EX-99.1 2 f6k082218bex99-1_biondvax.htm PRESS RELEASE DATED AUGUST 22, 2018

Exhibit 99.1

 

 

BiondVax Announces

Second Quarter 2018 Financial Results

 

Jerusalem, Israel - August 22, 2018 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a Phase 3 clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced its financial results for the quarter ended June 30, 2018.

 

Second Quarter 2018 Financial Summary

 

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.65 (NIS/$US) as at June 30, 2018.

 

Second quarter operating expenses were NIS 30.6m ($8.4m) compared with NIS 2.59m for the second quarter of 2017;

 

Second quarter R&D expenses amounted to NIS 29.2m ($8m) compared with NIS 2m for the second quarter of 2017;

 

As of June 30, 2018, BiondVax had cash and cash equivalents of NIS 37.1 million ($10.1 million) as compared to NIS 36.6m as of March 30, 2018. Expenses are related to execution of planned ongoing operations including the launch of a pivotal, clinical efficacy, Phase 3 trial of the Company’s M-001 Universal Flu Vaccine candidate, and construction of a mid-size commercial manufacturing facility.

 

About BiondVax

BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. Please visit www.biondvax.com.

 

Contact Details

Joshua E. Phillipson

+972 8 930 2529

j.phillipson@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 prosecution and outcome of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of the new manufacturing facility its products; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our  vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources 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, 2017 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. We undertake no obligation to revise or update any forward-looking statement for any reason.

 

** Tables to Follow **

 

 

 

 

BALANCE SHEETS

 

 

In thousands, except per share data

 

              

Convenience

translation

 
   December 31,   June 30,   June 30, 
   2017   2017   2018   2018 
   Audited   Unaudited   Unaudited 
   N I S   U.S. dollars 
CURRENT ASSETS:                
Cash and cash equivalents   71,382    31,334    37,128    10,172 
Marketable securities   -    4,067         - 
Short-term deposits   -    1,200    -    - 
Other receivables   3,923    2,812    4,067    1,114 
                     
    75,305    39,413    41,195    11,286 
LONG-TERM ASSETS:                    
Property, plant and equipment   5,510    1,233    18,793    5,149 
Other long term assets   880    505    880    241 
                     
    6,390    1,738    19,673    5,390 
                     
    81,695    41,151    60,868    16,676 
CURRENT LIABILITIES:                    
Trade payables   6,223    1,188    1,323    363 
Other payables   660    664    780    214 
                     
    6,883    1,852    2,103    577 
LONG-TERM LIABILITIES:                    
Liability in respect of government grants   10,300    -    12,790    3,504 
Loan from others   -    -    20,710    5,674 
Warrants   8,177    18,231    8,475    2,322 
Severance pay liability, net   83    79    79    22 
                     
    18,560    18,310    42,054    11,522 
SHAREHOLDERS’ EQUITY:                    
Ordinary shares of NIS 0.0000001 par value:                    
Authorized: 391,000,000 shares as of June 30, 2018, 2017 (unaudited) and December 31, 2017; Issued and Outstanding: 261,419,599, 179,595,199 and 261,419,599 shares respectively   *) -    *) -    *) -    *) - 
Share premium   179,669    132,824    179,821    49,265 
Options   -    533    -    - 
Other comprehensive income   -    2    -    - 
Accumulated deficit   (123,417)   (112,370)   (163,110)   (44,688)
                     
    56,252    20,989    16,711    4,577 
                     
    81,695    41,151    60,868    16,676 

 

*)Represents an amount lower than NIS 1.

 

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STATEMENTS OF COMPREHENSIVE INCOME

 

 

In thousands, except per share data

 

                       Convenience
translation
 
  

Year ended

December 31,

  

Three months ended

June 30,

  

Six months ended

June 30,

  

Six months

ended

June 30,

 
   2017   2017   2018   2017   2018   2018 
   Unaudited   Unaudited 
   N I S   U.S. dollars 
   (In thousands, except per share data) 
Operating expenses:                        
Research and development, net of participations   18,777    2,022    29,205    3,896    40,950    11,219 
Marketing, general and administrative   4879    569    1,445    1,663    2,329    638 
                               
Total operating expenses   23,656    2,591    30,650    5,559    43,279    11,857 
                               
Operating loss   (23,656)   (2,591)   (30,650)   (5,559)   (43,279)   (11,857)
                               
Financial income   18    5    6,386    13    6,386    1,255 
Financial expense   (10,913)   (9,086)   (1,227)   (17,958)   (2,800)   (273)
                              
Total finance (expense) income, net   (10,895)   (9,081)   5,159    (17,945)   3,586    982 
                               
Net loss    (34,551)   (11,672)   (25,491)   (23,504)   (39,693)   (10,875)
                               
Other comprehensive loss:                              
Items to be reclassified to profit or loss in subsequent periods:                              
Loss from available-for-sale financial assets   (6)   (4)   -    (4)   -    - 
                               
Total comprehensive loss   (34,557)   (11,676)   (25,491)   (23,508)   (39,693)   (10,875)
                               
Basic and diluted net loss per share (NIS)   (0.17)   (0.07)   (0.10)   (0.14)   (0.15)   (0.04)
                               
Weighted average number of shares outstanding used to compute basic and diluted loss per share   201,030,768    175,809,413    261,419,599    169,182,101    261,419,599    261,419,599 

 

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