Ness Ziona, Israel – April 28, 2017 – 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 ($774,000) 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 ($450,000) 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. 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, and The Washington Times 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.”
 UNISEC research has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n°602012.
 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.
 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/.
 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. 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. Please visit www.biondvax.com.
For further information, please contact:
Business Development Manager
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve certain risks and uncertainties reflect the management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. risks and uncertainties include, but are not limited to, the risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov, and in the Company’s periodic filings with the SEC and the Tel-Aviv Stock Exchange.
* Tables to Follow *
In thousands, except share and per share data
|December 31,||December 31,|
|N I S||U.S. dollars|
|Cash and cash equivalents||33,470||15,705||$ 4,084|
|Property, plant and equipment||2,044||1,443||375|
|Other long term assets||287||478||124|
|Trade payables||931||686||$ 178|
|Severance pay liability, net||69||76||20|
|SHAREHOLDERS’ EQUITY :-|
|Ordinary shares of NIS 0.0000001 par value:|
|Authorized: 391,000,000 shares as of
December 31, 2015 and 2016; Issued and
Outstanding 135,097,367 shares as of
December 31, 2015 and 2016
|*) –||*) –||*) –|
|Other comprehensive income||12||6||2|
*) Represents an amount lower than NIS 1.
STATEMENTS OF COMPREHENSIVE INCOME
In thousands, except share and per share data
|Year ended December 31||Year ended December 31,|
|N I S||U.S. dollars|
|Research and development, net of participations||5,492||7,906||7,794||$ 2,027|
|Marketing, general and administrative||2,650||3,397||4,106||1,068|
|Total operating expenses||8,142||11,303||11,900||3,095|
|Other comprehensive income (loss):|
|Items to be reclassified to profit or loss in subsequent periods:|
|Gain (loss) from available-for-sale marketable securities||(4)||(5)||(6)||(2)|
|Total comprehensive loss||(7,768)||(10,204)||(9,190)||$ (2,391)|
|Basic and diluted loss per share||(0.14)||(0.10)||(0.07)||$ (0.02)|
|Weighted average number of shares outstanding used to compute basic and diluted loss per share||54,286,227||105,522,642||135,097,367||135,097,367|
For notes and details, please see the 20F filing with the SEC.