Press Releases
BiondVax Receives Additional Grant Funding
Israel Innovation Authority Approves Additional Budget towards M‑001 Flu Vaccine DevelopmentNESS ZIONA, ISRAEL, August 14, 2017 –BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that the Israel Innovation Authority (IIA), formerly known as the Office of the Chief Scientist, agreed to fund up to 40% of a NIS 2.7 million (approximately US$ 750,000) budget towards ongoing development of M-001, the Company’s Universal Flu Vaccine candidate.In six previously completed human clinical trials, including the recently completed Phase 2b trial held in Europe, BiondVax’s M-001 was shown to be safe and immunogenic towards multiple flu strains. Including today’s grant approval, since 2006 the IIA has granted over US$ 6 million in funding to BiondVax. The non-dilutive grants will become repayable from royalties generated from future sales of BiondVax’s vaccine, once commercially available on the market.Dr. Tammy Ben-Yedidia, Chief Scientific Officer of BiondVax commented, “The ongoing support of our program by the IIA is proof of their long-term confidence in BiondVax's innovative flu vaccine. This grant, together with other generous recently approved financing to the company, brings us closer to launching a Phase 3 clinical trial.” About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact:Joshua PhillipsonBusiness Development Manager+972-8-930-2529j.phillipson@biondvax.comBiondVax Forward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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, uncertainties and risks in the clinical development process, including, among others, length, expense and the ability to enroll trial patients, timing of receipt of funding from grants, reliance on third parties and that the results of earlier research and/or preclinical or clinical trial results may not be predictive of actual results, conclusions or interpretations of subsequent research or trials, the results of the Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the lengthy and unpredictable nature of the FDA and other regulatory authorities approval processes, our ability to satisfy rigorous regulatory requirements, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the Company’s periodic filings with the SEC and the Tel-Aviv Stock Exchange.
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BiondVax Reports Positive Phase 2b Clinical Trial Results for its Universal Flu Vaccine
European UNISEC Co-Sponsored Trial Meets Both Primary Endpoints
Ness Ziona, Israel – July 20, 2017 –BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV), and the UNISEC consortium today reported statistically significant positive results from the Phase 2b clinical trial of M-001, BiondVax’s universal flu vaccine candidate.The study had two primary endpoints: Safety and influenza-specific cellular immune responses. Both endpoints were achieved.Trial Design: The randomized placebo-controlled double-blind trial consisted of 3 arms; The 219 participants, aged 18 to 60 years, twice received either 0.5mg M-001, 1.0mg M-001, or saline placebo. All participants were then immunized with a partial dose of avian H5N1 pandemic vaccine.Primary Safety Results: The Company previously reported1 and today confirms that M-001 has a good safety profile and is well-tolerated.Primary Cellular Results: TH1 cytokines including Il-2, Interferon-gamma, and TNF-alpha are biological molecules with known anti-viral and anti-influenza virus activity. These cytokines are produced by CD4 immune system cells when activated as part of T-cell dependent immunity. In this trial, T-cell (also known as cellular) immunity was measured at baseline (prior to immunization), and after immunization with M-001. Compared to the placebo group, statistically significant elevated T-cell dependent immune responses were found in both dosage forms, more notably in the 1.0mg dose group.The study’s secondary endpoint evaluated antibody (HAI) response to avian H5N1 pandemic vaccination after M-001 or placebo administration. In one of the four H5N1 strains tested, a statistically significant HAI elevation was observed in participants who had received M-001.Immunological assays and statistical analysis were performed by various UNISEC2 consortium partners. Dr. Ed Schmidt, Executive Manager of the UNISEC consortium, commented, “The development of universal influenza vaccines can be highly successful when public health institutes and companies work together, share expertise, technologies, and networks. In the UNISEC consortium, we are very pleased to have BiondVax with their M-001 vaccine as one of our partners. The cell mediated immunity observed in our Phase IIB clinical study with the M-001 vaccine is very impressive and of high scientific interest. We are certainly looking forward to continuing this collaboration with BiondVax.”In light of these encouraging clinical trial results that confirm previous study results, the recent €20 million EIB funding3, the Israel Ministry of Economy grant approval4, and following consultations with leading European and American regulatory experts, BiondVax is considering taking the opportunity to proceed directly to testing the clinical efficacy of vaccination with M-001 alone in a pivotal Phase 3 clinical trial. Clinical efficacy is planned to be assessed by measuring reduction of flu illness rate and severity.Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer (CSO), noted, “These significant results confirm that the M-001 is a unique and innovative influenza vaccine that elicits strong T-cell responses and is expected to provide multi-strain and multi-season protection against influenza illness. Along with the substantial funding recently brought to BiondVax we can now concentrate on performing all activities needed to launch the pivotal Phase 3 clinical trial.”---1. http://www.biondvax.com/2016/11/biondvax-phase-2b-trial-preliminary-safety-results-the-universal-flu-vaccine-candidate-is-safe-and-well-tolerated/2. Research leading to these results received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n°602012.3. http://www.biondvax.com/2017/06/european-investment-bank-eib-supports-late-stage-development-and-production-of-biondvaxs-universal-flu-vaccine-candidate-under-horizon-2020-initiative/4. http://www.biondvax.com/2017/03/biondvax-approved-for-grant-from-israels-ministry-of-economy-and-industry-to-build-facility-for-commercial-scale-production-of-its-universal-flu-vaccine/------About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact:Joshua PhillipsonBusiness Development Manager+972-8-930-2529 ext.5105j.phillipson@biondvax.comBiondVax Forward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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, uncertainties and risks in the clinical development process, including, among others, length, expense and the ability to enroll trial patients, reliance on third parties and that the results of earlier research and/or preclinical or clinical trial results may not be predictive of actual results, conclusions or interpretations of subsequent research or trials, the results of the Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the lengthy and unpredictable nature of the FDA’s approval process, our ability to satisfy rigorous regulatory requirements, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the Company’s periodic filings with the SEC and the Tel-Aviv Stock Exchange.
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BiondVax Signs Lease Agreement for Mid-Size Commercial Facility to Manufacture Universal Flu Vaccine
Ness Ziona, Israel – July 18, 2017 –BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV), developer of the Universal Flu Vaccine candidate M-001, today signed an agreement to lease approximately 1800m2 in the Jerusalem BioPark (JBP), located in the Ein Kerem Hadassah campus, next to Hadassah University Hospitals and Hebrew University’s Medical School. The mid-sized facility is planned to have capacity to annually produce tens of millions of doses of M-001 either in single-dose syringe or in bulk. M-001 is designed to provide protection against current and future seasonal and pandemic flu strains.Dr. Shimon Hassin, BiondVax’s COO, commented, “BiondVax’s previous manufacturing accomplishments include achieving GMP certification, twice passing European QP audits, and an ongoing collaboration with a US-based CMO for upscaling for Phase 3 clinical batches. We expect our new facility will optimize production timelines and significantly reduce production costs. This new planned mid-size commercial manufacturing facility will mark the culmination of BiondVax’s transformation into a fully integrated pharmaceutical company operating under international GMP standards.”Planning and design of the facility by a leading engineering company has begun, and while construction will begin soon, the agreement calls for BiondVax to begin lease payments in October 2018. The length of the lease is 10 years with an option for an additional 5 years at BiondVax’s discretion. As well, the agreement provides BiondVax with a 6-month advanced notice annual penalty-free exit clause. Costs of building and operating the facility are partially supported by a previously announced grant from Israel’s Ministry of Economy and Industry and a €20 million agreement with the European Investment Bank (EIB).About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact:BiondVax Joshua PhillipsonBusiness Development Manager+972-8-930-2529 x5105j.phillipson@biondvax.comBiondVax Forward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 building and timing of the commencement of manufacturing operations at the planned facility, the risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, our ability to procure the funds and permits and other governmental authorization for a commercial size manufacturing plant, our ability to satisfy rigorous regulatory requirements, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the Company’s periodic filings with the SEC and the Tel-Aviv Stock Exchange.
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BiondVax’s CEO Provides First Half 2017 General Corporate Update
Ness Ziona, Israel – June 28, 2017 –BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV), developer of the Universal Flu Vaccine candidate M-001, today provided a general corporate update of its activities in the first half of 2017.Ron Babecoff, BiondVax CEO, commented, “The first half of 2017 was exciting and important for BiondVax. Three major events occurred: (1) We welcomed a major strategic investor, Marius Nacht and his aMoon Fund, who currently hold approximately 20% of our company; (2) Israel’s Ministry of Economy approved a grant covering 20% of the construction costs of a commercial scale manufacturing facility; and also significantly advancing our goals, (3) the European Investment Bank (EIB) signed a €20 million non-dilutive funding agreement to support commercial production and Phase 3 trials. I am thrilled that we now have the resources to launch our Phase 3 program towards commercialization.”Recent Updates€20 million in non-dilutive funding
- On June 19, BiondVax signed a significant €20 million (approximately $US 22 million) non-dilutive funding agreement with the European Investment Bank (EIB).
- The funding will be provided as a zero-percent fixed interest long-term loan, with variable remuneration based on royalties of net sales of BiondVax’s Universal Flu vaccine.
- BiondVax retains the option to repay the loan and repurchase the royalties at any time.
- Further details in the joint EIB-BiondVax press release: http://www.biondvax.com/2017/06/european-investment-bank-eib-supports-late-stage-development-and-production-of-biondvaxs-universal-flu-vaccine-candidate-under-horizon-2020-initiative/.
New Patent Allowed in Canada
- On June 21, BiondVax received notice that its main patent application on the Multimeric Multi-Epitope Polypeptide Influenza Vaccines was allowed in Canada.
- This allowed patent application is part of a family of over 30 granted patents around the world, covering the multimeric multi-epitope influenza vaccine M-001 and its use for vaccination against influenza in humans.
European Phase 2b Trial Progress and Results Timetable
- BiondVax’s Phase 2b trial is being conducted as part of the European UNISEC[1] Consortium.
- This was M-001’s first international trial. In preparation, BiondVax’s manufacturing facilities, processes, and practices achieved European-audited GMP certification, BiondVax gained approval from the EU to conduct clinical trials in Europe, and funds were granted through UNISEC towards the costs of executing the trial.
- Positive preliminary safety results for the 219 participants were announced in November 2016[2]. Blood sample analysis conducted over the past few months by a member of the Consortium was recently completed. Subsequently, the Consortium informed BiondVax that statistical analysis of the results is expected to begin soon.
- While progressing, it is important to note that the pace of the analysis is outside of BiondVax’s control and while the results from the trial are expected in the near term, it will be beyond the end of the second quarter of 2017.
- While the process has taken longer than initially anticipated, it is not unusual when so many partners are involved in a complex project. BiondVax is privileged to be participating in the UNISEC consortium, and pleased to be part of this collaboration.
Commercial Mid-Size Manufacturing Facility
- We have identified a suitable existing location for our manufacturing plant, and are working with an engineering company on detailed planning.
- The mid-size factory is planned with annual production capacity of up to 20 million single-doses in syringes, or 40 million doses in bulk.
- For details, please see http://www.biondvax.com/2017/03/biondvax-approved-for-grant-from-israels-ministry-of-economy-and-industry-to-build-facility-for-commercial-scale-production-of-its-universal-flu-vaccine/.
Strategic Investment by Leading Investor
- aMoon Fund, part of Angels High Tech Investments, a company fully owned by Marius Nacht, Co-founder and Chairman of Check Point (NASDAQ: CHKP), invested NIS 10.9 million (close to $3 million) in BiondVax, at the then-prevailing market price. Following the transaction aMoon holds approximately 20% of the outstanding shares of the Company.
- For details, please see http://www.biondvax.com/2017/01/biondvax-receives-us-2-8-million-investment-from-angels-high-tech-investments-ltd/.
About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact:BiondVax Joshua Phillipson+972-8-930-2529 ext.5105j.phillipson@biondvax.comForward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 drug development involves a lengthy and expensive process with uncertain outcome, the results of the Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the receipt and timing of approved grant funds, our ability to procure the funds and permits and other governmental authorization for a commercial size manufacturing plant, our ability to satisfy rigorous regulatory requirements, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the Company’s periodic filings with the SEC and the Tel-Aviv Stock Exchange.
European Investment Bank (EIB) supports Late-Stage Development and Production of BiondVax’s Universal Flu Vaccine Candidate under Horizon 2020 Initiative
Luxembourg, and Ness Ziona, Israel – June 19, 2017 –The European Investment Bank (EIB) and BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV), developer of the Universal Flu Vaccine candidate M-001, announced that they have entered into a €20 million 
(approximately $22 million) loan agreement. The event organized to mark the collaboration and the granting of the loan occurs today at the EIB Headquarters in Luxembourg, in presence of Mr. Ambroise Fayolle, EIB Vice-President responsible for innovation, and Dr. Ron Babecoff, CEO of BiondVax.Flu viruses frequently and unpredictably mutate. Since it is impossible to predict future mutations, current flu vaccines may target strains that are not represented in the current wave of influenza. Mainly due to vaccine-virus mismatch, current flu vaccine effectiveness is on average only about 40% in the general population, and in elderly people as low as 9%. In addition, current vaccines take about 4 to 6 months to produce, and a new one must be produced each year. So when a mismatch is identified at the beginning of the flu season, there is insufficient time to make a new vaccine for that specific season.The World Health Organization (WHO) reports up to 500,000 annual seasonal flu related deaths, mostly affecting people above 65 years old. Seasonal flu is the 8th leading cause of death in the USA, and it causes high social and economic burdens to patients, their families, and health care providers.BiondVax’s M-001 vaccine candidate, consisting of nine widely conserved flu epitopes, is designed to protect against current and future, seasonal and pandemic flu strains. Clinical and pre-clinical trials have shown that M-001 is safe and immunogenic and that it has the capacity to enhance and broaden coverage of current flu vaccines. M-001 has also shown potential to improve upon current seasonal flu vaccines, and potential to serve as an immediate effective response to new flu pandemic strains. The vaccine candidate has been tested in a Phase IIb clinical trial in collaboration with UNISEC, which is funded by the EU under the 7th Framework Programme for Research and Technological Development.EIB support for the development of BiondVax’s Universal Flu Vaccine Candidate should be seen in the context of the Horizon 2020, the EU's Research Programme, in particular the EU Finance for Innovators finance facility "InnovFin Infectious Diseases", which offers bespoke products for financing high-risk projects in the field of infectious diseases.Carlos Moedas, European Commissioner for Research, Science and Innovation said, "A healthier population is a major priority for the EU, and preventing and treating the flu is becoming more and more important with the ageing of the European population. As the virus rapidly changes, we need to develop new ways to combat the disease. This €20 million loan agreement will help develop a more universal vaccine, effective in preventing a range of different types of flu."Mr. Othmar Karas, Member of the European Parliament and EPP-Shadow Rapporteur for the extension of the European Fund for Strategic Investments in the Parliament's Committee on Economic and Monetary Affairs, commented, “Joint investments in the future build strong bridges between nations. It is a strength of Europe’s innovation system to cooperate with the best innovators in our neighbourhood. We are glad to see today’s announcement as an important initiative for fostering innovation between the European Union and our Mediterranean neighbours.”“Supporting innovation is a key priority for the European Union’s Bank”, said EIB Vice-President Mr. Ambroise Fayolle. “This new financing shows our strong willingness to create optimal conditions for this clinical research and bring it to a successful conclusion. The EIB is proud to be supporting BiondVax with regard to its high expertise and pioneering research on such a universal flu vaccine. We hope that this innovative financing will contribute to improve the prevention of disease.”The technology behind BiondVax’s universal flu vaccine candidate was conceptualized in the lab of Professor Ruth Arnon at the Weizmann Institute of Science. Weizmann Institute Vice-President for technology transfer Prof. Mordechai Sheves noted, “Yeda, the tech transfer arm of the Weizmann Institute of Science, was delighted to learn that the European Union has found merit in BiondVax, a company based on the pioneering work of Prof. Ruth Arnon. The generous investment by the European Union paves the way to tackling one of today’s most lethal infectious diseases, and is yet another example of the outstanding basic research that typifies the Weizmann Institute of Science.”Dr. Ron Babecoff, CEO of BiondVax, commented, “We now have the resources to launch Phase 3 trials and set-up a mid-sized commercial manufacturing plant. The EIB’s funding is a monumental step forward for BiondVax towards bringing M-001 to the market. We are proud and honored that the EIB and the European Commission chose to collaborate with BiondVax in the development of our universal flu vaccine. Together with the support of Israel’s Ministry of Economy, we are closer than ever to accomplishing our mission of marketing the first universal flu vaccine for the benefit of people worldwide.”“It has been a pleasure working with the EIB team towards this collaboration, and I wish to thank them for their support and interest. We also greatly appreciate the assistance of Mr. Holm Keller and his team at kENUP for facilitating this financing,” continued Babecoff.The finance contract between BiondVax and the EIB has been facilitated by kENUP, a civic society organization promoting innovative industries in Europe. kENUP Chairman Mr. Holm Keller noted that, “The State of Israel’s substantive and smart investments in fundamental research are an important catalyst for establishing globally leading industries in Europe. We are proud to be a liaison between the relevant European institutions and Israel’s leading research institutions.”Innovation and skills are key ingredients for ensuring sustainable growth and creating high-value jobs. They play an important part in driving long-term competitiveness. For this reason, innovation and skills are a top priority for the EIB Group with a total financing of €18.7 billion in 2016.The EIB-BiondVax non-dilutive financing agreement will be structured as a zero-percent fixed interest loan, available for up to 36 months with a variable remuneration based on royalties of net sales of M-001 following commercialization. Funds will be advanced in three tranches. The tranches are available up to 12, 24, and 36 months following the date of the agreement, and are dependent on achievement of certain specified milestones, with the ultimate milestone including authorization to launch a Phase 3 trial. The tranches are repayable five years after each drawdown. BiondVax retains the option to repay the loan and repurchase the royalties at any time.General information on InnovFin – EU Finance for InnovatorsUnder Horizon 2020, the EU Research and Innovation Framework Programme for 2014-20, the European Commission and the European Investment Bank Group (EIB and EIF) launched a new generation of financial instruments and advisory services in 2014 to help innovative firms access finance more easily. Up until 2020, "InnovFin – EU Finance for Innovators" will offer a range of bespoke products which will make available more than €24 billion worth of finance in support of research and innovation (R&I) products undertaken by small, medium-sized and large companies and promoters of research infrastructure.Backed by funds set aside under Horizon 2020 and by the EIB Group, InnovFin financial products are used to support R&I activities, which by their nature are riskier and harder to assess than traditional investments, and therefore often face difficulties in accessing finance. Firms and other entities located in EU Member States and Horizon 2020 Associated Countries are eligible as final beneficiaries These debt instruments are complemented by a series of equity instruments managed by the EIF.The facility for financing research into infectious diseases enables a wide range of financial products to be offered, ranging from standard debt instruments to risk sharing instruments, amounting to between €7.5 million and €75 million, for researchers working to develop innovative vaccines, medicines, or medical and diagnostic equipment or new research infrastructure specialising in infectious diseases. The final beneficiaries are project promoters who have successfully negotiated the preclinical stage.About the European Investment Bank (EIB)The European Investment Bank (EIB) is the long-term lending institution of the European Union owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals. Further details are available at: www.eib.orgFollow the EIB on Twitter @eibAbout BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.About kENUPkENUP promotes research based innovation for the public and societal benefit. It facilitates the development of projects to pursue market-leading positions for European innovation businesses. kENUP is registered in the EU as a lawful purpose foundation.For further information, please contact: EIBAnne-Cécile Auguin+352 43 79 83330 / mobile: +352 621 36 19 48a.auguin@eib.orgPress Desk: +352 4379 21000 – press@eib.orgBiondVax Joshua PhillipsonBusiness Development Manager+972-8-930-2529 ext.5105j.phillipson@biondvax.comBiondVax Forward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 receipt and timing of approved grant funds, the risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, our ability to procure the funds and permits and other governmental authorization for a commercial size manufacturing plant, our ability to satisfy rigorous regulatory requirements, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the Company’s periodic filings with the SEC and the Tel-Aviv Stock Exchange.
BiondVax Announces First Quarter 2017 Financial Results and Update
NESS ZIONA, Israel, May 30, 2017 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced its financial results for the quarter ended March 31, 2017 and provided a business update.First Quarter 2017 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.63 (NIS/$US) as at March 31, 2017.
- First quarter operating expenses were NIS 2.97m ($817,000) compared with NIS 2.83m for the first quarter of 2016;
- First quarter R&D expenses amounted to NIS 1.87m ($516,000) compared with NIS 2.06m for the first quarter of 2016;
As of March 31, 2017, BiondVax had cash and cash equivalents, short-term investments and marketable securities of NIS 35 million ($9.6 million) as compared to NIS 27 million as of December 31, 2016. The increase is attributable to a private placement of NIS 10.9 million. Recent Corporate Update
- The European UNISEC consortium sponsored Phase 2b processed the final participant in September. Preliminary safety results were reported in November. Immunogenicity results and statistical analysis are currently being processed by other UNISEC consortium entities.
- In January, Angels High Tech Investments Ltd. invested NIS 10.9 million, approximately $2.8 million, in exchange for 33.8 million ordinary BiondVax shares on the Tel Aviv Stock Exchange (equivalent to 844,000 NASDAQ listed ADS) at the December 29, 2016 Tel Aviv closing market price. Following the transaction, Angels Investments held 19.99% of all issued and outstanding share capital of the Company.
- In January, the peer-reviewed journal Vaccinepublished an article titled, “Back to the future: Immunization with M-001 prior to trivalent influenza vaccine in 2011/12 enhanced protective immune responses against 2014/15 epidemic strain.” The article reports that blood plasma samples from people who received M-001 in 2011 (as part of BiondVax’s BVX-005 clinical trial in the elderly) showed a five-fold significant increase of protective antibodies against a new epidemic 2014/15 flu strain (A/Swiss) – a strain which did not exist when M-001 was administered to the BVX-005 participants.
- An article by BiondVax-affiliated authors titled, “Strategy for approving a universal flu vaccine” was published in March in the peer-reviewed journal Future Virology.
- Also in March, the Company received approval for a grant representing 20% of a NIS 20 million budget from Israel’s Ministry of Economy and Industry to build a facility for commercial scale production of its universal flu vaccine candidate.
- In April, the company presented at the Influenza Vaccines for the World (IVW2017) conference in Switzerland.
About BiondVax BiondVax is a biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. For more information, please visit www.biondvax.com. Contact DetailsJoshua PhillipsonBusiness Development Manager+972 8 930 2529j.phillipson@biondvax.comForward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov, and in the Company’s periodic filings with the SEC and the Tel-Aviv Stock Exchange.** Tables to Follow **
|
BALANCE SHEETS |
|||||||||
|
In thousands, except per share data |
|||||||||
|
Conveniencetranslation |
|||||||||
|
December 31, |
March 31, |
March 31, |
|||||||
|
2016 |
2016 |
2017 |
2017 |
||||||
|
Unaudited |
Unaudited |
||||||||
|
N I S |
U.S. dollars |
||||||||
|
CURRENT ASSETS: |
|||||||||
|
Cash and cash equivalents |
15,705 |
29,817 |
24,020 |
6,613 |
|||||
|
Marketable securities |
4,067 |
4,065 |
4,068 |
1,120 |
|||||
|
Short-term deposits |
7,602 |
- |
6,751 |
1,859 |
|||||
|
Other receivables |
815 |
2,282 |
4,979 |
1,371 |
|||||
|
28,189 |
36,164 |
39,818 |
10,963 |
||||||
|
LONG‑TERM ASSETS: |
|||||||||
|
Property, plant and equipment |
1,443 |
1,903 |
1,297 |
357 |
|||||
|
Other long term assets |
478 |
290 |
478 |
132 |
|||||
|
1,921 |
2,193 |
1,775 |
489 |
||||||
|
30,110 |
38,357 |
41,593 |
11,452 |
||||||
|
CURRENT LIABILITIES: |
|||||||||
|
Trade payables |
686 |
836 |
752 |
207 |
|||||
|
Other payables |
689 |
735 |
526 |
145 |
|||||
|
1,375 |
1,571 |
1,278 |
352 |
||||||
|
LONG‑TERM LIABILITIES: |
|||||||||
|
Options |
3,043 |
4,540 |
10,848 |
2,987 |
|||||
|
Severance pay liability, net |
76 |
71 |
76 |
21 |
|||||
|
3,119 |
4,611 |
10,924 |
3,008 |
||||||
|
SHAREHOLDERS' EQUITY (DEFICIT): |
|||||||||
|
Ordinary shares of NIS 0.0000001 par value: |
|||||||||
|
Authorized: 391,000,000 shares as ofMarch 31, 2017, 2016 (unaudited) andDecember 31, 2016; Issued andOutstanding: 162,481,153 ,135,097,367 and 135,097,367shares respectively |
*) - |
*) - |
*) - |
*) - |
|||||
|
Share premium |
113,041 |
111,083 |
129,550 |
35,668 |
|||||
|
Options |
1,435 |
2,536 |
533 |
147 |
|||||
|
Other comprehensive income |
6 |
14 |
6 |
2 |
|||||
|
Accumulated deficit |
(88,866) |
(81,458) |
(100,698) |
(27,725) |
|||||
|
25,616 |
32,175 |
29,391 |
8,092 |
||||||
|
30,110 |
38,357 |
41,593 |
11,452 |
||||||
|
*) Represents an amount lower than NIS 1.
|
|||||||||
|
STATEMENTS OF COMPREHENSIVE INCOME |
|||||||||||||||
|
In thousands, except per share data |
|||||||||||||||
|
Conveniencetranslation |
|||||||||||||||
|
Year ended December 31, |
Three months ended March 31, |
Three months ended March 31, |
|||||||||||||
|
2016 |
2016 |
2017 |
2017 |
||||||||||||
|
Unaudited |
Unaudited |
||||||||||||||
|
NIS |
U.S. dollars |
||||||||||||||
|
Operating expenses: |
|||||||||||||||
|
Research and development, net of participations |
7,794 |
2,063 |
1,874 |
516 |
|||||||||||
|
Marketing, general and administrative |
4,106 |
771 |
1,094 |
301 |
|||||||||||
|
Total operating expenses |
11,900 |
2,834 |
2,968 |
817 |
|||||||||||
|
Operating loss |
(11,900) |
(2,834) |
(2,968) |
(817) |
|||||||||||
|
Financial income |
3,019 |
1,481 |
8 |
2 |
|||||||||||
|
Financial expense |
(303) |
(423) |
(8,872) |
(2,443) |
|||||||||||
|
Net loss |
(9,184) |
(1,776) |
(11,832) |
(3,258) |
|||||||||||
|
Other comprehensive income (loss): |
|||||||||||||||
|
Gain (loss) from available-for-sale financial assets |
(6) |
2 |
- |
- |
|||||||||||
|
Total comprehensive loss |
(9,190) |
(1,774) |
(11,832) |
(3,258) |
|||||||||||
|
Basic and Diluted net loss per share |
(0.07) |
(0.01) |
(0.07) |
(0.02) |
|||||||||||
|
Weighted average number of sharesoutstanding used to compute basicand diluted loss per share |
135,097 |
135,097 |
162,481 |
162,481 |
|||||||||||
BiondVax Announces Fourth Quarter and Full Year 2016 Financial Results and Update
Ness Ziona, Israel – April 28, 2017 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced its fourth quarter and full year financial results for the year ended December 31, 2016, and provided a business update.The Company also filed its annual report for the year ended December 31, 2016, on Form 20F with the U.S. Securities and Exchange Commission. This can be downloaded from BiondVax’s website.Fourth Quarter 2016 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.845 as at December 31, 2016.
- Fourth quarter operating expenses, net, were NIS 3.12 million ($774,000) compared with NIS 4.06 million in the fourth quarter of last year;
- Fourth quarter R&D expenses, net, amounted to NIS 1.83 million ($450,000) compared with NIS 2.87 million in the fourth quarter of last year;
Full Year 2016 Financial Summary
- Total operating expenses, net, were NIS 11.90 million ($3.10 million) compared with NIS 11.30 million in 2015;
- R&D expenses, net, amounted to NIS 7.79 million ($2.03 million) compared with NIS 7.91 million in 2015;
As of December 31, 2016, BiondVax had cash and cash equivalents, short-term investments and marketable securities of NIS 27.4 million ($7.1 million) as compared to NIS 37.5 million as of December 31, 2015. This decrease was attributable to utilization of available cash resources to fund operations.Recent Corporate Update
- The Company announced positive preliminary safety results from the Phase 2b clinical trial of M-001, conducted in collaboration with the European UNISEC consortium[1]. Immunogenicity results, currently being processed by other UNISEC consortium entities, are expected by the end of Q2 2017.
- In January 2017, Angels High Tech Investments Ltd. invested NIS 10.9 million, approximately $2.8 million, in exchange for 33.8 million ordinary BiondVax shares on the Tel Aviv Stock Exchange (equivalent to 844,000 NASDAQ listed ADS) at the December 29, 2016 Tel Aviv closing market price. Following the transaction, Angels Investments held 19.99% of all issued and outstanding share capital of the Company.
- The peer-reviewed journal Vaccine published an article titled, “Back to the future: Immunization with M-001 prior to trivalent influenza vaccine in 2011/12 enhanced protective immune responses against 2014/15 epidemic strain.” The article reports that blood plasma samples from people who received M-001 in 2011 (as part of BiondVax’s BVX-005 clinical trial in the elderly) showed a five-fold significant increase of protective antibodies against a new epidemic 2014/15 flu strain (A/Swiss) – a strain which did not exist when M-001 was administered to the BVX-005 participants.
- An article by BiondVax-affiliated authors titled, “Strategy for approving a universal flu vaccine” was published in the peer-reviewed journal Future Virology.
- The Company received approval for a grant representing 20% of a NIS 20 million budget from Israel’s Ministry of Economy and Industry to build a facility for commercial scale production of M-001, its universal flu vaccine candidate
Dr. Ron Babecoff, BiondVax’s President and CEO, commented, “I am pleased we are progressing and keeping expenses at the planned level. Recent reports in CNN[2],[3] and The Washington Times[4] indicate flu pandemic threats like H7N9 are an increasingly urgent concern. Current solutions are insufficient. These concerns strengthen our unwavering commitment to bring our universal flu vaccine candidate to the market to improve pandemic preparedness.”------[1] UNISEC research has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n°602012.[2] The big one is coming, and it's going to be a flu pandemic. http://edition.cnn.com/2017/04/07/health/flu-pandemic-sanjay-gupta/index.html.[3] Seven reasons we're at more risk than ever of a global pandemic. http://edition.cnn.com/2017/04/03/health/pandemic-risk-virus-bacteria/.[4] Congress, WHO sound the alarm over pandemic avian flu in China. http://www.washingtontimes.com/news/2017/apr/21/congress-who-sound-alarm-over-pandemic-bird-flu-or/.------About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact: BiondVax Joshua PhillipsonBusiness Development Manager+972-8-930-2529 x5105j.phillipson@biondvax.comForward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the Company’s periodic filings with the SEC and the Tel-Aviv Stock Exchange. * Tables to Follow *BALANCE SHEETSIn thousands, except share and per share data
| Convenience translation | |||||||||
| December 31, | December 31, | ||||||||
| 2015 | 2016 | 2016 | |||||||
| N I S | U.S. dollars | ||||||||
| CURRENT ASSETS: | |||||||||
| Cash and cash equivalents | 33,470 | 15,705 | $ 4,084 | ||||||
| Marketable securities | 2,016 | 2,017 | 525 | ||||||
| Short-term deposits | - | 7,602 | 1,977 | ||||||
| Other receivables | 1,442 | 815 | 212 | ||||||
| 36,928 | 26,139 | 6,798 | |||||||
| LONG‑TERM ASSETS: | |||||||||
| Marketable securities | 2,048 | 2,050 | 533 | ||||||
| Property, plant and equipment | 2,044 | 1,443 | 375 | ||||||
| Other long term assets | 287 | 478 | 124 | ||||||
| 4,379 | 3,971 | 1,032 | |||||||
| 41,307 | 30,110 | $ 7,830 | |||||||
| CURRENT LIABILITIES: | |||||||||
| Trade payables | 931 | 686 | $ 178 | ||||||
| Other payables | 768 | 689 | 179 | ||||||
| 1,699 | 1,375 | 357 | |||||||
| LONG‑TERM LIABILITIES: | |||||||||
| Warrants | 5,994 | 3,043 | 791 | ||||||
| Severance pay liability, net | 69 | 76 | 20 | ||||||
| 6,063 | 3,119 | 811 | |||||||
| SHAREHOLDERS' EQUITY :- | |||||||||
| Ordinary shares of NIS 0.0000001 par value: | |||||||||
| Authorized: 391,000,000 shares as ofDecember 31, 2015 and 2016; Issued andOutstanding 135,097,367 shares as ofDecember 31, 2015 and 2016 | *) - | *) - | *) - | ||||||
| Share premium | 110,679 | 113,041 | 29,399 | ||||||
| Options | 2,536 | 1,435 | 373 | ||||||
| Other comprehensive income | 12 | 6 | 2 | ||||||
| Accumulated deficit | (79,682) | (88,866) | (23,112) | ||||||
| 33,545 | 25,616 | 6,662 | |||||||
| 41,307 | 30,110 | $ 7,830 | |||||||
*) Represents an amount lower than NIS 1. STATEMENTS OF COMPREHENSIVE INCOMEIn thousands, except share and per share data
| Convenience translation | ||||||||||
| Year ended December 31 | Year ended December 31, | |||||||||
| 2014 | 2015 | 2016 | 2016 | |||||||
| N I S | U.S. dollars | |||||||||
| Operating expenses: | ||||||||||
| Research and development, net of participations | 5,492 | 7,906 | 7,794 | $ 2,027 | ||||||
| Marketing, general and administrative | 2,650 | 3,397 | 4,106 | 1,068 | ||||||
| Total operating expenses | 8,142 | 11,303 | 11,900 | 3,095 | ||||||
| Operating loss | (8,142) | (11,303) | (11,900) | (3,095) | ||||||
| Financial income | 394 | 1,128 | 3,019 | 785 | ||||||
| Financial expense | (16) | (24) | (303) | (79) | ||||||
| Net loss | (7,764) | (10,199) | (9,184) | (2,389) | ||||||
| Other comprehensive income (loss): | ||||||||||
| Items to be reclassified to profit or loss in subsequent periods: | ||||||||||
| Gain (loss) from available-for-sale marketable securities | (4) | (5) | (6) | (2) | ||||||
| Total comprehensive loss | (7,768) | (10,204) | (9,190) | $ (2,391) | ||||||
| Basic and diluted loss per share | (0.14) | (0.10) | (0.07) | $ (0.02) | ||||||
| Weighted average number of shares outstanding used to compute basic and diluted loss per share | 54,286,227 | 105,522,642 | 135,097,367 | 135,097,367 | ||||||
For notes and details, please see the 20F filing with the SEC.
###
BiondVax Approved for Grant from Israel’s Ministry of Economy and Industry to Build Facility for Commercial Scale Production of its Universal Flu Vaccine
Ness Ziona, Israel – March 30, 2017 –
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced that the Israel Investment Center, a unit of the Government of Israel’s Ministry of Economy and Industry, approved a grant representing 20% of a NIS 20M budget to be utilized towards the construction of a factory for the production of Phase 3 and commercial batches of BiondVax’s universal flu vaccine candidate M-001. The grant is subject to certain terms and conditions including those outlined under the Encouragement of Capital Investment Law 1959.BiondVax plans to build the mid-sized factory in Jerusalem, with potential capacity to annually produce up to tens of millions of doses of M-001. M-001 is designed to provide protection against current and future seasonal and pandemic flu strains. Five completed Phase 1/2 and Phase 2 human clinical trials have shown the vaccine to be safe and immunogenic to multiple flu strains.Dr. Ron Babecoff, BiondVax’s CEO, commented, “This significant milestone signifies the evolution of BiondVax from a biotech start-up to a pharmaceutical company positioned for significant growth and contributions to society. I would like to thank the Ministry of Economy and Industry for helping translate BiondVax’s vision to reality.”Dr. Shimon Hassin, BiondVax’s COO noted, “In the past few years BiondVax focused on establishing a small scale GMP facility, one that was approved by the European Union. Our current facility laid the foundation for manufacturing quality excellence that will be implemented in the new factory.”An ongoing Phase 2b trial is being conducted in collaboration with the UNISEC consortium. The research has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n°602012. Positive preliminary safety results were announced[1] in November 2016. BiondVax’s consortium partners are continuing to analyze study samples. BiondVax expects the consortium will finalize and release results in Q2 2017.[1] http://www.biondvax.com/2016/11/biondvax-phase-2b-trial-preliminary-safety-results-the-universal-flu-vaccine-candidate-is-safe-and-well-tolerated/ About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact: BiondVax Joshua PhillipsonBusiness Development Manager+972-8-930-2529 x5105j.phillipson@biondvax.com Forward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 timing and pace of actual receipt of awards, our ability to satisfy conditions to receive the award, adequacy of cash resources generally and specifically to support the construction of the manufacturing facility, the ability to raise captal to support business plan and the risk that drug development involves a lengthy and expensive process with uncertain outcome. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Prospectus which was declared effective on May 11, 2015. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
###
BiondVax publishes regulatory approval strategy for novel universal flu vaccines in Future Virology journal
Ness Ziona, Israel – March 13, 2017BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, reports the publication this week of an article by BiondVax-affiliated authors titled, “Strategy for approving a universal flu vaccine” in the peer reviewed journal Future Virology.The article proposes a process for regulatory and marketing approval for next-generation influenza vaccines such as M-001. Current flu vaccines are strain-specific, and existing regulatory approval pathways are not directly applicable to M-001’s unique method of action, which is designed to protect against current and future seasonal and pandemic flu strains.The authors propose a step-wise regulatory strategy in which the novel vaccine is initially approved for use prior to flu season and followed, when available, by currently recommended strain-specific vaccines. Applied in this manner, human clinical trials have shown M-001 broadens and enhances the action of current flu vaccines. This is of particular importance for the elderly who, despite high seasonal flu vaccination rates suffer disproportionately from flu illness. Ultimately, based on clinical efficacy trials, M-001 will be approved as a standalone flu vaccine, potentially replacing existing seasonal strain-based vaccines.Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientist and the article’s lead author, commented, “In many ways, our universal flu vaccine candidate is blazing a trail. Heeding messages from European and American regulatory experts, we have identified what we believe to be the safest and most efficient path for bringing M-001 to the market. Publication in a peer-reviewed journal is a strong sign of support for our plans.”The Future Virology article is available for free to registered users via Infectious Diseases Hub at https://www.id-hub.com/2017/03/09/strategy-approving-universal-flu-vaccine/.The article complements a recently published article in Vaccine which discusses M-001’s mechanism of action. (http://www.biondvax.com/2017/01/back-to-the-future-study-published-in-vaccine-journal-indicates-biondvaxs-universal-flu-vaccine-candidate-may-cover-strains-which-dont-yet-exist/).About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact: Joshua E. PhillipsonBusiness Development+972-8-930-2529 x5105j.phillipson@biondvax.comForward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 drug development involves a lengthy and expensive process with uncertain outcome, the uncertainty of the regulatory approval process, the results of the current Phase 2 and contemplated Phase 3 trials, general business conditions in the industry, changes in regulatory and legal compliance environments in which BiondVax engages, the adequacy of available cash resources to fund product development and commercialization, and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
###
Back to the Future: Study Published in Vaccine Journal Indicates BiondVax’s Universal Flu Vaccine Candidate May Cover Strains Which Don’t Yet Exist
Ness Ziona, Israel – January 12, 2017BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV), developer of the Universal Flu Vaccine candidate M-001, reports the publication this week of an article titled, “Back to the future: Immunization with M-001 prior to trivalent influenza vaccine in 2011/12 enhanced protective immune responses against 2014/15 epidemic strain” in the prestigious peer-reviewed scientific journal Vaccine.
The Vaccine article reports that blood plasma samples from people who received M-001 in 2011 (as part of BiondVax’s BVX-005 clinical trial in the elderly) showed significantly increased protective antibodies against the new epidemic 2014/15 flu strain (A/Swiss) – a strain which did not exist when M-001 was administered to the BVX-005 participants.Despite the $4.3 billion market[1], current flu vaccines have many shortcomings including that they are specific to just 3 or 4 existing flu strains, and must be reformulated each year. Furthermore, seasonal flu vaccine effectiveness is only about 40% on average[2], and as low as 9% in the elderly[3] who are the most at risk group. Conversely, as a universal flu vaccine candidate, M-001 is designed to provide improved and broad protection against all current and future seasonal and pandemic flu strains.The study reported in Vaccine offers evidence of the broadening protective effects offered by M-001, a significant advantage over current flu vaccines.Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientist and co-inventor of M-001, commented, “We consider this study to provide validation of M-001’s potential. It is a promising indication that our vaccine may provide improved protection against future flu strains, including potentially pandemic strains that don’t yet exist!”The article also discusses M-001’s mechanism of action. It is available online at http://www.sciencedirect.com/science/article/pii/S0264410X1631297X.About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact: Joshua E PhillipsonBusiness Development+972-8-930-2529 x5105j.phillipson@biondvax.comForward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 drug development involves a lengthy and expensive process with uncertain outcome, general business conditions in the industry, changes in regulatory and legal compliance environments in which BiondVax engages, the adequacy of available cash resources to fund product development and commercialization and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
###
[1] EvaluatePharma: Quoted by Edison Research http://www.edisoninvestmentresearch.com/research/report/biondvax-pharmaceuticals/preview/ [accessed 12 January 2017].[2] CDC: Seasonal influenza vaccine effectiveness, 2005–2016. https://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm [accessed 11 January 2017].[3] CDC: Interim adjusted estimates of seasonal influenza vaccine effectiveness — United States, February 2013. Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6207a2.htm [accessed 11 January 2017].
BiondVax Receives $US 2.8 Million Investment from Angels High Tech Investments Ltd.
Investor Shares BiondVax Vision of Commercializing World’s First Universal Flu VaccineNess Ziona, Israel – January 2, 2017BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) is honored to announce that Angels High Tech Investments Ltd. has agreed to invest NIS 10.9 million, approximately $US 2.83 million, in exchange for 33.8 million ordinary BiondVax shares on the Tel Aviv Stock Exchange (equivalent to 844,000 NASDAQ listed ADS) at the December 29, 2016 Tel Aviv closing market price. Following the transaction, Angels Investments will hold 19.99% of all issued and outstanding share capital of the Company.Angels Investments is a company fully owned by Marius Nacht, Co-founder and Chairman of Check Point (NASDAQ: CHKP). Angels’ healthcare and life science portfolio is managed by aMoon Partners which is co-led by Dr. Yair Schindel and Marius Nacht.Ron Babecoff, BiondVax’s Founder, President and CEO noted, “This investment is a vote of confidence in BiondVax and its universal influenza vaccine candidate. We are now better positioned to complete our development plans and commercialize our vaccine worldwide. This strategic partnership, together with clinical results and ongoing clinical trial collaborations in Europe and the US (NIH) will enable us to proceed confidently into Phase 3 as planned.”Dr. Yair Schindel, aMoon Partners’ Co-founder and Managing Partner commented, "We see great potential in BiondVax's universal flu vaccine. We expect that this investment is the beginning of a strong partnership with BiondVax and we look forward to doing our part in helping reduce the global morbidity and mortality caused by influenza viruses." About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact:
| Joshua E PhillipsonBusiness Development+972-8-930-2529 x5105j.phillipson@biondvax.com |
Forward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 drug development involves a lengthy and expensive process with uncertain outcome, the results of the current Phase 2 & contemplated phase 3 trials, the adequacy of available cash resources to fund product development and commercialization and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
###
BiondVax Phase 2b Trial Preliminary Safety Results: The Universal Flu Vaccine candidate is safe and well tolerated
Ness Ziona, Israel – November 29, 2016 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV) today announced positive preliminary safety results from its European Phase 2b clinical trial of M-001, its universal flu vaccine candidate.The trial is designed to compare safety and immunogenicity of M-001 between (1) a control group receiving saline as a placebo and then the standard H5N1 avian pandemic vaccine, and (2) an experimental group receiving BiondVax’s M-001 as a primer prior to receiving the same H5N1 pandemic vaccine. As the data is still blinded, the distribution of adverse events between the total of 219 participants who completed the study in both the control and experimental groups is unknown. Only 3 moderate adverse events were considered to be possibly or probably related to the treatment and no related severe adverse events were reported.Professor Shai Ashkenazi, recently appointed to BiondVax’s Scientific Advisory Board, who has guided multiple vaccines through clinical and regulatory approval phases to market, commented that, “M-001 continues to display a remarkable safety profile. It is at least as safe, if not safer, than the current flu vaccines. As we can see in the entire study population, both control and experimental groups, the total number of adverse events is very low and mild.”The research leading to these preliminary results has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n°602012. Conducted in collaboration with the EU-sponsored UNISEC consortium, the trial is designed to evaluate the safety and immunogenicity of M-001 when used ahead of a pandemic influenza vaccine. BiondVax’s European consortium partners are continuing humoral and cellular immune response analysis, with results expected in the coming months.About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact:
| Joshua E PhillipsonBusiness Development+972-8-930-2529 x5105j.phillipson@biondvax.com |
Forward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 drug development involves a lengthy and expensive process with uncertain outcome, results in Phase 2b clinical trials may not be indicative of results from later stage or larger scale clinical trials, the adequacy of available cash resources to fund product development and commercialization, ultimate market acceptance of the vaccine candidate, assuming approval and commercialization, and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
###
BiondVax Announces Third Quarter 2016 Financial Results and Update
Ness Ziona, Israel, Nov. 28, 2016 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing a vaccine against current and future seasonal and pandemic influenza strains, today announced its third quarter 2016 financial results for the quarter ended September 30, 2016 and provided a business update.Third Quarter 2016 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to US$ is provided using the exchange rate of 3.758 (NIS/US$) as at September 30, 2016.
- Third quarter operating expenses were NIS 3.47m ($923,000) compared with NIS 2.21m for the third quarter of 2015;
- Third quarter R&D expenses amounted to NIS 2.42 ($644,000) compared with NIS 1.24m for the third quarter of 2015;
- Cash, cash equivalents and short and long-term marketable securities at the end of the quarter were NIS 29.67m ($7.97m) compared with NIS 37.53m as of December 31, 2015;
Recent Corporate Update
- The European UNISEC consortium sponsored Phase 2b processed the final participant in September. Study samples are currently being analyzed by the consortium and are expected to be finalized and released in the coming months.
- Preparations for the United States NIH Phase 2 clinical trial is ongoing and progressing according to plan.
- Professor Shai Ashkenazi, an experienced clinician-researcher who has guided multiple vaccines through clinical and regulatory approval phases to market was appointed to BiondVax's Scientific Advisory Board.
Dr. Ron Babecoff, CEO of BiondVax commented: "I am pleased that we are working according to plans both in the US and Europe."About BiondVax BiondVax is a biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. For more information, please visit www.biondvax.com.Contact Details
| Joshua PhillipsonBusiness Development Manager+972 8 930 2529j.phillipson@biondvax.com |
Forward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated Phase 2 & 3 trials, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Prospectus which was declared effective on May 11, 2015. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements. ** Tables to Follow **
|
BALANCE SHEETS |
||||||||
|
Conveniencetranslation(Note 2) |
||||||||
|
December 31, |
September 30, |
September 30, |
||||||
|
2015 |
2015 |
2016 |
2016 |
|||||
|
Audited |
Unaudited |
Unaudited |
||||||
|
N I S |
U.S. dollars |
|||||||
|
(In thousands except share and per share data) |
||||||||
|
CURRENT ASSETS: |
||||||||
|
Cash and cash equivalents |
33,470 |
36,294 |
15,091 |
4,016 |
||||
|
Short term bank deposit |
- |
578 |
10,510 |
2,797 |
||||
|
Marketable securities |
2,016 |
2,016 |
2,017 |
537 |
||||
|
Other receivables |
1,442 |
1,594 |
727 |
193 |
||||
|
36,928 |
40,482 |
28,345 |
7,543 |
|||||
|
LONG‑TERM ASSETS: |
||||||||
|
Marketable securities |
2,048 |
2,047 |
2,050 |
545 |
||||
|
Property, plant and equipment |
2,044 |
2,191 |
1,592 |
424 |
||||
|
Other long term assets |
287 |
24 |
370 |
98 |
||||
|
4,379 |
4,262 |
4,012 |
1,067 |
|||||
|
41,307 |
44,744 |
32,357 |
8,610 |
|||||
|
CURRENT LIABILITIES: |
||||||||
|
Trade payables |
931 |
571 |
477 |
127 |
||||
|
Other payables |
768 |
758 |
466 |
124 |
||||
|
1,699 |
1,329 |
943 |
251 |
|||||
|
LONG‑TERM LIABILITIES: |
||||||||
|
Options |
5,994 |
6,863 |
3,528 |
938 |
||||
|
Severance pay liability, net |
69 |
67 |
74 |
20 |
||||
|
6,063 |
6,930 |
3,602 |
958 |
|||||
|
SHAREHOLDERS' EQUITY (DEFICIT): |
||||||||
|
Ordinary shares of NIS 0.0000001 par value: |
||||||||
|
Authorized: 391,000,000 shares as of September30, 2016, 2015 (unaudited) and December 31,2015; Issued and Outstanding: 135,097,367,shares as of September 30, 2016, 2015(unaudited) and December 31, 2015. |
*) - |
*) - |
*) - |
*) - |
||||
|
Share premium |
110,679 |
110,352 |
111,697 |
29,722 |
||||
|
Options |
2,536 |
2,536 |
2,536 |
675 |
||||
|
Other comprehensive income |
12 |
12 |
8 |
2 |
||||
|
Accumulated deficit |
(79,682) |
(76,415) |
(86,429) |
(22,998) |
||||
|
33,545 |
36,485 |
27,812 |
7,401 |
|||||
|
41,307 |
44,744 |
32,357 |
8,610 |
|||||
|
*) Represents an amount lower than NIS 1. |
||||||||
|
STATEMENTS OF COMPREHENSIVE INCOME |
||||||||||||||||||||||||||||
|
Conveniencetranslation (Note 2) |
||||||||||||||||||||||||||||
|
Year ended December 31, |
Three months ended September 30, |
Nine months ended September 30, |
Nine months ended September30, |
|||||||||||||||||||||||||
|
2015 |
2015 |
2016 |
2015 |
2016 |
2016 |
|||||||||||||||||||||||
|
Audited |
Unaudited |
Unaudited |
||||||||||||||||||||||||||
|
N I S |
U.S. dollars |
|||||||||||||||||||||||||||
|
(In thousands, except per share data) |
||||||||||||||||||||||||||||
|
Operating expenses: |
||||||||||||||||||||||||||||
|
Research and development, net of participations |
7,906 |
1,247 |
2,421 |
5,032 |
5,962 |
1,586 |
||||||||||||||||||||||
|
Marketing, general and administrative |
3,397 |
966 |
1,049 |
2,216 |
2,819 |
750 |
||||||||||||||||||||||
|
Total operating expenses |
11,303 |
2,213 |
3,470 |
7,248 |
8,781 |
2,336 |
||||||||||||||||||||||
|
Operating loss |
11,303 |
2,213 |
3,470 |
7,248 |
8,781 |
2,336 |
||||||||||||||||||||||
|
Financial income |
1,118 |
1,540 |
10 |
651 |
59 |
16 |
||||||||||||||||||||||
|
Financial expense |
(24) |
(5) |
(291) |
(20) |
(491) |
(131) |
||||||||||||||||||||||
|
Financial income (expenses) due to revaluations of options |
10 |
812 |
1,395 |
(315) |
2,466 |
656 |
||||||||||||||||||||||
|
Total finance income , net |
1,104 |
2,347 |
1,114 |
316 |
2,034 |
541 |
||||||||||||||||||||||
|
Net loss (income) |
10,199 |
(134) |
2,356 |
6,932 |
6,747 |
1,795 |
||||||||||||||||||||||
|
Other comprehensive loss (income): |
||||||||||||||||||||||||||||
|
Items to be reclassified to profit or loss insubsequent periods: |
||||||||||||||||||||||||||||
|
Gain (loss) from available-for-sale financialassets |
(5) |
(2) |
1 |
(5) |
(4) |
(1) |
||||||||||||||||||||||
|
Total comprehensive loss (income) |
10,204 |
(132) |
2,355 |
6,937 |
6,751 |
1,796 |
||||||||||||||||||||||
|
Basic and diluted net loss per share (NIS) |
0.10 |
(0.00) |
0.02 |
0.07 |
0.05 |
0.01 |
||||||||||||||||||||||
|
Weighted average number of shares outstanding used to compute basic and diluted loss per share |
105,522,642 |
135,097,367 |
135,097,367 |
95,519,426 |
135,097,367 |
135,097,367 |
||||||||||||||||||||||
Highly Pathogenic Bird Flu Spreading Across Europe and Asia
BiondVax’s Universal Flu Vaccine Candidate Also Covers these Potential Pandemic Strains
Ness Ziona, Israel – November 22, 2016 – The first cases of highly pathogenic H5N6 Avian Influenza (“Bird Flu”) were confirmed last week in South Korea[1]. Over 62,000 birds have been culled in an effort to prevent the spread. H5N6 first emerged in 2014 and has since been found in China, Hong Kong, Laos, and Vietnam.At the same time, highly pathogenic H5N8 Avian Influenza is spreading rapidly throughout Europe and through multiple avian species. As predicted in September by the OIE[2], H5N8 is being transmitted along wild bird migratory routes originating in Russia. In the past month alone new outbreaks have been confirmed in Germany, Hungary, Poland, Austria, Croatia, Denmark, Iran, Israel, India, Switzerland, and the Netherlands.While H5N6 has caused severe illness in humans[3], there is not yet any evidence of human-to-human transmission. Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientist explains, “Despite the admirable efforts of the world’s leading experts, H5 bird flu strains continue to emerge, evolve, and spread. The concern of all experts is the reassortment of a new H5 strain capable of human-to-human transmission. This could lead to a new pandemic against which currently available vaccines are ineffective. Fortunately, BiondVax’s vaccine is designed to defend against these new potential pandemic viruses.”BiondVax’s universal flu vaccine candidate, M-001, has shown positive results in five human clinical trials to date. As previously reported by the Company, BiondVax has also entered strategic collaborations to conduct clinical trials in the USA and Europe, including the upcoming American NIH-sponsored Phase 2 trial, testing M-001 as a primer against H7 pandemic. Results from the Phase 2b EU-sponsored UNISEC consortium trial, testing M-001 as a primer against pandemic H5N1, are expected in the coming months. Ben-Yedidia continued, “Our vaccine candidate has induced immune responses against multiple strains including H5 and H7[4],[5]. Our investigations also confirm that M-001’s epitopes are a good match for H5N6 and H5N8.”BiondVax offers Proactive Preparedness for Future Pandemics: When the 2009 H1N1 Swine Flu Pandemic occurred, it took over six months until the specific pandemic vaccine was produced and administered. There were over 60 million swine flu cases and 274,000 hospitalizations in the USA[6], and an estimated 284,000 deaths worldwide[7], while vaccine manufacturers recognized $6.4 billion in additional revenue[8]. Since M-001 is designed as a common denominator vaccine against existing and future seasonal and pandemic flu strains, it can be stockpiled, thereby dramatically reducing response lead time to any new pandemic.
About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact:
| Joshua E PhillipsonBusiness Development+972-8-930-2529 x5105j.phillipson@biondvax.com |
Forward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 drug development involves a lengthy and expensive process with uncertain outcome, the timing and results of the current Phase 2 & contemplated phase 3 trials, the adequacy of available cash resources to fund product development and commercialization, ultimate market acceptance of the vaccine candidate, assuming approval and commercialization, and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
###
BiondVax Phase 2b European Trial: Last Patient Out
Top line results expected in the coming months
Ness Ziona, Israel – September 21, 2016 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) announced today that the last participant in a European Phase 2b clinical trial of M-001, its universal flu vaccine candidate, has completed their final visit. Conducted in collaboration with the EU-sponsored UNISEC consortium, the trial is designed to evaluate the safety and immunogenicity of M-001 when used ahead of a pandemic influenza vaccine.“This important milestone marks the conclusion of the patient facing part of our European trial. Laboratory analysis is now underway, and we look forward to the results in the coming months. The conclusion of this trial, along with the upcoming start of our NIH-sponsored Phase 2 trial in the USA, means we are on track to be Phase 3 ready in the 2017/18 timeframe. We are excited to be one step closer to bringing our multi-strain and multi-season vaccine against seasonal and pandemic flu to the market,” explained BiondVax’s Chief Scientist, Dr. Tamar Ben-Yedidia.In 2009, following the official World Health Organization (WHO) declaration of a H1N1 swine flu pandemic, it took about 6 months until vaccines against the new strain could be administered. During those 6 months the pandemic proliferated, ultimately killing up to 575,000 people globally1. The long delay is attributable to current egg-based manufacturing processes and the need for the new vaccine to be highly specific to the new pandemic flu strain.To mitigate against the 6-month delay some authorities currently stockpile pandemic flu vaccines. For example, under the U.S. Department of Health and Human Services (HHS) Pandemic Influenza Plan, one of the key goals for vaccine preparedness is to “stockpile vaccines against influenza viruses with pandemic potential to cover 20 million persons.”2However, given current flu vaccine technology, each different flu strain requires its own specific vaccine. As well, there is an unlimited number of potential future flu strains. BiondVax’s flu vaccine, M-001, is advantageous in that it is designed to provide protection against a broad range of current and future potential flu strains.The current trial in Europe is designed to compare humoral and cellular immune response between two groups. These are (1) a control group receiving the standard avian pandemic vaccine alone, and (2) a group receiving BiondVax’s M-001 as a primer prior to receiving the pandemic vaccine.The goal following its approval for use as a pandemic primer would be to administer stockpiled M-001 immediately upon declaration of any new pandemic, thereby providing broad flu protection until a virus-specific vaccine is produced a few months later. BiondVax’s long-term intent is to license M-001 as a standalone universal flu vaccine, replacing both the current seasonal and pandemic vaccine technology.
- http://www.cdc.gov/flu/spotlights/pandemic-global-estimates.htm, retrieved 19 Sept 2016.
- https://www.medicalcountermeasures.gov/barda/pandemic-influenza.aspx, retrieved 19 Sept 2016.
About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact:Joshua E PhillipsonBusiness Development+972-8-930-2529 x5105j.phillipson@biondvax.comForward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 drug development involves a lengthy and expensive process with uncertain outcome, the results of the current Phase 2 & contemplated phase 3 trials, the adequacy of available cash resources to fund product development and commercialization and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
###
Professor Shai Ashkenazi Appointed to BiondVax’s Scientific Advisory Board
An experienced clinician-researcher, Prof Ashkenazi has guided multiple vaccines through clinical and regulatory approval phases to market.
Ness Ziona, Israel – September 7, 2016 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing a vaccine against current and future seasonal and pandemic influenza strains, is pleased to announce the appointment of Professor Shai Ashkenazi to its Scientific Advisory Board (SAB).Ashkenazi is a clinical and regulatory vaccine expert, with significant contributions to flu and other infectious disease vaccine research and development. He has served on the clinical trial advisory boards for the development of a pediatric flu vaccine, vaccines for enteric infections, as well as other infectious diseases.Ashkenazi has a deep understanding and experience with BiondVax’s universal flu vaccine as he served as the head of the data and safety monitoring board (DSMB) in all of the company’s clinical trials in Israel and abroad.Professor Ashkenazi commented, “I am excited to join BiondVax’s SAB and to be part of the efforts to bring better protection against the flu in order to save lives.”The head of BiondVax’s Scientific Advisory Board, Professor Ruth Arnon stated, “We’re honored Prof. Ashkenazi has joined the team. His breadth of experience in marshalling pharma products through clinical trials, regulatory and marketing approval will be of great value as BiondVax begins to progress towards Phase 3 trials. Our team – the SAB, board, and employees - are well positioned to achieve approval for M-001 as the first universal flu vaccine.”
Our team – the SAB, board, and employees - are well positioned to achieve approval for M-001 as the first universal flu vaccine
Among other positions, Ashkenazi currently holds the Lea and Arieh Pickel Chair for Pediatric Research at the Sackler Faculty of Medicine, Tel Aviv University. He is also Chair of the Department of Pediatrics A at Schneider Children’s Medical Center and Head of the Research Laboratory for Pediatric Infectious Diseases at the Felsenstein Medical Research Center.Ashkenazi is an editorial board member of several international medical journals, has served on numerous national and international committees, authored over 200 medical publications and is editor of the Israeli Textbook of Pediatrics.
Notice of Annual General Meeting of Shareholders
Please follow this link to the proxy statement for the AGM of shareholders to take place on September 22, 2016.
BiondVax Announces Second Quarter 2016 Financial Results and Update
Ness Ziona, Israel, August 18, 2016 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing a vaccine against current and future seasonal and pandemic influenza strains, today announced its second quarter 2016 financial results ended June 30, 2016 and provided a business update.Second Quarter 2016 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to US$ is provided using the exchange rate of 3.846 as at June 30, 2016.
- Second quarter operating expenses were NIS 2.47m ($644,000) compared with NIS 3.21m in the second quarter of last year;
- Second quarter R&D expenses amounted to NIS 1.48m ($385,000) compared with NIS 2.61m in the second quarter of last year;
- Cash, cash equivalents and short and long-term marketable securities at the end of the quarter were NIS 30.65m ($7.97m) compared with NIS 37.53m as of December 31, 2015;
Recent Corporate Update
- Clinical trials are progressing. The EU UNISEC sponsored Phase 2b clinical trial completed enrolment and results are being analyzed. The US NIH Phase 2 trial preparations are well into advanced stages. Furthermore, US-based Cytovance is beginning to scale-up production of BiondVax’s universal flu vaccine candidate M-001 for Phase 3 clinical trials, which is expected to be ready by H1 2017.
- In August, a video feature on BiondVax was published by a leading Israeli portal. The video can be viewed at https://www.youtube.com/watch?v=iqzZd4hsvSw. In addition, BiondVax launched a newsletter. The most recent edition can be viewed at http://us12.campaign-archive2.com/?u=37c158f4953dfecaabf88a035&id=763a628862. To receive BiondVax updates directly to your inbox please email j.phillipson@biondvax.com.
Dr. Ron Babecoff, CEO of BiondVax commented: “Our progress continued into the second quarter according to plans. The work with our partners in our different collaborations is also moving forward at a good pace. As each quarter passes, we are coming closer towards our goal of bringing a universal flu vaccine to market.”About BiondVax BiondVax is a biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. For more information, please visit www.biondvax.com. Contact Details
| Joshua PhillipsonBusiness Development Manager+972 8 930 2529j.phillipson@biondvax.com |
Forward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated Phase 2 & 3 trials, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements. ** Tables to Follow ** BALANCE SHEETS
| Convenience translation | ||||||||
| December 31, | June 30, | June 30, | ||||||
| 2015 | 2015 | 2016 | 2016 | |||||
| Audited | Unaudited | Unaudited | ||||||
| N I S | U.S. dollars | |||||||
| (In thousands except share and per share data) | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | 33,470 | 37,955 | 15,084 | 3,922 | ||||
| Short term deposit | - | - | 11,503 | 2,991 | ||||
| Marketable securities | 2,016 | 2,016 | 2,017 | 524 | ||||
| Other receivables | 1,442 | 763 | 3,188 | 829 | ||||
| 36,928 | 40,734 | 31,792 | 8,266 | |||||
| LONG‑TERM ASSETS: | ||||||||
| Marketable securities | 2,048 | 2,047 | 2,049 | 533 | ||||
| Property, plant and equipment | 2,044 | 2,355 | 1,746 | 454 | ||||
| Other long term assets | 287 | 286 | 490 | 127 | ||||
| 4,379 | 4,688 | 4,285 | 1,114 | |||||
| 41,307 | 45,422 | 36,077 | 9,380 | |||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | 931 | 635 | 457 | 119 | ||||
| Other payables | 768 | 828 | 697 | 181 | ||||
| 1,699 | 1,463 | 1,154 | 300 | |||||
| LONG‑TERM LIABILITIES: | ||||||||
| Options | 5,994 | 7,958 | 4,923 | 1,280 | ||||
| Severance pay liability, net | 69 | 66 | 72 | 19 | ||||
| 6,063 | 8,024 | 4,995 | 1,299 | |||||
| SHAREHOLDERS' EQUITY (DEFICIT): | ||||||||
| Ordinary shares of NIS 0.0000001 par value: | ||||||||
| Authorized: 391,000,000 shares as of June 30, 2016, 2015 (unaudited) and December 31, 2015; Issued and Outstanding: 135,097,367, shares as of June 30, 2016, 2015 (unaudited) and December 31, 2015. | *) - | *) - | *) - | *) - | ||||
| Share premium | 110,679 | 109,934 | 111,458 | 28,980 | ||||
| Options | 2,536 | 2,536 | 2,536 | 659 | ||||
| Other comprehensive income | 12 | 14 | 7 | 2 | ||||
| Accumulated deficit | (79,682) | (76,549) | (84,073) | (21,860) | ||||
| 33,545 | 35,935 | 29,928 | 7,782 | |||||
| 41,307 | 45,422 | 36,077 | 9,380 | |||||
*) Represents an amount lower than NIS 1. STATEMENTS OF COMPREHENSIVE INCOME
| Convenience translation(Note 2) | ||||||||||||||||||||||||||||
| Year endedDecember 31, | Three months endedJune 30, | Six months endedJune 30, | Six months endedJune 30, | |||||||||||||||||||||||||
| 2015 | 2015 | 2016 | 2015 | 2016 | 2016 | |||||||||||||||||||||||
| Unaudited | Unaudited | |||||||||||||||||||||||||||
| N I S | U.S. dollars | |||||||||||||||||||||||||||
| (In thousands, except per share data) | ||||||||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||||
| Research and development, net of participations | 7,906 | 2,613 | 1,478 | 3,785 | 3,541 | 921 | ||||||||||||||||||||||
| Marketing, general and administrative | 3,397 | 600 | 999 | 1,250 | 1,770 | 460 | ||||||||||||||||||||||
| Total operating expenses | 11,303 | 3,213 | 2,474 | 5,035 | 5,311 | 1,381 | ||||||||||||||||||||||
| Operating loss | 11,303 | 3,213 | 2,474 | 5,035 | 5,311 | 1,381 | ||||||||||||||||||||||
| Financial income | 1,128 | 3 | 252 | 8 | 49 | 13 | ||||||||||||||||||||||
| Financial expense | (24) | (865) | (6) | (912) | (200) | (52) | ||||||||||||||||||||||
| Financial income (expenses) due to issuance of options | - | (1,127) | (383) | (1,127) | 1,071 | 278 | ||||||||||||||||||||||
| Total finance (expense) income, net | 1,104 | (1,989) | (138) | (2,031) | 920 | 239 | ||||||||||||||||||||||
| Net loss | 10,199 | 5,202 | 2,615 | 7,066 | 4,391 | 1,142 | ||||||||||||||||||||||
| Other comprehensive income (loss): | ||||||||||||||||||||||||||||
| Items to be reclassified to profit or loss in subsequent periods: | ||||||||||||||||||||||||||||
| Gain (loss) from available-for-sale financial assets | (5) | (2) | (7) | (3) | (5) | (1) | ||||||||||||||||||||||
| Total comprehensive loss | (10,204) | (5,204) | (2,622) | (7,069) | (4,396) | (1,143) | ||||||||||||||||||||||
| Basic and Diluted net loss per share (NIS) | (0.10) | (0.05) | (0.02) | (0.09) | (0.03) | (0.008) | ||||||||||||||||||||||
| Weighted average number of shares outstanding used to compute basic and diluted loss per share | 105,522,642 | 96,284,034 | 135,097,367 | 75,290,700 | 135,097,367 | 135,097,367 | ||||||||||||||||||||||
BiondVax Invited to WHO Influenza Vaccine Meeting
Invitation-only event to discuss and review progress towards improved flu vaccines
Ness Ziona, Israel – August 10, 2016 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced that it has been invited to participate in the ‘Eighth WHO meeting on the development of influenza vaccines that induce broadly protective and long-lasting immune responses’. The meeting will be held in Chicago, IL on August 23 and 24, 2016.
The Global Vaccine Action Plan (GVAP) aims for at least one licensed universal influenza vaccine by 2020. The World Health Organization (WHO) Initiative for Vaccine Research monitors progress toward the achievement of GVAP goalsthrough consultations of experts in the field. Having completed 5 clinical trials, and with two ongoing Phase 2 trials sponsored by the EU’s UNISEC and the US NIH/DMID, BiondVax’s M-001 is recognized as a leading universal flu vaccine candidate. M-001’s clinical trial results have shown safety and immunogenicity in both young and elderly adults against a broad range of seasonal and pandemic flu strains.Joshua Phillipson, BiondVax’s Head of Business Development, commented, “The meeting’s participants, leading public health and influenza experts, recognize the urgent need for a next generation flu vaccine that broadly protects against future seasonal and pandemic flu strains. Current solutions fall short. BiondVax’s vaccine candidate is unique in that it’s in advanced human clinical trials, and is designed to be a ‘one size fits all’ flu vaccine. It can be used year round, and stockpiled for future pandemics. I’m looking forward to meeting with our colleagues and contributing to the discussion at the upcoming WHO meeting.”BiondVax will be participating along with representatives from WHO, NIH, BARDA, and other leading industry experts.For more information about the WHO meeting, please see http://who.int/immunization/research/meetings_workshops/8th_influenza_vaccine_chicago2016/en/.###
BiondVax CEO to Present Universal Flu Vaccine Technology at BIO International Convention
Ness Ziona, Israel – June 2, 2016 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that BiondVax’s CEO, Dr. Ron Babecoff, will be presenting and participating in a panel discussion at BIO International Convention in San Francisco.The session, titled “Solving the Flu Problem: Can New Technologies Lead to Universal Flu Vaccines?” will be held on Tuesday, June 7 at 1:00pm in the Moscone Center, room West 3004.Dr. Babecoff will discuss the technology and promising clinical trial results of M-001, BiondVax’s universal flu vaccine candidate. Also participating in the panel moderated by the US Biomedical Advanced Research and Development Authority (BARDA) will be representatives from FluGen and Janssen Pharmaceuticals.Accompanying Dr. Babecoff will be Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer. Those wishing to meet with Drs. Babecoff and Ben-Yedidia are invited to contact BiondVax’s Business Development team.About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact:
| CompanyJoshua PhillipsonBusiness Development Manager+972-8-930-2529 x5105j.phillipson@biondvax.com |
Forward Looking StatementsThis 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. These forward-looking statements involve certain risks and uncertainties reflect the 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 drug development involves a lengthy and expensive process with uncertain outcome. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Prospectus which was declared effective on May 11, 2015. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements. ###