On November 26, 2019 BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a Phase 3 clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, reported its financial results for the quarter ended September 30, 2019 (Press release, BiondVax Pharmaceuticals, NOV 26, 2019, View Source [SID1234551738]).
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Third Quarter 2019 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.482 (NIS/$US) as at September 30, 2019.
Third quarter operating expenses were NIS 18.9m ($5.4m) compared with NIS 5.8m for the third quarter of 2018;
Third quarter R&D expenses amounted to NIS 16.1m ($4.6m) compared with NIS 4.3m for the third quarter of 2018;
Expenses were related to execution of planned ongoing operations, including the ongoing pivotal, clinical efficacy, Phase 3 trial of the Company’s M-001 Universal Flu Vaccine candidate and construction of a mid-size pilot manufacturing facility.
As of September 30, 2019, BiondVax had cash and cash equivalents of NIS 75.2 million ($21.6 million) as compared to NIS 33.9 million as of June 30, 2019.
Recent Business highlights:
$20 million was raised in a shareholder rights offering that concluded in July 2019. As a consequence of the offering and an associated option to purchase ordinary shares that were not purchased by other shareholders in the offering, Angels Investments in High Tech Ltd., wholly owned by Marius Nacht, lead investor of the aMoon Fund, held approximately 42% of outstanding BiondVax shares.
Mr. Mark Germain was appointed Chairman of BiondVax’s Board of Directors, effective September 30, 2019.
In October 2019, BiondVax received €4 million from the European Investment Bank (EIB). These funds are the final tranche of the previously announced co-financing agreement signed in June 2017 and extended in April 2019 from €20 million to €24 million.
Laboratory work for the primary and secondary outcome measures in the NIAID-sponsored Phase 2 clinical trial in the USA is now complete and the analysis is ongoing. Results are expected in Q2 2020.
Enrollment and randomization of 12,463 participants was successfully completed in the pivotal, clinical efficacy, Phase 3 trial of BiondVax’s M-001 Universal Influenza Vaccine candidate.