EX-99.1 2 f6k110915ex99i_biondvax.htm PRESS RELEASE, DATED NOVEMBER 9, 2015

Exhibit 99.1

 

 

 

BiondVax Announces

Third Quarter 2015 Financial Results and Update

 

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 designatged 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 appearences 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.

 

About BiondVax

BiondVax is an innovative biopharmaceutical company developing a universal flu vaccine, designed to provide multi-season and multi-strain protection against most human influenza virus strains, including both seasonal and pandemic flu strains.

 

BiondVax’s technology utilizes a unique, proprietary combination of conserved and common peptides from influenza virus proteins to activate both arms of the immune system for a cross-protecting and long-lasting effect.

 

Contact Details

 

Company Contact

Limor Chen, Director of BD

limor.c@biondvax.com

 

Investor Relations Contact

GK Investor Relations

Kenny Green, Partner

+1 646 201 9246

kenny@biondvax.com

 

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 contempalted Phase 2 & 3 trials, the impact of the global economic environment on the Company customer target base, the adequacy of available csah resoure 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 Prospectus which was declared effective on May 11, 2015. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.

 

** Tables to Follow **

 

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BALANCE SHEETS

 

  

               Convenience translation (Note 2) 
   December 31,   September 30,   September 30, 
   2014   2014   2015   2015 
       Unaudited   Unaudited 
   N I S   U.S. dollars 
   (In thousands except share and per share data) 
CURRENT ASSETS:                
Cash and cash equivalents   9,612    12,411    36,294    9,252 
Marketable securities   2,016    2,014    2,016    514 
Short term deposits   -    -    578    147 
Other receivables   1,081    266    1,594    406 
                     
    12,709    14,691    40,482    10,319 
LONG-TERM ASSETS:                    
Marketable securities   2,049    2,047    2,047    522 
Property, plant and equipment   2,638    2,793    2,191    559 
Other long term assets   1,066    288    24    6 
                     
    5,753    5,128    4,262    1,087 
                     
    18,462    19,819    44,744    11,406 
CURRENT LIABILITIES:                    
Trade payables   524    299    571    146 
Other payables   1,289    1,155    758    194 
                     
    1,813    1,454    1,329    340 
LONG-TERM LIABILITIES:                    
Options   -    -    6,863    1,749 
Severance pay liability, net   62    61    67    17 
                     
    62    61    6,930    1,766 
                     
SHAREHOLDERS' EQUITY (DEFICIT):                    
Ordinary shares of NIS 0.0000001 par value:                    
Authorized: 391,000,000 shares as of September 30, 2015, 2014 (unaudited) and December 31, 2014; Issued and Outstanding: 135,097,367, 54,284,367 and 54,297,367 shares respectively    *)    *)    *)    *)
Share premium   83,517    83,459    110,352    28,129 
Options   2,536    2,536    2,536    646 
Other comprehensive income   17    18    12    3 
Accumulated deficit   (69,483)   (67,709)   (76,415)   (19,478)
                     
    16,587    18,304    36,485    9,300 
                     
    18,462    19,819    44,744    11,406 

 

*) Represents an amount lower than NIS 1.

 

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STATEMENTS OF COMPREHENSIVE INCOME

 

 

                      

Convenience translation

(Note 2)

 
   Year ended December 31,   Three months ended September 30,   Nine months ended
September 30,
  

Nine months

ended

September 30,

 
   2014   2014   2015   2014   2015   2015 
   Unaudited   Unaudited 
   N I S   U.S. dollars 
   (In thousands, except per share data) 
                         
Operating expenses:                        
Research and development, net of participations   5,492    1,399    1,247    4,474    5,032    1,283 
Marketing, general and administrative   2,650    561    966    1,688    2,216    564 
                               
Total operating expenses   8,142    1,960    2,213    6,162    7,248    1,847 
                               
Operating loss   (8,142)   (1,960)   (2,213)   (6,162)   (7,248)   (1,847)
                               
Financial income   (394)   (166)   (1,540)   (184)   (651)   (166)
Financial expense   16    6    5    12    20    5 
Financial expenses due to issuance of warrants   -    -    (812)   -    315    80 
                               
Total finance expense (income), net   (378)   (160)   (2,347)   (172)   (316)   (81)
                               
Net loss (income)    7,764    1,800    (134)   5,990    6,932    1,766 
                               
Other comprehensive loss (income):                              
Items to be reclassified to profit or loss in subsequent periods:                              
Loss (gain) from available-for-sale financial assets   4    -    2    3    5    2 
                               
Total comprehensive loss (income)   7,768    1,800    (132)   5,993    6,937    1,768 
                               
Basic and Diluted net loss (gain) per share (NIS)   0.14    0.03    (0.00)   0.11    0.07    0.02 
                               
Weighted average number of shares outstanding used to compute basic and diluted loss per share   54,286,227    54,284,367    135,097,367    54,284,367    95,519,426    95,519,426

 

 

 

 

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