BiondVax Pharmaceuticals Ltd. (Nasdaq:BXVX) announced today that the Management Committee of the European Investment Bank (EIB) has agreed to extend the 2017 financing agreement with BiondVax by an additional €4 million. The funds will be used in support of the ongoing pivotal, clinical efficacy, Phase III trial of BiondVax's M-001 universal flu vaccine candidate in Europe.
The original €20 million EIB-BiondVax non-dilutive co-financing agreement was signed in June 2017 to support both construction of BiondVax's new mid-size commercial-scale manufacturing facility in Israel and the pivotal, clinical efficacy, Phase III trial in Europe. The funds, which were advanced over the course of 2018, are structured as a zero-percent fixed interest loan repayable five years after drawdown, with a variable remuneration based on royalties of net sales of M-001 following commercialization.
The additional €4m, 20% of the original loan, will be given on enrollment of the first participant in the clinical trial's second season and with agreed matching funds provided by BiondVax. Other terms in the new agreement including BiondVax's option to repay the loan and repurchase the royalties at any time carry over from the 2017 agreement.
BiondVax is currently conducting a pivotal, clinical efficacy, Phase III trial of M-001. 4,094 participants were recruited prior to the 2018/19 flu season. With the additional funds, the trial's second cohort is expected to increase up to 8,000 participants, bringing the planned total size of the trial to approximately 12,000 participants. The increase in the number of participants is intended to compensate for the relatively mild 2018/19 flu season in Europe. The placebo-controlled trial will assess safety and effectiveness of M-001 alone in reducing flu illness and severity in adults aged 50 years and older. Results are expected by the end of 2020.
BiondVax's CEO Dr. Ron Babecoff said, "I am grateful to the EIB and the people of Europe for their long-term support of BiondVax's efforts to bring our universal flu vaccine candidate to the world. The World Health Organization (WHO) recently stated that global influenza pandemic is one of the top threats to global health. The extension of the EIB agreement attests that we have continued to meet our milestones towards the important goal of developing a vaccine that provides multi-season and multi-strain protection against seasonal and pandemic influenza illness."
Published by Globes, Israel business news - en.globes.co.il - on April 22, 2019
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