Ness Ziona, Israel, April 27, 2016 – 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 fourth quarter and full year financial results ended December 31, 2015 and provided a business update.
The Company also filed its annual report on form 20F with the US Securities and Exchange Commision. This can be downloaded from BiondVax’s website. A hard copy will be made available upon request.
Fourth Quarter 2015 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to US$ is provided using the exchange rate of 3.902 as at December 31, 2015.
- Fourth quarter operating expenses were NIS 4.06m ($1.04m) compared with NIS 1.98m last year;
- Fourth quarter R&D expenses amounted to NIS 2.87m ($737,000) compared with NIS 1.11m last year;
Full Year 2015 Financial Summary
- Total operating expenses were NIS 11.30m ($2.90m) compared with NIS 8.14m in 2014;
- R&D expenses amounted to NIS 7.91m ($2.03m) compared with NIS 5.49m in 2014; the increase was primarily due to an increase in subcontractor expenses, in preparation for the European cGMP audit of BiondVax’s production facility;
- Cash, cash equivalents and short and long-term marketable securities at the end of the quarter were NIS 37.53m ($9.62m) compared with NIS 13.68m as of December 31, 2014; the growth was primarily due to the US public offering completed during May 2015;
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. Among other goals the study aims to show the dose sparing potential of M-001 when given prior to avian vaccine, a highly desirable feature in a pandemic scenario, when existing stockpiles of vaccine may be insufficient. On March 28, 2016, the enrollment of 224 participants was completed. Results from this trial are expected towards the end of 2016 or early 2017.
- On September 2, 2015, BiondVax announced a collabotaration with National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), to commence a phase a 2b trial in the United States. This trial is which is expected to take place in 2016 and include 180 participants;
- Since November 2015, the Company achieved three patent approvals: in Korea, United States and Israel;
- In February 2016, the National Authority for Technological Innovation (NATI), formerly known as the Office of the Chief Scientist, agreed to partly fund an additional project towards the ongoing development of the Company’s Universal Flu Vaccine;
- The company and its management continue to actively engage in an investor and public relations program including monthly non-deal roadshows and investor conference appearences with US and international investors;
- Three articles about BiondVax were published in mass media including the Huffington Post and Living Well magazine. Additionally, Zacks Research launched research coverage on BiondVax’s stock with a Buy rating. Furthermore, BiondVax launched a newsletter and blog (blog.biondvax.com) for those interested in the flu and BiondVax;
Dr. Ron Babecoff, CEO of BiondVax commented: “The fourth quarter of 2015 and beyond remain very active for BiondVax. We continue to make progress towards our interim goal of being phase 3 ready in the 2017/2018 timeframe, having recently completed full enrollment in our European phase 2 trial. Following FDA acceptance of our IND application earlier this year for a phase 2 study, we are also excited that the NIAID/NIH agreed to collaborate and fund an upcoming trial in the United States. We are currently working with them closely in order to start this trial later this year.
“While the 2015/2016 flu season was a relatively tame one, the current flu vaccine effectiveness has not changed from the typical range, averaging about 40% over the last decade. We are encouraged because as time passes and we look back on our progress over the past year, we see that we are closer to our goal,” concluded Dr. Babecoff.
BiondVax is a biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. For more information, please visit www.biondvax.com.
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