BiondVax Announces Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update.

JERUSALEM: BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its fourth quarter and full year financial results for the year ended December 31, 2019 and provided a business update.

Fourth Quarter 2019 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.456 (NIS/$US) as at December 31, 2019.

Total operating expenses were NIS 32.5 million (approximately $9.4 million) compared with NIS 27.9 million for the fourth quarter of 2018.

R&D expenses for the fourth quarter amounted to NIS 31.6 million ($9.1 million) compared with NIS 26.6 million for the fourth quarter of 2018.

Full Year 2019 Financial Summary

Total operating expenses for 2019 were NIS 78.3 million ($22.6 million) compared with NIS 77 million in 2018.

R&D expenses for 2019 amounted to NIS 68.6 million ($19.8 million) compared with NIS 71.9 million in 2018.

As of December 31, 2019, BiondVax had cash and cash equivalents of NIS 72.4 million ($20.9 million) compared to NIS 75.8 million as of December 31, 2018. Complete financial results are available in the Company's annual report on Form 20-F for the year ended December 31, 2019, which is being filed with the Securities and Exchange Commission today.

*Tables to follow*

2019 Highlights and Recent Corporate Update

Pivotal clinical efficacy Phase 3 trial: The pivotal Phase 3 clinical trial aims to compare the safety and clinical efficacy of M-001 versus a placebo in preventing flu illness (as primary endpoints), and in reducing flu illness severity (as a secondary endpoint) from circulating influenza strains. Prior to both the 2018/19 and 2019/20 flu seasons, a total of over 12,400 adult volunteers aged 50+ (with half aged 65+) in seven European countries were enrolled. To date, no serious treatment related adverse events have been identified. Monitoring of the trial's second cohort (enrolled for the 2019/20 flu season) is nearly complete, and the Phase 3 clinical trial results are expected by the end of 2020.

NIH-supported Phase 2 clinical trial: The clinical study report (CSR) of the NIH-supported Phase 2 clinical trial was...