Ness Ziona, Israel, August 18, 2016 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing a vaccine against current and future seasonal and pandemic influenza strains, today announced its second quarter 2016 financial results ended June 30, 2016 and provided a business update.
Second Quarter 2016 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to US$ is provided using the exchange rate of 3.846 as at June 30, 2016.
- Second quarter operating expenses were NIS 2.47m ($644,000) compared with NIS 3.21m in the second quarter of last year;
- Second quarter R&D expenses amounted to NIS 1.48m ($385,000) compared with NIS 2.61m in the second quarter of last year;
- Cash, cash equivalents and short and long-term marketable securities at the end of the quarter were NIS 30.65m ($7.97m) compared with NIS 37.53m as of December 31, 2015;
Recent Corporate Update
- Clinical trials are progressing. The EU UNISEC sponsored Phase 2b clinical trial completed enrolment and results are being analyzed. The US NIH Phase 2 trial preparations are well into advanced stages. Furthermore, US-based Cytovance is beginning to scale-up production of BiondVax’s universal flu vaccine candidate M-001 for Phase 3 clinical trials, which is expected to be ready by H1 2017.
- In August, a video feature on BiondVax was published by a leading Israeli portal. The video can be viewed at https://www.youtube.com/watch?v=iqzZd4hsvSw. In addition, BiondVax launched a newsletter. The most recent edition can be viewed at http://us12.campaign-archive2.com/?u=37c158f4953dfecaabf88a035&id=763a628862. To receive BiondVax updates directly to your inbox please email email@example.com.
Dr. Ron Babecoff, CEO of BiondVax commented: “Our progress continued into the second quarter according to plans. The work with our partners in our different collaborations is also moving forward at a good pace. As each quarter passes, we are coming closer towards our goal of bringing a universal flu vaccine to market.”
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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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, 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. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
** Tables to Follow **
|December 31,||June 30,||June 30,|
|N I S||U.S. dollars|
|(In thousands except share and per share data)|
|Cash and cash equivalents||33,470||37,955||15,084||3,922|
|Short term deposit||–||–||11,503||2,991|
|Property, plant and equipment||2,044||2,355||1,746||454|
|Other long term assets||287||286||490||127|
|Severance pay liability, net||69||66||72||19|
|SHAREHOLDERS’ EQUITY (DEFICIT):|
|Ordinary shares of NIS 0.0000001 par value:|
|Authorized: 391,000,000 shares as of June 30, 2016, 2015 (unaudited) and December 31, 2015; Issued and Outstanding: 135,097,367, shares as of June 30, 2016, 2015 (unaudited) and December 31, 2015.||*) –||*) –||*) –||*) –|
|Other comprehensive income||12||14||7||2|
*) Represents an amount lower than NIS 1.
STATEMENTS OF COMPREHENSIVE INCOME
|Three months ended
|Six months ended
|N I S||U.S. dollars|
|(In thousands, except per share data)|
|Research and development, net of participations||7,906||2,613||1,478||3,785||3,541||921|
|Marketing, general and administrative||3,397||600||999||1,250||1,770||460|
|Total operating expenses||11,303||3,213||2,474||5,035||5,311||1,381|
|Financial income (expenses) due to issuance of options||–||(1,127)||(383)||
|Total finance (expense) income, net||1,104||(1,989)||(138)||(2,031)||920||239|
|Other comprehensive income (loss):|
|Items to be reclassified to profit or loss in subsequent periods:|
|Gain (loss) from available-for-sale financial assets||(5)||(2)||(7)||(3)||(5)||(1)|
|Total comprehensive loss||(10,204)||(5,204)||(2,622)||(7,069)||(4,396)||(1,143)|
|Basic and Diluted net loss per share (NIS)||(0.10)||(0.05)||(0.02)||(0.09)||(0.03)||(0.008)|
|Weighted average number of shares outstanding used to compute basic and diluted loss per share||105,522,642||96,284,034||135,097,367||75,290,700||135,097,367||135,097,367|