Nes Ziona, Israel, November 9, 2015 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced its financial results for the third quarter of 2015 and provided a business update.
Third Quarter 2015 Financial Summary
Results are in New Israel Shekels (NIS) and a translation to US$ is provided, using the exchange rate of 3.923 as at September 30, 2015.
- Total operating expenses were NIS 2.21m ($563,000) compared with NIS 1.96m in the third quarter of last year;
- R&D expenses amounted to NIS 1.25m ($319,000) compared with NIS 1.40m in the third quarter of last year;
- Cash, cash equivalents and short and long-term marketable securities at the end of the quarter were NIS 40.94m ($10.41m) compared with NIS 13.68m as of December 31, 2014;
Recent Corporate Update
- On October 1, 2015, BiondVax designated Cytovance Biologics Inc., a Contract Manufacturing Organization (CMO), for the production of clinical batches of BiondVax’s Universal Flu Vaccine (M-001) in order to be ready for phase 3 clinical trials in the 2017/2018 timeframe;
- At the end of September, 2015, a phase 2b clinical trial was initiated in Europe in collaboration with the UNISEC European Consortium. The trial will examine BiondVax’s Universal Flu Vaccine (M-001) as a primer for an Avian (H5N1) flu pandemic outbreak;
- On September 2, 2015, BiondVax announced its intention to launch a phase 2 trial in the United States in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), which is expected to take place in 2016;
- Results are expected from both these phase 2b trials in the second half of 2016;
- In August 2015, BiondVax reported that sera samples from elderly participants in the BVX-005 trial in 2012, contained significantly more protective antibodies against the current epidemic flu strain, H3N2, which did not exist in 2012;
- The company and its management are actively engaging an investor relations program including monthly non-deal roadshows and investor conference appearances with US and international investors;
Dr. Ron Babecoff, CEO of BiondVax Commented: “The third quarter of 2015 was a very eventful one for BiondVax, and we made significant progress towards our interim goal of reaching phase 3 trials in the 2017/2018 timeframe. We are very excited to be working together with a European consortium in a phase 2b trial in Europe, where in the past few weeks we admitted and successfully vaccinated the first patients with our Universal Flu Vaccine. Following FDA acceptance of our IND application earlier this year, we are also excited that the NIAID/NIH agreed to collaborate and fund an upcoming trial in the United States, which we look forward to starting in early 2016.”
Continued Mr. Babecoff, “In the next few weeks, I plan to meet with investors and analysts in New York, Boston, Chicago, Toronto and Los Angeles in order to raise our profile amongst the investor community. This is a particularly timely visit, as the 2015/2016 flu season is now unfortunately well underway in North America.”
“As is typical every year, millions of people will contract flu – including many who have taken the currently available trivalent vaccine. Hence, at this time of year, we see the increased importance in our mission and what we are working so hard for. We are encouraged because we are nearing the finishing line when we expect our vaccine will become commercially available for people who need it in the US and worldwide,” concluded Dr. Babecoff.
The financial tables can be found in the financial section of the investor relations website.