BiondVax Announces Notice of Annual General Meeting of Shareholders and Provides a Clinical Trial Update
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) announced its Annual General Meeting on September 2, 2020, in Tel Aviv, Israel. Shareholders can view the Proxy Statement on the SEC website. The company is also set to release results from its pivotal Phase 3 clinical trial for the M-001 universal flu vaccine candidate between late September and October 2020, though delays are possible. BiondVax's vaccine aims for multi-strain protection against influenza and has completed seven trials showing it is safe and immunogenic.
- BiondVax's M-001 vaccine has completed seven trials with 818 participants, demonstrating safety and immunogenicity.
- The upcoming results from the Phase 3 trial may offer significant insights into the vaccine's effectiveness.
- Potential delays in announcing Phase 3 trial results.
- Risks associated with COVID-19 may impact the clinical trial timeline.
JERUSALEM, Aug. 13, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the Phase 3 clinical trial M–001 universal influenza vaccine candidate, today announced that the Annual General Meeting of Shareholders of the Company will be held on September 2, 2020 in Tel Aviv, Israel. Details, including a link to the Proxy Statement and voting card, are available on the SEC website at https://www.sec.gov/Archives/edgar/data/1611747/000121390020020357/ea125062-6k_biondvaxpharma.htm. Shareholders are invited to contact their broker for voting procedures. Note that votes must be received prior to the deadline noted on the proxy.
Clinical trial update: BiondVax currently anticipates announcing results from the pivotal Phase 3 clinical trial in late September to the end of October this year based on the schedule of current operational activities. However, there are no assurances that this timetable will be met in the event that we encounter any delays.
About BiondVax
BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please visit www.biondvax.com.
Contact Details
Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements 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, risks relating to the COVID-19 (coronavirus) pandemic, including a risk of delay in the availability of the top line results from our pivotal clinical efficacy Phase 3 trial for M-001, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional 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, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
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SOURCE BiondVax Pharmaceuticals Ltd.
FAQ
What is the purpose of BiondVax's Phase 3 clinical trial for M-001?
When will BiondVax announce the results of its Phase 3 clinical trial?
What challenges does BiondVax face regarding its vaccine trials?
Where can shareholders find details about the Annual General Meeting?
What safety data is available for BiondVax's M-001 vaccine?
