UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

 

For the Month of August 2021

 

Commission File Number: 001-37353

 

BIONDVAX PHARMACEUTICALS LTD.

(Translation of registrant’s name into English)

 

Jerusalem BioPark, 2nd Floor

Hadassah Ein Kerem Campus

Jerusalem, Israel

(Address of principal executive office)

  

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F ☒     Form 40-F ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____

 

 

 

 

 

 

 

On August 26, 2021, BiondVax Pharmaceuticals Ltd. issued a press release announcing second quarter 2021 financial results.

 

Exhibit Index

 

Exhibit No.

  Description
99.1   Press Release dated August 26, 2021
99.2   BiondVax Pharmaceuticals Ltd. unaudited interim financial statements for the period ending June 30, 2021

 

This Report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (Registration No. 333-240189) and its Registration Statement on Form S-8 (Registration No. 333-239344).

 

1

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  BiondVax Pharmaceuticals Ltd.
     
Date: August 26, 2021 By: /s/ Amir Reichman
    Amir Reichman
    Chief Executive Officer

 

 

2

 

 

Exhibit 99.1

 

 

BiondVax Announces Second Quarter 2021 Financial Results and Provides Business Update

 

Jerusalem, Israel – August 26, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses, today published its second quarter financial results for the quarter ended June 30, 2021.

 

Financial Summary

 

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.26 (NIS/$US), the rate as of the close of business on June 30, 2021.

 

R&D expenses for the three months ended June 30, 2021 decreased to NIS 1.9 million ($0.6 million) from NIS 11.9 million for the three months ended June 30, 2020. This decrease was primarily attributable to expenses related to a Phase 3 clinical trial and related operations at our manufacturing facility. As previously reported, the trial concluded in Q4 2020.

  

Marketing, general and administrative expenses for the three months ended June 30, 2021 increased to NIS 7 million ($2.1 million) from NIS 4.1 million for the three months ended June 30, 2020. This increase of NIS 2.9 million ($0.6 million) was primarily due to salary and salary related expenses related to the former CEO’s termination, an increase in Board of Directors expenses, the new CEO’s salary, share based compensation expenses, and an increase in professional services.

 

Operating expenses for the three months ended June 30, 2021 were NIS 8.9 million ($2.7 million) compared with NIS 16.0 million for the three months ended June 30, 2020.

 

Financial expenses for the three months ended June 30, 2021 were NIS 3.1 million ($0.95 million) compared with NIS 25.9 million for the three months ended June 30, 2020. This reduction was attributable primarily due to a decrease in financial expenses as a result of a $21 million warrants revaluation charge during the three months ended June 30, 2020 compared to none in the three months ended June 30, 2021.

 

As of June 30, 2021, BiondVax had cash and cash equivalents of NIS 39.9 million ($12.2 million) as compared to NIS 48.6 million as of March 31, 2021.

 

Unaudited Q2 financial results will be submitted to the Securities and Exchange Commission. A summary is included in the tables below.

 

CEO Statement

 

Chief Executive Officer of BiondVax Mr. Amir Reichman commented, “Since joining the Company earlier this year, my team and I, with the support of the Board of Directors, have been identifying and are assessing a number of promising technologies and potential partners with the goal of building a diversified pipeline of biological products and platforms for therapeutic use through in licensing, co-developing, acquiring or partnering. Our potential partners include top tier researchers, institutes and/or companies that possess relevant Intellectual Property that may fit with BiondVax’s strategic aspirations, experience and capabilities. We are currently engaged in deep-dive evaluations of some particularly intriguing opportunities. In collaboration with these potential partners and relevant experts we are assessing these potential avenues from several perspectives, including scientific merit, complementary synergies with our manufacturing infrastructure and product development expertise, as well as their potential for commercial market success.”

 

 

Jerusalem BioPark, 2nd floor ● Hadassah Ein Kerem Campus ● Jerusalem, Israel

Telephone: +972-8-9302529 ● Fax: +972-8-9302531 ● www.BiondVax.com

 

 

 

 

 

Reichman continued, “Last week, I relocated with my family to Israel from Belgium where I had been serving in a senior leadership role at GSK Vaccines headquarters. I am pleased to now be working face-to-face with the highly experienced, motivated and talented BiondVax team, and I am increasingly optimistic with regard to our potential to rebuild BiondVax to become a successful biopharmaceutical company excelling in identifying, developing, manufacturing and ultimately commercializing biological therapeutics and vaccines.” 

 

About BiondVax

 

BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses. The Company had been developing M-001, a novel influenza vaccine candidate that was designed to provide multi-strain and multi-season protection against current and future seasonal and pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials designed to test for immunogenicity, the Company was able to demonstrate M-001 was effective in stimulating an immune response to a broad range of influenza virus strains. In October 2020, the Company completed a Phase 3 clinical trial of M-001 which did not meet the trial’s primary and secondary efficacy endpoints. The Company is now pursuing the goal of developing a pipeline of diversified and commercially viable products and platforms.

 

Contact Details

 

Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com

Investor Relations: Kenny Green (Israel) | +1 646 201 9246 | kgreen@edisongroup.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, including statements regarding future business strategies that BiondVax may explore. These forward-looking statements reflect 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 BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 or implement a strategy that will diversify BiondVax’s risk, and, if executed, may not be successful; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on May 13, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.

 

 

Jerusalem BioPark, 2nd floor ● Hadassah Ein Kerem Campus ● Jerusalem, Israel

Telephone: +972-8-9302529 ● Fax: +972-8-9302531 ● www.BiondVax.com

 

2

 

 

 

BALANCE SHEETS

In thousands, except share and per share data

 

                      Convenience Translation  
    December 31,     June 30,     June 30,  
    2020     2020     2021     2021  
    Audited     Unaudited     Unaudited  
          N I S     U.S. dollars  
CURRENT ASSETS:                        
Cash and cash equivalents     9,421       38,752       39,883       12,234  
Other receivables     1,204       2,467       2,641       810  
      10,625       41,219       42,524       13,044  
LONG-TERM ASSETS:                                
Property, plant and equipment     39,607       36,937       38,979       11,957  
Right-of-use assets     6,206       6,662       6,109       1,874  
Other long-term assets     473       891       437       134  
                                 
      46,286       44,490       45,525       13,965  
                                 
      56,911       85,709       88,049       27,009  
                                 
CURRENT LIABILITIES:                        
Trade payables     1,868       4,070       2,635       808  
Operating lease liabilities     654       676       764       234  
Loan from others     60,421       -       64,248       19,708  
Other payables     1,246       1,609       1,739       534  
                                 
      64,189       6,355       69,386       21,284  
LONG-TERM LIABILITIES:                                
Liability in respect of government grants     -       12,686       -       -  
Operating lease liabilities     6,088       6,457       6,047       1,855  
Loan from others     -       122,041       -       -  
Other payables     1,135       -       1,135       348  
Severance pay liability, net     95       92       95       29  
                                 
      7,318       141,276       7,277       2,232  
SHAREHOLDERS' EQUITY:                                
Ordinary shares of no par value: Authorized: 1,800,000,000 shares at June 30, 2021 (unaudited) and 600,000,000 shares at June 30, 2020 (unaudited) and 700,000 shares at December 31, 2020, respectively; Issued and outstanding: 573,285,824 shares at June 30, 2021 (unaudited), 460,822,640 shares at June 30, 2020 (unaudited) and 461,285,824 shares at December 31, 2020     - *)     - *)     - *)     - *)
Share premium     310,197       304,089       356,358       109,313  
Accumulated deficit     (324,793 )     (366,011 )     (344,972 )     (105,820 )
                                 
      (14,596 )     (61,922 )     11,386       3,493  
                                 
      56,911       85,709       88,049       27,009  

 

*) Represents less than 1 NIS\USD

 

 

Jerusalem BioPark, 2nd floor ● Hadassah Ein Kerem Campus ● Jerusalem, Israel

Telephone: +972-8-9302529 ● Fax: +972-8-9302531 ● www.BiondVax.com

 

3

 

 

 

STATEMENTS OF COMPREHENSIVE 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,
 
    2020     2020     2021     2020     2021     2020  
    Audited     Unaudited     Unaudited  
    N I S     U.S. dollars  
    (In thousands, except per share data)  
Operating expenses:                                    
Research and development, net of participations     51,463       11,948       1,900       31,016       4,653       1,427  
Marketing, general and administrative     16,687       4,139       7,002       5,120       11,007       3,376  
Other income     (75,484 )     -       -       -       -       -  
                                                 
Total operating expenses (income)     (7,334 )     16,087       8,902       36,136       15,660       4,803  
                                                 
Operating income (loss)     7,334       (16,087 )     (8,902 )     (36,136 )     (15,660 )     (4,803 )
                                                 
Financial income     3,843       (11,291 )     (360 )     5,211       822       252  
Financial expense     (15,632 )     (14,600 )     (2,731 )     (14,748 )     (5,341 )     (1,638 )
                                                 
Net loss and total comprehensive loss     (4,455 )     (41,978 )     (11,993 )     (46,673 )     (20,179 )     (6,189 )
                                                 
Basic and diluted net loss per share     (0.01 )     (0.10 )     (0.03 )     (0.11 )     (0.04 )     (0.01 )
                                                 
Weighted average number of shares outstanding used to compute basic and diluted loss per share     443,260,878       433,498,227       573,205,607       431,485,801       552,140,030       552,140,030  

 

The notes in the Company’s quarterly report are an integral part of the financial statements. The complete financial results are available in the Form 6-K to be filed with the Securities and Exchange Commission.

 

 

Jerusalem BioPark, 2nd floor ● Hadassah Ein Kerem Campus ● Jerusalem, Israel

Telephone: +972-8-9302529 ● Fax: +972-8-9302531 ● www.BiondVax.com

 

 

4

 

 

Exhibit 99.2

 

BIONDVAX PHARMACEUTICALS LTD.

 

INTERIM FINANCIAL STATEMENTS

 

AS OF JUNE 30, 2021

NIS IN THOUSANDS

 

UNAUDITED

  

INDEX  

 

 

Page

   
Balance Sheets F-2 - F-3
   
Statements of Comprehensive Loss F-4
   
Statements of Changes in Shareholders’ Equity (Deficiency)   F-5 – F-7
   
Statements of Cash Flows F-8- F-9
   
Notes to Interim Financial Statements F-10 - F-13

 

- - - - - - - - - - -

 

F-1

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

BALANCE SHEETS

In thousands, except share and per share data

 

    December 31,     June 30,    

Convenience
Translation
(Note 2c)
June 30,

 
    2020     2020     2021     2021  
    Audited     Unaudited     Unaudited  
          N I S     U.S. dollars  
CURRENT ASSETS:                        
Cash and cash equivalents     9,421       38,752       39,883       12,234  
Other receivables     1,204       2,467       2,641       810  
                                 
      10,625       41,219       42,524       13,044  
LONG-TERM ASSETS:                                
Property, plant and equipment     39,607       36,937       38,979       11,957  
Right-of-use assets     6,206       6,662       6,109       1,874  
Other long-term assets     473       891       437       134  
                                 
      46,286       44,490       45,525       13,965  
                                 
      56,911       85,709       88,049       27,009  

 

The accompanying notes are an integral part of the interim financial statements.

 

F-2

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

BALANCE SHEETS

In thousands, except share and per share data

 

    December 31     June 30,     Convenience
Translation
(Note 2c)
June 30,
 
    2020     2020     2021     2021  
    Audited     Unaudited     Unaudited  
          N I S     U.S. dollars  
CURRENT LIABILITIES:                        
Trade payables     1,868       4,070       2,635       808  
Operating lease liabilities     654       676       764       234  
Loan from others     60,421       -       64,248       19,708  
Other payables     1,246       1,609       1,739       534  
                                 
      64,189       6,355       69,386       21,284  
LONG-TERM LIABILITIES:                                
Liability in respect of government grants     -       12,686       -       -  
Operating lease liabilities     6,088       6,457       6,047       1,855  
Loan from others     -       122,041       -       -  
Other payables     1,135       -       1,135       348  
Severance pay liability, net     95       92       95       29  
                                 
      7,318       141,276       7,277       2,232  
SHAREHOLDERS’ EQUITY:                                
Ordinary shares of no par value: Authorized: 1,800,000,000 shares at June 30, 2021 (unaudited) and 600,000,000 shares at June 30, 2020 (unaudited) and 700,000 shares at December 31, 2020, respectively; Issued and outstanding: 573,285,824 shares at June 30, 2021 (unaudited), 460,822,640 shares at June 30, 2020 (unaudited) and 461,285,824 shares at December 31, 2020     - *)     - *)     - *)     - *)
Share premium     310,197       304,089       356,358       109,313  
Accumulated deficit     (324,793 )     (366,011 )     (344,972 )     (105,820 )
                                 
      (14,596 )     (61,922 )     11,386       3,493  
                                 
      56,911       85,709       88,049       27,009  

 

*) Represents less than NIS\USD 1.

 

The accompanying notes are an integral part of the interim financial statements.

 

August 26, 2021            
Date of approval of the   Mark Germain   Amir Reichman   Uri Ben-Or
financial statements   Chairman of the Board   Chief Executive officer   Chief Financial officer

 

F-3

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

STATEMENTS OF COMPREHENSIVE LOSS

 

In thousands, except share and per share data

 

                                  Convenience translation (Note 2)  
    Year ended December 31,     Three months ended
June 30,
    Six months ended
June 30,
    Six months
ended
June 30,
 
    2020     2020     2021     2020     2021     2020  
    Audited     Unaudited     Unaudited  
    N I S     U.S. dollars  
    (In thousands, except per share data)  
Operating expenses:                                                
Research and development, net of participations     51,463       11,948       1,900       31,016       4,653       1,427  
Marketing, general and administrative     16,687       4,139       7,002       5,120       11,007       3,376  
Other income     (75,484 )     -       -       -       -       -  
                                                 
Total operating expenses (income)     (7,334 )     16,087       8,902       36,136       15,660       4,803  
                                                 
Operating income (loss)     7,334       (16,087 )     (8,902 )     (36,136 )     (15,660 )     (4,803 )
                                                 
Financial income     3,843       (11,291 )     (360 )     5,211       822       252  
Financial expense     (15,632 )     (14,600 )     (2,731 )     (14,748 )     (5,341 )     (1,638 )
                                                 
Net loss and total comprehensive loss     (4,455 )     (41,978 )     (11,993 )     (46,673 )     (20,179 )     (6,189 )
                                                 
Basic and diluted net loss per share     (0.01 )     (0.10 )     (0.03 )     (0.11 )     (0.04 )     (0.01 )
                                                 
Weighted average number of shares outstanding used to compute basic and diluted loss per share     443,260,878       433,498,227       573,205,607       431,485,801       552,140,030       552,140,030  

  

The accompanying notes are an integral part of the interim financial statements.

 

F-4

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIENCY)

In thousands, except share and per share data

 

    Share capital     Share premium    

Accumulated

deficit

   

Total

equity (deficiency)

 
    Unaudited  
    NIS in thousands  
                         
Balance as of January 1, 2021        - *)     310,197       (324,793 )     (14,596 )
                                 
Total comprehensive loss     -       -       (20,179 )     (20,179 )
Issuance of shares, net     - *)     42,129       -       42,129  
Share-based compensation     -       4,032       -       4,032  
                                 
Balance as of June 30, 2021     - *)     356,358       (344,972 )     11,386  
                                 
Balance as of June 30, 2021 (convenience translation into U.S. dollars (see Note 2c)     - *)     109,312       (105,820 )     3,493  

 

    Share capital     Share premium    

Accumulated

deficit

   

Total

deficiency

 
    Unaudited  
    NIS in thousands  
                         
Balance as of March 31, 2021        - *)     353,783       (332,979 )     20,804  
                                 
Total comprehensive loss     -       -       (11,993 )     (11,993 )
Share-based compensation     -       2,575       -       2,575  
                                 
Balance as of June 30, 2021     - *)     356,358       (344,972 )     11,386  
                                 
Balance as of June 30, 2021 (convenience translation into U.S. dollars (see Note 2c)     - *)     109,312       (105,820 )     3,493  

 

*) Represents less than NIS\USD 1.

 

The accompanying notes are an integral part of the interim financial statements.

 

F-5

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIENCY)

In thousands, except share and per share data

 

    Share capital     Share premium    

Accumulated

deficit

   

Total

deficiency

 
    Unaudited  
    NIS  
                         
Balance as of January 1, 2020     - *)     255,285       (320,338 )     (65,053 )
                                 
Total comprehensive loss     -       -       (45,673 )     (45,673 )
Exercise of warrants     -       45,274       -       45,274  
Share-based compensation     -       3,530       -       3,530  
                                 
Balance as of June 30, 2020     - *)     304,089       (366,011 )     (61,922 )
                                 
Balance as of June 30, 2020 (convenience translation into U.S. dollars (see Note 2c)     - *)     93,279       (112,273 )     (18,994 )

 

    Share capital     Share premium     Accumulated deficit     Total deficiency  
    Unaudited  
    NIS in thousands  
                         
Balance as of April 1, 2020        - *)     262,729       (324,033 )     (61,304 )
                                 
Total comprehensive loss     -       -       (41,978 )     (41,978 )
Exercise of warrants     -       38,034       -       38,034  
Share-based compensation     -       3,326       -       3,326  
                                 
Balance as of June 30, 2020     - *)     304,089       (366,011 )     (61,922 )
                                 
Balance as of June 30, 2020 (convenience translation into U.S. dollars (see Note 2c)     - *)     93,279       (112,273 )     (18,994 )

 

*) Represents less than NIS\USD 1.

 

The accompanying notes are an integral part of the interim financial statements.

 

F-6

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIENCY)

In thousands, except share and per share data

 

    Share capital     Share premium    

Accumulated

deficit

   

Total

deficiency

 
    Audited  
    NIS in thousands  
                         
Balance as of January 1, 2020       - *)     255,285       (320,338 )     (66,053 )
                                 
Total comprehensive loss     -       -       (4,455 )     (4,455 )
                                 
Exercise of warrants     -       45,274       -       45,274  
Exercise of options     -       166       -       166  
Share-based compensation     -       9,472       -       9,472  
                                 
Balance as of December 31, 2020     - *)     310,197       (324,793 )     (14,596 )
                                 
Balance as of December 31, 2020 (convenience translation into U.S. dollars (see Note 2c)     - *)     95,152       (99,630 )     4,478  

 

*) Represents less than NIS\USD 1.

 

The accompanying notes are an integral part of the interim financial statements.

 

F-7

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

STATEMENTS OF CASH FLOWS

In thousands, except share and per share data

 

                                  Convenience translation (Note 2)  
    Year ended
December 31,
    Three months ended
June 30,
    Six months ended
June 30,
   

Six months

ended

June 30,

 
    2020     2020     2021     2020     2021     2021  
    Audited     Unaudited     Unaudited  
    N I S     U.S. dollars  
Cash flows from operating activities:                                    
Net loss     (4,455 )     (41,978 )     (11,993 )     (45,673 )     (20,179 )     (6,189 )
                                                 
Adjustments to reconcile net loss to net cash used in operating activities:                                                
                                                 
Adjustments to profit and loss items:                                                
Depreciation of property, plant and equipment and right-of-use assets     2,436       603       604       1,204       1,209       371  
Net financial expenses (income)     12,940       21,601       520       13,062       (471 )     (144 )
Capital gain     (160 )     -       -       (160 )     -       -  
Increase (decrease) in liability with respect to loans from others     (63,359 )     4,257       1,902       (1,739 )     3,827       3,174  
Decrease in liability with respect to government grants     (14,812 )     (305 )     -       (2,126 )     -       -  
Share-based compensation     9,472       3,326       2,575       3,530       4,032       1,237  
Change in employee benefit liabilities, net     6       2       -       3       -       -  
      (53,477 )     29,484       5,601       13,774       8,597       4,638  
Changes in asset and liability items:                                                
Increase in other receivables     (548 )     (927 )     (2,191 )     (1,811 )     (1,467 )     (450 )
Increase (decrease) in trade payables     (15,194 )     792       550       (12,992 )     767       235  
Increase in short- and long-term other payables     1,178       801       99       405       493       151  
                                                 
      (14,564 )     666       (1,542 )     (14,398 )     (207 )     (64 )
Cash paid and received during the year for:                                                
Interest paid     (45 )     (12 )     24       (24 )     15       4  
Interest received     2       1       -       1       -       -  
                                                 
      (43 )     (11 )     24       (23 )     15       4  
                                                 
Net cash flows used in operating activities   (72,539 )   (11,839 )   (7,910 )   (46,320 )   (11,774 )   (3,612 )

 

*) Represents an amount lower than NIS\USD 1.

 

The accompanying notes are an integral part of the interim financial statements.

 

F-8

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

STATEMENTS OF CASH FLOWS

In thousands, except share and per share data

 

                                  Convenience translation (Note 2)  
    Year ended
December 31,
    Three months ended
June 30,
    Six months ended
June 30,
    Six months
ended
June 30,
 
    2020     2020     2021     2020     2021     2021  
    Audited     Unaudited     Unaudited  
    N I S     U.S. dollars
Cash Flows from Investing Activities:                                    
Purchase of property and equipment     (6,132 )     (1,315 )     (106 )     (2,687 )     (128 )     (39 )
Proceeds from sale of property and equipment     160       -       -       160       -       -  
Increase (decrease) in other long term assets     37       8       (1 )     (381 )     36       11  
                                                 
Net cash used in investing activities     (5,935 )     (1,307 )     (107 )     (2,908 )     (92 )     (28 )
                                                 
Cash Flows from Financing Activities:                                                
                                                 
Repayment of operating lease liabilities     (1,240 )     (310 )     (317 )     (622 )     (623 )     (171 )
Proceeds from exercise of options to employees     166                                          
Proceeds from exercise of warrants to public     14,790       10,344       -       14,790       -       12,923  
Proceeds from issuance of shares, net of issuance costs     -       -       -       -       42,129       -  
                                                 
Net cash provided by (used in) financing activities     13,716       10,034       (317 )     14,168       41,506       12,732  
                                                 
Exchange differences on balances of cash and cash equivalents     1,712       (642 )     (360 )     1,345       822       252  
                                                 
Increase (decrease) in cash and cash equivalents     (63,046 )     (3,754 )     (8,694 )     (33,715 )     30,462       9,345  
Balance of cash and cash equivalents at the beginning of the period     72,467       42,506       48,577       72,467       9,421       2,890  
                                                 
Balance of cash and cash equivalents at the end of the period     9,421       38,752       39,883       38,752       39,883       12,235  
                                                 
Non cash financing activities                                                
                                                 
Exercise of warrants to the public   30,484     27,690       -     30,484     -     -  

 

The accompanying notes are an integral part of the interim financial statements.

 

F-9

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

NOTES TO INTERIM FINANCIAL STATEMENTS

In thousands, except share and per share data

 

NOTE 1: GENERAL

 

a. BiondVax Pharmaceuticals Ltd. (“the Company”) is focused on developing and ultimately commercializing products for prevention and treatment of infectious diseases and related illnesses. The Company was incorporated on July 21, 2003 in Israel, and started its activity on March 31, 2005. The Company’s principal executive offices and main laboratory are located at Jerusalem BioPark, 2nd floor, Hadassah Ein Kerem Campus, Jerusalem, Israel, next to Hadassah University Hospitals and Hebrew University’s Medical School.

 

b. On May 15, 2015, the Company completed a public offering of securities in the United States.

 

c. On March 28, 2017, the Company received an approval from the Investment Center of the Ministry of Economy and Industry of the State of Israel, for a grant (“the Grant”) representing 20% of a NIS 20,000 budget to be utilized towards the construction of a factory for the production of Phase 3 and commercial batches of the Company’s product. The receipt of the Grant was subject to certain terms and conditions, including those outlined under the Israeli Encouragement of Capital Investment Law,1959. The terms and conditions included, inter alia, the following: (a) at least 24% of the investments in the planned manufacturing facility’s fixed assets would be financed by additional share capital; (b) the Company would maintain its intellectual property and manufacturing facility in Israel for a period of at least 10 years.

 

To the report date the Investment Center of the Ministry of Economy and Industry of the State of Israel has yet to approve the grant to the company.

 

d. On June 19, 2017, the Company entered into a Finance Contract with the European Investment bank (EIB) for a total amount of € 20,000 (approximately $ 23,200) and up to 50% of the Company’s expected cost of developing and marketing the Company’s product candidate, M-001. In addition, as repayment features, EIB was entitled to receive the higher between 3% of any M-001 sales revenues for a period of ten years, or realizing a cash-on-cash multiple of 2.8 times.

 

e. On April 22, 2019, the EIB agreed to expand the 2017 financing agreement to the Company by an additional € 4,000 to a total of € 24,000 (approximately $ 27,600).

 

f. On October 23, 2020, the Company announced Phase 3 clinical trial results of its M-001 universal vaccine product. The results did not demonstrate a statistically significant difference between the vaccinated group and the placebo group in reduction of flu illness and severity. Therefore, the study failed to meet both the primary and secondary efficacy endpoints. However, the study’s primary safety endpoint was met.

 

g. On January 26, 2021, the EIB notified us, among other things, that they will not consider the failure of our pivotal phase 3 trial for M-001 to meet the primary and secondary efficacy endpoints as a trigger for prepayment of the loan extended under the Finance Contract.

 

F-10

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

NOTES TO INTERIM FINANCIAL STATEMENTS

In thousands, except share and per share data

 

NOTE 1: GENERAL (Cont.)

 

However, the EIB cautioned us that their letter is not a consent, agreement, amendment or waiver in respect of the terms of the Finance Contract, reserving any other right or remedy the EIB may have now or subsequently. There is no guarantee that the decision by the EIB in their letter will not change at any time and without any notice or that the EIB will not determine that an event of default has occurred under the Finance Contract, which could result in all loans extended under the Finance Contract being accelerated and secured creditor remedies being exercised. If some or all of the loans under the Finance Contract are accelerated by the EIB, or secured creditor remedies are exercised, we expect such events to adversely impact our ability to continue as a going concern.

 

As of June 30, 2021, the EIB loan balance is $19,708 (approximately NIS 64,248).

 

h. On January 21, 2021, the Company announced the appointment of Amir Reichman as its new Chief Executive Officer. Mr. Reichman and Dr. Ron Babecoff, its founder and former CEO, shared duties during a transition period while Mr. Reichman completed his former work obligations. Effective March 2, 2021, Mr. Reichman assumed the CEO position full time and Dr. Babecoff continued as Senior Advisor to the Company.

 

i. On February 2, 2021, the Company closed an underwritten offering in which it sold 2,434,783 ADSs at a public offering price of $4.95 per ADS. On February 10, 2021, Aegis Capital Corp., the sole bookrunning manager for the underwritten offering, fully exercised its over-allotment option to purchase an additional 365,217 ADSs, bringing total gross proceeds to the Company from the offering including exercise of the over-allotment option of approximately $13,800. The Company received a net sum of $12,750 (approximately NIS 42,129).

 

j. In the six months ended June 30, 2021, the Company incurred a loss of NIS 20,179 ($ 6,189) and negative cash flows from operating activities of NIS 11,774 ($ 3,612) and it has an accumulated deficit of NIS 344,972 ($ 105,820) as of that date.

 

To date the Company has not generated any revenues and will need additional funds to finance its operations in the future.

 

Furthermore, the Company intends to continue to finance its operating activities by raising capital. There are no assurances that the Company will be successful in obtaining an adequate level of financing needed for its long-term research, development and potential commercialization activities.

 

If the Company will not have the sufficient liquidity resources, the Company may not be able to continue the development of its prospective products or may be required to implement a cost reduction and may be required to delay part of its development program. The Company’s management and Board of Directors are of the opinion that its current financial resources will be sufficient to continue the operations of the Company for at least the next twelve months.

 

F-11

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

NOTES TO FINANCIAL STATEMENTS

In thousands, except share and per share data

 

NOTE 2:- CONVENIENCE TRANSLATION INTO U.S. DOLLARS

 

The financial statements as of June 30, 2021 and for the six months then ended have been translated into dollars using the representative exchange rate as of that date ($ 1 =  NIS 3.26). The translation was made solely for the convenience of the reader. The amounts presented in these financial statements should not be construed to represent amounts receivable or payable in dollars or convertible into dollars, unless otherwise indicated in these statements.

 

NOTE 3: SIGNIFICANT ACCOUNTING POLICIES

 

These financial statements have been prepared in a condensed format as of June 30, 2021, and for the three and six months then ended (“interim financial statements”). These financial statements should be read in conjunction with the Company’s annual financial statements as of December 31, 2020, and for the year then ended and accompanying notes (“annual financial statements”).

 

Basis of preparation of the interim financial statements

 

The interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles for the preparation of financial statements for interim periods, as prescribed in IAS 34, “Interim Financial Reporting”, and in accordance with the disclosure requirements of Chapter D of the Securities Regulations (Periodic and Immediate Reports), 1970.

 

The significant accounting policies and methods of computation adopted in the preparation of the interim financial statements are consistent with those followed in the preparation of the Company’s annual financial statements.

 

NOTE 4: MAJOR EVENTS DURING THE PERIOD

 

a. On April 6, 2021, the Company held an Extraordinary Meeting of Shareholders (the “Meeting”). At the Meeting, among other approved resolutions, the Company approved grants to the board members and CEO:

 

1. 30,000 RSUs to 6 directors, to vest in equal monthly installments during a period of three (3) years (if they continue to serve as directors) commencing one (1) month following the date of shareholder approval and would become fully vested, in accordance with the terms of the grant, on April 6, 2024. The RSUs would be subject to accelerated vesting in the event of a change of control.

 

2. Options to purchase 150,000 ADSs of the Company at an exercise price of the greater of (i) $6.95, which is the greater of (x) 130% of the average closing price on Nasdaq during the 30 trading days prior to board approval and (y) 130% of the weighted average closing price on Nasdaq during the 30 calendar days prior to board approval), and (ii) 100% of the weighted average closing price on Nasdaq in the 30 calendar days prior to shareholder approval. The options, which would include the ability to exercise on a cashless basis, would vest in equal monthly installments during a period of three (3) years commencing one (1) month following the date of shareholder approval and would become fully vested, in accordance with the terms of the grant, on April 6, 2024. The options would be subject to accelerated vesting and would become immediately exercisable in the event of a change of control. In addition, the options would have a term of ten (10) years following the date of shareholder approval and, to the extent the options are vested, such vested options would continue to be exercisable during such term in the event of termination of service to the Company without cause.

 

F-12

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

NOTES TO INTERIM FINANCIAL STATEMENTS

In thousands, except share and per share data

 

NOTE 4: MAJOR EVENTS DURING THE PERIOD (cont.)

 

3. An amendment to the Company’s Articles of Association increasing the registered share capital of the Company by an additional 1,100,000,000 Ordinary Shares (the equivalent of 27.5 million ADSs) such that the total registered share capital of the Company would consist of 1,800,000,000 Ordinary Shares, no par value (the equivalent of 45 million ADSs).

 

4. The Company will issue to the new CEO 600,000 restricted share units (the “RSUs”) under the Company’s 2018 Israeli Share Option Plan, which will vest over a period of five years, 20% to vest each year on the anniversary date of the commencement date, and would become fully vested, in accordance with the terms of the grant, on March 2, 2026. The ADSs underlying the RSUs may not be sold by Mr. Reichman during the term of his employment.

 

5. The shareholders approved the amendment to the following options held by directors of the Company, as follows: Mr. Mark Germain (130,710 options), Prof. Avner Rotman (20,000 options), Mr. Adi Raviv (18,000 options), Prof. George H. Lowell (20,000 options), Dr. Morris Laster (18,000 options), Dr. Yael Margolin (18,000 options) and Mr. Isaac Devash (18,000 options) as follows:

 

a. accelerated vesting and the ability to immediately exercise such options in the event of a change of control; and

 

b. to the extent vested, allow the options to be exercised during the existing ten (10) year terms of the options in the event of the foregoing directors’ termination of service to the Company without cause.

 

NOTE 4: SUBSEQUENT EVENTS

 

- - - - - - - - - - -

 

 

F-13