Biondvax announces fourth quarter and full year 2017 financial results and update electricity voltage in germany

• Pivotal clinical efficacy Phase 3 trial: The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) allowed BiondVax to proceed with the pivotal Phase 3 clinical trial plan for M-001, BiondVax’s universal flu vaccine candidate. The CHMP wrote that a successful pivotal efficacy trial could suffice for approval of the vaccine. BiondVax signed a Master Service Agreement with a contract research organization (CRO) in March, 2018, and the Phase 3 trial is planned to begin later this year, prior to the 2018/19 Northern Hemisphere flu season. 9,630 participants aged 50 years and over will be enrolled across four to six countries in eastern Europe. The pivotal trial is expected to follow participants for up to two flu seasons.

• Mid-size commercial manufacturing facility: The Israeli Ministry of Economy granted BiondVax 20% of a NIS 20 million budget towards construction. The company secured a lease for an entire floor (approximately 20,000 square feet or 1850m 2) in the Jerusalem Bio Park, a biotech hub on the Hadassah Ein Kerem campus, and construction began in January 2018. BiondVax intends to produce a batch in the new facility for the upcoming Phase 3 clinical trial‘s second participant group.

• NIH-sponsored Phase 2 clinical trial: Earlier this month (April, 2018), the first participant was enrolled in the United States in a Phase 2 clinical trial of the BiondVax’s universal flu vaccine candidate, M-001. The trial is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Conducted under an FDA Investigational New Drug (IND), the trial marks M-001’s clinical debut in the United States.

• EU-sponsored Phase 2b clinical trial: M-001 successfully met the UNISEC consortium’s Phase 2b clinical trial primary endpoints. The universal flu vaccine candidate showed statistically significant elevated T-cell immune responses, a good safety profile and was well-tolerated.

BiondVax (Nasdaq: BVXV) is an advanced clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. Please visit

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. 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 Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2017 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, , and in the Company’s periodic filings with the SEC and the Tel-Aviv Stock Exchange.