BiondVax announces financial plans to support its ongoing NanoAb pipeline development – QNT Press Release

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JERUSALEMIsrael , Sept. 30, 2022 /PRNewswire/ — BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV) (“BiondVax”), a biotechnology company focused on developing, manufacturing, and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, announced the filing yesterday of a Registration Statement (“Form F-1″) with the US Securities and Exchange Commission (” SEC”) for a firm commitment underwritten offering of BiondVax American Depositary Shares (“ADSs”). Once declared effective by the SEC the Form F-1 can be used to raise capital.

BiondVax is currently developing, under an exclusive worldwide license, a nanosized antibody (“NanoAb”) for the treatment of COVID-19, developed by researchers at the Max Planck Institute for Multidisciplinary Sciences (MPG) and the University Medical Center Göttingen (UMG). As recently reported, in the coming weeks BiondVax intends to initiate a preclinical proof-of-concept study of the COVID-19 NanoAb as an inhaled therapy in COVID-19 infected animals. Assuming successful results, a first-in -human Phase 1/2a clinical trial of the COVID-19 NanoAb inhaled therapy will be initiated in 2023.

Under the five-year BiondVax-MPG-UMG research collaboration agreement (RCA) for additional “biobetter” NanoAbs, Professor Dirk Görlich of MPG and his team have successfully generated, identified and isolated NanoAbs addressing a number of additional biological target molecules. Professor Görlich and his colleague Professor Matthias Dobbelstein of UMG verified strong affinity by the new NanoAbs to their biological target molecules and high thermostability. The research teams have also demonstrated strong neutralization by several NanoAb candidates of their respective target molecules. As a result of the above progress, BiondVax decided earlier this month to initially focus on additional pipeline development beginning with NanoAbs as drug candidates for the potential treatment of psoriasis, psoriatic arthritis, and asthma.

These recent successful developments present BiondVax with an opportunity to not only initiate a Phase 1/2a clinical trial of its inhaled COVID-19 therapeutic NanoAb next year as planned, but also to significantly expand its portfolio of NanoAbs in development. Consequently, the proceeds of the firm commitment underwriting share issuance contemplated by the F-1 are designed to provide BiondVax with the capital necessary to continue to aggressively execute its strategy.

In addition, BiondVax received a notification letter from The Nasdaq Stock Market (“Nasdaq”) dated September 28, 2022 advising BiondVax that it is not in compliance with Listing Rule 5550(b)(1) …

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