NASDAQ: BiondVax Pharmaceuticals Rings The Nasdaq Stock Market Closing Bell

About this Marketsite Event

BiondVax Pharmaceuticals Ltd. (Nasdaq:BVXV), a pharmaceutical company dedicated to the development of a Universal Flu Vaccine, covering all human strains and providing protection for both seasonal and pandemic flu strains, will visit the Nasdaq MarketSite in Times Square.In honor of the occasion, Dr. Ron Babecoff, Chief Executive Officer rang the Closing Bell.BiondVax Pharmaceuticals, a publicly-traded company (TASE:BNDX) (Nasdaq:BVXV) located in the Weizmann Science Park in Ness-Ziona (Israel), is dedicated to the development of a novel Universal Influenza Vaccine. BiondVax's Universal Flu Vaccine is based on research carried out over a period of 20 years by Weizmann Institute Professor Ruth Arnon, who heads the company's Scientific Advisory Board. Professor Arnon is well-known for her part in the development of Copaxone, a blockbuster drug for the treatment of multiple sclerosis.

Media from the Event

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BiondVax to Ring Closing Bell and Close Market Trading on NASDAQ on July 10, 2015

BiondVax launches a new investor relations website providing international investors with comprehensive information about the Company, progress and its strategy

Ness Ziona, Israel – July 2, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced that it will be closing trading on the NASDAQ market on Friday, July 10, 2015, in celebration of its recent initial public offering in the United States and the launch of its international investor relations program. This event will be the culmination of a week of meetings as part of a non-deal roadshow with US-based institutional investors and financial analysts.In addition, BiondVax today announced the launch of its new investor relations website, which can be found at www.biondvax.com.Institutional investors or analysts interested in meeting with BiondVax management in New York or wishing to attend the market closing event should contact the Company’s investor relations team.Ron Babecoff, BiondVax’s President and CEO, commented, “We are very much looking forward to launching our investor relations operations in the US. The closing event at the NASDAQ is an excellent starting point and the culmination of a long and an important process for us, of listing our shares in the United States, and by that making ourselves accessible to the US capital market.”

BiondVax Presents BVX-006 Preliminary Phase II Results: The Universal Flu Vaccine at Higher Doses is Safe and Improves Immunogenicity in Older Adults

Preliminary results of BVX-006 show that M-001 is well tolerated and provides improved flu immunity by enhancing antibody responses to multiple strains when administered as a primer in a 1 mg dose

Ness Ziona, Israel – June 29, 2015 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV) today announced positive preliminary results from its BVX-006 Phase II clinical trial of M-001, BiondVax's candidate for a universal influenza vaccine. In this trial, M-001 was injected intramuscularly to volunteers between the ages of 50 to 65, followed by an administration of the 2014/15 season trivalent influenza vaccine (TIV) 3 weeks later. M-001 was found to be safe and well tolerated and induced humoral immune responses, successfully meeting the primary safety and secondary immunogenicity endpoints.M-001 in a 1mg dose, primed for immune responses in a manner consistent with previous data in this age group, confirming BiondVax’s approach to the development of a universal influenza vaccine. Furthermore, as demonstrated in previous tests, a broadening of the immune response to elicit responses against strains not included in the standard influenza vaccine was detected.M-001 also elevated the immune response to other strains which were not included in the current influenza seasonal vaccine including against the drifted H3N2 strain of influenza that has caused this year’s epidemic in the United States. These results support BiondVax’s claim that M-001 provides a broaden and improved coverage against multiple influenza type A and B virus strains.In addition, the excellent safety profile demonstrated for the 1 mg dose of M-001 will enable BiondVax to safely administer this dose in upcoming trials (such as BVX-007 in Europe). The increased dose is expected to further improve the immune responses against multiple influenza strains when given as a primer or as a standalone product without an adjuvant. Furthermore, the 1mg dose can be particularly beneficial to a population with weakened immunity, such as the elderly.Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, noted that, “We are very pleased with the results of this trial, which provide us with additional supporting data that our M-001 increases the immune response against multiple flu strains. The results indicating that the 1mg dosage level was well tolerated is very important and these positive results support our continued research and ongoing trials.”Added Dr. Ron Babecoff, BiondVax’s President and CEO, “We are very happy with these results, as they demonstrate the importance and value to society of developing M-001. This successful trial brings us one step further towards the phase 3 clinical trial.” 

BiondVax Pharmaceuticals Ltd. Announces a Closing of Over-Allotment Option

Ness Ziona, Israel, June 24, 2015 – BiondVax Pharmaceuticals Ltd. (TASE: BVXV, Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced the closing of an additional and partial exercise of the over-allotment option granted to the underwriters. The underwriters purchased 110,000 additional American Depositary Shares (ADSs) at a public offering price of $5.00 per ADS, whereby each ADS represents 40 of BiondVax’s ordinary shares, bringing aggregategross proceeds from the offering to $10,120,380, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BiondVax. The closing with respect to these over-allotment option shares was consummated on June 24, 2015.Aegis Capital Corp. acted as the sole book-running manager for the offering.A registration statement relating to these securities has been declared effective by the Securities and Exchange Commission on May 11, 2015.A prospectus relating to the offering has been filed with the SEC and is available on the SEC’s web site at http://www.sec.gov.  Copies of the final prospectus relating to the offering may be obtained from the offices of Aegis Capital Corp., Prospectus Department, 810 Seventh Avenue, 18th Floor, New York, NY, 10019, telephone: 212-813-1010 or email: prospectus@aegiscap.com, or from the above-mentioned SEC website.

BiondVax Announces FDA Acceptance of IND Application for its Investigational Universal Flu Vaccine

Nes Ziona, Israel – June 17, 2015 – BiondVax Pharmaceuticals Ltd. (TASE: BVXV, Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced that its Investigational New Drug Application (IND) for its Multimeric-001 vaccine (M-001), has been accepted by the US Food and Drug Administration (FDA), and the Company was notified by its regulatory advisors that the ‘study may proceed’. FDA acceptance of an IND provides authorization for the distribution and administration in the U.S. of medical products that have not yet been approved for commercial use for purposes of conducting clinical trials.This IND continues BiondVax's clinical program, and will allow BiondVax to conduct an FDA approved Phase 2 clinical trial that will involve the administration of M-001, BiondVax's product candidate.Dr. Ron Babecoff, BiondVax's CEO commented, "FDA acceptance of our IND application is an important milestone, representing a major step forward for BiondVax and for the development program of our universal flu vaccine.”Dr. Tamar Ben-Yedidia, BiondVax's CSO said, “Influenza is a serious global concern - it spreads rapidly, leading to serious illness which can directly or indirectly lead to death, particularly among the elderly. Today’s vaccines are far from ideal - they mostly protect against the strains within them, but frequent mismatches between these strains and the circulating ones lead to low vaccine effectiveness. We believe our solution, whereby one vaccine protects against each and every flu strain, will save the lives and suffering of many millions around the world each year.”

BiondVax to Present at Workshop on Immunoassay Standardization for Universal Flu Vaccines Organized in Cooperation with the NIH and EDUFULVAC

The presentation will take place in London on June 18-19 as part of the Company’s participation in the UNISEC (Universal Influenza Vaccines Secured) consortium aimed to advance the concept of a universal vaccineNes Ziona, Israel – June 15, 2015 – BiondVax Pharmaceuticals Ltd. (TASE: BNDX, Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced that it has been invited to present in a workshop organized by EDUFULVAC, (EDUcate inFLUenza VACcine) a corresponding European Consortium coordinated by the European Vaccine Initiative (Germany) and NIAID (the National Institute of Allergy and Infectious Diseases, a National Institute of Health branch) in the United States.The workshop will bring together experts from research institutions, industry, public health and regulatory agencies with the aim of evaluating immunoassays that can be used to assess broadly reactive or universal influenza vaccines and their standardization. The workshop focuses on assays for cell mediated immune responses that are specific to multiple influenza strains.. Dr. Tamar Ben-Yedidia, the Chief Scientist of BiondVax, will present data and discuss the Company’s own experience and views on assays for the assessment of future vaccines.Ron Babecoff, BiondVax's CEO commented, "This invitation is further recognition by the European Commission and the NIH of BiondVax's central position and contribution to this important field of new influenza vaccine development. Our scientific and clinical experience is well recognized both in Europe and in the US. We hope that together with the other participants, we can facilitate the acceptance of new standard assays that will promote regulatory approval for universal flu vaccines."

BiondVax Selected as part of OCS/IATI Delegation to 2015 BIO International Convention in Philadelphia

Nes Ziona, Israel, June 10, 2015 – BiondVax Pharmaceuticals Ltd. (TASE: BNDX, Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced that it was seleted to participdate in the 2015 BIO International Convention, which is being held from June 15-18 in Philadelphia, Pennsylvania.Biondvax was selected to be a part of the Israeli delegation, together with some of the other leading and most promising biotech companies in Israel, and is attending under the auspices of the Office of the Chief Scientist in Israel (OCS). The OCS has supported BiondVax’s research, pre-clinical and clinical development by awarding the Company with substantial research funds for the past 6 years.Dr. Hassin, BiondVax’s Chief Operating officer (COO) will discuss BiondVax’s achievements. Dr Hassin will take the opportunity of meeting with potential CMOs to discuss collaboration for technology transfer and large scale production of phase 3 and commercial batches of Biondvax’s M-001 universal flu vaccine.Commented Dr. Ron Babecoff, CEO of Biondvax, “We are pleased with the validation given to us by the Office of the Chief Scientist in Israel, selecting us amongst a unique group to represent Israeli biotech innovation at the major BIO international convention in the United States. In particular, given the recent widespread Bird Flu outbreak in the United States, our solution is very relevent at the show this year where the spotlight has been put on the need for an efficient broad-coverage vaccine.” Dr. Shimon Hassin, BiondVax's COO, said, "In order to be ready for the phase 3 and the market we need to partner with a leading CMO for the production of our universal flu vaccine on a large scale. The meetings scheduled during the BIO and beyond, are of utmost importance for selection of our manufacturing partner."

BiondVax Announces First Quarter 2015 Financial Results

Nes Ziona, Israel,  June 1, 2015 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BNDX), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced its financial results for the first quarter of 2015 and provided a business update.First Quarter 2015 Financial SummaryResults are in New Israel Shekels (NIS) and a convenience translation to US$ is provided, using the exchange rate of 3.98 as at March 31, 2015

• Total operating expenses were NIS 1.82m ($457,000) compared with NIS 2.02m in the first quarter of last year;
• R&D expenses amounted to NIS 1.17m ($294k) compared with NIS 1.47m in the first quarter of last year;
• Cash, cash equivalents and short and long-term marketable securities at the end of the quarter were NIS 11.46m ($2.88m) compared with NIS 13.68m as of December 31, 2014;
• Following a succesful IPO on Nasdaq, the Company’s current cash position amounts to approximately $11 million.

 Recent Corporate Update

• On May 15, 2015 Biondvax completed a public offering in the United States, selling 1,910,000 American Depositary Shares (ADS) and warrants, where each ADS represents 40 ordinary shares. In addition, the underwriter has partially exercised their warrants to purchase an additional 128,000 ADSs;
• Biondvax launched an international investor relations program in order to increase awareness amongst US and global investors;
• During the second quarter, Biondvax expects to report the results of its BVX-006 trial;

 Dr. Ron Babecoff, CEO of Biondvax Commented: “We are excited with our new US listing which we believe will bring new interest to our business and increased tradability in our shares. The influenza virus is a major global problem which humanity is constantly struggling against – one example is the recent "Avian Flu" outbreak and the massive cull in the Southern United States. Today’s solution of specific-strain vaccines is very inefficient and tends to have a particularly low success rate. The search for a universal flu vaccine is the "holy grail". Our solution was invented by Weizmann Institute Professor Ruth Arnon, also known for co-development of Copaxone, and further developed by BiondVax to its current advanced clinical stage. As we move through 2015, and as we continue to progress on our phase II trials, we are getting ever closer to bringing our solution to market.”For the tables please see our financial information page.

BiondVax Pharmaceuticals Ltd. Announces Closing of U.S. Initial Public Offering

Nes Ziona, Israel, May 15, 2015 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced the closing of its previously announced U.S. initial public offering of 1,910,000 American Depositary Shares (ADSs), each ADS representing 40 of its ordinary shares, and warrants to purchase up to an aggregate of 1,910,000 ADSs at an offering price of $5.00 per ADS and $0.01 per warrant. In addition, the underwriter has partially exercised their option to purchase an additional 128,000 warrants to purchase 128,000 ADSs. The warrants have a per ADS exercise price of $6.25, are exercisable immediately and will expire on May 15, 2020. Gross proceeds to BiondVax from this offering are approximately $9.57 million before deducting underwriting discounts and commissions and other estimated offering expenses payable by BiondVax.Aegis Capital Corp. acted as the sole book-running manager for the offering.A registration statement relating to these securities has been declared effective by the Securities and Exchange Commission on May 11, 2015.A preliminary prospectus relating to the offering has been filed with the SEC and is available on the SEC’s web site at http://www.sec.gov.  Copies of the final prospectus relating to the offering may be obtained from the offices of Aegis Capital Corp., Prospectus Department, 810 Seventh Avenue, 18th Floor, New York, NY, 10019, telephone: 212-813-1010 or email: prospectus@aegiscap.com, or from the above-mentioned SEC website.This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Biondvax Files Registration Statement

The Company hereby announces that on December 29, 2014, the Company filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission relating to a proposed offering of American Depositary Shares in the United States. The timing of the offering, the number of shares to be offered and the price range for the proposed offering have not yet been determined.A registration statement related to these securities has been filed with the Securities and Exchange Commission, but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective, and there is no guarantee that this submission of such registration statement will result in the completion of the proposed offering. The registration statement can be accessed through the SEC’s website at www.sec.gov.This immediate report does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

BiondVax Receives Approvals for Patent in Europe and Japan for its Universal Flu Vaccine

The patent approvals extend and strengthen BiondVax's intellectual property portfolio Nes Ziona, Israel – October 29, 2014 – BiondVax Pharmaceuticals Ltd. (TASE: BNDX), which is developing the Universal Flu Vaccine, announced today that it received approvals from the European Union and from Japan's patent authorities for the Company's patent on the Multimeric Multi-Epitope Polypeptide Influenza Vaccines family. This is a family of patents for vaccination against influenza in humans, and specifically vaccines that confer a longlasting protection against multiple flu strains. The patent approvals in Europe and Japan extend and strengthen BiondVax's intellectual property.The newly-approved patent in Europe and Japan has already been approved in the US, , Hong Kong, Australia, China, Russia and Mexico. In addition, the Company is in the process for patent approval in Israel, where it may be completed soon.Ron Babecoff, CEO of BiondVax said “We are excited on the dual patent approvalstoday: both in the EU and in Japan, which strengthen the acknowledgement for BiondVax around the world. The patent approval in Europe and Japan can set the ground and support the Company, if and as we work towards signing agreements with governments to use our unique technology."

BiondVax Receives a Confirmation for a Grant of 4.87 million NIS from the Office of the Chief Scientist

The budget is intended for the Continued Clinical Program of the Universal Influenza Vaccine of the Company The Chief Scientist Demonstrates His Continued Confidence, Granting BiondVax NIS 15.7 million Nes Ziona, Israel – 8 September 2014 – BiondVax Pharmaceuticals Ltd. (TASE: BNDX), which is developing the Universal Flu Vaccine, today announced that it has been awarded a sum of 4.87 million NIS by the Chief Scientist in the Ministry of Economy (OCS) for the continued development of BiondVax's Universal Influenza Vaccine in advanced clinical trials. The grant is awarded in accordance with the Israeli law to promote research and development in the industry.The grant approved by OCS will be used to promote the company's effort towards a phase 3 trial with its Universal Vaccine. In addition, the funds will be used for improvements in the manufacturing process and preparation for its scale up, activities which will contribute significantly to its commercialization.Ron Babecoff, BiondVax's CEO's said today: "We are proud for been awarded yet another grant by the OCS. In the last years OCS has expressed its repeated trust in our Universal Vaccine program and we enjoyed considerable financial support that led to our clinical successes. This is another step in our journey to approve the first Universal Flu Vaccine".

BiondVax to Initiate the Process for Trading the Company's Shares in the US through ADR

Nes Ziona, Israel – April 1, 2014 – BiondVax Pharmaceuticals Ltd (TASE: BNDX), developer of a universal flu vaccine, announced today that its Board of Directors has approved initiation of the process for listing the Company's shares for trading in the US through American Depository Receipt (ADR).The Company will act to register an ADR Level 1 Over-The-Counter (OTC), which does not include the option for public offerings in the US (without additional registration). The Company’s key goals are to increase the visibility of the Company and its game changing technology to the public and analysts globally, facilitate access to professional and institutional investors, increase the volume of trading and, more generally, maximize its value for shareholders.Dr. Ron Babecoff, BiondVax’s CEO: "So far, the universal flu vaccine being developed by the Company was demonstrated to be safe and active against seasonal and pandemic flu strains in four human clinical trials, and to match newly emerging strains. Now, as we focus on seeking commercial agreements with governments around the world or strategic partners, we have decided to make our shares accessible also to US investors and broaden awareness of BiondVax’s successes."

BiondVax Meets with the US Biomedical Advanced Research and Development Authority (BARDA) to Present the Use of its Universal Flu Vaccine against Global Pandemic Influenza Outbreak

Nes Ziona, Israel – February 26, 2014 – BiondVax Pharmaceuticals Ltd (TASE: BNDX), developer of a universal flu vaccine, announced today that the Company has just returned from a meeting with officials at the Biomedical Advanced Research and Development Authority/Health and Human Services (BARDA/HHS) at which clinical trial results for BiondVax’s universal flu vaccine, the Multimeric 001, was presented. BiondVax was invited to give this seminar to the Influenza Division at BARDA, during which the Company’s solution for global pandemic flu outbreaks was discussed. At the meeting the Company was informed that BARDA will consider proposals to provide pandemic vaccines and funding of clinical trials examining the usage of BiondVax’s universal flu vaccine as a primer that provides preparedness ahead of pandemic flu outbreaks. In addition, at the seminar the Company discussed the use of its vaccine as a standalone universal flu vaccine.The Influenza Division at BARDA is considered world expert on pandemic preparedness and the deliberations of national governments when evaluating medical counter measures.“The US is a key market for influenza vaccines and so it is critical to BiondVax’s success that our development strategy reflects the needs of US stakeholders, such as BARDA. The US health authorities have a major impact on the global health system and sets the agenda and the level of global preparedness for pandemic outbreaks,” comments Dr. Ron Babecoff, BiondVax’s CEO. "We continue to work in parallel with regulatory bodies and health authorities around the world to promote agreements with governments for licensing the universal flu vaccine”.

BiondVax will Present Clinical Results and the Company's Strategy for Pandemic Preparedness Ahead of Flu Outbreak at the World Health Organization's Key Influenza Meeting

Nes Ziona, Israel – February 17, 2014 – BiondVax (TASE: BNDX), developer of a universal flu vaccine, announced today that it will present at the World Health Organization (WHO)'s invitation-only meeting for influenza vaccine experts, which will be held May 5-7, 2014 in Geneva, Switzerland. The conference is part of WHO's Initiative for Vaccine Research and will focus on flu vaccination developments, with the goal of promoting achievement of long term, efficient protection of the global population against a broad array of influenza strains. Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientist, will present the results of BiondVax's various studies and the Company's strategy for pandemic preparedness ahead of flu outbreak, as part of a session on new approaches for broadly protective flu vaccines. Key stakeholders in the global vaccination industry, as well as representatives from regulatory bodies, top tier academic research labs and opinion leaders will also attend the closed meeting."We are excited to participate in this important event, which provides the Company with a unique opportunity to present its achievements and pandemic preparedness plans in front of global decision and policy makers in the flu space. Governments and health organizations around the world look to the WHO for guidance about influenza policies and therefore it is critical for the Company’s success to be there", said Ron Babecoff, CEO of BiondVax.This WHO meeting is a closed-door event that is attended only by organizations and companies selectively invited to participate, with just a few participants given the opportunity to present. The topics presented at the conference go through a process of review and selection, and the meeting is reported in a peer-reviewed article. There will be representatives from foundations such as Bill and Melinda gates foundation and the major flu vaccine manufacturers, including Sanofi, GSK, Novartis, Baxter and bioCSL. The pivotal role of the WHO in the influenza arena is indicated by the wealth of programs currently run by this organization, including, Global Influenza Program (GIP), Global Action Plan for Influenza Vaccines (GAP), Strategic Advisory Group of Experts (SAGE) on Immunization Pandemic Influenza Preparedness (PIP) Framework and Global Influenza Surveillance and Response System (GISRS).

BiondVax Receives Patent Registration Approval for Multimeric Multiepitope Influenza Vaccines in Hong Kong as well as Allowance of Patent Registration in US for the Company’s Universal Flu Vaccine

Company considers the Hong Kong and US approvals to be of great importance, as these patents will complement the company’s business strategy of universal flu vaccine stockpiling agreements with governments around the world Nes Ziona, Israel – February 10th , 2014 – BiondVax (TASE: BNDX), developer of a universal flu vaccine, announced receiving approval from Hong Kong’s patent office to register its patent concerning Multimeric Multiepitopes for the Company's universal flu vaccine, as well as an approval from the US patent office for the completion of the testing process for patent registration. As part of the US registration process, the patent was found eligible and currently is pending fees. The patent addresses the vaccine structure and composition as well as the manufacturing methods and the usages of the universal flu vaccine, while providing scope for possible changes in the structure of the protein that is the basis for the universal vaccine. The patent extends and secures the coverage provided by existing patents that protect BiondVax’s intellectual property.These approvals in Hong Kong and the US build on patent approvals already received in Australia, China, Russia and Mexico. In parallel, the Company is in the process of registering the patent in other locations worldwide such as Europe and Israel.BiondVax’s business model is to engage in multi-year stockpiling agreements with health organizations and governments around the world, for stockpiling BiondVax’s universal vaccine as a pandemic primer vaccine, agreements that would include completion of clinical trials and regulatory approvals in each country, as needed. Since the appearance of new and potentially pandemic flu strains in humans often occurs in Asia, BiondVax has made sure to secure patent approvals in this region, including in Hong Kong.BiondVax recognizes an interest and a need among various governments around the world to prepare ahead of time for a flu pandemic. The Company estimates that the clinical information gathered and analyzed by the company to date supports that BiondVax’s universal flu vaccine can serve as a pandemic primer. More specifically, the data indicates that if BiondVax’s universal flu vaccine is given to citizens immediately following a pandemic flu outbreak, and then subsequently the conventional pandemic specific vaccine is administered, the result expected is that more people would be protected against a broader set of flu strains. The Company considers that taking this approach has unique advantages as it enables countries to be prepared right now, ahead of any flu outbreak, so that once the pandemic outbreak is official, the governments could protect their people and keep their country safe –both its health and economy.“This important patent expands BiondVax’s intellectual property, and will help our goal of signing agreements with governmental organizations”, said Ron Babecoff, CEO of BiondVax. “BiondVax believes it is critical to achieve preparedness for a deadly pandemic flu ahead of outbreak, and that the universal vaccine can already enable governments today to protect their populations for when the pandemic flu breaks out.”

BiondVax is a member of the UNISEC consortium awarded a European Commission FP7 grant of 6 million EURO

BiondVax to get half a million EUROThe 12 UNISEC members, each expert in the influenza field, are committed to accelerating clinical development of universal influenza vaccines. Nes Ziona, Israel – October 3rd 2013 – BiondVax is a member of the UNISEC consortium, which has successfully merited an FP7 award and just finalized the mandatory agreements to allow activation of a 6 million EURO grant, of which about 550 thousand is allocated to BiondVax. The Seventh Framework Program for Research (FP7) is a prestigious grant awarded by the European Commission to top tier research teams in academia and industry conducting studies with groundbreaking potential. The UNISEC consortium brings together 4 industry partners, 3 university partners and 5 National Health Institutes, each with expertise in influenza research and development and the shared goal of bringing to the public a universal influenza vaccine.Utilizing the clinical trial network of the consortium, BiondVax will perform a human clinical study examining the benefits of priming with BiondVax's universal flu vaccine, a new approach to public preparedness ahead of pandemic outbreak. In addition, BiondVax is responsible for harnessing the experience of all the consortium members to define a set of criteria concerning the technical and immunological characteristics of a universal influenza vaccine - including candidate cellular biomarkers for protection. BiondVax’s role in this consortium reflects our expertise in clinical development of a universal influenza vaccine.Dr Tanya Gottlieb, responsible for BiondVax’s BD and international grant applications, comments “Our participation in this multinational FP7 collaboration dedicated to improving public protection against seasonal and pandemic influenza signifies BiondVax’s standing in the global universal flu vaccine space.”

Priming with BiondVax’s universal influenza (flu) vaccine broadens the activity of conventional bird pandemic vaccine against emerging strains

Nes Ziona, Israel – August 25th , 2013 – BiondVax announced today that priming with universal flu vaccine before boosting with a conventional bird flu H5N1 vaccine (containing a single strain from Clade 1) resulted in mice exhibiting a significantly higher level of immunity to the strain contained in the conventional bird flu vaccine and in addition, broadened immunity to other H5N1 flu strains (from Clade 2). Bird flu viruses are classified into two main families, Clade 1 and Clade 2. Conventional pandemic bird flu vaccines are strain-specific and therefore trigger immunity predominantly against the particular virus contained within the vaccine, either Clade 1 or Clade 2. In our most recent study, we show that this limitation of conventional bird flu vaccines can be overcome by priming with BiondVax’s universal flu vaccine, as mice administered BiondVax’s universal vaccine and then the conventional pandemic bird flu vaccine exhibit immunity to multiple bird flu strains from both clades. Indeed, BiondVax’s universal flu vaccine contains viral regions common to diverse strains, including H1N1 (swine flu), H5N1 (bird flu) and H7N9 (bird flu), and so can enhance all kinds of conventional strain-specific flu vaccines when administered in a prime-boost regimen: first the universal flu vaccine is administered (primer) and then a few weeks later the seasonal or pandemic flu vaccine is administered (boost). Furthermore, this new study confirms our earlier finding that priming with BiondVax’s universal flu vaccine overcomes another challenge of pandemic preparedness, namely the difficulty in supplying enough conventional bird flu vaccine to the population in time. For priming with BiondVax’s universal flu vaccine enables one instead of two conventional bird flu doses per person to be sufficient.With multiple deadly H5N1 and H7N9 flu strains circulating in animals and humans globally, uncertainty about the identity of the next pandemic flu strain is driving governments to reconsider how best to protect their populations against an unknown virus. This uncertainty can be addressed by exploiting the capability of BiondVax’s universal flu vaccine to make a conventional pandemic flu vaccine effective against a broader array of pandemic strains. Governments worldwide should implement a Pandemic Preparedness Plan (PPP) whereby BiondVax’s universal flu vaccine is stockpiled during inter-pandemic phases to enable immediate response to ANY and ALL pandemic flu strains. Upon pandemic outbreak, the stockpiled universal flu vaccine would be administered immediately to the population while the pandemic strain is characterized and a conventional pandemic-specific vaccine is manufactured (takes up to 6 months). As indicated by multiple pre-clinical studies and human trials, priming with BiondVax’s universal flu vaccine would ensure that more people are protected against pandemic illness.Dr Ron Babecoff, BiondVax’s CEO adds, “Priming with a universal flu vaccine is the only approach that enables pandemic preparedness ahead of flu outbreak, whatever the emerging strain, and at the same time, enables pandemic vaccine dose sparing and cross strain activity without resorting to adjuvant.”

The eminent business executive and philanthropist Jack Rosen joins the Board of Directors at BiondVax

BiondVax’s shareholders approve appointment of Jack Rosen to the Board of DirectorsNes Ziona, Israel – July 17 th 2013 – BiondVax announced today that Jack Rosen, current President of the American Jewish Congress, Chairman of the American Council for World Jewry, Inc., and founder and Chief Executive Officer of the successful New York real estate firm, Rosen Partners LLC, has joined BiondVax’s Board of Directors. Since founding Rosen Partners LLC almost 30 years ago, Mr Rosen has grown his company to become a leader in creating residential, commercial and hotel developments worldwide. In addition, Mr. Rosen currently serves as a Board Director at Fusion Telecommunications International, Inc., New York, NY. His wide array of business interests includes ventures operating throughout the United States, Europe and Asia in healthcare, cosmetics, telecommunications and security. Notably, a longtime advisor to US presidents from both parties, Mr Rosen has received various appointments including membership of the NASA Advisory Council.BiondVax’s CEO, Dr Ron Babecoff, comments “Mr Rosen brings to the Board his many years of global business experience and entrepreneurship. BiondVax's universal influenza vaccine represents a new paradigm for influenza pandemic preparedness AHEAD of the next pandemic. I strongly believe that together with Jack Rosen we can revolutionize protection against influenza worldwide".

BiondVax's universal influenza vaccine M-001 significantly enhances the efficacy of the human pandemic H5N1 bird flu vaccine.

Administration of M-001 before H5N1 avian influenza vaccine significantly increased immune responses to the pandemic vaccine. Utilization of BiondVax's M-001 would allow one instead of two H5N1 vaccine doses to be administered. Immunization with M-001 would be performed even before H5N1 bird influenza vaccine reaches the market and would improve public preparedness.Nes Ziona, Israel – 10th December 2012 – BiondVax Pharmaceuticals Ltd. (TASE: BNDX) today announced positive results from repeated pre-clinical studies in which administration of BiondVax’s universal influenza vaccine M-001 before H5N1 pandemic vaccine significantly increased levels of antibodies directed against H5N1 bird flu hemagglutinin protein, the accepted measure of pandemic vaccine activity. Indeed, priming with M-001 resulted in more animals exhibiting anti-H5N1 antibody levels considered protective. The significant enhancement of immune responses afforded by priming with M-001 vaccine before H5N1 pandemic vaccine indicates that only one instead of two H5N1 pandemic vaccine doses would need to be given to each person. BiondVax will present the data from these studies at the WHO conference in Hong Kong in January 2013.Human infection with H5N1 flu viruses is often deadly and therefore governments worldwide are preparing for the likely event of an H5N1 pandemic. Currently all influenza vaccines are strain-specific, meaning that manufacturers can begin preparing a pandemic-specific vaccine only after the outbreak of a pandemic. About 6 months could pass between pandemic alert and pandemic vaccines reaching the market. The Company estimates that administration of M-001 during this time period will increase ultimately the proportion of people responding to the pandemic strain-specific vaccine (enhance immunity). In addition, M-001 priming will enable many more people to receive the pandemic strain-specific vaccine (extend coverage), as only one instead of two pandemic vaccine doses will be required per person. In this way, when given as a pre-pandemic primer, M-001 is overcoming the typically limited immunogenicity and restricted availability of pandemic strain-specific flu vaccines.The CSO of BiondVax, Dr Tamar Ben-Yedidia comments, “These new pandemic H5N1 data are extremely encouraging and confirm earlier results in human clinical trials concerning pandemic H1N1 swine flu. We already demonstrated that administration of M-001 to elderly persons (aged 65+ years) before a seasonal flu vaccine containing the pandemic H1N1 swine influenza strain results in 20% more responders.”BiondVax’s CEO, Dr Ron Babecoff adds, “BiondVax has accomplished another milestone, pre-clinical proof-of-principle for M-001 serving as a pre-pandemic primer. This achievement, along with BiondVax’s success in passing a QP GMP audit, paves the way for multinational human clinical studies examining M-001 priming of bird flu vaccines.Recently, BiondVax launched a public offering of options (series 3), for which the exercise price until the end of December is 0.8 NIS and 1.8 NIS thereafter.