Press Releases
BiondVax to present at Recent Advances in Fermentation Technology (RAFT) 14 Conference
Jerusalem, Israel – November 3, 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, announced today that Dr. Dalit Weinstein Fischer, BiondVax’s Head of Technical R&D, will attend and present at Recent Advances in Fermentation Technology (RAFT) 14, a conference of the Society for Industrial Microbiology and Biotechnology (SIMB) taking place November 6 to 9, 2022 in Orlando, Florida. RAFT provides a forum for academic and industrial scientists to discuss the latest developments in fermentation technology.
Presentation Details:
Topic: Nano-sized solution for a massive challenge: NanoAbs as a platform for COVID-19, asthma, and psoriasis therapies
When: Tuesday, November 8 at 3:35pm (ET)
Where: Caribe Royale Orlando - Grand Sierra E
The presentation will focus on BiondVax’s yeast fermentation system to manufacture innovative alpaca-derived recombinant nanosized VHH-antibodies (NanoAbs). NanoAbs are monoclonal antibody (mAbs) ‘bio-betters’ in terms of cost, heat and shear force stability, high target affinity, and potential convenience to patients. BiondVax’s lead NanoAb candidate, for treatment of COVID-19, exhibits significant competitive advantages over currently available mAbs and oral COVID-19 therapies. Development is also underway for additional NanoAbs addressing diseases with large unmet medical needs and attractive commercial opportunities, such as psoriasis and asthma.
Further information regarding the RAFT conference is available via the conference website at https://www.simbhq.org/raft/.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, BiondVax 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: 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); 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.
BiondVax provides plan to address Nasdaq compliance
Jerusalem, Israel – November 2, 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, announced updates regarding two non-compliance letters received from the Nasdaq Stock Market (“Nasdaq”), including one dated October 27, 2022 regarding non-compliance with the requirement to maintain a minimum bid price of $1.00 per share. The company previously disclosed in a press release dated September 30, 2022, receipt of a first letter related to minimum shareholders’ equity.
The Nasdaq letters are only notifications of deficiency and have no immediate effect on the listing or trading of the Company's American Depository Shares (“ADSs”).
In response to the first notification letter from Nasdaq dated September 28, 2022, the company has submitted a plan to Nasdaq regarding actions by which it may regain compliance with Listing Rule 5550(b)(1) requiring listed Nasdaq companies to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing. The notification letter related to non-compliance was triggered by BiondVax's Form 6-K/A, dated August 29, 2022, disclosing financial information for the period ended June 30, 2022, which reported shareholders’ equity of $1,277,000. BiondVax’s executive leadership and board of directors believe the plan will enable the Company to regain compliance with the rule and sustain such compliance in the long term.
In addition, on October 27, 2022, the company received a second letter from Nasdaq indicating that, based on the closing bid price of the Company's ADSs for the last thirty consecutive business days, the company does not meet the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq under Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days to regain compliance. The letter states that the Nasdaq staff will provide written confirmation that the Company has achieved compliance with Rule 5550(a)(2) if at any time before the 180-day period ends on April 25, 2023 the closing bid price of the Company's ADSs closes at $1.00 per share or more for a minimum of ten consecutive business days. BiondVax intends to monitor the closing bid price of its ADSs and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid Price Requirement.
Amir Reichman, BiondVax’s CEO, explained, “We are optimistic that BiondVax’s ADSs will regain compliance with Nasdaq listing rules for several reasons. To begin, as previously announced, we soon anticipate initial data from a preclinical proof-of-concept study of our inhaled COVID-19 NanoAb therapy. This will be the first scientific data readout of our nascent NanoAb pipeline. As well, exciting recent progress by our scientific collaborators at the Max Planck Institute for Multidisciplinary Sciences (MPG), and the University Medical Center Göttingen (UMG) may advance development of additional NanoAbs for the treatment of diseases such as psoriasis, asthma, psoriatic arthritis and macular degeneration. Further, we have several mechanisms available for generating cash including potential revenue by providing CDMO services leveraging our GMP-ready biologics manufacturing facility and team, applications for several non-dilutive research grants from governments and NGOs in addition to participation in research consortiums. Moreover, we filed an F1 with the SEC last month to maintain flexibility with respect to funding options of our R&D programs. While the stock market remains unfavorable for capital raising transactions, particularly for small cap companies, we believe aggressively advancing our scientific programs is the best path to create shareholder value to be reflected when the market regains some stability.”
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, BiondVax 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: 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.
BiondVax to present at LD Micro Investor Conference in Los Angeles
Jerusalem, Israel – October 11, 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, announced today that Joshua Phillipson, BiondVax’s Director of Investor Relations, will attend and present at the LD Micro Main Event XV, an investor conference taking place October 25 to 27, 2022 in Los Angeles. The event is a leading small cap investor conference showcasing over 200 companies.
Mr. Phillipson is scheduled to present on Tuesday, October 25 at 9am (PT) in Track 3. He will also be available for 1-1 meetings with investors throughout the conference.
The presentation will focus on BiondVax’s investment case, including its highly experienced leadership team, innovative nanosized antibody (NanoAb) platform, derisked pipeline development, in-house GMP biologics manufacturing facility, and key upcoming milestones.
Investors interested in meeting with Mr. Phillipson are welcome to contact BiondVax’s investor relations team whose contact details are below. Investors may also register to attend in-person or virtually via the conference website at https://www.meetmax.com/sched/event_86249/conference_home.html.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, BiondVax 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 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.
BiondVax announces financial plans to support its ongoing NanoAb pipeline development
Jerusalem, Israel – September 30, 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, announced the filing yesterday of a Registration Statement (“Form F-1”) with the US Securities and Exchange Commission (“SEC”) for a firm commitment underwritten offering of BiondVax American Depositary Shares (“ADSs”). Once declared effective by the SEC the Form F-1 can be used to raise capital.
BiondVax is currently developing, under an exclusive worldwide license, a nanosized antibody (“NanoAb”) for the treatment of COVID-19, developed by researchers at the Max Planck Institute for Multidisciplinary Sciences (MPG) and the University Medical Center Göttingen (UMG). As recently reported, in the coming weeks BiondVax intends to initiate a preclinical proof-of-concept study of the COVID-19 NanoAb as an inhaled therapy in COVID-19 infected animals. Assuming successful results, a first-in-human Phase 1/2a clinical trial of the COVID-19 NanoAb inhaled therapy will be initiated in 2023.
Under the five-year BiondVax-MPG-UMG research collaboration agreement (RCA) for additional “biobetter” NanoAbs, Professor Dirk Görlich of MPG and his team have successfully generated, identified and isolated NanoAbs addressing a number of additional biological target molecules. Professor Görlich and his colleague Professor Matthias Dobbelstein of UMG verified strong affinity by the new NanoAbs to their biological target molecules and high thermostability. The research teams have also demonstrated strong neutralization by several NanoAb candidates of their respective target molecules. As a result of the above progress, BiondVax decided earlier this month to initially focus additional pipeline development beginning with NanoAbs as drug candidates for the potential treatment of psoriasis, psoriatic arthritis, and asthma.
These recent successful developments present BiondVax with an opportunity to not only initiate a Phase 1/2a clinical trial of its inhaled COVID-19 therapeutic NanoAb next year as planned, but also to significantly expand its portfolio of NanoAbs in development. Consequently, the proceeds of the firm commitment underwriting share issuance contemplated by the F-1 are designed to provide BiondVax with the capital necessary to continue to aggressively execute its strategy.
In addition, BiondVax received a notification letter from The Nasdaq Stock Market (“Nasdaq”) dated September 28, 2022 advising BiondVax that it is not in compliance with Listing Rule 5550(b)(1) requiring companies listed on the Nasdaq Capital Market to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing. The notification letter from Nasdaq was based on BiondVax's Form 6-K/A, dated August 29, 2022, disclosing financial information for the period ended June 30, 2022, which reported shareholders’ equity of $1,277,000, and noted that BiondVax does not meet the alternatives of market value of listed securities or net income from continued operations.
The letter states that under Nasdaq’s Listing Rules, BiondVax has 45 calendar days to submit a plan to Nasdaq to regain compliance with the minimum stockholders’ equity listing requirement. If a plan is submitted by BiondVax, and if it is accepted by Nasdaq, Nasdaq can grant an extension of up to 180 days from the date of the Nasdaq letter for BiondVax to evidence compliance with the minimum stockholders’ equity listing requirement. If BiondVax submits a plan and the plan is not accepted by Nasdaq, BiondVax will have the opportunity to appeal such decision to a Nasdaq Hearings Panel under Nasdaq Listing Rule 5815(a).
The notification letter has no immediate effect on the listing of BiondVax’s ADSs, and its ADSs will continue at this time to trade on the Nasdaq Capital Market under the symbol “BVXV”.
The contemplated equity offering, if consummated, would rectify the stockholders’ equity deficiency. Furthermore, BiondVax will pursue additional definitive steps to regain and maintain compliance with Nasdaq listing rules.
Amir Reichman, BiondVax’s CEO, explained, “As we updated last week, in addition to the upcoming COVID‑19 NanoAb milestones, following exciting progress made by our scientific collaborators at the Max Planck Institute for Multidisciplinary Sciences (MPG), and the University Medical Center Göttingen (UMG) we intend to advance development of additional NanoAbs for the treatment of diseases such as asthma, psoriatic arthritis and psoriasis. While the stock market remains unfavorable, particularly for small cap companies, we believe aggressively advancing our programs is the best path to create shareholder value to be reflected when the market regains some stability. We view the registration statement filed yesterday for a proposed equity offering as one piece of a well-crafted set of activities to ensure BiondVax continues to deliver. While the decision to pursue an offering was made in advance of the letter of non-compliance, we are optimistic that the offering’s successful conclusion will address the deficiency and put the issue behind us. To be prudent we will pursue additional measures in parallel, consistent with our proactive approach to restructuring our loan from the European Investment Bank, as previously announced.”
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, BiondVax 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: 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.
BiondVax’s Strategic Research Collaboration: Significant progress towards development of innovative nanosized antibodies (NanoAbs) for therapeutic indications in addition to COVID-19
Jerusalem, Israel – September 20, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), which focuses on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today provided encouraging updates related to 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 alpaca‑derived nanosized antibody (NanoAb) therapies.
As reported in March 2022, in addition to the exclusive license for the ongoing development and commercialization of an inhaled COVID-19 NanoAb therapy, the parties signed a five-year research collaboration agreement (RCA) for additional NanoAbs for the treatment of diseases such as psoriasis, psoriatic arthritis, asthma, and wet macular degeneration. Today, BiondVax reported that Professor Dirk Görlich of MPG and his team have successfully generated, identified and isolated NanoAbs addressing a number of additional biological target molecules as specified in the relevant RCA. Professor Görlich and his colleague Professor Matthias Dobbelstein of UMG verified strong affinity by the new NanoAbs to their biological target molecules and high thermostability. The academic research teams have also demonstrated strong neutralization by several NanoAb candidates of their respective target molecules. Neutralization studies of the other NanoAbs are expected to begin later this year.
Based on these promising results, the BiondVax-MPG-UMG Joint Steering Committee, established to guide the NanoAb collaboration, decided earlier this month to focus further development beginning with the following NanoAbs, targeting immune system cytokines:
NanoAbs targeting IL-17A, IL-17F and IL-17A/F complex as drug candidates for the potential treatment of psoriasis and psoriatic arthritis.
NanoAbs targeting IL-13 and NanoAbs targeting TSLP as drug candidates for the potential treatment of asthma.
Derisked strategy: This advancement is aligned with BiondVax’s derisked R&D strategy as these cytokine targets are already validated to exert beneficial clinical results in human beings when treated with conventional monoclonal antibodies. Moreover, these conventional monoclonal antibodies are already approved for marketing and generate billions of dollars in annual commercial sales. The BiondVax-MPG-UMG research collaboration team aims to generate and develop NanoAbs with the potential to capture significant market share as “bio-betters” answering needs underserved by currently approved conventional monoclonal antibody therapeutics as the NanoAbs exhibit strong potential for superior patient convenience, safety, and clinical outcomes, at lower costs. Pursuant to the RCA, BiondVax holds exclusive options for worldwide exclusive licenses to further develop and commercialize these NanoAbs.
Inhaled COVID-19 therapy: These new NanoAbs are in addition to the ongoing development of a previously announced COVID-19 NanoAb therapy exclusively licensed to BiondVax from Max Planck Innovation GmbH, which acts as the technology transfer agency of MPG. In the coming weeks, BiondVax intends to initiate a preclinical proof-of-concept study of the COVID-19 NanoAb as an inhaled therapy in COVID-19 infected animals. The study will be conducted in collaboration with two world renowned institutions: The Fraunhofer Institute for Toxicology and Experimental Medicine ITEM and The University of Veterinary Medicine Hannover (TiHo), Germany. Assuming successful results, a first-in-human Phase 1/2a clinical trial of the COVID-19 NanoAb inhaled therapy will be initiated in 2023.
Mr. Amir Reichman, BiondVax’s Chief Executive Officer, noted, “The next two targets we have decided to pursue, asthma and psoriasis, are both conditions for which the antibody target is validated by existing treatments for which the mechanism of action is well understood. Both represent large and growing markets. We strongly believe in the potential of our NanoAbs to be ‘bio-betters’ compared to the existing treatments, in that the NanoAbs are expected to demonstrate very high potency, safety, stability and with convenient routes of delivery to patients at an affordable cost. Thanks to the leading scientific support provided by Professor Dirk Görlich and Professor Matthias Dobbelstein and their teams at Max Planck and UMG, we are confidently working with urgency to bring more drug candidates of this exciting NanoAb therapy platform to the market as soon as possible.”
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | 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 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 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.
BiondVax to Present at H.C. Wainwright 24th Annual Global Investment Conference
Jerusalem, Israel – September 8, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced that the company’s Chief Executive Officer, Mr. Amir Reichman, will attend the H.C. Wainwright 24th Annual Global Investment Conference in‑person, and his pre‑recorded presentation will be available during the conference via the online conference portal at https://hcwevents.com/annualconference. The conference is being held September 12-14, 2022, in New York City.
At the conference, there will be an opportunity for investors to schedule one-on-one meetings with Mr. Reichman and BiondVax’s Chairman of the Board Mr. Mark Germain via the HCW conference scheduling platform. In addition, Mr. Reichman and Mr. Germain will be meeting investors throughout the week on a non-deal roadshow in New York City. Investors interested in scheduling a meeting with them should contact BiondVax’s Investor Relations team at ir@biondvax.com.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline generated through scientific collaboration with and exclusive licensing from the Max Planck Institute for Multidisciplinary Sciences and the University Medical Center Gottingen, both in Germany. For more information, please visit 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 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 management’s participation in investor conferences; 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 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.
BiondVax announces Second Quarter 2022 Financial Results and Provides Business Update
Jerusalem, Israel - August 25, 2022 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), which focuses on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today published its financial results for the quarter ended June 30, 2022 and provided a business update.
Business Update
Development of the NanoAb program is proceeding according to plan. A pilot quantity of the lead NanoAb, a COVID-19 therapy, was manufactured in-house then sent for preclinical inhalation device evaluation and selection of an inhaler for human use.
In September 2022, BiondVax plans to initiate an inhalation proof of concept study with its anti-SARS-COV-2 NanoAbs in COVID-19 infected animals with readout expected in November 2022.
BiondVax currently holds several anti-SARS-COV-2 NanoAb candidates, generated and initially characterized by Max Planck Institute for Multidisciplinary Sciences in Göttingen together with University Medical Center Göttingen and exclusively licensed from Max-Planck-Innovation GmbH, which demonstrated high affinity to and strong neutralization of COVID-19 VoCs including Omicron BA1&2 and will be testing them in the coming months for neutralization of BA2.75 and BA5.
BiondVax received supportive Scientific Advice from the Paul Ehrlich Institute (PEI) for its COVID-19 NanoAb development plans. PEI supported BiondVax's plan for first-in-human clinical trial to be conducted directly in sick patients as a combined Phase 1/2a, testing both safety and efficacy, thereby shortening BiondVax's clinical development timelines.
As part of their broader research collaboration with BiondVax, the researchers at Max Planck Institute for Multidisciplinary Sciences in Göttingen and University Medical Center Gottingen have been able to successfully isolate new NanoAbs targeting IL-17A/F and other cytokines, which can be used for treatment of other diseases such as psoriasis, psoriatic arthritis, asthma, and macular degeneration. BiondVax has an exclusive option for an exclusive license to further develop and commercialize these drug candidates.
Second Quarter 2022 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.5 (NIS/$US), the rate as of the close of business on June 30, 2022.
R&D expenses for the three months ended June 30, 2022 were NIS 6.5 million ($1.85 million) compared to NIS 1.9 million for the three months ended June 30, 2021. Total R&D expenses for the six months ended June 30, 2022 were NIS 10.1 million ($2.9 million) compared to NIS 4.6 million for the six months ended June 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 June 30, 2022 were NIS 4.3 million ($1.2 million) compared to NIS 7.0 million for the three months ended June 30, 2021. Total marketing, general and administrative expenses for the six months ended June 30, 2022 were NIS 8.9 million ($2.5 million) compared to NIS 11 million for the six months ended June 30, 2021. These decreases were primarily due to salaries and related expenses of NIS 1.2 million and share based payment of NIS 1 million.
Financial expenses for the three months ended June 30, 2022 were NIS 2.1 million ($0.6 million) compared to NIS 3.0 million for the three months ended June 30, 2021. Financial expenses for the six months ended June 30, 2022 were NIS 3.2 million ($1 million) compared to NIS 4.5 million for the six months ended June 30, 2021. These decreases were primarily due to currency exchange differences and EIB loan financial expenses.
Total operating expenses for the three months ended June 30, 2022 were NIS 10.8 million ($3.1 million) compared to NIS 8.9 million for the three months ended June 30, 2021. Total operating expenses for the six months ended June 30, 2022 were NIS 19 million ($5.5 million) compared to NIS 15.6 million for the six months ended June 30, 2021.
Net loss for the for the three months ended June 30, 2022 was NIS 12.9 million ($3.7 million) compared to NIS 12.0 million for the three months ended June 30, 2021. Net loss for the six months ended June 30, 2022 was NIS 22.3 million ($6.4 million) compared to NIS 20.2 million for the six months ended June 30, 2021. These increases were primarily due to an increase in R&D expenses, offset by a decrease in marketing, general and administrative expenses as described above.
As of June 30, 2022, BiondVax had cash and cash equivalents of NIS 39.5 million ($11.3 million) compared to NIS 54.0 million as of December 31, 2021.
Unaudited second quarter financial results will be submitted to the Securities and Exchange Commission. A summary is included in the tables below.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | 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 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 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.
BALANCE SHEETS | |||||||||||
In thousands, except share and per share data | |||||||||||
Convenience | |||||||||||
Translation | |||||||||||
December 31, | June 30, | June 30, | |||||||||
2021 | 2021 | 2022 | 2022 | ||||||||
Audited | Unaudited | Unaudited | |||||||||
NIS | N I S | U.S. dollars | |||||||||
CURRENT ASSETS: | |||||||||||
Cash and cash equivalents | 54,036 | 39,883 | 39,499 | 11,285 | |||||||
Other receivables | 1,012 | 2,641 | 626 | 179 | |||||||
Total current assets | 55,048 | 42,524 | 40,125 | 11,464 | |||||||
LONG TERM ASSETS: | |||||||||||
Property, plant and equipment | 38,519 | 38,979 | 39,250 | 11,214 | |||||||
Right-of-use assets | 5,588 | 6,109 | 5,227 | 1,494 | |||||||
Restricted cash | 444 | 437 | 484 | 138 | |||||||
Other long-term assets | - | - | 485 | 139 | |||||||
Total non-current assets | 44,551 | 45,525 | 45,446 | 12,985 | |||||||
Total assets | 99,599 | 88,049 | 85,571 | 24,449 | |||||||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||||||
CURRENT LIABILITIES: | |||||||||||
Trade payables | 3,107 | 2,635 | 2,057 | 588 | |||||||
Operating lease liabilities | 773 | 764 | 857 | 245 | |||||||
Loan from others | - | 64,248 | 18,706 | 5,345 | |||||||
Other payables | 3,327 | 1,739 | 1,898 | 542 | |||||||
Total current liabilities | 7,207 | 69,386 | 23,518 | 6,720 | |||||||
LONG TERM LIABILITIES: | |||||||||||
Operating lease liabilities | 5,712 | 6,047 | 5,536 | 1,582 | |||||||
Loan from others | 63,252 | - | 51,954 | 14,843 | |||||||
Other payables | - | 1,135 | - | - | |||||||
Severance pay liability, net | 95 | 95 | 95 | 27 | |||||||
Total long-term liabilities | 69,059 | 7,277 | 57,585 | 16,452 | |||||||
SHAREHOLDERS' EQUITY: | |||||||||||
Ordinary shares of no par value: Authorized: 1,800,000,000 shares at June 30, 2022, (unaudited) June 30, 2021 (unaudited) and at December 31, 2021; Issued and outstanding: 747,153,064 shares at June 30, 2022 (unaudited), 573,285,824 shares at June 30, 2021 (unaudited) and 739,048,544 shares at December 31, 2021
| (*) - | (*) - | (*) - | (*) - | |||||||
Share premium | 388,104 | 356,358 | 391,507 | 111,859 | |||||||
Accumulated deficit | (364,771) | (344,972) | (387,039) | (110,582) | |||||||
Total Equity | 23,333 | 11,386 | 4,468 | 1,277 | |||||||
Total liabilities and shareholders' equity | 99,599 | 88,049 | 85,571 | 24,449 | |||||||
(*) Represents less than NIS\USD 1. |
STATEMENTS OF COMPREHENSIVE LOSS | |||||||||||||||
In thousands, except share and per share data | |||||||||||||||
Convenience translation | |||||||||||||||
Year ended December 31, | Three months ended June 30, | Six months ended June 30, | Six months ended June 30, | ||||||||||||
2021 | 2021 | 2022 | 2021 | 2022 | 2022 | ||||||||||
Audited | Unaudited | Unaudited | |||||||||||||
N I S | U.S. dollars | ||||||||||||||
(In thousands, except per share data) | |||||||||||||||
Operating expenses: | |||||||||||||||
Research and development, net of participations
| 10,341
| 1,900
| 6,495
| 4,653
| 10,148
| 2,900
| |||||||||
Marketing, general and administrative
| 24,528
| 7,002
| 4,286
| 11,007
| 8,919
| 2,548
| |||||||||
Other income | (40) | - | - | - | - | - | |||||||||
Total operating expenses | 34,829 | 8,902 | 10,781 | 15,660 | 19,067 | 5,448 | |||||||||
Operating loss | (34,829) | (8,902) | (10,781) | (15,660) | (19,067) | (5,448) | |||||||||
- | |||||||||||||||
Financial income | 5,716 | - | 1,571 | 822 | 2,783 | 796 | |||||||||
Financial expense | (10,865) | (3,091) | (3,642) | (5,341) | (5,984) | (1,710) | |||||||||
Net loss and total comprehensive loss | (39,978) | (11,993) | (12,852) | (20,179) | (22,268) | (6,362) | |||||||||
Basic and diluted net loss per share | (0.07) | (0.03) | (0.02) | (0.04) | (0.03) | (0.01) | |||||||||
Weighted average number of shares | 564,575,9 67 | 573,205 ,607 | 746,898,6 71 | 552,140,0 30 | 745,817, 220 | 745,817,2 20 | |||||||||
The notes in the Company's quarterly report are an integral part of the financial statements. The complete financial results are available in the Form 6-K to be filed with the Securities and Exchange Commission.
BiondVax and European Investment Bank sign definitive amendment extending maturity of loan until December 2027 with additional terms in support of BiondVax's new strategy
Jerusalem, Israel - August 10, 2022 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing, and commercializing innovative biological medicinal products for the prevention and treatment of infectious diseases and other illnesses, announced today the successful conclusion of negotiations and formal approval by the European Investment Bank (the "EIB") of new terms of its outstanding €24 million loan (the "Loan") to BiondVax.
BiondVax previously announced on March 14, 2022, that general terms of the restructuring had been agreed upon in principle.
The new terms include:
Loan extension: An extension of the maturity dates from 2023 (€20 million) and 2024 (€4 million) until December 2027.
Interest accrual: Although the Loan has been outstanding since 2018, interest on the Loan will only begin to accrue starting January 1, 2022, at an annual rate of 7%. The interest payments will be deferred until the new maturity date and will be added to the principal balance at the end of each year during the Loan period.
Principal repayment: $900,000 will be paid by BiondVax shortly after the execution of the relevant amendment letter with the EIB. This amount will be applied to reduce the outstanding Loan. Going forward 10% of any capital raises until maturity will be used to further repay the Loan principal including any outstanding accrued interest.
Variable remuneration to the EIB: Once BiondVax's commercial sales exceed €5 million, 3% of BiondVax's topline revenues will be paid to the EIB as royalties until the EIB receives (from the Loan repayment, inter alia the interest and the royalties) the higher of (i) a total of 2.8 times the original €24 million principal (as provided in the original Loan agreement) and (ii) 20% IRR on the principal calculated from January 1, 2022.
Prepayment indemnity: In case BiondVax decides to discharge all liabilities under the Finance Contract inter alia payments of the variable remuneration BiondVax would need to repay to the EIB an indemnity amount in addition to the Loan principle and the accrued interest. The indemnity will be calculated such that the EIB receives an additional payment equal to the greater of (i) the prepayment amount (i.e. twice the prepayment amount in the aggregate) and (ii) the amount required to realize 20% IRR on the prepayment amount at the time of prepayment.
Amir Reichman, CEO of BiondVax, commented, "I am extremely pleased to announce the achievement of another major milestone in the relaunch of BiondVax; another 'promise made, promise kept'. With the cooperation and support of the EIB, we have signed an amendment to our loan facility extending the maturity to December 2027 and clearing the path for us to aggressively pursue development of a nanosized antibody (NanoAb) pipeline under an exclusive license and related collaboration agreements with the Max Planck Institute for Multidisciplinary Science and University Medical Center Gottingen, Germany. Since the March 2022 announcement of an agreement in principle to restructure the loan, all parties have worked diligently and in good faith to finalize documentation consistent with the announced terms, and we are grateful to our counterparties at the EIB for their efforts in this regard and support of our strategy and our team. We can now devote even more attention to the successful development of NanoAbs that address significant unmet medical needs in a patient friendly, efficacious and cost-efficient manner."
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative biological medicinal products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.
Contact Details: 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 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 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 25, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax receives supportive Scientific Advice from the Paul Ehrlich Institute (PEI) for COVID-19 NanoAb development plans including first‑in‑human Phase 1/2a safety and efficacy clinical trial
PEI supports BiondVax’s plan for first-in-human clinical trial to be conducted in patients as a combined Phase 1/2a, testing both safety and efficacy, thereby shortening BiondVax’s clinical development timelines for its first NanoAb product, a COVID-19 therapeutic;
PEI is a part of the German national medicines agency; its experts are also involved in European Medicines Agency (EMA) committees. As PEI Scientific Advice is generally considered a first key step towards regulatory approval, the encouraging feedback is an important milestone towards BiondVax’s successful development of the COVID-19 NanoAb;
Based on PEI’s feedback and following proof-of-concept animal studies anticipated later this year to demonstrate efficacy via the inhalation route of administration, BiondVax plans to initiate a first-in-human Phase 1/2a clinical trial in 2023.
Jerusalem, Israel – June 7, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing a pipeline of innovative NanoAbs for the prevention and treatment of infectious diseases and other illnesses, today announced receipt of supportive minutes of its recent Scientific Advice meeting with the Paul Ehrlich Institute (PEI) in Germany. The Scientific Advice addressed preclinical, clinical, and manufacturing development plans for the COVID-19 NanoAb therapy that BiondVax is developing based on an exclusive license from Max-Planck-Innovation GmbH and an accompanying research collaboration with the Max Planck Institute for Multidisciplinary Sciences and University Medical Center Göttingen.
PEI Scientific Advice is generally considered a first key step towards regulatory approval. It also informs Germany’s pharmaceutical regulatory authority of new pharmaceutical product developments. While alignment with PEI advice is not a guarantee for marketing approval, it provides important advice regarding the scientific and regulatory principles for development of the COVID-19 NanoAb. Therefore, a company’s alignment with PEI advice is widely considered a key drug development milestone.
The Scientific Advice Meeting minutes sent by PEI state, “Generally, the PEI concurs with the proposed proof-of-concept study...and the overall nonclinical strategy that are required to support further clinical development as well as potential regulatory approval.” Notably, PEI indicated support for conducting a combined Phase 1/2a first-in-human clinical trial that would include patients with confirmed COVID-19 infection. This would allow BiondVax to assess safety and efficacy in a single trial rather than the typical two trials, and therefore significantly accelerate its development timeline. This combined Phase 1/2a trial would follow preclinical proof-of-concept and toxicology, with a target start date in 2023.
Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, who oversees BiondVax’s clinical development commented, “We thank the experts at the Paul Ehrlich Institute for their helpful and informative advice. BiondVax intends to align our development plans to PEI’s advice, and I am pleased we have a clear path through preclinical and into clinical testing of the COVID-19 NanoAb therapy. As COVID‑19 is expected to continue circulating for many years, its high infectivity rate poses a real challenge to vaccination campaigns due to the high costs to health care systems combined with the observed continuously declining immunity. Having a safe and effective therapeutic product, which is also convenient to use, since it may be self-administered directly to the infection site via inhalation, would offer tremendous value both for patients and to our health care systems.”
BiondVax’s COVID-19 NanoAb is being developed as a patient friendly primary care product that may be self-administered through inhalation directly to the site of infection. Other valuable competitive advantages over existing therapies, demonstrated to-date in lab tests, include stability at higher temperatures, superior binding affinity, and more efficient production. With the expectation that COVID-19 will continue to circulate while public interest in repetitive vaccinations wanes, the Company believes that these attributes position a successfully developed product to capture significant market share.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 participation in conferences, the timing of future clinical trials, the therapeutic and commercial potential of NanoAbs and execution of a definitive amendment agreement with EIB. These forward-looking statements reflect management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 28, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces First Quarter 2022 Financial Results and Provides Business Update
Jerusalem, Israel – June 1, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceuticals company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today published its first quarter financial results for the quarter ended March 31, 2022 and provided a business update.
Business Update
Development of the NanoAb program is proceeding according to plan:
Demonstrated successful technology transfer from the Max Planck Institute for Multidisciplinary Sciences (MPG) to BiondVax’s manufacturing facility in Jerusalem. Testing showed that BiondVax was able to successfully manufacture its first exclusively licensed NanoAb for the treatment of COVID‑19 and demonstrated strong neutralization of live COVID‑19 virus in‑vitro at levels similar to those demonstrated by NanoAbs originally produced at MPG.
The NanoAbs produced at BiondVax's facility demonstrated similarly strong COVID‑19 in‑vitro neutralization capacity after being sprayed through a medical device inhaler that is expected to be used in the first in-human clinical trials planned for 2023.
A new NanoAb targeting Omicron that was generated at MPG was recently shown to successfully neutralize the Omicron variant of COVID‑19 in‑vitro. This NanoAb is expected to be manufactured and used in BiondVax’s first in‑human clinical trials.
Our team of 26 full‑time employees includes 12 new employees who joined BiondVax in 2022 to support all aspects of BiondVax’s NanoAb program, including quality assurance, quality control, R&D, manufacturing, preclinical and clinical trials.
In April and May, BiondVax hosted two investor webinars and presented in person at the Biomed Israel and HC Wainwright Global Investment conferences.
First Quarter 2022 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.176 (NIS/$US), the rate as of the close of business on March 31, 2022.
Total operating expenses for the three months ended March 31, 2022 were NIS 8.3 million ($2.6 million) compared to NIS 6.8 million for the three months ended March 31, 2021.
R&D expenses for the three months ended March 31, 2022 were NIS 3.65 million ($1.1 million) compared to NIS 2.8 million for the three months ended March 31, 2021. This increase was primarily due to activity related to the new NanoAb program.
Marketing, general and administrative expenses for the three months ended March 31, 2022 were NIS 4.6 million ($1.5 million) compared to NIS 4.0 million for the three months ended March 31, 2021.
As of March 31, 2022, BiondVax had cash and cash equivalents of NIS 48.9 million ($15.4 million) as compared to NIS 54.0 million as of December 31, 2021.
Unaudited first quarter financial results will be submitted to the Securities and Exchange Commission. A summary is included in the tables below.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. For more information, please visit www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 clinical trials, the therapeutic and commercial potential of NanoAbs and execution of a definitive amendment agreement with EIB. These forward-looking statements reflect management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BALANCE SHEETS | ||||||||
In thousands, except share and per share data | ||||||||
Convenience | ||||||||
Translation | ||||||||
December 31, | March 31, | March 31, | ||||||
2021 | 2021 | 2022 | 2022 | |||||
Audited | Unaudited | Unaudited | ||||||
N I S | U.S. dollars | |||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | 54,036 | 48,577 | 48,886 | 15,391 | ||||
Other receivables | 1,012 | 481 | 619 | 196 | ||||
55,048 | 49,058 | 49,505 | 15,587 | |||||
LONG–TERM ASSETS: | ||||||||
Property, plant and equipment | 38,519 | 39,252 | 39,745 | 12,514 | ||||
Right-of-use assets | 5,588 | 5,978 | 5,359 | 1,687 | ||||
Other long-term assets | 444 | 436 | 929 | 293 | ||||
44,551 | 45,666 | 46,033 | 14,494 | |||||
99,599 | 94,724 | 95,538 | 30,081 | |||||
CURRENT LIABILITIES: | ||||||||
Trade payables | 3,107 | 2,085 | 4,102 | 1,292 | ||||
Operating lease liabilities | 773 | 641 | 802 | 253 | ||||
Loan from others | - | 62,346 | - | |||||
Other payables | 3,327 | 1,640 | 3,598 | 1,133 | ||||
7,207 | 66,712 | 8,502 | 2,677 | |||||
LONG–TERM LIABILITIES: | ||||||||
Operating lease liabilities | 5,712 | 5,978 | 5,585 | 1,759 | ||||
Loan from others | 63,252 | - | 65,187 | 20,524 | ||||
Other payables | - | 1,135 | - | - | ||||
Severance pay liability, net | 95 | 95 | 95 | 30 | ||||
69,059 | 7,208 | 70,867 | 22,313 | |||||
SHAREHOLDERS' EQUITY: | ||||||||
Ordinary shares of no par value: Authorized: | *) - | *) - | *) - | *) - | ||||
Share premium | 388,104 | 353,783 | 390,356 | 122,908 | ||||
Accumulated deficit | (364,771) | (332,979) | (374,187) | (117,817) | ||||
23,333 | 20,804 | 16,169 | 5,091 | |||||
99,599 | 94,724 | 95,538 | 30,081 | |||||
*) Represents less than NIS\USD 1. |
STATEMENTS OF COMPREHENSIVE LOSS | |||||||||||||||
In thousands, except share and per share data | |||||||||||||||
Convenience translation | |||||||||||||||
Year ended December 31, | Three months ended March 31, | Three months March 31, | |||||||||||||
2021 | 2021 | 2022 | 2022 | ||||||||||||
Audited | Unaudited | Unaudited | |||||||||||||
NIS | U.S. dollars | ||||||||||||||
Operating expenses: | |||||||||||||||
Research and development, net of | 10,341 | 2,750 | 3,653 | 1,150 | |||||||||||
Marketing, general and administrative | 24,528 | 4,005 | 4,633 | 1,459 | |||||||||||
Other income | (40) | - | - | - | |||||||||||
Total operating expenses (income) | 34,829 | 6,755 | 8,286 | 2,609 | |||||||||||
- | |||||||||||||||
Operating income (loss) | (34,829) | (6,755) | (8,286) | (2,609) | |||||||||||
Financial income | 5,716 | 1,182 | 1,212 | 382 | |||||||||||
Financial expense | (10,865) | (2,613) | (2,342) | (737) | |||||||||||
Net loss and total comprehensive loss | (39,978) | (8,186) | (9,416) | (2,965) | |||||||||||
Basic and Diluted net loss per share | (0.07) | (0.02) | (0.02) | (0.005) | |||||||||||
Weighted average number of shares | 564,575,967 | 530,840,391 | 570,114,429 | 570,114,429 |
BiondVax to Present at H.C. Wainwright Global Investment Conference
Jerusalem, Israel – May 19, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced that it will present in-person at the H.C. Wainwright Global Investment Conference, on May 24, 2022 in Miami, Florida.
The presentation, which will be delivered by BiondVax’s Chairman, Mr. Mark Germain, on Tuesday, May 24th at 9:30am ET, will focus on BiondVax’s development of innovative nanosized antibodies (NanoAbs) that exhibit significant competitive advantages over existing therapies. The NanoAbs are being developed in collaboration with the Max Planck Institute for Multidisciplinary Sciences and University Medical Center Göttingen, Germany, to address diseases with large unmet medical needs and attractive commercial opportunities such as COVID-19, asthma, psoriasis, psoriatic arthritis, and macular degeneration.
Any attending investors that wish to meet with Mr. Germain at the conference are encouraged to contact investor relations by email using the contact information listed below.
Further information about the conference is available at https://hcwevents.com/globalconference.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. For more information, please visit www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 participation in conferences, the timing of future clinical trials, the therapeutic and commercial potential of NanoAbs and execution of a definitive amendment agreement with EIB. These forward-looking statements reflect management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 28, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax Provides Update at Biomed Israel Conference and Announces Significant Progress in its Nanosized Antibodies Program
Jerusalem, Israel – May 12, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, announced that Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, today presented BiondVax’s progress, achieving certain milestones, under its nanosized antibodies (NanoAbs) program.
Dr. Ben-Yedidia today presented at the Biomed Conference in Tel Aviv, Israel and the associated presentation will be accessible from the Company’s investor relations website. The main highlights of the progress are summarized below.
The NanoAb program, in collaboration with the Max Planck Institute for Multidisciplinary Sciences and University Medical Center Göttingen, Germany, aims to address diseases with large unmet medical needs and attractive commercial opportunities, such as COVID-19, asthma, psoriasis, psoriatic arthritis, and macular degeneration.
Summary of Recent Achievements
Successful technology transfer from Max Planck to BiondVax’s manufacturing facility in Jerusalem was demonstrated. Upon testing, it was shown that BiondVax was able to successfully manufacture its first exclusively licensed NanoAb for the treatment of COVID-19 and demonstrated strong in-vitro COVID-19 neutralization capability at levels similar to those demonstrated by NanoAbs originally produced at Max Planck.
Those NanoAbs produced at BiondVax's facility demonstrated similarly strong COVID-19 in-vitro neutralization capacity also after being sprayed through a medical device inhaler that is expected to be used in the first in-human clinical trials planned for 2023.
A new NanoAb targeting Omicron, that was generated by Max Planck, has recently been shown to successfully neutralize the Omicron variant of COVID-19, in-vitro. This NanoAb is expected to be manufactured and used in BiondVax’s first in-human trials.
Amir Reichman, CEO of BiondVax, added, “I am very pleased with the solid progress we have made in recent months. Demonstrating our ability to successfully take a drug candidate from an academic setting, develop a manufacturing process that follows industrial pharmaceutical principals for quality and analytics while keeping the targeted drug viral neutralization capacity, is a testimony to BiondVax’s competencies. In addition, as NanoAbs are in-fact a platform, those achievements will be leveraged towards our next in-line NanoAbs, which we expect to receive from our partners at Max Planck and UMG. I am very excited with the potential inherent to our NanoAb program.”
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. For more information, please visit www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 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 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 28, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax to Present at this week’s Biomed Israel Conference
Jerusalem, Israel – May 9, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced that it will present at the 20th Biomed Israel Conference and Exhibition, to be held May 10-12, 2022, in Tel Aviv, Israel.
The presentation, which will be delivered in-person by Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, on Thursday, May 12th at 1:45pm, will focus on BiondVax’s development of innovative nanosized antibodies (NanoAbs) that exhibit significant competitive advantages over existing therapies. The NanoAbs are being developed in collaboration with the Max Planck Institute for Multidisciplinary Sciences and University Medical Center Göttingen (UMG), Germany, to address diseases with large unmet medical needs and attractive commercial opportunities such as asthma, psoriasis, psoriatic arthritis, and macular degeneration.
Any attending investors that wish to meet with BiondVax management at the conference are welcome to contact investor relations.
Further information about the conference is available at https://kenes-exhibitions.com/biomed/.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. For more information, please visit www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 participation in conferences, the timing of future clinical trials, the therapeutic and commercial potential of NanoAbs and execution of a definitive amendment agreement with EIB. These forward-looking statements reflect management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 28, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax to host a Hebrew-language analyst and investor webinar on April 6th
Jerusalem, Israel – April 5, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, announced today that the Company will host an analyst and investors webinar event tomorrow, April 6th, in Hebrew.
CEO Amir Reichman will discuss recent business updates including:
The nanosized antibody (NanoAb) pipeline development collaboration with the Max Planck Institute for Multidisciplinary Sciences (MPG) and University Medical Center Göttingen (UMG), Germany
In-house preparations for the manufacturing of NanoAbs at the Company’s GMP biologics manufacturing facility in Jerusalem
Negotiations regarding restructuring of the European Investment Bank’s loan providing continued long-term support for BiondVax
FY’21 financial results
Time permitting the webinar will be opened to questions and answers.
Webinar Details
Language: Hebrew
Time: Wednesday, April 6th at 7am (ET)/14:00 (Israel)
Zoom link (no registration required): https://us02web.zoom.us/j/85410118728?pwd=cytBQkd5ZjJTTEJLa09oSU9KbnU3dz09
Recording of yesterday’s English-language Webinar
Tomorrow’s Hebrew webinar complements yesterday’s English-language webinar, which also featured Professor Dr. Matthias Dobbelstein briefly discussing recent NanoAb research results. A recording of yesterday’s English language webinar is available at https://us06web.zoom.us/webinar/register/WN_e82cz5jMQtGeJc6xUmPjZw (registration required) and from BiondVax’s website.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 participation in conferences, the timing of future clinical trials, the therapeutic and commercial potential of NanoAbs and execution of a definitive amendment agreement with EIB. These forward-looking statements reflect management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 28, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax to host analyst and investor webinar on April 4th
Jerusalem, Israel - March 31, 2022 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, announced today that the Company will host an analyst and investors webinar event next week.
Register now at https://us06web.zoom.us/webinar/register/WN_e82cz5jMQtGeJc6xUmPjZw
CEO Amir Reichman will discuss recent business updates including:
The nanosized antibody (NanoAb) pipeline development collaboration with the Max Planck Institute for Multidisciplinary Sciences (MPG) and University Medical Center Göttingen (UMG), Germany
In-house preparations for the manufacturing of NanoAbs at the Company's GMP biologics manufacturing facility in Jerusalem
Negotiations regarding restructuring of the European Investment Bank's loan providing continued long-term support for BiondVax.
FY'21 financial results
The webinar will also feature Professor Dr. Matthias Dobbelstein, a Fellow at MPG and Professor at UMG, who will briefly discuss the recent NanoAb research results. Time permitting, the webinar will be opened to questions and answers.
Webinar Details and Registration:
Monday, April 4th at 10am (ET)
Register now at https://us06web.zoom.us/webinar/register/WN_e82cz5jMQtGeJc6xUmPjZw
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com | Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 participation in conferences, the timing of future clinical trials, the therapeutic and commercial potential of NanoAbs and execution of a definitive amendment agreement with EIB. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax's ability to acquire rights to additional product opportunities; BiondVax's ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax's manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
Jerusalem, Israel – March 25, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today published its fourth quarter and full year financial results for the year ended December 31, 2021 and provided a business update. At the same time, the Company filed its Annual Report on Form 20-F with the Securities and Exchange Commission.
Business Update
BiondVax signed an exclusive license agreement for the development and commercialization of a COVID‑19 innovative nanosized antibody (NanoAbs) therapy in December 2021 with the Max Planck Institute for Multidisciplinary Sciences (MPG) and University Medical Center Göttingen (UMG), Germany.
BiondVax signed an additional definitive collaboration agreement in March 2022 with MPG and UMG for development of a pipeline of NanoAb therapies addressing diseases with large unmet medical needs and attractive commercial opportunities such as asthma, psoriasis, psoriatic arthritis, and macular degeneration; BiondVax has the option for an exclusive worldwide license for further development and commercialization of each of these NanoAbs.
In-house manufacturing: BiondVax has initiated preparations for the manufacturing of NanoAbs at the Company’s GMP biologics manufacturing facility in Jerusalem, including acquiring and installing additional equipment and hiring talent highly experienced in the field. Owning a biological GMP manufacturing site provides BiondVax with a competitive edge compared to other development stage biotechnology companies as it reduces its dependency on contract manufacturers, allows direct control over manufacturing of the entire NanoAb pipeline during development and enhances preparedness for seamless clinical supplies and future commercial launch. It also provides the opportunity to create additional intellectual property.
The European Investment Bank (EIB) has indicated that it supports BiondVax’s strategic turnaround plans. In March 2022, the EIB agreed in principle to extend the maturity of its loan until December 2027 with additional terms that provide continued long-term support for BiondVax.
Jay Green, former Senior Vice President Finance and CFO of GlaxoSmithKline plc (NYSE: GSK) global vaccines business, joined BiondVax’s Board of Directors in December 2021.
Amir Reichman, BiondVax’s CEO, stated, “I am very happy with our recent strategic developments which launch a new era for BiondVax. These achievements are very much in line with our strategy to build a broad product pipeline which strongly leverages BiondVax’s research and clinical development expertise and in-house manufacturing capabilities. We are excited to work with our collaborators at Max Planck and UMG, both considered world class scientific institutions, as we progress the entire NanoAb opportunity.”
Mr. Reichman continued, “Our initial goal is to demonstrate proof of concept of inhaled NanoAb therapy in animals in 2022 and conduct human clinical trials in 2023. In parallel we will begin to generate NanoAbs for the additional indications covered by the new research collaboration agreement, creating a robust pipeline for the Company with multiple opportunities for strategic partnering.”
Full Year 2021 Financial Summary
As BiondVax is based in Israel, results are recorded in New Israel Shekels (NIS) and a convenience translation to $US is provided using the exchange rate of 3.11 (NIS/$US), the rate as of the close of business on December 31, 2021.
Total operating expenses for 2021 were NIS 34.8 million ($11.2 million), compared with NIS 68.8 million in 2020, which were offset by other income of NIS 75.4 million due to the revaluation of the EIB loan.
R&D expenses for 2021 amounted to NIS 10.3 million ($3.3 million) compared with NIS 51.4 million in 2020.
Marketing, general and administrative expenses for 2021 were NIS 24.5 million ($7.8 million) compared with NIS 16.7 million in 2020.
Fourth Quarter 2021 Financial Summary
Total operating expenses for the three months ended December 31, 2021 were NIS 10.9 million ($3.5 million) compared with NIS 12.1 million for the three months ended December 31, 2020.
R&D expenses for the three months ended December 31, 2021 decreased to NIS 3.6 million ($1.15 million) from NIS 7.8 million for the three months ended December 31, 2020. This decrease was primarily attributable to expenses related to a Phase 3 clinical trial and related operations at our biologics manufacturing facility that was completed during Q4 2020.
Marketing, general and administrative expenses for the three months ended December 31, 2021 increased to NIS 7.3 million ($2.3 million) from NIS 4.2 million for the three months ended December 31, 2020. This increase was primarily due to an increase in compensation, consulting and legal services, and other related expenses, in support of changes in corporate strategy and management during 2021.
As of December 31, 2021, BiondVax had cash and cash equivalents of NIS 54 million ($17.4 million) as compared to NIS 9.4 million as of December 31, 2020. The increase in cash was primarily due to secondary offerings of shares in February and December 2021, which resulted in gross proceeds of $13.8 million and $9.8 million, respectively.
The complete audited financial results are available in the Company’s Annual Report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission. A summary is included in the tables below.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 clinical trials, the therapeutic and commercial potential of NanoAbs and execution of a definitive amendment agreement with EIB. These forward-looking statements reflect management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BALANCE SHEETS | |||||||||||||
In thousands, except share and per share data | |||||||||||||
Convenience | |||||||||||||
December 31, | December 31, | ||||||||||||
2020 | 2021 | 2021 | |||||||||||
New Israeli Shekels | U.S. dollars | ||||||||||||
CURRENT ASSETS: | |||||||||||||
Cash and cash equivalents | 9,421 | 54,036 | 17,375 | ||||||||||
Other receivables | 1,204 | 1,012 | 325 | ||||||||||
10,625 | 55,048 | 17,700 | |||||||||||
LONG–TERM ASSETS: | |||||||||||||
Property, plant and equipment | 39,607 | 38,519 | 12,386 | ||||||||||
Right-of-use assets | 6,206 | 5,588 | 1,797 | ||||||||||
Other long-term assets | 473 | 444 | 143 | ||||||||||
46,286 | 44,551 | 14,326 | |||||||||||
56,911 | 99,599 | 32,026 | |||||||||||
CURRENT LIABILITIES: | |||||||||||||
Trade payables | 1,868 | 3,107 | 999 | ||||||||||
Current maturities of lease liabilities | 654 | 773 | 249 | ||||||||||
Loan from others | 60,421 | - | - | ||||||||||
Other payables | 1,246 | 3,327 | 1,070 | ||||||||||
64,189 | 7,207 | 2,318 | |||||||||||
LONG–TERM LIABILITIES: | |||||||||||||
Lease Liabilities | 6,088 | 5,712 | 1,837 | ||||||||||
Loan from others | - | 63,252 | 20,338 | ||||||||||
Other payables | 1,135 | - | - | ||||||||||
Severance pay liability, net | 95 | 95 | 31 | ||||||||||
7,318 | 69,059 | 22,206 | |||||||||||
SHAREHOLDERS' EQUITY: | |||||||||||||
Ordinary shares of no par value: Authorized: 1,800,000,000 | *) - | *) - | *) - | ||||||||||
Share premium | 310,197 | 388,104 | 124,792 | ||||||||||
Accumulated deficit | (324,793) | (364,771) | (117,290) | ||||||||||
(14,596) | 23,333 | 7,502 | |||||||||||
56,911 | 99,599 | 32,026 |
STATEMENTS OF COMPREHENSIVE INCOME AND LOSS | ||||||||||||
In thousands, except share and per share data | ||||||||||||
Year ended | Year ended | |||||||||||
December 31, | December 31, | |||||||||||
2019 | 2020 | 2021 | 2021 | |||||||||
N I S | U.S. dollars | |||||||||||
Operating expenses: | ||||||||||||
Research and development, net of | 68,645 | 51,463 | 10,341 | 3,325 | ||||||||
Marketing, general and administrative | 9,706 | 16,687 | 24,528 | 7,887 | ||||||||
Other income | - | (75,484) | (40) | (13) | ||||||||
Total operating expenses (income) | 78,351 | (7,334) | 34,829 | 11,199 | ||||||||
Operating income (loss) | (78,351) | 7,334 | (34,829) | (11,199) | ||||||||
Financial income | 4 | 3,843 | 5,716 | 1,838 | ||||||||
Financial expense | (30,847) | (15,632) | (10,865) | (3,494) | ||||||||
Income (Loss) | (109,194) | (4,455) | (39,978) | (12,855) | ||||||||
Total comprehensive income (loss) | (109,194) | (4,455) | (39,978) | (12,855) | ||||||||
Basic and diluted income (loss) per share | (0.33) | (0.01) | (0.07) | (0.02) | ||||||||
Weighted average number of shares | 326,651,721 | 443,260,878 | 564,575,967 | 564,575,967 |
BiondVax signs definitive collaboration agreement for the development of a pipeline of innovative nanosized antibody (NanoAb) therapies
Broad collaboration with Max Planck Institute for Multidisciplinary Sciences and University Medical Center Göttingen (UMG), Germany, for development of NanoAbs addressing diseases with large unmet medical needs and attractive commercial opportunities such as asthma, psoriasis, psoriatic arthritis, and macular degeneration; BiondVax to have exclusive option for exclusive worldwide license for further development and commercialization;
NanoAbs to target disease markers validated by currently marketed antibody therapies thereby de-risking development and regulatory process timelines;
The unique NanoAbs previously developed by the Max Planck and UMG teams exhibit significant competitive advantages over existing antibody therapies including hyper-thermostability, patient convenience, and efficient production;
Builds on existing collaboration for development of COVID-19 NanoAbs that are stable at very high temperatures and will be developed for convenient inhalation administration targeting the virus directly in the lungs and airways;
COVID-19 NanoAb initial human clinical trials results expected in 2023; New NanoAb pipeline development already initiated with preclinical results anticipated 2023.
Jerusalem, Israel – March 24, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced the signing of definitive agreements with the Max Planck Society, the parent organization of the Max Planck Institute for Multidisciplinary Sciences (MPI), and the University Medical Center Göttingen (UMG), both in Germany, to enter into a strategic collaboration for the development of innovative nanosized antibodies (NanoAbs). BiondVax will have an exclusive option for an exclusive worldwide license at pre-agreed commercial terms for further development and commercialization of each generated NanoAb.
The NanoAbs previously developed by BiondVax’s collaborators exhibit several valuable competitive advantages over existing therapies including uniquely strong binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration. The collaboration targets indications with large and growing market sizes where the NanoAb advantages have the potential to capture significant market share such as psoriasis, asthma, macular degeneration, and psoriatic arthritis. As with the parallel and previously announced exclusive license agreement for development of an inhaled COVID-19 therapeutic NanoAb, these are all diseases with known and validated antibody drug targets, which should shorten development timelines while increasing probability for drug approval.
BiondVax is planning a rapid development path that leverages the company’s expertise and capabilities in biological drug development and manufacturing. In particular, NanoAbs can be mass-produced through recombinant protein manufacturing in sites such as BiondVax’s GMP biologics manufacturing facility in Jerusalem. Development of NanoAbs covered under today’s agreement has already begun, and initial preclinical results are expected in 2023. BiondVax anticipates conducting a preclinical proof of concept study of inhaled COVID-19 NanoAbs in 2022 with initial human clinical trials results in 2023.
Mr. Amir Reichman, BiondVax’s CEO, commented, “The NanoAb platform is an incredible opportunity for BiondVax. It will serve as a basis for an exciting new pipeline of commercially attractive products to address large and growing markets significantly underserved by existing biological treatments. We are going after targets already validated, but with a proprietary NanoAb that we expect will have meaningful advantages in efficacy, cost and ease of use and treatment; a true ‘biobetter’ capable of capturing significant market share and expanding the market. The technology is also a great fit to our manufacturing site in Jerusalem and our experience and expertise in biological drug development. I would like to thank Professors Görlich and Dobbelstein for their enthusiasm for this project, and Max Planck Innovation’s technology transfer team including Dr. Dieter Link and Florian Beilhack for their assistance in developing this innovative collaboration.”
The NanoAb platform underlying this agreement was developed by the teams of Professor Dirk Görlich, Director at the MPI, with supporting bioassay development by Professor Matthias Dobbelstein, Professor of Molecular Oncology at the UMG. Professor Görlich commented, “We believe that the innovative platform developed at the Max Planck Institute for Multidisciplinary Sciences and the University Medical Center of Göttingen has great potential to provide patients with superior therapies. We are particularly pleased to team with BiondVax to use their drug development and manufacturing capabilities and expertise to advance the nanosized antibodies through additional development towards marketing approvals.”
Prof. Dr. Martin Stratmann, President of the Max Planck Society, stated, “I am pleased that with BiondVax we have succeeded not only in finding a licensee but also a cooperation partner for the promising technology of nano-antibodies. Dirk Görlich and his team at the Max Planck Institute for Multidisciplinary Sciences, together with the University Medical Center Göttingen, have developed an innovative therapeutic approach within less than two years, which could also be used against COVID-19, among other things. Additional targets in other clinical settings are now pursued under a broader collaboration agreement. In this respect, we all hope that BiondVax will succeed in bringing these approaches to market."
The initial NanoAb blueprints are extracted from small blood samples of immunized alpacas, then selected and optimized in laboratories before being used for NanoAb production in large fermenters. The NanoAbs exhibit potential to serve as highly attractive therapies for diseases including COVID-19, as described in Görlich and Dobbelstein’s paper titled “Neutralization of SARS-CoV-2 by highly potent, hyperthermostable, and mutation-tolerant nanobodies,” published in The EMBO Journal and available at https://doi.org/10.15252/embj.2021107985. NanoAbs are also known as VHH-antibodies or nanobodies. Nanobody is a trademark registered by ABLYNX N.V., a wholly owned subsidiary of Sanofi. BiondVax has no affiliation with and is not endorsed by Sanofi.
The collaboration has been facilitated by kENUP, a civic society organization promoting innovative industries in Europe.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms, beginning with an innovative nanosized antibody (NanoAb) pipeline. For more information, please visit www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 execution of a definitive amendment agreement with EIB. These forward-looking statements reflect management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company's prospectus supplement filed with the Securities and Exchange Commission on December 28, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
European Investment Bank Agrees in Principle to Extend the Maturity of its Loan until December 2027 with Additional Terms that Provide Continued Long-Term Support for BiondVax’s New Strategy
Jerusalem, Israel – March 14, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced today that it had been negotiating with the European Investment Bank (the “EIB”) terms of restructuring of its outstanding €24 million loan (the “Loan”). The parties have reached a commercial agreement, which is still subject to EIB’s formal approval of the new terms, that would entail the following:
An extension of the maturity dates from 2023 (€20 million) and 2024 (€4 million) until December 2027.
Although the Loan has been outstanding since 2018, interest on the Loan will only begin to accrue starting January 1, 2022 at an annual rate of 7%. The interest payments will be deferred until the new maturity date and will be added to the principal balance at the end of each year during the Loan period.
$900,000 will be paid by BiondVax as a reduction of principal shortly after the new terms become effective, and going forward 10% of any capital raises by BiondVax until maturity will be used to further repay the Loan principal.
Once BiondVax’s commercial sales exceed €5 million, 3% of BiondVax’s topline revenues will be paid to EIB as royalties up to a combined maximum of 2.8 times the original €24 million principal.
If BiondVax chooses to prepay any portion of the Loan (other than as required from future capital raises) the amount prepaid will be calculated such that the EIB realizes at least 20% IRR on its investment at the point of prepayment.
Amir Reichman, CEO of BiondVax, commented, “The EIB has been a loyal partner to BiondVax since 2018, having supported our activities and the building of our GMP biologics manufacturing site. The contemplated restructuring of our loan from the EIB would remove the near-term obligation to repay the loan and would allow us to continue to move forward with our activities at full throttle. I am very pleased that our partners at the EIB have chosen to continue to support BiondVax, allowing us to further develop and advance our new nanosized antibody (NanoAb) activities related to our recently announced exclusive license agreement and the five-year research collaboration agreement with the Max Planck Institute and University Medical Center Gottingen, Germany. Furthermore, the fact that the EIB considers tying a significant part of the loan restructuring scheme to our future sales signals its belief in our strategy and its trust in our scientific and leadership team at BiondVax. I would like to thank the EIB’s officers involved in these negotiations for their thorough work and collaborative approach.”
The EIB is currently undergoing an internal approval process regarding the new terms of the Loan. If the new terms are approved by EIB’s management committee, BiondVax and the EIB would aim to sign an amendment agreement in the second quarter of 2022. Until the definitive amendment is signed, the new terms described above are not legally binding on the EIB and there is a risk that the definitive amendment will not be signed.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its universal influenza vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms, beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 54 223 3860 | j.phillipson@biondvax.com | Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 execution of a definitive amendment agreement with EIB. These forward-looking statements reflect management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that BiondVax will not execute an additional agreement with the Max Planck Society and the University Medical Center Göttingen or that it will be delayed; the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company's prospectus supplement filed with the Securities and Exchange Commission on December 28, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax to Present at Aegis Virtual Conference
Jerusalem, Israel – February 22, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced that it will present a company overview at the Aegis Capital Corp. Virtual Conference on February 23rd at 9:30am ET.
The presentation, which will focus on BiondVax’s development of innovative nanosized antibodies (NanoAbs) that exhibit significant competitive advantages over existing therapies, will be available by request to Aegis for the duration of the conference from February 23 through 25, 2022. The slide deck will also be made available on BiondVax’s website at https://www.biondvax.com/investors. Further information about the conference is available at https://www.aegiscapcorp.com/2022-aegis-virtual-conference/.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms, beginning with an innovative nanosized antibody (NanoAb) pipeline. For more information, please visit www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com | Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 management’s participation in investor conferences. 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 will not execute an additional agreement with the Max Planck Society and the University Medical Center Göttingen or that it will be delayed; the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company's prospectus supplement filed with the Securities and Exchange Commission on December 28, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax to Present at BIO CEO & Investor Conference
Jerusalem, Israel – February 15, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced that CEO Amir Reichman is presenting at the BIO CEO & Investor Conference being held this week.
Mr. Reichman’s presentation focuses on BiondVax’s new collaboration for development of innovative therapeutic NanoAbs, and is available on-demand to conference participants via the conference portal and on BiondVax’s website at https://www.biondvax.com/events/event-bio-ceo-22.
BiondVax’s management will be meeting with investors in a virtual 1-1 setting at this conference. If you wish to set up a meeting with management, please do so via the conference portal or speak directly with investor relations at BiondVax.
About BiondVax: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms, beginning with an innovative nanosized antibody (NanoAb) pipeline. For more information, please visit www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com | Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 management’s participation in investor conferences. 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 will not execute an additional agreement with the Max Planck Society and the University Medical Center Göttingen or that it will be delayed; the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company's prospectus supplement filed with the Securities and Exchange Commission on December 28, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.