EX-99.1 2 ea125924ex99-1_biondvax.htm PRESS RELEASE DATED AUGUST 20, 2020

Exhibit 99.1

 

 

 

BiondVax Announces Second Quarter 2020 Financial Results

 

Jerusalem, Israel – August 20, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its second quarter financial results for the quarter ended June 30, 2020.

 

Second Quarter 2020 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of3.466   (NIS/$US) as at June 30, 2020.

 

Total operating expenses for the second quarter were NIS 16.0 million (approximately $4.61 million) compared with NIS 19.7 million for the second quarter of 2019.

 

R&D expenses for the second quarter amounted to NIS 11.9 million (approximately $3.4 million) compared with NIS 15.2 million for the second quarter of 2019.

 

Net loss for the second quarter was NIS 42 million (approximately $12.1 million) compared to net loss of NIS 47.4 million for the second quarter of 2019.

 

The decrease in total operating expenses compared to the second quarter of 2019 was primarily due to fewer costs associated with the nearly complete pivotal Phase 3 trial and completion of construction of the manufacturing facility.

 

As of June 30, 2020, BiondVax had cash and cash equivalents of NIS 38.7 million (approximately $11.2 million) compared to NIS 72.4 million as of December 31, 2019.

 

*Tables to follow*

 

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-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, 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 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, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; 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 U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional 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, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.

 

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BALANCE SHEETS

In thousands, except share and per share data

 

               Convenience 
               Translation 
   December 31   June 30,   June 30, 
   2019   2019   2020   2020 
   Audited   Unaudited   Unaudited 
   N I S   U.S. dollars 
CURRENT ASSETS:                
Cash and cash equivalents   72,467    33,916    38,752    11,181 
Other receivables   656    1,258    2,467    712 
                     
    73,123    35,174    41,219    11,893 
LONG-TERM ASSETS:                    
Property, plant and equipment   34,981    32,475    36,937    10,658 
Right-of-use assets   7,136    7,610    6,662    1,922 
Other long-term assets   510    510    891    257 
                     
    42,627    40,595    44,490    12,837 
                   - 
    115,750    75,769    85,709    24,730 
                     
CURRENT LIABILITIES:                    
Trade payables   17,062    7,977    4,070    1,174 
Operating lease liabilities   694    686    676    195 
Other payables   1,203    1,348    1,609    464 
                     
    18,959    10,011    6,355    1,835 
LONG-TERM LIABILITIES:                    
Liability in respect of government grants   14,812    14,621    12,686    3,660 
Operating lease liabilities   6,809    7,076    6,457    1,863 
Loan from others   123,780    110,971    122,041    35,211 
Warrants   16,354    5,517    -    - 
Severance pay liability, net   89    86    92    26 
                     
    161,844    138,271    141,276    40,760 
SHAREHOLDERS’ EQUITY:                    
Ordinary shares of no par value: Authorized: 600,000,000, 391,000,000 and 600,000,000 shares at June 30, 2020 and 2019 (unaudited) and December 31, 2019, respectively; Issued and outstanding: 460,822,640, 261,419,599 and 402,351,657 shares at June 30, 2020 and 2019 (unaudited) and December 31, 2019, respectively   *)-   *)-   *)-   *)-
Share premium   255,285    185,454    304,089    87,735 
Accumulated deficit   (320,338)   (257,967)   (366,011)   (105,600)
                     
    (65,053)   (72,513)   (61,922)   (17,865)
                     
    115,750    75,769    85,709    24,730 

 

*)Represents less than NIS\USD 1.

 

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STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

In thousands, except share and per share data

 

                       Convenience translation 
   Year ended December 31,   Three months ended
June 30,
   Six months ended
June 30,
  

Six months

ended

June 30,

 
   2019   2019   2020   2019   2020   2020 
   Audited   Unaudited   Unaudited 
   N I S   U.S. dollars 
   (In thousands, except per share data) 
Operating expenses:                        
Research and development, net of participations   68,645    15,172    11,948    20,904    31,016    8,949 
Marketing, general and administrative   9,706    4,518    4,139    5,951    5,120    1,477 
                               
Total operating expenses   78,351    19,690    16,087    26,855    36,136    10,426 
                             - 
Operating loss   (78,351)   (19,690)   (16,087)   (26,855)   (36,136)   (10,426)
Financial income   4    -    (11,291)   24    5,211    1,503 
Financial expense   (30,847)   (27,699)   (14,600)   (19,992)   (14,748)   (4,255)
                               
Net loss    (109,194)   (47,389)   (41,978)   (46,823)   (46,673)   (13,177)
                               
Basic and diluted net loss per share (NIS)   (0.33)   (0.18)   (0.10)   (0.18)   (0.11)   (0.03)
                               
Weighted average number of shares outstanding used to compute basic and diluted loss per share   326,651,721    261,482,786    433,498,227    261,435,179    431,485,801    431,485,801 

 

 

 

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