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BiondVax Announces Rights Offering in Support of Ongoing Pivotal, Clinical Efficacy Phase 3 Trial of the M-001 Universal Flu Vaccine and Scale Up of Manufacturing Process

JERUSALEM, Israel, June 10, 2019 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced a rights offering to holders of the Company's American Depositary Shares ("ADSs").

BiondVax Pharmaceuticals Logo (PRNewsfoto/Biondvax Pharmaceuticals Ltd)

Proceeds from the rights offering will be used to fund operations including completion of the ongoing pivotal, clinical efficacy Phase 3 trial of BiondVax's M-001 universal flu vaccine candidate, and scale up of the M-001 production process in BiondVax's newly constructed mid-size manufacturing facility. The Company anticipates results of the Phase 3 trial will be announced by the end of 2020.

ADS holders shall receive 0.537823255 ADS rights for each ADS owned of record at 5:00 p.m., New York City time, on June 9, 2019 (which effectively is all settled positions as of close of business on Friday June 7, 2019). One ADS right entitles an ADS holder to subscribe for and purchase one new ADS. The rights offering will begin on June 10, 2019 and end on July 12, 2019 at 5:00p.m., New York City time.

ADS holders who are interested in exercising their rights in this rights offering are encouraged to contact their bank or broker for further information. Alternatively, they may contact MacKenzie Partners, Inc., the information agent, at +1-(212)-929-5500 or toll free at +1-800-322-2885, or by email at rightsoffer@mackenziepartners.com. ADS holders may also direct questions to BiondVax's lawyer Mr. Mark Hamilton at mhamilton@pearlcohen.com or by phone at +972-(0)3-303-9063 at Pearl Cohen Zedek Latzer Baratz in Tel Aviv, Israel.

About BiondVax

BiondVax (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 6 completed Phase 1/2 and Phase 2 clinical trials, covering 698 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. Please visit www.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, the prosecution and outcome of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of the new manufacturing facility; 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 United States Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources 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, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the Company's periodic filings with the SEC. We undertake no obligation to revise or update any forward-looking statement for any reason.

Contact Details

Joshua E. Phillipson
+972-8-930-2529
j.phillipson@biondvax.com 

 

Cision

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