BiondVax Announces First Quarter 2016 Financial Results and Update

Ness Ziona, Israel, May 31, 2016 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases today announced its first quarter 2016 financial results ended March 31, 2016 and provided a business update. The Company’s leading product, M-001, is a universal flu vaccine.First Quarter 2016 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to US$ is provided using the exchange rate of 3.766 as at March 31, 2016.

• First quarter operating expenses were NIS 2.83 million ($753,000) compared with NIS 1.82 million ($483,000) in the first quarter of last year;
• First quarter R&D expenses, net of participations, amounted to NIS 2.06 million ($548,000) compared with NIS 1.17 million ($311,000) 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 33.88 million ($8.99m) compared with NIS 37.53 million ($9.96m) as of December 31, 2015;

Recent Corporate Update

• On March 28, 2016 BiondVax announced that its phase 2b clinical trial in Europe completed enrollment of 224 participants. The trial is being conducted in collaboration with the EU-sponsored UNISEC consortium. Results are expected towards the end of the year or early 2017;
• On February 18, 2016 the National Authority for Technological Innovation (NATI), formerly known as the Office of the Chief Scientist, agreed to partly fund an additional project towards the ongoing development of the Company's Universal Flu Vaccine;
• On January 27, 2016 BiondVax broadened its global IP portfolio with a new US patent grant. The patent, entitled "Multimeric Multi-Epitope Polypeptides in Improved Seasonal and Pandemic Influenza Vaccines" completed examination and is allowed for issuance as a patent. This builds on the three patent approvals received in Korea, United States and Israel at the end of 2015;
• Zacks Investment launched equity research coverage on BiondVax.

Dr. Ron Babecoff, CEO of BiondVax commented: “In the first quarter we continued to make solid progress in our universal flu vaccine development program. I am pleased with our progress, and we remain on target to achieve our goals.”About BiondVaxBiondVax 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 DetailsBiondVaxJoshua 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, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resources and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports and other documents 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 ** 

Inthousands, except per share data								Convenience translation (**)
		December 31,		March 31,				March 31,
		2015		2015		2016		2016
		Audited		Unaudited				Unaudited
		N I S						U.S. dollars
CURRENT ASSETS:
Cash and cash equivalents		33,470		7,397		29,817			7,917
Marketable securities		2,016		2,016		2,016			535
Other receivables		1,442		1,005		2,282			606
		36,928		10,418		34,115			9,058
LONG_TERM ASSETS:
Marketable securities		2,048		2,049		2,049			544
Property, plant and equipment		2,044		2,480		1,903			505
Other long term assets		287		1,423		290			77
		4,379		5,952		4,242			1,126
		41,307		16,370		38,357			10,184
CURRENT LIABILITIES:
Trade payables		931		774		836			222
Other payables		768		860		735			195
		1,699		1,634		1,571			417
LONG_TERM LIABILITIES:
Options		5,994		-		4,540			1,205
Severance pay liability, net		69		64		71			19
		6,063		64		4,611			1,224
SHAREHOLDERS' EQUITY (DEFICIT):
Ordinaryshares of NIS 0.0000001 par value:
Authorized: 391,000,000 shares as ofMarch 31, 2016, 2015 (unaudited) and December 31, 2015; Issued andOutstanding: 135,097,367,   54,297,367 and 135,097,367 sharesrespectively		*)-		*)-		*)-			*)-
Share premium		110,679		83,467		111,083			29,496
Options		2,536		2,536		2,536			673
Other comprehensive income		12		16		14			4
Accumulated deficit		(79,682)		(71,347)		(81,458)			(21,630)
		33,545		14,672		32,175			8,543
		41,307		16,370		38,357			10,184

BiondVax to Present Tomorrow at Joseph Gunner Pioneers 2016 Conference

Ness Ziona, Israel – May 4, 2016 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that BiondVax’s CEO, Dr. Ron Babecoff, will be attending the Joseph Gunnar Pioneers 2016 conference in New York City.On Thursday, May 5, Dr. Babecoff will be presenting at 10:30am at Pioneers 2016, a conference presented by Joseph Gunner & Co, taking place at the New York Palace Hotel.The BiondVax presentation that Dr. Babecoff will be using is downloadable from BiondVax’s website: http://www.biondvax.com/investor-presentation. Those wishing to meet one-on-one with Dr. Babecoff are invited to contact BiondVax.About BiondVax Pharmaceuticals LtdBiondVax 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.For further information, please contact:

Company ContactJoshua PhillipsonBusiness Development Manager+972-8-930-2529 x5105j.phillipson@biondvax.com

BiondVax Announces Fourth Quarter and Full Year 2015 Financial Results and Update

Ness Ziona, Israel,  April 27, 2016 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced its fourth quarter and full year financial results ended December 31, 2015 and provided a business update.The Company also filed its annual report on form 20F with the US Securities and Exchange Commision. This can be downloaded from BiondVax’s website. A hard copy will be made available upon request.Fourth Quarter 2015 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to US$ is provided using the exchange rate of 3.902 as at December 31, 2015.

• Fourth quarter operating expenses were NIS 4.06m ($1.04m) compared with NIS 1.98m last year;
• Fourth quarter R&D expenses amounted to NIS 2.87m ($737,000) compared with NIS 1.11m last year;

Full Year 2015 Financial Summary

• Total operating expenses were NIS 11.30m ($2.90m) compared with NIS 8.14m in 2014;
• R&D expenses amounted to NIS 7.91m ($2.03m) compared with NIS 5.49m in 2014; the increase was primarily due to an increase in subcontractor expenses, in preparation for the European cGMP audit of BiondVax’s production facility;
• Cash, cash equivalents and short and long-term marketable securities at the end of the quarter were NIS 37.53m ($9.62m) compared with NIS 13.68m as of December 31, 2014; the growth was primarily due to the US public offering completed during May 2015;

Recent Corporate Update

• On October 1, 2015, BiondVax designated Cytovance Biologics Inc., a Contract Manufacturing Organization (CMO), for the production of clinical batches of BiondVax’s Universal Flu Vaccine (M-001) in order to be ready for phase 3 clinical trials in the 2017/2018 timeframe;
• At the end of September 2015, a phase 2b clinical trial was initiated in Europe in collaboration with the UNISEC European Consortium. Among other goals the study aims to show the dose sparing potential of M-001 when given prior to avian vaccine, a highly desirable feature in a pandemic scenario, when existing stockpiles of vaccine may be insufficient. On March 28, 2016, the enrollment of 224 participants was completed. Results from this trial are expected towards the end of 2016 or early 2017.
• On September 2, 2015, BiondVax announced a collabotaration with National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), to commence a phase a 2b trial in the United States. This trial is which is expected to take place in 2016 and include 180 participants;
• Since November 2015, the Company achieved three patent approvals: in Korea, United States and Israel;
• In February 2016, the National Authority for Technological Innovation (NATI), formerly known as the Office of the Chief Scientist, agreed to partly fund an additional project towards the ongoing development of the Company's Universal Flu Vaccine;
• The company and its management continue to actively engage in an investor and public relations program including monthly non-deal roadshows and investor conference appearences with US and international investors;
• Three articles about BiondVax were published in mass media including the Huffington Post and Living Well magazine. Additionally, Zacks Research launched research coverage on BiondVax’s stock with a Buy rating. Furthermore, BiondVax launched a newsletter and blog (blog.biondvax.com) for those interested in the flu and BiondVax;

Dr. Ron Babecoff, CEO of BiondVax commented: “The fourth quarter of 2015 and beyond remain very active for BiondVax. We continue to make progress towards our interim goal of being phase 3 ready in the 2017/2018 timeframe, having recently completed full enrollment in our European phase 2 trial. Following FDA acceptance of our IND application earlier this year for a phase 2 study, we are also excited that the NIAID/NIH agreed to collaborate and fund an upcoming trial in the United States. We are currently working with them closely in order to start this trial later this year.“While the 2015/2016 flu season was a relatively tame one, the current flu vaccine effectiveness has not changed from the typical range, averaging about 40% over the last decade. We are encouraged because as time passes and we look back on our progress over the past year, we see that we are closer to our goal,” concluded Dr. Babecoff. 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

BiondVaxJoshua PhillipsonBusiness Development Manager+972 8 930 2529j.phillipson@biondvax.com

BiondVax’s Universal Flu Vaccine Phase 2b Clinical Trial Recruitment Complete

All 224 participants successfully recruited in EU-sponsored trialNESS ZIONA, ISRAEL, March 28, 2016 –BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) announced today that enrolment of 224 participants in a Phase 2b clinical trial of M-001, its universal flu vaccine candidate, is complete. The trial, conducted in collaboration with the EU-sponsored UNISEC consortium, is designed to evaluate the safety and immunogenicity of M-001 when used ahead of an avian influenza vaccine. Among other goals the study aims to show the dose sparing potential of M-001 when given prior to avian vaccine, a highly desirable feature in a pandemic scenario, when existing stockpiles of vaccine may be insufficient.Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientist, explained, “This important milestone, along with the NIH-sponsored Phase 2 trial in the USA, keeps BiondVax on track to be Phase 3 ready by 2017/18. 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.”Prof. Dr. Eelko Hak, UNISEC clinical trial program work package leader, commented, “This important clinical trial is a major contribution to the mission of the European UNISEC consortium to learn more about the potential of these promising broadly reactive new vaccines.”Results from this trial are expected late 2016 or early 2017.About BiondVax Pharmaceuticals Ltd.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.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 success of the phase 2b clinical trial of the universal vaccine candidate, risks inherent in the development and commercialization of potential candidate products, dependence upon collaborators and adequacy of capital resources for product development and commercialization. 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.For further information, please contact:

BiondVaxJoshua PhillipsonBusiness Development Manager+972-8-930-2529 x5105j.phillipson@biondvax.com

BiondVax CEO to Present at Roth Conference

Ness Ziona, Israel – March 7, 2016 –BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that BiondVax’s CEO, Dr. Ron Babecoff, will present at the Annual Roth Conference to be held March 13 - 16, 2016 at the Ritz Carlton Hotel in Dana Point, California.Dr. Babecoff will discuss recent updates and share BiondVax's corporate presentation on Wednesday, March 16, 2016 at 9am Pacific Time.  The presentation will be available for download from the investor relations section of BiondVax’s website. There will also be an opportunity for investors to meet one-on-one with Dr. Babecoff at the conference on Tuesday, March 15.Management will also be meeting with analysts and investors in Boca Raton, Florida on Monday, March 14 and in New York City on Thursday, March 17.Those wishing to meet with Dr. Babecoff are invited contact the Investor Relations team at BiondVax.About BiondVax Pharmaceuticals LtdBiondVax 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.For further information, please contact:Company ContactJoshua Phillipson, Business Development  Manager+972-8-930-2529 x5105j.phillipson@biondvax.com

###

BiondVax Receives Additional Grant Approval

Israel’s National Authority for Technological Innovation to fund 40% of additional $0.9M budget towards Universal Flu Vaccine

NESS ZIONA, ISRAEL, February 18, 2016 -BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that the National Authority for Technological Innovation (NATI), formerly known as the Office of the Chief Scientist, agreed to fund up to 40% of a NIS 3.6 million (US$920,000) project towards ongoing development of the Company’s Universal Flu Vaccine.Currently undergoing late Phase 2 clinical trials, BiondVax’s vaccine has shown significantly increased effectiveness against multiple seasonal and pandemic flu strains when compared to today’s existing flu vaccines. With today’s grant approval, NATI has, since 2006, granted $5.5M to BiondVax. The non-dilutive grants are repayable from royalties generated from future sales of BiondVax’s vaccine, once available on the market.Ron Babecoff, CEO of BiondVax commented, “The continued support of our program by NATI represents a strong and ongoing vote of confidence in BiondVax and what we are aiming to achieve. They were impressed with the positive results from our five completed clinical trials to-date, and strongly support our current and planned activities.”About BiondVax Pharmaceuticals Ltd.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.

BiondVax's Universal Flu Vaccine Recieves Additional US Patent

Broadens BiondVax’s global intellectual property portfolio

NESS ZIONA, ISRAEL, January 27, 2016 - 

BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) developer of a Universal Flu Vaccine currently undergoing late-stage 2 clinical trials, announced today that its patent application in the United States titled “Multimeric Multi-Epitope Polypeptides in Improved Seasonal and Pandemic Influenza Vaccines” has completed examination and is allowed for issuance as a patent.

The invention covers the use of BiondVax’s universal flu vaccine as a prime-boost to the current commercially available flu vaccine. Results from BiondVax’s completed clinical trials have shown significantly increased effectiveness against multiple flu strains.   

Ron Babecoff, CEO of BiondVax commented, “Current flu vaccines are strain specific and are not particularly effective against circulating ‘wild-type’ strains due to mismatches. In fact, last year’s seasonal flu vaccine was only 23% effective¹. Conversely, our vaccine provides long-lasting and higher effectiveness against multiple flu strains.”

Continued Dr. Babecoff, “Our newly approved US patent demonstrates the novel nature of our vaccine technology and strengthens our IP portfolio for many years to come.”

About BiondVax Pharmaceuticals Ltd.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.

¹ http://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm

Patent Approval for BiondVax: BiondVax Receives Approval for a Patent for its Universal Flu Vaccine in Israel

The patent approval extends and strengthens BiondVax's international intellectual property portfolio BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) which is developing the Universal Flu Vaccine, announced today that its patent application in Israel on the Multimeric Multi-Epitope Polypeptide Influenza Vaccines (a universal flu vaccine), was accepted.This patent application belongs to the main family of patents of BiondVax for vaccination against influenza in humans, and specifically vaccines that confer long-lasting protection against multiple and differing flu strains. The Israeli Intellectual Property Office accepted BiondVax’s claims for M-001 (BiondVax’s universal flu vaccine) and similar polypeptides.Patent protection has already been granted in a number of other countries, namely the United States, Europe, Japan, Hong Kong, Australia, China, Russia, Mexico and Korea.Ron Babecoff, CEO of BiondVax said “We are very pleased that the Israeli patent authorities accepted the uniqueness of our universal flu vaccine solution, approving this main patent of BiondVax. Our solution is patent protected in many of the countries where we believe our vaccine will provide increased protection to the local population from flu, including multiple European countries, in the United States and in the Far East.”

BiondVax Receives Approval for Patent in Korea for its Universal Flu Vaccine

The patent approval extends and strengthens BiondVax's intellectual property portfolio internationallyBiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) which is developing the Universal Flu Vaccine, announced today that its main patent on the Multimeric Multi-Epitope Polypeptide Influenza Vaccines family, was granted in Korea.This is a family of patents for vaccination against influenza in humans, and specifically vaccines that confer long-lasting protection against multiple and differing flu strains. The Korean Intellectual Property Office accepted BiondVax’s claims for M-001 and similar polypeptides. This patent approval strengthens BiondVax's intellectual property in international markets.Patent protection has already been granted in other countries: the US, Europe, Japan, Hong Kong, Australia, China, Russia and Mexico.Ron Babecoff, CEO of BiondVax said “Asia has been the site of the start of many recent bird-flu pandemics, including H5N1 and H7N9. Our new patent approval in Korea provides us with an opportunity to establish a strategic partnership in this market. This will enable us to offer local health authorities and governments our pandemic preparedness plan, with the establishment of national stockpiles against all types of influenza pandemics.”

BiondVax Announces Third Quarter 2015 Financial Results and Update

Nes Ziona, Israel,  November 9, 2015 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced its financial results for the third quarter of 2015 and provided a business update.Third Quarter 2015 Financial SummaryResults are in New Israel Shekels (NIS) and a  translation to US$ is provided, using the exchange rate of 3.923 as at September 30, 2015.

• Total operating expenses were NIS 2.21m ($563,000) compared with NIS 1.96m in the third quarter of last year;
• R&D expenses amounted to NIS 1.25m ($319,000) compared with NIS 1.40m in the third quarter of last year;
• Cash, cash equivalents and short and long-term marketable securities at the end of the quarter were NIS 40.94m ($10.41m) compared with NIS 13.68m as of December 31, 2014;

 Recent Corporate Update

• On October 1, 2015, BiondVax designated Cytovance Biologics Inc., a Contract Manufacturing Organization (CMO), for the production of clinical batches of BiondVax’s Universal Flu Vaccine (M-001) in order to be ready for phase 3 clinical trials in the 2017/2018 timeframe;
• At the end of September, 2015, a phase 2b clinical trial was initiated in Europe in collaboration with the UNISEC European Consortium. The trial will examine BiondVax’s Universal Flu Vaccine (M-001) as a primer for an Avian (H5N1) flu pandemic outbreak;
• On September 2, 2015, BiondVax announced its intention to launch a phase 2 trial in the United States in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), which is expected to take place in 2016;
• Results are expected from both these phase 2b trials in the second half of 2016;
• In August 2015, BiondVax reported that sera samples from elderly participants in the BVX-005 trial in 2012, contained significantly more protective antibodies against the current epidemic flu strain, H3N2, which did not exist in 2012;
• The company and its management are actively engaging an investor relations program including monthly non-deal roadshows and investor conference appearances with US and international investors;

 Dr. Ron Babecoff, CEO of BiondVax Commented: “The third quarter of 2015 was a very eventful one for BiondVax, and we made significant progress towards our interim goal of reaching phase 3 trials in the 2017/2018 timeframe. We are very excited to be working together with a European consortium in a phase 2b trial in Europe, where in the past few weeks we admitted and successfully vaccinated the first patients with our Universal Flu Vaccine. Following FDA acceptance of our IND application earlier this year, we are also excited that the NIAID/NIH agreed to collaborate and fund an upcoming trial in the United States, which we look forward to starting in early 2016.”Continued Mr. Babecoff, “In the next few weeks, I plan to meet with investors and analysts in New York, Boston, Chicago, Toronto and Los Angeles in order to raise our profile amongst the investor community. This is a particularly timely visit, as the 2015/2016 flu season is now unfortunately well underway in North America.”“As is typical every year, millions of people will contract flu – including many who have taken the currently available trivalent vaccine. Hence, at this time of year, we see the increased importance in our mission and what we are working so hard for. We are encouraged because we are nearing the finishing line when we expect our vaccine will become commercially available for people who need it in the US and worldwide,” concluded Dr. Babecoff.The financial tables can be found in the financial section of the investor relations website.

BiondVax Announces Upcoming Investor Events: Presenting at the LD Micro Conference in Los Angeles Following Investor non-deal Roadshow

Ness Ziona, Israel – November 4, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that the Company’s CEO, Dr. Ron Babecoff, will be meeting with US and Canadian investors on the week of November 9-13, 2015. Over the course of that week, Dr. Babecoff will be visiting New York, Boston, Chicago and Toronto.On December 2-3, 2015, Dr. Babecoff will be attending and presenting at the LD Micro Conference taking place at the Luxe Sunset Hotel in Los Angeles. This will provide investors located on the West Coast an opportunity to meet with management. Dr. Babecoff’s presentation is scheduled for Thursday, December 3, 2015 at 8:30am Pacific Time.On both the roadshow and the LD Micro conference there will be an opportunity for investors to meet one-on-one with Dr. Babecoff. Investors interested in meeting with management should contact the Investor Relations team at BiondVax.The corporate presentation which will be used on the roadshow and at the conference is available for download from the investor relations section of BiondVax’s website at www.biondvax.com.

BiondVax Announces Successful Recruitment of the First Participants in a Phase IIb Clinical Trial in Europe with its Universal Flu Vaccine: Multimeric M-001

Trial in line with BiondVax clinical plan for Phase 3 trial in 2017/18 Nes Ziona, Israel – October 21, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that it has successfully recruited the first two participants in this trial, BVX-007. The trial is being conducted in Budapest, Hungary at the St Istvan and St Lazslo Hospital, as well as additional satellite sites in Hungary, together with the partners from the UNISEC European Consortium.This phase IIb trial will include 222 adults. It is designed to evaluate the safety and immunogenicity of the Universal influenza vaccine when used ahead of an avian influenza vaccine (provided by FluArt, Hungary). The avian influenza vaccine will be given only once, at a sub-optimal dose, aiming to show the dose sparing potential of the universal vaccine when given prior to the avian vaccine, a highly desirable feature in a pandemic scenario, where existing stockpiles of vaccine may not be sufficient.Eligibility criteria for the trial include participants aged 18-60 years in good health that do not suffer from immune deficiencies and were not vaccinated against Influenza in the 6 months prior to the trial. Results are expected in the second half of 2016.Tamar Ben-Yedidia, CSO of BiondVax commented, “The trial will provide insight into the ability of BiondVax’s universal vaccine to stimulate broad immunity to influenza viruses including the highly pathogenic H5N1 bird flu virus. It is clear that a universal vaccine for influenza, that will also cover this aggressive and particularly dangerous strain is greatly needed.”

UNISEC Press Release: UNISEC consortium including BiondVax started a clinical trial for a Universal Influenza Vaccine

The UNISEC consortium has started a clinical trial study for one of its Universal Influenza Vaccines16 October 2016, RUG Groningen, The Netherlands: The European consortium, UNISEC, has started the next phase in its search for an Universal Influenza Vaccine. Founded and coordinated from Groningen, The Netherlands, it  is hereby one of the first parties, and probably the most advanced one on the globe, to find an answer against the dangerous threat to human population by a serious outbreak of pandemic influenza.Influenza is a serious and expensive threat to the human population. The current strategy to prevent influenza-associated health risks is an annual vaccination of risk populations. Yet, current vaccines need to be adjusted each year and even then it is not guaranteed that they will match the circulating virus. Unfortunately, current vaccines are not effective against newly emerging influenza virus strains as demonstrated during the Mexican Flu Pandemic in 2009. Universal influenza vaccines, effective against a broad spectrum of influenza virus strains, are thus urgently needed. Such vaccines are based on conserved constituents of the virus and should raise humoral as well as cellular immunity that protect against influenza disease.UNISEC* is a European consortium www.unisecconsortium.eu consisting of 3 academic partners, 5 National Health Institutes and 3 companies, all with leading expertise in influenza vaccine research and development. In addition, UNISEC has access to a network of clinical trial centers. UNISEC develops and evaluates a number of vaccine concepts in order to identify, develop and clinically test the most promising leads for a universal influenza vaccine, which must demonstrate adequate protection, and be technically suitable for development to a marketable product.UNISEC is launching its first clinical study in October 2015. This phase IIb trial is a multicenter, randomized, double-blind, active-controlled study conducted under the auspices of the  UNISEC consortium. The aim of the trial is to assess the safety and immunogenicity of the universal influenza vaccine candidate Multimeric-001 (developed by BiondVax Pharmaceuticals ltd (Israel).  The trial will include 222 healthy adults aged 18-60 years, a group representing the target population for receiving vaccines when a pandemic outbreak occurs.The trial is being conducted at the St. Istvan and St. Laszlo Hospital in Budapest, Hungary as well as additional satellite sites in the country. Recruitment of participants for the trial has started, and results are expected in the second half of 2016.This clinical study will examine the benefits of priming with BiondVax's universal flu vaccine prior to immunization with a bird flu prototype influenza vaccine (FluArt, Hungary). This new approach will enable public health authorities to be proactive and prepared in advance of any flu pandemic outbreak, by building a national stockpile of the universal flu vaccine. Such a stockpile allows vaccinations to start immediately upon any pandemic outbreak, compared to the current-day situation, in which there will be a delay of approximately 6 months due to the manufacture of the pandemic strain-specific vaccine.The current trial is led by Prof. Dr. Eelko Hak, Trial Coordinator on behalf of the UNISEC consortium from the University of Groningen, The Netherlands and Dr. Zsofia Meszner, General Director of the National Institute of Child Health from St. Istvan and St. Laszlo Hospital (Hungary) as Principle Investigator and Dr. Dora Mathiazs the Strategic Director of the hospital. BiondVax, as well as other partners of the UNISEC consortium including the Robert Koch Institute in Berlin and the National Center of Epidemiology in Budapest, will be involved in the immunogenicity testing of the cellular and humoral responses.Additional phase IIb clinical study with another universal influenza vaccine candidate, developed by the UK-based company SEEK (PepTcell Ltd), also member of the UNISEC consortium, is scheduled for 2016. For further information please contact:Prof. Erik Frijling (coordinator UNISEC consortium)Tel: +31 (0)503633285Fax: +31 (0)503632500E-mail: h.w.frijlink@rug.nl Dr. Limor Chen (BiondVax Pharmaceuticals ltd)Tel: +972 (0)89302529E-Mail: Limor.C@Biondvax.com Prof. John Oxford (dissemination)Tel : +44 (0)7831 165 847Email : j.oxford@qmul.ac.uk www.unisecconsortium.euThis project has received funding from the European Union’s Seventh Framework Program for research, technological development and demonstration under grant agreement no. 602012. *Universal Influenza Vaccine Consortium UNISECUniversity of Groningen RUG The Netherlands:Academic Medical Center Groningen UMCG The Netherlands.SEEK (PepTcell Ltd) United KingdomBiondVax Pharmaceuticals Ltd IsraelhVIVO Services Ltd (formerly Retroscreen Virology Ltd) United KingdomNational Institute for Biological Standards and Control NIBSC United KingdomStatens Serum Institute SSI DenmarkNational Center of Epidemiology NCE HungaryThe Norwegian Institute of Public Health NIPH NorwayRobert Koch Institute RKI GermanyUGOT, Sweden    

BiondVax to Present on October 8 at the Aegis Growth Conference

Ness Ziona, Israel – October 6, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that BiondVax’s CEO, Dr. Ron Babecoff, will participate in the Aegis Growth Conference, taking place at The Encore at Wynn Hotel in Las Vegas, NV from October 7-9, 2015.BiondVax’s CEO, Dr. Ron Babecoff, is scheduled to present on Thursday, October 8, 2015 at 2pm Pacific Time.  The corporate presentation which Dr. Babecoff will present at the conference is available for download from the investor relations section of BiondVax’s website.At the conference there will be an opportunity for investors to meet one-on-one with Dr. Ron Babecoff. Investors interested in meeting with management should contact the Investor Relations team at BiondVax.

BiondVax Establishes Capability for the Manufacture of Clinical Grade Universal Flu Vaccine for Phase III Clinical Trials

Appoints Cytovance Biologics for the production of clinical batches of M-001

Nes Ziona, Israel – October 1, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that it has entered into a Development and Manufacturing Agreement for the production of clinical batches of its universal flu vaccine, M-001, with Cytovance Biologics Inc., a Contract Manufacturing Organization (CMO), based in Oklahoma, USA.Under the terms of the Agreement, Cytovance Biologics will scale up and optimize the small-scale cGMP manufacturing process of M-001, previously developed by BiondVax and audited by a European Qualifying Person (QP). The technology transfer will start immediately, with the initial clinical batches expected to be manufactured by the fourth quarter of 2016. The clinical grade M-001 batch is intended to be used by BiondVax for its phase III trial, planned for the 2017/18 timeframe, which is a critical step towards commercialization of M-001 in the US, Europe and the rest of the world.Shimon Hassin, COO of BiondVax commented: “This new strategic relationship with Cytovance Biologics, a U.S. leader in contract manufacturing with a significant track record in the production of clinical materials, is a key development for BiondVax. Their expertise will play a major role in accelerating the clinical development and large scale manufacture of our universal flu vaccine, M-001, that will hopefully improve the lives of the millions of individuals who suffer, and some of which die, every year from Influenza and its complications.”

BiondVax Initiates a Phase IIb Clinical Trial in Europe for its Universal Flu Vaccine for Pandemic Outbreak

The regulatory approval was received for the trial enabling BiondVax to examine its vaccine as a primer for an Avian (H5N1) flu pandemic outbreak in collaboration with the UNISEC European Consortium Nes Ziona, Israel – September 30, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) announced today that it received regulatory clearance from the Hungarian Regulatory Authority (National Institute of Pharmacology and Nutrition, OGYEI) and the Central Ethics Committee in Budapest to initiate a Phase IIb clinical trial. The initiation meeting was scheduled for today, September 30, 2015,  together with the partners from the UNISEC European Consortium.This phase IIb trial is a multicenter, randomized, double-blind, active-controlled trial. It is being conducted under the auspicies of an EU-funded UNISEC project,  assessing the immunogenicity and safety of BiondVax’s universal influenza vaccine (Multimeric-001), followed by an administration of the H5N1 influenza vaccine. The trial will include 222 healthy adults aged 18-60 years, a group representing the target population for receiving vaccines when a pandemic outbreak occurs.The trial is primarily being conducted at the St. Istvan and St. Laszlo Hospital in Budapest, Hungary as well as additional satellite sites in the country. Recruitment of participants for the trial has started, and results are expected in the second half of 2016.Utilizing the clinical trial network and specialised laboritories of UNISEC’s consortium, BiondVax is initiating this clinical study to examine the benefits of priming with BiondVax's universal flu vaccine. This new approach enables public health authorities to be proactive and prepared in advance of any flu pandemic outbreak, by building a national stockpile of the universal flu vaccine. This allows vaccinations to start immediately upon any pandemic outbreak, compared to the current-day situation, whereby there is a delay of approximately 6 months due to the manufacture of the pandemic strain specific vaccine. In addition, BiondVax has demonstrated in previous trials that using its vaccine as a primer provides  additional protection against flu strains in the current TIV (current seasonal flu vaccine) as well as drifted strains not included in this vaccine.The current trial is led by Prof. Dr. Eelko Hak, Trial Coordinator on behalf of the UNISEC consortium from  the University of Groningen,  Netherlands and Dr. Zsofia Meszner, General Director of the National Institute of Child Health from St. Istvan and St. Laszlo Hospital, as  Principle Investigator and Dr. Dora Mathiazs the Strategic Director of the hospital. BiondVax, as well as other partners of the UNISEC consortium including RKI, Berlin and NCE, Budapest,  will be involved in the immunogenicity testing of the cellular and humoral responses.To date, BiondVax has successfully completed five clinical trials (two phase I/II and three phase II), conducted with 479 participants for its Universal Flu Vaccine. The vaccine was found safe, effective, and capable of triggering both cellular and humoral responses of the human immune system, against different strains of the influenza virus including existing and future strains. Tamar Ben-Yedidia, CSO of BiondVax commented, “I am pleased to see our clinical program taking a significant step forward. This marks our progression to the international phase of our clinical development program, with trials now starting in Europe and soon in the United States in collaboration with the NIAID/NIH as we recently announced.”

BiondVax to Present on September 10 at the Rodman & Renshaw Global Investment Conference

Ness Ziona, Israel – September 8, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced today that the Company’s CEO, Dr. Ron Babecoff, will participate in the Rodman & Renshaw 17th Annual Global Investment Conference, taking place at the St. Regis hotel in New York from September 8-10, 2015.BiondVax CEO, Dr. Ron Babecoff, is scheduled to present on Thursday, September 10, 2015 at 10:25am Eastern Time.  The corporate presentation which Dr. Babecoff will present at the conference is available for download from the investor relations section of BiondVax’s website.At the conference there will be an opportunity for investors to meet one-on-one with Dr. Ron Babecoff. In addition, Dr. Babecoff will be meeting investors and analysts throughout the week on a non-deal roadshow in both Boston and New York. Investors interested in meeting with management should contact the Investor Relations team at BiondVax. 

BiondVax Announces Intent to Launch a Phase 2 Trial in the United States in Collaboration with the U.S. National Institutes of Health

Ness Ziona, Israel – September 2, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced the intent of the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) within the Department of Health and Human Services (HHS), to launch a new phase 2 trial to be held in the United States in the 2015-16 timeframe. The trial will examine the use of BiondVax’s universal flu vaccine candidate, Multimeric-001 (M-001), as a primer vaccine, which would be administered several weeks before a pandemic vaccine. The trial will be a collaboration between BiondVax and the National Institute of Allergy and Infectious Diseases.The trial will assess the ability of M-001 in humans to serve as a pandemic primer to the H7N9 avian pandemic vaccine, by enhancing protective immunity to these highly pathogenic avian influenza H7 strains. It will also look to strengthen previous clinical and pre-clinical findings on M-001 priming capacity to other seasonal and pandemic strains.Typically, a strain-specific flu vaccine for a pandemic outbreak takes 4-6 months to manufacture, a period during which the virus can spread rapidly, causing high levels of illness and mortality. Stockpiling of M-001 as a pandemic primer would enable vaccination schedules to start immediately upon any pandemic declaration.BiondVax is currently producing the M-001 vaccine batch for this clinical trial.Ron Babecoff, BiondVax’s President and CEO, commented, “The recognition of the potential of our technology by a foremost public health authority in the United States, is a significant milestone in our clinical development program. This trial will assess our vaccines’ ability to be used as the stockpiled flu vaccine for pandemic protection. The scenario is that immediately following a flu pandemic outbreak of any strain, our vaccine could be used from day zero, saving multiple lives and limiting the wild spread of a flu pandemic. This collaboration with NIAID brings us a significant step closer to our Phase 3 clinical trial.”Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, commented, ”This important trial is examining the use of M-001 in the event of an H7 avian influenza outbreak. It is complementary to a previous clinical trial in the elderly that concluded successfully, showing enhanced immunogenicity against the H1N1 swine pandemic virus in participants that received our M-001 vaccine as primer. This study is also complementary to our upcoming European clinical trial in which the M-001 will serve as a primer to the H5N1 avian pandemic vaccine.”

BiondVax Announces Second Quarter 2015 Financial Results and Update

Nes Ziona, Israel,  August 23, 2015 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced its financial results for the second quarter of 2015 and provided a business update.Second Quarter 2015 Financial SummaryResults are in New Israel Shekels (NIS) and a convenience translation to US$ is provided, using the exchange rate of 3.769 as at June 30, 2015

• Total operating expenses were NIS 3.21m ($852,000) compared with NIS 2.18m in the second quarter of last year;
• R&D expenses amounted to NIS 2.61m ($693,000) compared with NIS 1.61m 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 42.02 m ($11.15m) compared with NIS 13.68m as of December 31, 2014;

 Recent Corporate Update

• In May, Biondvax completed its public offering in the United States and on July 10, BiondVax celebrated this milestone event by ringing the Nasdaq closing bell;
• BiondVax reported the succesful results of its BVX-006 trial for older adults. BiondVax’s universal flu vaccine (M-001) was reported to be safe, well tolerated, providing improved flu immunity by enhancing antibody responses to multiple strains when administered as a primer in a 1 mg dose;
• BiondVax reported that sera samples from elderly participants in the BVX-005 trial in 2012, contained significantly more protective antibodies against the current epidemic flu strain, H3N2, which did not exist back in 2012;
• The main television news show in Israel showcased BiondVax’s impressive results and a subtitled recording is available at http://www.biondvax.com/?p=1300;
• By the end of the year, BiondVax expects to be starting BVX-007 trials in Europe which will be mostly funded by the European consortium UNISEC;

 Dr. Ron Babecoff, CEO of BiondVax Commented: “The second quarter of 2015 was very eventful for BiondVax, culminating in a number of successes. A few weeks following our successful public offering on Nasdaq, we completed and reported successful results for our BVX-006 trial. We showed that our universal flu vaccine enhanced antibody responses to multiple flu strains when administered  as a primer, and was safe and well tolerated. More than that, a few weeks later, we showed that participants who received our vaccine in our 2012 trial, presented higher immunogenicity to the 2014-15 flu season strain - a strain which didn’t exist back then. Both these successful results are additional important data points, validating our work and further demonstrating the universality of our vaccine and its potential for improving global public health. Our work is particularly poignant as the 2015/2016 flu season approaches."“In terms of our efforts to broaden our shareholder base, I will be marketing our story to investors on non-deal roadshows, and presenting at a number of investor conferences in New York, Las Vegas and Los Angeles, in the coming quarter. We see a number of near-term catalysts, such as our EU funded study in Europe, and we are all very much looking forward to the coming few months. We believe our upcoming efforts will further support our concept of the universal flu vaccine,” concluded Dr. Babecoff.Please see our financial information page for the detailed results tables. 

Independent Results Show that BiondVax’s Universal Flu Vaccine Administered in a Trial 3 years ago Improves Immunogenicity against Current Flu H3N2 Epidemic

Ness Ziona, Israel – August 3, 2015 – BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced it received the statistical analysis of results from a study which demonstrates that BiondVax’s universal flu vaccine (M-001), administered in the BVX-005 phase II trial which took place in 2012, provided participants with increased immunogenicity against future strains which did not exist at the time of the study- in particular the current newly emerged H3N2 influenza (flu) strain that caused the epidemic in the United States in 2015.In 2012, 120 elderly participants aged 65 or over, participated in the BVX-005 trial. This trial was concluded successfully, demonstrating induction of both humoral and cellular immune responses to BiondVax’s vaccine and to multiple influenza viruses. In that trial, 90 participants were injected with the M-001 universal flu vaccine a few weeks prior to immunization with TIV (the commercially available seasonal flu vaccine of that time). The remaining group of 30 was a control group which was provided with a placebo followed by the TIV.Three years later, in 2015, BiondVax exposed the blood plasma samples from the BVX-005 participants (taken following the completion of the trial in 2012) to the current influenza flu epidemic H3N2 strain (A/Switzerland/9715293/2013), which in 2012 did not yet exist.BiondVax examined the immunogenicity (HAI) antibodies in each blood plasma sample and found significantly increased level of protective antibodies against the H3N2 strain in the samples taken from participants that received the M-001 vaccine in comparison to the control group. An average of 50% or greater of the participants in the experimental group receiving M-001 showed immunogenicity  against this new strain versus only 10% on average in the control group, a result which has statistically high significance.This concurs with the similar results found in BiondVax's recent BVX-006 phase II trial, showing increased antibody response to the H3N2 epidemic flu strain in those that received BiondVax’s universal vaccine, although it was not included in the commercially available seasonal flu vaccine of the 2014/15 season. Management believe that this data confirms the universal nature of BiondVax's vaccine, protecting against all types of flu strains.Ron Babecoff, BiondVax’s President and CEO, commented, “We are happy that the participants which received our vaccine in the trial three years ago present a higher immunogenicity, even to actual flu strains in circulation now. The independently provided statistical analysis we reported today is very important as it demonstrates that M-001 provides a safety net by broadening the immunogenicity to existing and future flu strains - in this case, against a specific flu strain that back when the trial was conducted, did not yet exist. If our vaccine was approved by the necessary regulatory bodies and available in the market during the last winter, we believe that the recent epidemic could have been prevented. These results are another important data point showing the importance of our work for global public health and in particular for the elderly which are most vulnerable to this dangerous virus.”