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BiondVax Pharmaceuticals Announces Fourth Quarter And Full Year 2016 Financial Results And Update

Published: Apr 28, 2017

NESS ZIONA, Israel, April 28, 2017 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV; TASE: BVXV),  a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced its fourth quarter and full year financial results for the year ended December 31, 2016, and provided a business update.

The Company also filed its annual report for the year ended December 31, 2016, on Form 20F with the U.S. Securities and Exchange Commission. This can be downloaded from BiondVax's website.

Fourth Quarter 2016 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.845 as at December 31, 2016.

  • Fourth quarter operating expenses, net, were NIS 3.12 million($811,000) compared with NIS 4.06 million in the fourth quarter of last year;
  • Fourth quarter R&D expenses, net, amounted to NIS 1.83 million($476,000) compared with NIS 2.87 million in the fourth quarter of last year;

Full Year 2016 Financial Summary

  • Total operating expenses, net, were NIS 11.90 million ($3.10 million) compared with NIS 11.30 million in 2015;
  • R&D expenses, net, amounted to NIS 7.79 million ($2.03 million) compared with NIS 7.91 million in 2015;

As of December 31, 2016, BiondVax had cash and cash equivalents, short-term investments and marketable securities of NIS 27.4 million ($7.1 million) as compared to NIS 37.5 million as of December 31, 2015. This decrease was attributable to utilization of available cash resources to fund operations.

Recent Corporate Update

  • The Company announced positive preliminary safety results from the Phase 2b clinical trial of M-001, conducted in collaboration with the European UNISEC consortium[1]. Immunogenicity results, currently being processed by other UNISEC consortium entities, are expected by the end of Q2 2017.
  • In January 2017, Angels High Tech Investments Ltd. invested NIS 10.9 million, approximately $2.8 million, in exchange for 33.8 million ordinary BiondVax shares on the Tel Aviv Stock Exchange (equivalent to 844,000 NASDAQ listed ADS) at the December 29, 2016, Tel Aviv closing market price. Following the transaction, Angels Investments held 19.99% of all issued and outstanding share capital of the Company.
  • The peer-reviewed journal Vaccine published an article titled, "Back to the future: Immunization with M-001 prior to trivalent influenza vaccine in 2011/12 enhanced protective immune responses against 2014/15 epidemic strain." The article reports that blood plasma samples from people who received M-001 in 2011 (as part of BiondVax's BVX-005 clinical trial in the elderly) showed a five-fold significant increase of protective antibodies against a new epidemic 2014/15 flu strain (A/Swiss) a strain which did not exist when M-001 was administered to the BVX-005 participants.
  • An article by BiondVax-affiliated authors titled, "Strategy for approving a universal flu vaccine" was published in the peer-reviewed journal Future Virology.
  • The Company received approval for a grant representing 20% of a NIS 20 million budget from Israel's Ministry of Economy and Industry to build a facility for commercial scale production of M-001, its universal flu vaccine candidate.

Dr. Ron Babecoff, BiondVax's President and CEO, commented, "I am pleased we are progressing and keeping expenses at the planned level. Recent reports in CNN[2],[3] and The Washington Times[4] indicate flu pandemic threats like H7N9 are an increasingly urgent concern. Current solutions are insufficient. These concerns strengthen our unwavering commitment to bring our universal flu vaccine candidate to the market to improve pandemic preparedness."

[1] UNISEC research has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n°602012.

[2] The big one is coming, and it's going to be a flu pandemic. http://edition.cnn.com/2017/04/07/health/flu-pandemic-sanjay-gupta/index.html.

[3] Seven reasons we're at more risk than ever of a global pandemic. http://edition.cnn.com/2017/04/03/health/pandemic-risk-virus-bacteria/.

[4] Congress, WHO sound the alarm over pandemic avian flu in China. http://www.washingtontimes.com/news/2017/apr/21/congress-who-sound-alarm-over-pandemic-bird-flu-or/.

About BiondVax Pharmaceuticals Ltd

BiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine.

To read full press release, please click here.

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