanoAb, leading to a highly successful preclinical study, attests to the strong potential of this unique collaboration to develop bio-better NanoAbs addressing underserved medical needs for millions of patients,” Reichman continued.

We are very pleased that the next VHH antibody candidates out of a larger group pursued by the collaborators have successfully been generated, discovered and characterized by the Max Planck Institute of Multidisciplinary Sciences. BiondVax is well positioned to move this closer to and into clinical application,” commented Dr. Dieter Link, patent and licensing manager at Max Planck Innovation, the technology transfer organization of the Max Planck Society (MPG).

 

IL-17’s Role in Disease

The IL-17 family of cytokines consists of six isoforms. Among these, IL-17A, IL-17F, and the IL-17A/F complex are particularly important in immune regulation and inflammation. Excess presence of IL‑17 is implicated in a wide range of autoimmune and inflammatory diseases including psoriasis, and therefore is the molecular target for several commercially available therapeutics.

Psoriasis is a chronic autoimmune disease that causes inflammation and scaling of the skin. The National Psoriasis Foundation notes that the disease affects more than 7.5 million adults in the U.S. and an estimated 125 million people worldwide. The most common form of psoriasis, representing 80%-90% of cases, is plaque psoriasis. Current plaque psoriasis treatments include topical steroid creams, phototherapy, oral drugs and several injectable biologicals. According to industry sources, the current biologics treatment market for psoriasis is over $9 billion per year and the anti-17 antibody market is growing at 9% CAGR.

Of the biological treatments, monoclonal antibodies (mAbs) targeting IL-17A were the first mAbs to be approved for treatment of plaque psoriasis. The latest and most effective mAbs for the treatment of plaque psoriasis that are currently marketed, as well as those that, to BiondVax’s knowledge, are under clinical development by other companies, target not only IL-17A but also IL-17F and IL-17A/F complex. It has been demonstrated in clinical trials that targeting both IL‑17A and IL-17F generates superior clinical efficacy in treatment of plaque psoriasis, as IL‑17F is the most abundant IL-17 isoform in the psoriatic lesions. Currently available mAb therapies for psoriasis require inconvenient systemic injection every four to eight weeks, are approved only for treatment of moderate to severe plaque psoriasis (representing only 25% of plaque psoriasis patients) and are associated with adverse side effects including exacerbation of IBD.

Bio-Better NanoAbs

In contrast to mAb therapies, the single-monomer NanoAb licensed by BiondVax may be effective even at extremely low concentrations, against all three key isoforms of IL-17. This potential multi‑target effect by a single NanoAb creates an opportunity for a significantly more effective therapeutic, at lower doses and with fewer side effects, for a broader range of disease conditions in addition to plaque psoriasis such as psoriatic arthritis and hidradenitis suppurativa. BiondVax’s NanoAbs, which are approximately one tenth the size of a standard mAb, are expected to have better tissue penetration thanks to their small size, and in lab experiments have demonstrated superior thermostability, which could translate to superior shelf life, easier transportation, and more convenient routes of administration.

Development Pathway

Under the BiondVax-MPG-UMG research collaboration agreement, NanoAb candidates must satisfy rigorous criteria relating to binding affinity, neutralization of the target and other attributes prior to being in-licensed by BiondVax. An ex vivo proof-of-concept for psoriasis using the anti-IL-17 NanoAb in a psoriatic human skin model is expected later this year. BiondVax plans to initiate a preclinical in vivo efficacy study in 2024 followed later by human clinical trials.

As an initial target indication, BiondVax plans to test the antibody in humans with local, intradermal injections directly to psoriatic lesions to test the NanoAb’s ability to provide a safe and affordable biologic treatment for mild to moderate psoriatic patients for whom the available mAbs are not authorized, and who represent 85% of plaque psoriasis cases. BiondVax is working on plans to develop the drug also as a subcutaneous injection for systemic treatment targeting patients with moderate to severe plaque psoriasis.

Innovative NanoAb Platform and Collaboration

BiondVax’s NanoAb platform targets treatments of diseases with large unmet medical needs and attractive commercial opportunities, such as COVID-19, psoriasis, psoriatic arthritis, asthma and macular degeneration. NanoAbs exhibit several advantages over conventional antibody treatments, including improved stability, increased potency and the potential for safer and more convenient routes of administration.

The NanoAbs are being developed as part of a broad collaboration with the world-leading research institutes Max Planck Institute of Multidisciplinary Sciences and the University Medical Center Göttingen. Recent positive preclinical in vivo data indicates BiondVax’s innovative inhaled anti‑SARS‑CoV‑2 NanoAb virtually prevented COVID-19 illness when administered prophylactically to hamsters. 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’s NanoAb platform has the potential to address a wide range of unmet medical needs, and the company is committed to developing innovative therapies that improve the lives of patients.

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About BiondVax: 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.

About the Max Planck Institute for Multidisciplinary Sciences: The Max Planck Institute (MPI) for Multidisciplinary Sciences was founded on 1 January 2022 through the merger of two existing Göttingen institutes, the MPI for Biophysical Chemistry and the MPI for Experimental Medicine. The two locations of the institutes remained City Campus and Faßberg Campus. At the Institute, we explore scientific issues ranging from physics and chemistry to structural and cell biology, neuroscience and biomedical research. Basic research in the natural sciences can thus be linked even more effectively with medical research approaches. We are guided by the conviction that great scientific discoveries can be achieved when scientists from different disciplines and research cultures - such as physics, chemistry and biology - work together and exchange ideas in an unbiased way. https://www.mpinat.mpg.de/en.

About University Medical Center Göttingen: The University Medical Center Göttingen (UMG) is one of Germany’s leading medical centers. With funding allocated by the state of Lower Saxony and third-party funding, UMG conducts research at the very highest level and are one of the largest medical faculties in Germany, based on the number of students enrolled. The Medical Faculty is as old as the University itself, founded in 1737. The UMG is the region’s largest employer and training institution. As the only maximum care medical center in the region, UMG takes on responsibility for inpatient and outpatient care of difficult, complex, and special cases and is an integral part of the emergency medical services in Southern Lower Saxony. www.umg.eu/en/.

About Max Planck Innovation: As the technology transfer organization of the Max Planck Society, Max Planck Innovation is the link between industry and basic research. With our interdisciplinary team, we advise and support scientists at the Max Planck Institutes in evaluating inventions, filing patents and starting businesses. We offer industry central access to the innovations of the Max Planck Institutes. We are therefore fulfilling an important task: The transfer of results from basic research into commercially and socially useful products. www.max-planck-innovation.com.

Contact: 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 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 preclinical clinical studies, and the therapeutic and commercial potential of anti-IL-17 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 of delay of preclinical studies for anti-IL-17 NanoAbs; 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 obtaining preclinical and clinical data for NanoAbs, if any; the risk that the Company’s 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.

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Josh Phillipson Josh Phillipson

BiondVax Announces First Quarter 2023 Financial Results and Provides Business Update

Jerusalem, Israel - May 15, 2023 - 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 financial results for the first quarter ended March 31, 2023, and provided a business update.

First Quarter 2023 Financial Summary

  • R&D expenses for the three months ended March 31, 2023, amounted to $2 million compared with $1.2 million for the three months ended March 31, 2022. The increase of $0.8 million was primarily due to the initiation of R&D activities for the innovative nanosized antibody (NanoAb) platform.

  • Marketing, general and administrative expenses for the three months ended March 31, 2023, amounted to $1.2 million compared with $1.4 million for the three months ended March 31, 2022.

  • Total operating expenses for the three months ended March 31, 2023, amounted to $3.2 million compared with $2.6 for the three months ended March 31, 2022.

  • Financial (loss) income for the three months ended March 31, 2023, amounted to $(0.3) million compared with $0.14 million for the three months ended March 31, 2022.

  • Net loss for the three months ended March 31, 2023, amounted to $3.5 million compared with $2.47 million for the three months ended March 31, 2022.

As of March 31, 2023, BiondVax had cash and cash equivalents of $10.9 million as compared to $14.2 million as of December 31, 2022. The decrease in cash from December 31, 2022, to March 31, 2023, was primarily due to net cash used in operating activities of $3.1 million.

The complete unaudited financial results are available in the Company's Quarterly Report on Form 10-Q for the period ended March 31, 2023, filed with the Securities and Exchange Commission. A summary is included in the tables below.

Business Update

  • 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. Additional information is available at www.biondvax.com/cdmo.

  • 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. The Company previously 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.

  • In pursuit of scientific and business development collaborations, in Q1 2023, the Company attended the BioTech Showcase 2023 in San Francisco, the BIO CEO & Investor Conference in New York, and BIO Europe Spring in Basel, Switzerland.

About BiondVax: 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.

Contact Details: Investor Relations | +972 8 930 2529 | ir@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 preclinical 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.  

CONDENSED BALANCE SHEETS (Unaudited)
U.S. dollars in thousands (except share and per share data)

March 31, December 31,
2023 2022
Unaudited Audited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$10,799 $14,075
Restricted cash
127 140
Prepaid expenses and other receivables
119 155
Total current assets
11,045 14,370
NON-CURRENT ASSETS:
Property, plant and equipment, net
10,817 11,245
Operating lease right-of-use assets
1,430 1,452
Total non-current assets
12,247 12,697
Total assets
$23,292 $27,067
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables
$1,313 $716
Operating lease liabilities
420 382
Other payables
846 1,240
Total current liabilities
2,579 2,338
NON-CURRENT LIABILITIES:
Warrants liability
2,664 5,329
Loan from others
21,851 20,082
Non-current operating lease liabilities
1,008 1,078
Total non-current liabilities
25,523 26,489
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS' EQUITY (DEFICIT):
Ordinary shares of no par value: Authorized: 20,000,000,000 shares at March 31, 2023, and at December 31, 2022; Issued and outstanding 1,313,623,184 shares at March 31, 2023, and 989,290,784 shares at December 31, 2022
- -
Additional paid-in capital
116,431 116,082
Accumulated deficit
(119,350) (115,835)
Accumulated other comprehensive loss
(1,891) (2,007)
Total shareholders' deficit
(4,810) (1,760)
Total liabilities and shareholders' deficit
$23,292 $27,067

CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
U.S. dollars in thousands (except share and per share data)

Three months ended
March 31,
2023 2022
Unaudited Unaudited
Research and development
$1,995 $1,163
Marketing, general and administrative
1,191 1,452
Total operating loss
3,186 2,615
Financial loss (income), net
329 (140)
Net loss
$3,515 $2,475
Basic and diluted net loss per share
(0.003) (0.003)
Weighted average number of shares used for computing basic and diluted net loss per share
1,295,256,604 744,711,465

The accompanying notes in the Company's financial report are an integral part of the financial statements. The complete financial results are available on Form 10-Q filed with the Securities and Exchange Commission (SEC).


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BiondVax Files FY 2022 Financial Statements and Annual Report on Form 10-K and Provides Business Update

Jerusalem, Israel - April 17, 2023 - 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.

About BiondVax: 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.

Contact Details: Investor Relations | +972 8 930 2529 | ir@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.  

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BiondVax to Present at BIO-Europe Spring

Jerusalem, Israel - March 16, 2023 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, announces today that its CEO Amir Reichman will be presenting in-person at the 17th annual BIO-Europe Spring taking place March 20–22, 2023, in Basel, Switzerland. The event is expected to bring together over 2,800 executives from biotech, pharma and finance companies to engage in 15,000+ one-to-one meetings. 

Presentation Details:

  • Date: Tuesday, March 21, 2023

  • Time: 11:30 a.m.

  • Location: Messe Basel, North Entrance, Exhibit Hall Stage

Reichman’s presentation will focus on recent successful preclinical in vivo results of BiondVax’s innovative inhaled COVID-19 treatment and additional pipeline plans, including nanosized VHH-antibodies (NanoAbs) for the treatment of autoimmune diseases such as psoriasis, asthma, psoriatic arthritis and macular degeneration. BiondVax’s de-risked R&D strategy includes generating a pipeline of bio-better NanoAbs aimed at molecular targets validated by currently approved monoclonal antibodies (mAbs) addressing diseases with underserved medical needs and attractive commercial opportunities.

Reichman and Joshua Phillipson, Director of Investor Relations and Communications, will be available to meet potential partners, collaborators, and investors. To schedule a meeting with BiondVax register now at https://informaconnect.com/bioeurope-spring/. Alternatively, reach out to the Company directly at the contact information below.

About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. Since its inception, BiondVax has executed eight clinical trials including a seven-country, 12,400-participant Phase 3 trial of its prior 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: 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, acquiring an additional license from Max Planck for the therapeutic and commercial potential of nanosized antibodies (NanoAbs); and the timing of NanoAb proof-of-concept studies and clinical trials and the necessary steps needed for such studies and 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 we may not obtain a second NanoAb license from Max Planck for a NanoAb targeting IL-17 as a treatment for psoriasis, the risk of a delay in proof-of-concept studies and the commencement of clinical trials for NanoAbs, if any, and delays in the necessary steps needed for such studies and trials; the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk that clinical trials relating to NanoAbs will fail in whole or in part; 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.

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BiondVax Presenting at BIO CEO & Investor Conference

Jerusalem, Israel – February 2, 2023 – 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, announced today that its CEO Amir Reichman will present at the BIO CEO & Investor Conference. The conference is taking place Feb. 6-9, 2023, in New York.

Reichman’s presentation will focus on recent successful preclinical in vivo results of BiondVax’s innovative inhaled COVID-19 treatment and additional pipeline plans, including nanosized VHH-antibodies (NanoAbs) for the treatment of autoimmune diseases, such as psoriasis, asthma, psoriatic arthritis and macular degeneration. BiondVax’s de-risked R&D strategy includes generating a pipeline of biobetter NanoAbs aimed at molecular targets validated by currently approved monoclonal antibodies (mAbs) addressing diseases with underserved medical needs and attractive commercial opportunities.

Details of BiondVax’s presentation are as follows:

  • Date: Monday, Feb. 6, 2023

  • Time: 4:15 p.m. (ET)

  • Location: Winter Garden Room, New York Marriott Marquis

Reichman and Mark Germain, BiondVax’s chairman of the board, will be available to meet potential partners, collaborators, and investors. Parties registered for the conference are encouraged to schedule one-to-one appointments via the Biotechnology Innovation Organization (BIO) partnering platform at https://www.partnering.bio.org/ceo2023. Alternatively, parties interested in meeting with Reichman and Germain may contact the Company directly at the contact information below.

About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. Since its inception, BiondVax has executed eight clinical trials including a seven-country, 12,400-participant Phase 3 trial of its prior 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: 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, acquiring an additional license from Max Planck for the therapeutic and commercial potential of nanosized antibodies (NanoAbs); and the timing of NanoAb proof-of-concept studies and clinical trials and the necessary steps needed for such studies and 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 we may not a second NanoAb license from Max Planck for a NanoAb targeting IL-17 as a treatment for psoriasis, the risk of a delay in proof-of-concept studies and the commencement of clinical trials for NanoAbs, if any, and delays in the necessary steps needed for such studies and trials; the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk that clinical trials relating to NanoAbs will fail in whole or in part; 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.

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BiondVax’s Innovative Inhaled Anti-SARS-CoV-2 NanoAb Virtually Prevented Illness When Administered Prophylactically in Preclinical In Vivo Study

  • COVID-19 illness was virtually prevented in hamsters administered BiondVax’s inhaled NanoAb and infected three hours later with SARS-CoV-2  

  • Data further strengthens value proposition of BiondVax’s COVID-19 NanoAb as prophylactic and therapeutic drug; Previously announced data indicated NanoAb treatment one day post infection led to significantly milder illness, faster recovery, and lower viral lung titer in comparison to the placebo group

  • First-in-human Phase 1/2a clinical trial is planned for 2023

  • The COVID-19 NanoAb is BiondVax’s first in a new pipeline of innovative NanoAb drugs addressing diseases with large underserved medical needs and attractive commercial opportunities such as psoriasis, asthma, psoriatic arthritis and wet AMD

Jerusalem, Israel – Jan. 23, 2023 – 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 announced additional results in a preclinical proof-of-concept study of its innovative inhaled NanoAb COVID-19 drug. Using an industry-standard animal model, the study compared weight loss in two groups of hamsters. Hamsters administered a mid-sized 0.66mg dose of the NanoAb three hours prior to infection experienced no significant weight loss over the six-day trial, whereas the untreated control group’s weight declined 12% on average, a highly statistically significant difference (p<0.0005).

The study’s design is intended to mimic a real-world situation in which at-risk groups, such as the elderly, people with comorbidities, the immunocompromised, travelers, those attending densely packed social situations such as weddings, sporting events and flights, and front-line health care professionals, may proactively protect themselves ahead of potential exposure to SARS-CoV-2 using BiondVax’s self‑administered inhaled NanoAb therapy.

These promising prophylactic results follow previously reported data from the same study indicating that compared to the control (placebo) group, hamsters treated with a 2mg dose of BiondVax’s inhaled NanoAb one day after infection had negligible (below detection level) SARS-CoV-2 viral titers in their lungs, and experienced a milder and shorter illness in comparison to the placebo group that had at least 30-times higher viral titers in their lungs at the end of the trial. Furthermore, and being reported here for the first time, lung histopathology revealed that therapeutic inhalation of NanoAbs reduced damage to alveoli, pulmonary vessels, and the conductive system.

We continue to be thrilled with the results of this ongoing trial,” stated Amir Reichman, BiondVax’s CEO. “There is strong market demand for COVID prophylactics as evidenced by AstraZeneca’s reported Q1 through Q3 2022 EVUSHELD revenues of $1.5 billion. EVUSHELD is currently the only prophylactic COVID medication with FDA approval, under emergency use authorization. Our inhaled NanoAb is designed to be self-administered at the time of choosing to generate rapid protection from COVID illness. In contrast, EVUSHELD must be administered via two separate consecutive intramuscular (IM) injections in a health care setting, and the FDA has confirmed it does not effectively neutralize recent Omicron variants of concern.”  

“Data from our trial indicate that our NanoAb may effectively serve as both a therapeutic and protective prophylactic drug, which further enhances its value proposition. COVID vaccine uptake is declining, effectiveness wanes over a short period of time, and vaccination campaigns demand vast health care system resources. The way forward must include effective prophylactic and therapeutic drugs. We believe the additional ‘biobetter’ value provided by our NanoAb potentially positions it to capture significant market share both for treatment and prevention of COVID illness,” Mr. Reichman concluded.

BiondVax’s Chief Science Officer (CSO) Dr. Tamar Ben-Yedidia explained, “We anticipate that our convenient self-administered inhaled NanoAbs will be highly attractive to at-risk people wishing to proactively, effectively, conveniently, and safely protect themselves. This builds on the trial’s exciting data indicating that our NanoAbs can also treat COVID illness after infection. We look forward to completing this preclinical trial and moving towards a first-in-human Phase 1/2a clinical trial later this year.”

The study is using an industry-standard animal model for COVID-19 prophylactics, therapeutics, and vaccines. Weight loss is the key parameter for assessing disease severity in hamsters used as experimental animals in development of therapeutics and vaccines for COVID-19 disease. As noted in the paper titled Hamsters as a Model of Severe Acute Respiratory Syndrome Coronavirus-2, hamsters are “an ideal animal model of SARS-CoV-2 infections because they recapitulate many aspects of human infections.” The paper noted that weight loss in hamsters was reduced when treated with REGN-COV2, a human mAb combination therapy that ultimately received FDA approval for SARS-CoV-2 treatment. A similar model was also used by Pfizer when developing Paxlovid, as noted in the paper titled The oral protease inhibitor (PF-07321332) protects Syrian hamsters against infection with SARS-CoV-2 variants of concern.

The study is being conducted by two world-renowned institutions: The Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) and The University of Veterinary Medicine Hannover (TiHo), Germany.

Next steps: This preclinical trial is continuing with additional arms testing lower therapeutic doses (0.66mg and 0.22mg). The study will also evaluate safety parameters. Results of the dosing study will inform the design of future studies of BiondVax’s anti‑COVID‑19 inhaled NanoAb. Specifically, in 2023, BiondVax is expected to conduct a preclinical toxicity study to assess safety as required by regulatory authorities for approval of human clinical trials. The Company is also expected to scale up its manufacturing processes to produce, at its GMP manufacturing site in Jerusalem, the NanoAbs for the first-in-human Phase 1/2a clinical trial, which is planned for Q4 2023.

NanoAb as mAb biobetter: As part of a strategic research collaboration with the Max Planck Institute for Multidisciplinary Sciences and the University Medical Center Göttingen, BiondVax is developing a pipeline of innovative alpaca‑derived nanosized VHH-antibody (NanoAb) therapies addressing diseases with large underserved medical needs and attractive commercial opportunities, such as COVID-19, asthma, psoriasis, psoriatic arthritis, and macular degeneration. While these diseases are currently treated with conventional monoclonal antibodies (mAbs), NanoAbs exhibit the potential to capture significant market share as biobetters. In particular, as reported by Pfizer, Paxlovid has shown the demand for COVID-19 therapeutic treatments with ~$22 billion in sales projected for the year ended Dec. 31, 2022, even with significant limitations of use due to adverse cross-reactions with other drugs and several other comorbidity contraindications that limit its use. In contrast, NanoAbs exhibit strong potential for superior patient convenience, safety, and clinical outcomes, at lower costs. For example, as demonstrated by this preclinical study, BiondVax’s NanoAb is efficacious when administered through inhalation rather than by injection as with currently available COVID-19 mAb therapies. In addition, most of the currently approved mAbs for the treatment of COVID-19 are not sufficiently efficacious against the Omicron variants of concern (VoCs) while BiondVax’s lead drug candidate demonstrated strong neutralization of all SARS-CoV-2 VoCs from Wuhan through Omicron, including the recent BA4/5 and BQ1 sub-variants.

—-

About BiondVax: 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, BiondVax has executed eight clinical trials including a seven-country, 12,400-participant Phase 3 trial of its prior 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: Investor Relations | +972 8 930 2529 | ir@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 of a delay in preclinical trials and the commencement of clinical trials for NanoAbs, if any; the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk that preclinical or clinical trials relating to NanoAbs will fail in whole or in part; the risk that the Company will not be able to scale up its manufacturing processes; 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.

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BiondVax’s Innovative Inhaled COVID-19 Therapy Virtually Eliminated SARS-COV-2 Virus in Preclinical In Vivo Study

  • Hamsters infected with SARS-COV-2 and then treated with BiondVax’s inhaled anti-COVID-19 nanosized antibodies (NanoAbs) had over 30-times lower lung viral titer on average compared to those treated with inhaled placebo

  • Result builds on recently announced data indicating NanoAb treatment led to significantly milder illness and faster recovery in comparison to the placebo group

  • BiondVax’s NanoAbs are being formulated as a convenient self‑administered inhaled drug for treatment and potential prophylactic prevention of COVID-19  

  • First-in-human Phase 1/2a clinical trial planned for 2023

  • The COVID-19 therapy is BiondVax’s first in a new pipeline of innovative alpaca-derived NanoAb therapies addressing diseases with large underserved medical needs and attractive commercial opportunities such as psoriasis and asthma

Jerusalem, Israel – Jan. 6, 2023 – 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, recently announced additional results in a preclinical in vivo proof-of-concept study of its innovative inhaled nanosized antibody (NanoAb) COVID-19 therapy, namely that the presence of the SARS-COV-2 virus in the lungs of hamsters treated with BiondVax’s NanoAb was below detectable levels and significantly (p<0.0005) less than the amount of virus detected in the placebo group.

The first (experimental) group was treated with BiondVax’s anti-COVID-19 NanoAb, administered via inhalation, starting 24 hours after being infected, while the second (control) group was treated in the same manner but with a placebo. The study’s design is intended to mimic a real-world situation in which treatment is provided well after, and not simultaneously, to the moment of infections.

Six days after infection, compared to the placebo group, hamsters treated with BiondVax’s inhaled NanoAb not only had over 30 times lower SARS-COV-2 viral titers in their lungs as measured by median tissue culture infectious dose (TCID50) but also those levels were at the border of detection, suggesting potential virtual elimination of the virus from their lungs. These results were corroborated also by PCR.

As reported on Nov. 29, 2022, the efficacy of BiondVax’s inhaled COVID-19 NanoAb is also supported by additional data from the same study showing that compared to their weight immediately prior to infection, the control group’s weight declined on average 12.01%, while the weight of the experimental group, which was administered BiondVax’s NanoAb through inhalation, declined on average only 3.80%, a highly statistically significant result (p<0.001). These successful results were further supported by eight other tracked parameters, including heart rate and social behaviors, that indicated the group treated with inhaled NanoAbs experienced a milder and shorter illness.

Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer (CSO), explained, “These lung viral titer results indicate that our inhaled NanoAbs essentially eliminated viral presence in the lungs, and led to a shorter and milder illness. This data is unequivocal and exciting. We’re looking forward to continuing this study this month by testing additional dose levels of the inhaled NanoAb therapy and as a prophylactic (preventive) treatment. Results of the trial will inform design of the first-in-human clinical trial of the inhaled NanoAb COVID-19 therapy, which is planned for late 2023.

Amir Reichman, BiondVax’s CEO, stated, “We are thrilled with the results of this ongoing trial. This study is not only a proof-of-concept for the inhaled COVID-19 NanoAb, but also lights the way to development of a larger NanoAb pipeline. The current Omicron outbreak in China has demonstrated that continuous development of innovative and safe therapeutics for COVID-19 is the more effective and economical way to contain this disease. Having a self-administered inhaled therapeutic for those already infected that may also be used as prophylactic prevention for those at risk will address current unmet needs, potentially bring massive relief to global public health, and save millions of lives going forward. I’m proud of the BiondVax team who are scaling-up in-house manufacturing of the NanoAbs and are already beginning to prepare for the next NanoAbs as therapies for other underserved medical conditions such as psoriasis and asthma.” 

The study is using an industry-standard animal model for COVID-19 therapeutics and vaccines. Weight loss is the key parameter for assessing disease severity in hamsters used as experimental animals in development of therapeutics and vaccines for COVID-19 disease. As noted in the paper titled Hamsters as a Model of Severe Acute Respiratory Syndrome Coronavirus-2, hamsters are “an ideal animal model of SARS-CoV-2 infections because they recapitulate many aspects of human infections.” The paper noted that weight loss in hamsters was reduced when treated with REGN-COV-2, a human mAb combination therapy that ultimately received FDA approval for SARS-CoV-2 treatment. A similar model was also used by Pfizer when developing Paxlovid, as noted in the paper titled The oral protease inhibitor (PF-07321332) protects Syrian hamsters against infection with SARS-CoV-2 variants of concern

The study is being conducted by two world-renowned institutions: The Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) and The University of Veterinary Medicine Hannover (TiHo), Germany.

Next steps: This preclinical trial continues in Jan. 2023 with additional arms testing lower therapeutic doses and a prophylactic dose of the inhaled COVID-19 NanoAb. The study will also evaluate safety parameters. Results of the dosing study will inform the design of future studies of BiondVax’s anti‑COVID‑19 inhaled NanoAb. Specifically, in 2023, BiondVax is expected to conduct a pre‑clinical toxicity study to assess safety as required by regulatory authorities for approval of human clinical trials. The Company is also expected to scale up its manufacturing processes to produce, at its GMP manufacturing site in Jerusalem, the NanoAbs for the first-in-human Phase 1/2a clinical trial, which is planned for Q4 2023.

NanoAb as mAb biobetter: As part of a strategic research collaboration with the Max Planck Institute for Multidisciplinary Sciences and the University Medical Center Göttingen, BiondVax is developing a pipeline of innovative alpaca‑derived nanosized antibody (NanoAb) therapies addressing diseases with large underserved medical needs and attractive commercial opportunities, such as COVID-19, asthma, psoriasis, psoriatic arthritis, and macular degeneration. While these diseases are currently treated with conventional monoclonal antibodies (mAbs), NanoAbs exhibit the potential to capture significant market share as biobetters. In particular, as reported by Pfizer, Paxlovid has shown the demand for COVID-19 therapeutic treatments with ~$22 billion in sales projected for the year ended Dec. 31, 2022, even with significant limitations of use due to adverse cross-reactions with other drugs and several other comorbidity contraindications that limit its use. In contrast, NanoAbs exhibit strong potential for superior patient convenience, safety, and clinical outcomes, at lower costs. For example, as demonstrated by this preclinical study, BiondVax’s NanoAb is efficacious when administered through inhalation rather than by injection as with currently available COVID-19 mAb therapies. In addition, most of the currently approved mAbs for the treatment of COVID-19 are not sufficiently efficacious against the Omicron variants of concern (VoCs) while BiondVax’s lead drug candidate demonstrated strong neutralization of all SARS-COV-2 VoCs from Wuhan through Omicron, including the recent BA4/5 and BQ1 sub-variants.

 

About BiondVax: 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, BiondVax has executed eight clinical trials including a seven-country, 12,400-participant Phase 3 trial of its prior 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: Investor Relations | +972 8 930 2529 | ir@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 of a delay in proof-of-concept studies and the commencement of clinical trials for NanoAbs, if any; the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk that clinical trials relating to NanoAbs will fail in whole or in part; 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.

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Josh Phillipson Josh Phillipson

BiondVax to Present at Biotech Showcase 2023

Jerusalem, Israel - January 5, 2023 – 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, announced today that Mr. Amir Reichman, BiondVax’s CEO, will present at the Biotech Showcase Conference being held January 9-11, 2023. The conference is taking place in San Francisco in parallel to the J.P. Morgan (JPM) 41st Annual Healthcare Conference.

Details of BiondVax’s presentation are as follows:

  • Date: Monday, Jan. 9, 2023

  • Time: 9:30 a.m. (PT) / 12:30 p.m. (ET)

  • Location: Hilton San Francisco Union Square

  • Track: Yosemite A, Ballroom Level

The presentation will focus on recent successful preclinical in vivo trial results of BiondVax’s inhaled COVID-19 therapy, and additional pipeline plans including a nanosized VHH-antibody (NanoAb) targeting IL-17 for the treatment of autoimmune diseases such as psoriasis and additional NanoAbs for the treatment of additional autoimmune diseases such as asthma, psoriatic arthritis and macular degeneration. Amir will describe BiondVax’s derisked R&D strategy generating a pipeline of NanoAbs all aimed at molecular targets already validated for efficient clinical results by currently approved monoclonal antibodies (mAbs). Nevertheless, these mAbs underserve needs and certain large populations thereby generating a commercial opportunity for BiondVax’s NanoAbs that present superior characteristics.

Mr. Reichman, along with Mr. Mark Germain, BiondVax’s Chairman of the Board, will be available to meet potential partners, collaborators, and investors. One-to-one appointments may be requested as follows:

About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. Since its inception, BiondVax has executed eight clinical trials including a seven-country, 12,400-participant Phase 3 trial of its prior 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: Investor Relations | +972 8 930 2529 | ir@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, acquiring an additional license from Max Planck for the therapeutic and commercial potential of nanosized antibodies (NanoAbs); and the timing of NanoAb proof-of-concept studies and clinical trials and the necessary steps needed for such studies and 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 we may not a second NanoAb license from Max Planck for a NanoAb targeting IL-17 as a treatment for psoriasis, the risk of a delay in proof-of-concept studies and the commencement of clinical trials for NanoAbs, if any, and delays in the necessary steps needed for such studies and trials; the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk that clinical trials relating to NanoAbs will fail in whole or in part; 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.

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Josh Phillipson Josh Phillipson

BiondVax CEO Issues Letter to Shareholders  

Jerusalem, Israel – December 30, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biotechnology company focused on developing, manufacturing and commercializing innovative immunotherapeutic products for the treatment of infectious and autoimmune diseases, today published a letter from its CEO, Amir Reichman, addressing 2022 accomplishments, successful preclinical trial results of the inhaled COVID-19 NanoAb therapy as well as recent financing activities to support 2023 objectives. The letter reads as follows: 

Dear BiondVax Shareholders, 

BiondVax’s 2022 achievements leave me incredibly optimistic about BiondVax’s growth potential and ability to deliver value to our stakeholders

My optimism is based on our people, our partnerships and BiondVax’s remarkable turnaround. When I became CEO in 2021, I inherited a company with strong leadership, extensive pharmaceutical development experience, and a new state-of-the-art biologics manufacturing facility but lacking a technology base to develop meaningful pharmaceutical products. After an extensive search in collaboration with industry expert consultants, we identified an opportunity to partner with the Max Planck Institute for Multidisciplinary Sciences (MPI) and the University Medical Center Göttingen, Germany (UMG) for development of new VHH nanosized antibodies (NanoAbs). In late 2021 and early 2022 we signed exclusive agreements with MPI and UMG to build a pipeline of “biobetter” NanoAbs, which are NanoAbs that interact with previously validated therapeutic targets and have strong potential for significant advantages over currently approved human monoclonal antibodies (mAbs). 

As compared to mAbs, NanoAbs being generated at MPI demonstrate several unique attributes such as greater binding affinity, stability at high temperatures, and formulation advantages. We believe that if NanoAbs with these attributes can be successfully developed they would provide an opportunity to capture a meaningful share of several large and growing markets while reducing upfront costs and risks commonly associated with new drug development (e.g., biological target validation) and accelerating initiation of clinical development. In addition, having access to a pipeline would diversify our risk of failure from any one product candidate and provide greater opportunity and flexibility in pursuing partnering deals with big pharma companies.

With this foundation established, we began building a successful biopharmaceutical company and in 2022 achieved a number of exciting and meaningful milestones: 

Q1 2022:

  • We completed signing a series of collaboration agreements with MPI and UMG for development of NanoAbs addressing diseases with large unmet medical needs and attractive commercial opportunities such as asthma, psoriasis, psoriatic arthritis, and macular degeneration, in addition to the COVID-19 program signed in Q4 2021.

Q2 2022:

  • We successfully executed tech transfer from Max Planck and began in-house manufacturing of the lead NanoAb candidate, an inhaled COVID-19 therapy, and received supportive scientific advice from the Paul Ehrlich Institute (PEI) to conduct the first clinical trials in patients as a combined Phase 1/2a, testing both safety and efficacy, thereby shortening BiondVax’s clinical development timelines.

Q3 2022:

  • We further strengthened our financial position by signing a definitive amendment to our loan agreement with the European Investment Bank (EIB) extending maturity of our €24 million loan until Dec. 31, 2027, with additional terms in support of our new strategy.

  • We initiated discussions with potential clients interested in hiring us as their contract development and manufacturing organization (CDMO). While serving in this capacity is not intended to become a primary activity for the company, it allows us to use our state-of-the-art facility to generate revenues and offset certain fixed costs while still using it for our NanoAbs.

Q4 2022:

  • We reported the successful first readout results in the preclinical in vivo study of our innovative inhaled COVID-19 NanoAb therapy. Hamsters infected with SARS-COV-2 and then treated with inhaled anti-COVID-19 NanoAbs demonstrated significantly milder illness and faster recovery in comparison to infected hamsters treated with inhaled placebo. 

Today, I am thrilled to share even more compelling results from the preclinical trial. New data from the same study shows that the inhaled NanoAb eliminated viral loads in the lungs:  

Hamsters treated with BiondVax’s NanoAb had over 30 times lower SARS-COV-2 viral titers in their lungs, six days after infection compared to the placebo group.

Experts continue to believe COVID-19 will remain a serious health risk in the coming years and as the uptake of vaccines wanes, therapeutics will become an important defense against severe illness. As reported by Pfizer, Paxlovid has shown the demand for COVID-19 therapeutic treatments with ~$22 billion in sales projected for 2022 despite significant limitations of use due to adverse cross-reactions with other drugs and several other comorbidity contraindications that limit its use.

Furthermore, previously approved mAb therapies have shown limited effectiveness against the new Omicron variants. Encouragingly, our lead NanoAb candidate, currently being prepared for clinical trials, has demonstrated neutralization of all relevant Omicron subvariants.

Indeed, the emergence of new variants remains a concern and NanoAb therapeutics have the potential to quickly and effectively address new variants. Our collaborators at MPI and UMG have generated libraries each with ~300 million COVID-19 NanoAb candidates, as compared to mAb libraries that contain only thousands of options. Thus, as new variants emerge, we would expect to be in a position to rapidly develop a new neutralizing NanoAb.  If we are able to replicate in human trials the efficacy demonstrated to date in our hamster studies, we believe the flexibility inherent in our massive libraries, combined with the ease of self-administered inhalation, high thermo-stability (which implies longer shelf life and simpler shipping and storage), and low cost of goods, position us to capture a significant share of the COVID-19 therapeutics market.

Looking forward to 2023:

The collaboration with MPI and UMG has been more successful than we originally contemplated with a number of new potential NanoAb candidates for indications beyond COVID-19 identified well ahead of schedule, in particular, anti-IL-17 NanoAbs for the treatment of psoriasis as well as other disorders. 

The highly favorable results from our COVID-19 hamster study and the identification of the IL-17 NanoAbs furthered our confidence to move both programs forward aggressively. Rather than slow down progress, in Q4 we determined to raise the capital to fast-track these programs. This was a difficult decision given overall market conditions. After careful consideration and with no certainty that market conditions would soon improve and realizing that delaying financing would impede progress and heighten the risk that funding would be increasingly difficult to obtain, we concluded that now presented the best opportunity to secure capital.

With funding in place to continue development, our plans include executing several steps required to bring our inhaled COVID-19 NanoAb therapy into a first-in-human Phase 1/2a clinical trial by the end of 2023. These steps include toxicology studies and GMP manufacturing of the NanoAb. We also intend to exercise our option to obtain an exclusive license at pre-agreed financial terms to anti-IL-17 NanoAbs from our partners in Germany, scale up in-house NanoAb manufacturing, conduct an in vitro proof-of-concept study and potentially also a preclinical trial of the IL-17 NanoAb as a therapy for psoriasis. 

Bringing innovative pharmaceutical products through manufacturing, clinical trials and regulatory approvals requires substantial resources and entail a high degree of risk. Our biobetter NanoAb approach is specifically designed to mitigate the cost and risk ordinarily incurred in drug development, and we aim to aggressively pursue partnerships with big pharma that can bring in upfront and milestone payments, royalties, and funding for development activities, thereby further reducing our own funding needs and risk. A NanoAb pipeline may provide us with multiple partnering opportunities as well as flexibility in structuring relationships so as to preserve our upside. We also intend to pursue sources of non-dilutive funding, including grants from NGOs and from Israeli and European governmental organizations and have several grant applications in process. Securing meaningful partnerships with large pharma companies requires generating compelling data from pre-clinical and early clinical trials, which is exactly what we intend to pursue with the funds recently raised and with any grant money we are able to secure in the near future.  

I believe we have set the stage in 2022 for a highly successful 2023. The BiondVax team, in collaboration with our scientific partners from MPI and UMG, has worked exceedingly hard to develop the company into a global leader in NanoAb technology and I truly appreciate their dedication, creativity and tireless efforts. I also want to thank our shareholders for their continued support as we progress toward our objectives. I’m grateful for the opportunity to lead BiondVax during this exciting period and pledge my utmost to build the company into a financial success by providing caregivers and patients high quality, innovative, de-risked, pharmaceutical products that help protect and improve human life. 

Sincerely,

Amir Reichman

CEO

About BiondVax: 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 prior 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: Investor Relations | +972 8 930 2529 | ir@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, acquiring an additional license from Max Planck for the therapeutic and commercial potential of nanosized antibodies (NanoAbs); and the timing of NanoAb proof-of-concept studies and clinical trials and the necessary steps needed for such studies and 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 we may not a second NanoAb license from Max Planck for a NanoAb targeting IL-17 as a treatment for psoriasis, the risk of a delay in proof-of-concept studies and the commencement of clinical trials for NanoAbs, if any, and delays in the necessary steps needed for such studies and trials; the risk that the company may not raise capital on acceptable terms or at all, the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk that clinical trials relating to NanoAbs will fail in whole or in part; 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.

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BiondVax Announces Closing of $8 Million Underwritten Public Offering

Jerusalem, Israel – December 20, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV)(“Company”), a biotechnology company which focuses on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, today announced the closing of its underwritten public offering with gross proceeds to the Company to be $8,000,000, before deducting underwriting discounts and other expenses payable by the Company. The offering consists of 1,600,000 units and pre-funded units. Each unit consists of one American Depositary Share (“ADS”) and two warrants, each to purchase one ADS, and each pre-funded unit consists of one pre-funded warrant to purchase one ADS and two warrants each to purchase one ADS. One of the warrants will expire three years from the date of issuance, and the other warrant will expire one year from the date of issuance and may be exercised for half an ADS on or prior to six (6) months following the original issuance for no additional consideration. Each ADS (or pre-funded warrant) is being sold together with two warrants at a combined purchase price of $5.00 per unit (or $4.999 per pre-funded unit after reducing $0.001 attributable to the exercise price of the pre-funded warrants). Each ADS represents 400 of our ordinary shares, no par value per share.

The Company expects to use the net proceeds from the offering, together with its existing cash and cash equivalents, for the advancement of its NanoAbs development program, as well as general corporate purposes, which may include working capital, research and development activities, regulatory matters, capital investment or other related purposes.

Aegis Capital Corp. acted as the sole book-running manager for the offering.

A registration statement on Form F-1 (File No. 333-267648) relating to the offering of the securities has been filed with the U.S. Securities and Exchange Commission (SEC) and declared effective by the SEC on December 15, 2022. The offering is being made only by means of a prospectus, copies of which may be obtained by contacting Aegis Capital Corp., 1345 Avenue of the Americas, 27th Floor, New York, NY 10105, by telephone at (212) 813-1010 or by email at syndicate@aegiscap.com. Copies of the registration statement can be accessed through the SEC's website at www.sec.gov.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About BiondVax: 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 prior 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: Investor Relations | +972 8 930 2529 | ir@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 expected closing date of the offering, the expected use of proceeds from the offering, the timing of future pre-clinical or 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 the Company’s expected use of proceeds changes, and that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in receipt of the preclinical and clinical trials data for NanoAbs, if any;  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 28, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.

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BiondVax Announces Pricing of $8 Million Underwritten Public Offering

Jerusalem, Israel – December 16, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) (“Company”), which focuses on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, today announced the pricing of its underwritten public offering with gross proceeds to the Company expected to be approximately $8,000,000, before deducting underwriting discounts and other expenses payable by the Company. The offering consists of 1,600,000 units and pre-funded units. Each unit consists of one American Depositary Share (“ADS”) and two warrants, each to purchase one ADS, and each pre-funded unit consists of one pre-funded warrant to purchase one ADS and two warrants each to purchase one ADS. One of the warrants will expire three years from the date of issuance, and the other warrant will expire one year from the date of issuance and may be exercised for half an ADS on or prior to the sixtieth (60th) day following the original issuance for no additional consideration. Each ADS (or pre-funded warrant) is being sold together with two warrants at a combined purchase price of $5.00 per unit (or $4.999 per pre-funded unit after reducing $0.001 attributable to the exercise price of the pre-funded warrants). Each ADS represents 400 of our ordinary shares, no par value per share.

The offering is expected to close on December 20, 2022, subject to the satisfaction of customary closing conditions.

The Company expects to use the net proceeds from the offering, together with its existing cash and cash equivalents, for the advancement of its NanoAbs development program, as well as general corporate purposes, which may include working capital, research and development activities, regulatory matters, capital investment or other related purposes.

Aegis Capital Corp. is acting as sole book-running manager for the offering.

A registration statement on Form F-1 (File No. 333-267648) relating to the offering of the securities was filed with the U.S. Securities and Exchange Commission (SEC) and declared effective by the SEC on December 15, 2022. The offering is being made only by means of a prospectus, copies of which may be obtained by contacting Aegis Capital Corp., 1345 Avenue of the Americas, 27th Floor, New York, NY 10105, by telephone at (212) 813-1010 or by email at syndicate@aegiscap.com. Copies of the registration statement can be accessed through the SEC's website at www.sec.gov.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About BiondVax: 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 prior 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: Investor Relations | +972 8 930 2529 | ir@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 expected closing date of the offering, the expected use of proceeds from the offering, 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 of a delay in the closing date of the offering or that the Company’s expected use of proceeds changes, 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 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 28, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.

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Josh Phillipson Josh Phillipson

BiondVax regains Nasdaq compliance  

Jerusalem, ISRAEL – December 12, 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, announces today the receipt of formal notifications from the Nasdaq Stock Market (“Nasdaq”) that the Company has regained compliance with Nasdaq listing rules regarding minimum stockholders’ equity and minimum bid price. The Company previously reported on Sept. 30, 2022, and Nov. 2, 2022, receipt of the respective non-compliance notifications.

Nasdaq indicated they have determined, based on the Company’s Form 6-K dated Nov. 30, 2022, reporting third-quarter financial results, that the Company once again complies with Listing Rule 5550(b)(1) regarding minimum $2.5 million stockholders’ equity. Similarly, Nasdaq communicated to BiondVax that since the minimum bid price has now closed over $1.00 per share for the past ten trading days, the Company once again complies with Listing Rule 5550(a)(2).

Thus, Nasdaq has confirmed the Company now complies with Nasdaq Listing Rules and considers the abovementioned non-compliance matters to be closed.

About BiondVax: 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, BiondVax has executed eight clinical trials including a seven-country, 12,400-participant Phase 3 trial of its prior 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: 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.

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Professor Dr. Matthias Dobbelstein joins BiondVax’s Scientific Advisory Board

Jerusalem, Israel – December 6, 2022 – 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 announced that Professor Dr. med. Matthias Dobbelstein has been appointed a member of the company’s Scientific Advisory Board (SAB).

Professor Dr. med. Matthias Dobbelstein

Professor Dobbelstein has served as Director of the Institute of Molecular Oncology at the University Medical Center Göttingen (UMG), Germany since 2005 and is also an Associate Member of the Max Planck Institute for Multidisciplinary Sciences (MPI-NAT). He received his training as a physician at the University of Munich (LMU) and performed research as a virologist and cancer biologist at Princeton University (USA), the University of Marburg (Germany) and the University of Southern Denmark.

Professor Dobbelstein’s research interests focus on principles of infections and cancer, including the application of anti-cancer drugs as antivirals, as well as alpaca-derived NanoAbs (nanosized antibodies also known as nanobodies and VHH antibodies) as therapeutics. His collaboration with Professor Dr. Dirk Görlich at MPI-NAT as highlighted in their 2021 EMBO Journal article titled “Neutralization of SARS-CoV-2 by highly potent, hyperthermostable, and mutation-tolerant nanobodies” forms the scientific basis of BiondVax’s exclusive license for development and commercialization of an innovative, self-administered, inhaled NanoAb for the treatment of COVID-19. As recently reported, a preclinical trial of the inhaled anti-COVID-19 NanoAbs demonstrated significantly milder illness and faster recovery in comparison to infected hamsters treated with inhaled placebo.

In addition, Professor Dobbelstein, together with Professor Görlich, is collaborating with BiondVax under a five-year strategic research agreement for the discovery, characterization and cloning of additional NanoAbs for the treatment of autoimmune diseases such as psoriasis, psoriatic arthritis, asthma and macular degeneration. BiondVax holds an exclusive option for exclusive licenses for development and commercialization of each of these NanoAbs.

Professor Ruth Arnon, head of BiondVax’s SAB and The Paul Ehrlich Professor of Immunology at the Weizmann Institute of Science, Israel, commented, “We are pleased to welcome Matthias’ broad and relevant expertise to BiondVax’s SAB. With his deep knowledge of molecular oncology, virology, and immunology, Matthias’s unique cross-discipline expertise aligns well with BiondVax’s mission to develop a pipeline of innovative products for the prevention and treatment of infectious diseases and other illnesses.

Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer, remarked, “We have been enjoying productive scientific cooperation with Professor Dobbelstein over the past year through our collaboration to develop his and Professor Görlich’s translational NanoAb research into a drug candidate for the treatment of COVID-19, which is currently being tested in a preclinical study. As previously disclosed, BiondVax and its scientific partners at MPI-NAT and UMG have decided that we will focus the next NanoAbs pipeline products on treatment of psoriasis and related skin autoimmune diseases and NanoAbs for the treatment of asthma. On behalf of BiondVax’s executive team, I am pleased to welcome Matthias to our SAB and am confident his deep scientific and clinical knowledge will meaningfully contribute to further building BiondVax into an innovative multi-asset pharmaceutical company.

Professor Dr. Matthias Dobbelstein stated, “Throughout my collaboration with BiondVax’s team over the past year, I have been impressed with the team’s professionalism, expertise, creativity, and motivation to develop innovative pharmaceutical products. Our NanoAb collaboration is hopefully only the first step of BiondVax’s drive towards developing and manufacturing a diverse pipeline of innovative technologies. I am pleased to join the company’s scientific advisory board, a role through which I hope to contribute to the company’s new growth.

____

About BiondVax: 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, BiondVax has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its prior 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: 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 of a delay in proof-of-concept studies and the commencement of clinical trials for NanoAbs, if any; 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 that clinical trials relating to NanoAbs will fail in whole or in part; 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.

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BiondVax announces Third Quarter 2022 Financial Results and Provides Business Update

Jerusalem, Israel – November 30, 2022 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), which focuses on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, today published its financial results for the quarter ended Sept. 30, 2022, and provided a business update.

Business Update

The strategic research collaboration between BiondVax, the Max Planck Institute for Multidisciplinary Sciences (MPG), and the University Medical Center Göttingen (UMG) towards the development of a pipeline of innovative nanosized antibody (NanoAb) therapies is proceeding according to plan:

  • A preclinical proof-of-concept study of the COVID-19 NanoAb as an inhaled therapy in COVID-19-infected animals is being conducted in Germany. Using an industry-standard animal model, the study has compared weight loss in two groups of hamsters after infection with SARS-COV-2. As reported yesterday, compared to their weight immediately prior to infection, the control group’s weight declined on average 12.01%, while the weight of the experimental group, which was administered BiondVax’s NanoAb through inhalation, declined on average only 3.80%, a highly statistically significant result (p<0.001).

  • The trial is expected to continue in January 2023 with additional arms testing lower therapeutic doses and a prophylactic dose of the inhaled COVID-19 NanoAb. A first-in-human Phase 1/2a clinical trial of the COVID-19 NanoAb inhaled therapy will be initiated in 2023.

  • The next NanoAbs to be developed will target IL-17 as drug candidates for the potential treatment of psoriasis, psoriatic arthritis and other autoimmune diseases.

As previously reported, BiondVax has received notice of non-compliance with Nasdaq listing rules regarding minimum Shareholders’ Equity and minimum share bid price.

  • To regain compliance with bid price requirements, the Company executed a ratio change between its ordinary shares and its American Depositary Shares (ADSs) traded on the Nasdaq exchange effective Nov. 25, 2022. The new ratio is 400 ordinary shares for each ADS (changing from 40 ordinary shares for each ADS). Based on communications from Nasdaq, the Company expects to regain compliance once the ADS price closes above $1 per share for 10 consecutive trading days.

  • The Company has responded to Nasdaq with a plan to regain compliance with the minimum Shareholders’ Equity requirement. As previously communicated, on Aug. 15, the Company signed with its main lender, the European Investment Bank, a new financial contract restructuring the repayment schedule of its €24 million debt. The value generated to shareholders by the debt repayment terms restructuring was $3.161 million as reflected in “other income” in the current Q3 2022 financial report. This by itself brought the shareholders’ value to above the minimum threshold to meet Nasdaq requirements as of Sept. 30, 2022.  BiondVax is currently communicating its plans with Nasdaq and will announce once Nasdaq determines that it is back in compliance.

BiondVax leadership has recently presented in person at the following conferences: HCW 24th Annual Global Investment Conference, LD Micro Main Event XV, and RAFT 14. BiondVax’s CEO Amir Reichman is scheduled to present in person at the Biotech Showcase, held in conjunction with the annual JPM Healthcare Conference in San Francisco on Jan. 9 to 11, 2023. He also plans to present in person at the BIO CEO & Investor Conference taking place in New York on Feb. 6 to 9, 2023. Investors and industry leaders interested in meeting with Mr. Reichman may contact the company via the contact information provided below.     

Third Quarter 2022 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.543 (NIS/$US), the rate as of the close of business on Sept. 30, 2022.

  • R&D expenses for the three months ended Sept. 30, 2022, were NIS 3.9 million ($1.1 million) compared to NIS 2 million for the three months ended Sept. 30, 2021. Total R&D expenses for the nine months ended Sept. 30, 2022, were NIS 14.1 million ($3.9 million) compared to NIS 6.7 million for the nine months ended Sept. 30, 2021. These increases were primarily due to drug development activities related to the new COVID-19 NanoAb program licensed from Max-Planck-Innovation GmbH in December 2021.

  • Marketing, general and administrative expenses for the three months ended Sept. 30, 2022, were NIS 3.3 million ($1 million) compared to NIS 6.0 million for the three months ended Sept. 30, 2021. Total marketing, general and administrative expenses for the nine months ended Sept. 30, 2022, were NIS 12.2 million ($3.4 million) compared to NIS 17 million for the nine months ended Sept. 30, 2021. These decreases were primarily due to reduced salaries and related expenses of NIS 0.36 million, share-based payment of NIS 2.2 million, directors’ fees of NIS 0.8 million and professional services of NIS 1.6 million

  • Other income: For the three months ended Sept. 30, 2022, the Company recorded ‘other income' in the amount of NIS 11,201 ($3,161) as a result of the EIB loan revaluation. No additional other income was recorded in the first nine months of 2022.

  • Financial expenses for the three months ended Sept. 30, 2022, were NIS 0.1 million compared to NIS 0.8 million for the three months ended Sept. 30, 2021. Financial expenses for the nine months ended Sept. 30, 2022, were NIS 3.3 million ($0.9 million) compared to NIS 5.3 million for the nine months ended Sept. 30, 2021. These decreases were primarily due to currency exchange differences and EIB loan financial valuation expenses.

  • Total operating expenses / income for the three months ended Sept. 30, 2022, were income of NIS 3.8 million ($1.08 million) compared to expenses of NIS 8.2 million for the three months ended Sept. 30, 2021. Total operating expenses for the nine months ended Sept. 30, 2022, were NIS 15.2 million ($4.2 million) compared to NIS 23.2 million for the nine months ended Sept. 30, 2021. 

  • Net Profit / loss for the three months ended Sept. 30, 2022, was a profit of NIS 3.7 million ($1.05 million) compared to a loss of NIS 9 million for the three months ended Sept. 30, 2021. Net loss for the nine months ended Sept. 30, 2022, was NIS 18.52 million ($5.2 million) compared to NIS 29.2 million for the nine months ended Sept. 30, 2021.

As of Sept. 30, 2022, BiondVax had cash and cash equivalents of NIS 29.4 million ($8.3 million) compared to NIS 54 million as of Dec. 31, 2021.

Unaudited third quarter financial results will be submitted to the Securities and Exchange Commission on Form 6-K.

 

About BiondVax: 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.

Contact Details: Investor Relations | +972 8 930 2529 | ir@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 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 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. 

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BiondVax reports successful results in preclinical in vivo study of its innovative inhaled COVID-19 NanoAb therapy

  • Hamsters infected with SARS-COV-2 and then treated with inhaled anti-COVID-19 NanoAbs demonstrated significantly less severe illness and faster recovery in comparison to infected hamsters treated with inhaled placebo

  • BiondVax’s nanosized antibodies (NanoAbs) are being formulated as a convenient self‑administered, at-home, inhaled COVID-19 therapy

  • First-in-human Phase 1/2a clinical trial planned for 2023

  • The COVID-19 therapy is BiondVax’s first in a new pipeline of innovative alpaca-derived NanoAb therapies addressing diseases with large underserved medical needs and attractive commercial opportunities such as psoriasis and asthma 

Jerusalem, Israel – November 29, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) (“BiondVax”), a biotechnology company focused on developing, manufacturing and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, announced today statistically significant (p<0.001) efficacy results in a preclinical in vivo proof-of-concept study of its innovative inhaled nanosized antibody (NanoAb) COVID-19 therapy. 

Study design: Using an industry-standard animal model for COVID-19 therapeutics and vaccines, the study compared weight loss in two groups of hamsters after infection with SARS-COV-2. The first (experimental) group was treated with BiondVax’s anti-COVID-19 NanoAb, administered via inhalation, starting one day after being infected, while the second (control) group was treated in the same manner but with saline serving as a placebo. The study was conducted by two world renowned institutions: The Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) and The University of Veterinary Medicine Hannover (TiHo), Germany.

Results: Compared to their weight immediately prior to infection, the control group’s weight declined on average 12.01%, while the weight of the experimental group, which was administered BiondVax’s NanoAb through inhalation, declined on average only 3.80%, a highly statistically significant result (p<0.001).

The successful result was further supported by eight other tracked parameters, including heart rate and social behaviors, that indicated the group treated with inhaled NanoAbs experienced a milder and shorter illness.

NanoAb as mAb biobetter: As part of a strategic research collaboration with the Max Planck Institute for Multidisciplinary Sciences (MPG) and the University Medical Center Göttingen (UMG), BiondVax is developing a pipeline of innovative alpaca‑derived nanosized antibody (NanoAb) therapies addressing diseases with large underserved medical needs and attractive commercial opportunities, such as COVID-19, asthma, psoriasis, psoriatic arthritis, and macular degeneration. While these diseases are currently treated with conventional monoclonal antibodies (mAbs) which generate billions of dollars in annual commercial sales, NanoAbs exhibit the potential to capture significant market share as biobetters. In particular, NanoAbs exhibit strong potential for superior patient convenience, safety, and clinical outcomes, at lower costs. For example, as demonstrated by this preclinical study, BiondVax’s NanoAb is efficacious when administered through inhalation rather than by injection as with currently available COVID-19 monoclonal antibody therapies.

We are excited that the study results confirm the inhalation concept of our exclusively licensed NanoAb as a therapy for COVID-19 illness,” said BiondVax’s Chief Science Officer (CSO), Dr. Tamar Ben-Yedidia PhD. “Following these promising results, we intend to continue the study early next year by testing additional dose levels of the inhaled NanoAb therapy and as a prophylactic (preventive) treatment. Results of the trial will inform design of the first-in-human clinical trial of the inhaled NanoAb COVID-19 therapy, which is planned for late 2023.

Ben-Yedidia concluded, “On behalf of BiondVax’s team, I would like to thank the teams at Fraunhofer ITEM and TiHo for their professionalism in conducting this ongoing trial, and also our research partners Professor Dr. Dirk Görlich of the Max Planck Institute for Multidisciplinary Sciences (MPG) and Professor Dr. Matthias Dobbelstein of the University Medical Center Göttingen and their teams for the ongoing collaboration.

Mr. Amir Reichman, BiondVax’s CEO, added, “Recent papers have highlighted the limitations of existing therapeutics, in particular Paxlovid (Pfizer) in at-risk populations, the absence of monoclonal antibodies that are highly effective against Omicron, and the need for new improved treatments to prevent severe disease. On top of that, there is a decrease in uptake of COVID-19 vaccinations and boosters. We believe our inhaled NanoAb therapeutic can serve this unmet need with a patient-friendly route of administration directly to the original source of infection.”

Next steps: This preclinical trial will continue in January 2023 with additional arms testing lower therapeutic doses and a prophylactic dose of the inhaled COVID-19 NanoAb. As well, the amount of live SARS-COV-2 virus in the lungs following treatment will be assessed in each of the study groups. The study will also evaluate safety parameters. Results of the dosing study will inform design of future clinical studies of BiondVax’s anti‑COVID‑19 inhaled NanoAb. In 2023, BiondVax will conduct a pre‑clinical toxicity study as required by regulatory authorities for approval of human clinical trials. The Company will also scale-up its manufacturing processes to produce, at its GMP manufacturing site in Jerusalem, the NanoAbs for the first-in-human Phase 1/2a clinical trial in patients which is planned for Q4 2023.

 

About BiondVax: 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, BiondVax has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its prior 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: Investor Relations | +972 8 930 2529 | ir@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 of a delay in proof-of-concept studies and the commencement of clinical trials for NanoAbs, if any; 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 that clinical trials relating to NanoAbs will fail in whole or in part; 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.

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BiondVax CEO to Present at the January 2023 Biotech Showcase in San Francisco

Jerusalem, Israel – November 21, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) (“BiondVax”), a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, announced today that its CEO Amir Reichman will present at the January 9-11, 2023 Biotech Showcase conference. The Biotech Showcase Conference is taking place in San Francisco in parallel to the J.P. Morgan (JPM) 41st Annual HealthCare Conference.

Mr. Reichman will be available to meet potential partners, collaborators, and investors. One-to-one appointments may be requested as follows:

Note that while both events occur during the same week in San Francisco, the Biotech Showcase is not affiliated with the JPM Conference.


About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. Since its inception, BiondVax has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its prior 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: Investor Relations | +972 8 930 2529 | ir@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 clinical trials relating to NanoAbs will fail in whole or in part; 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.

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BiondVax Congratulates Dirk Görlich on $1.4 million WLA Prize in Life Sciences

Jerusalem, Israel – November 15, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) (“BiondVax”), a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious diseases and autoimmune diseases, congratulates the company’s co-lead scientific research collaborator Professor Dr. Dirk Görlich, director at the Max Planck Institute for Multidisciplinary Sciences (MPI), on being awarded the inaugural $1.4 million World Laureates Association (WLA) Prize in Life Sciences or Medicine for his seminal work describing protein transport within the cell.

Professor Dr. Dirk Görlich

In close collaboration with BiondVax, the teams led by Görlich and Prof. Dr. Matthias Dobbelstein of the University Medical Center Göttingen (UMG), lead discovery of nanosized antibodies (NanoAbs) with the potential to serve as therapeutics for treating diseases, such as Covid-19, psoriasis, psoriatic arthritis, asthma and wet macular degeneration. The first preclinical proof-of-concept study of an innovative and game changing inhaled NanoAb as a COVID-19 therapy is currently underway, with results expected by the end of this year.

According to MPI, Görlich has received several other scientific awards including the Heinz-Maier-Leibnitz Prize, the EMBO Gold Medal, the Alfried-Krupp-Förderpreis, and the Animal Protection Research Prize of the German Federal Ministry of Food and Agriculture.

On behalf of BiondVax’s team,” said Amir Reichman, BiondVax’s CEO, “I wish to offer my sincere congratulations to Dirk on being awarded the inaugural WLA Prize in Life Sciences. The award signals recognition and appreciation of his important research achievements and deep scientific acumen. His expertise extends to the unique and innovative NanoAb candidates being developed under our collaboration. We look forward to forging ahead together with Dirk, Matthias, and their teams as we strive to bring a pipeline of NanoAb therapies that exhibit significant competitive advantages for conditions underserved by currently approved therapeutics.

Further reading:

 

About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. Since its inception, BiondVax has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its prior 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: Joshua 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); the timing of results of the first preclinical proof-of-concept study of NanoAb as a COVID-19 therapy; 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 a delay in the timing of results of the first preclinical proof-of-concept study of NanoAb as a COVID-19 therapy; 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 clinical trials relating to NanoAbs will fail in whole or in part; 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.

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Josh Phillipson Josh Phillipson

BiondVax Announces Plan to Implement ADS Ratio Change

Jerusalem, Israel – November 10, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) (“BiondVax”), a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious diseases and autoimmune diseases, announces today that it plans to effect a ratio change of the Company’s American Depositary Shares (ADSs) to its non-traded ordinary shares from the current ratio of one (1) ADS representing forty (40) ordinary shares to a new ratio of one (1) ADS representing four hundred (400) ordinary shares. The ratio change will have the same effect as a reverse split of the existing ADSs of one (1) new ADS for every ten (10) old ADSs. The anticipated effective date for the ratio change is November 25, 2022, and the Company’s ADSs will continue to be traded on the Nasdaq Capital Market (“Nasdaq”) under the symbol “BVXV” with a new CUSIP Number 09073Q204.

No action is required by holders of ADSs to effect the ratio change, as the change will be effected on the books of the ADS depositary.

No fractional new ADSs will be issued in connection with the change in the ADS ratio. Instead, fractional entitlements to new ADSs will be aggregated and the depositary bank will attempt to sell them with the net cash proceeds from the sale of the fractional ADS entitlements to be distributed to the applicable ADS holders by the depositary bank.

On November 2, 2022, the Company announced that it received notification from Nasdaq regarding non-compliance with the requirement to maintain a minimum bid price of $1.00 per share. As a result of the change in ADS ratio, the price of its ADS is expected to increase proportionally, although BiondVax can give no assurance that the ADS price after the change in ADS ratio will be equal to or greater than ten times the ADS price before the change.

 

About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. Since its inception, BiondVax has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its prior 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: Investor Relations | +972 8 930 2529 | ir@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 future price of our ADSs. 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 price of our ADSs will not increase proportionally as a result of the change in ADS ratio, 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 clinical trials relating to NanoAbs will fail in whole or in part; 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.

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