0001213900-18-011551.txt : 20180822 0001213900-18-011551.hdr.sgml : 20180822 20180822080025 ACCESSION NUMBER: 0001213900-18-011551 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20180822 FILED AS OF DATE: 20180822 DATE AS OF CHANGE: 20180822 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BiondVax Pharmaceuticals Ltd. CENTRAL INDEX KEY: 0001611747 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 STATE OF INCORPORATION: L3 FISCAL YEAR END: 1213 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37353 FILM NUMBER: 181031423 BUSINESS ADDRESS: STREET 1: 14 EINSTEIN ST. CITY: NES-ZIONA STATE: L3 ZIP: 74036 BUSINESS PHONE: 972-8-9302529 MAIL ADDRESS: STREET 1: 14 EINSTEIN ST. CITY: NES-ZIONA STATE: L3 ZIP: 74036 6-K 1 f6k082218b_biondvaxpharma.htm REPORT OF FOREIGN PRIVATE ISSUER

 

 

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 2018

 

001-37353

(Commission File Number)

 

BIONDVAX PHARMACEUTICALS LTD.

(Exact name of Registrant as specified in its charter)

 

14 Einstein St.

Ness Ziona

Israel 7414002

(Address of principal executive offices)

 

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): ____

 

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

 

Yes ☐     No ☒

 

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-N/A

  

 

 

 

 

   

On August 22, 2018, BiondVax Pharmaceuticals Ltd. (“BiondVax”) issued a press release announcing its financial results for the period ended June 30, 2018. A copy of this press release and interim unaudited financial statements for period ended June 30, 2018, are attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively, and are incorporated herein by reference. 

 

Exhibit Index

 

Exhibit No.   Description
     
99.1   Press Release dated August 22, 2018.
99.2   BiondVax Pharmaceuticals Ltd. unaudited financial statements for the period ended June 30, 2018.

 

 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 22, 2018 By: /s/ Ron Babecoff
    Ron Babecoff
    Chief Executive Officer

 

 2 

 

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.

 

 2 

 

 

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 

 

 3 

EX-99.2 3 f6k082218bex99-2_biondvax.htm BIONDVAX PHARMACEUTICALS LTD. UNAUDITED FINANCIAL STATEMENTS FOR THE PERIOD ENDED JUNE 30, 2018

Exhibit 99.2 

 

 

 

BIONDVAX PHARMACEUTICALS LTD.

  

INTERIM FINANCIAL STATEMENTS

  

AS OF JUNE 30, 2018

  

NIS IN THOUSANDS

  

UNAUDITED

 

INDEX

 

  Page
   

Balance Sheets

2
   
Statements of Comprehensive Loss 3
   
Statements of Changes in Shareholders’ Equity 4 – 6
   
Statements of Cash Flows 7 – 8
   
Notes to Financial Statements 9 – 11

 

 

 

- - - - - - - - - - - - -

 

 

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

BALANCE SHEETS

 

In thousands, except share and per share data

 

              Convenience translation (Note 2) 
   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.

 

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

 

             
Date of approval of the   Avner Rotman   Ron Babecoff   Uri Ben-Or
financial statements   Chairman of the Board   Chief Executive officer   Chief Financial officer

 

2 

 

 

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,

 
   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)
    0                          
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 

 

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

 

3 

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

 

 

   Share
capital
   Share premium  

Accumulated

deficit

  

Total

Equity

 
   Unaudited 
   NIS in thousands 
                 
Balance as of January 1, 2018   *) -   179,669    (123,417)   56,252 
                     
Total comprehensive loss   -    -    (39,693)   (39,693)
                     
Share-based compensation   -    152    -    152 
                     
Balance as of June 30, 2018   *) -   179,821    (163,110)   16,711 
                     
Balance as of June 30, 2018 (convenience translation into U.S. dollars (see Note 2)   *) -   49,265    (44,688)   4,577 

 

   Share
capital
   Share premium   Options  

Other

Comprehensive income

  

Accumulated

deficit

  

Total

Equity

 
   Unaudited 
   NIS in thousands 
                         
Balance as of January 1,  2017   *) -   113,041    1,435    6    (88,866)   25,616 
                               
Loss   -    -    -    -    (23,504)   (23,504)
Other comprehensive loss   -    -    -    (4)   -    (4)
Total comprehensive loss   -    -    -    (4)   (23,504)   (23,508)
                               
Issuance of ordinary shares   *) -   15,387    -    -    -    15,387 
Exercise of Options   -    3,069    -    -    -    3,069 
Expiration of Options series 4   -    902    (902)   -    -    - 
Share-based compensation   -    425    -    -    -    425 
                               
Balance as of June 30, 2017 (unaudited)   *) -   132,824    533    2    (112,370)   20,989 

 

*) Represents an amount lower than NIS 1.

 

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

 

4 

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

 

   Share
capital
   Share premium  

Accumulated

deficit

  

Total

Equity

 
   Unaudited 
   NIS in thousands 
                 
Balance as of April 1, 2018   *) -    179,747    (137,619)   42,128 
                     
Total comprehensive loss   -    -    (25,491)   (25,491)
                     
Share-based compensation   -    74    -    74 
                     
Balance as of June 30, 2018   *) -    179,821    (163,110)   16,711 
                     
Balance as of June 30, 2018 (convenience translation into U.S. dollars (see Note 2)   *) -    49,265    (44,688)   4,577 

  

   Share
capital
   Share premium   Options  

Other

Comprehensive income

  

Accumulated

deficit

  

Total 

Equity

 
   Unaudited 
   NIS in thousands 
                         
Balance as of April 1,  2017   *) -   129,550    533    6    (100,698)   29,391 
                               
Loss   -    -    -    -    (11,672)   (11,672)
Other comprehensive loss   -    -    -    (4)   -    (4)
Total comprehensive loss   -    -    -    (4)   (11,672)   (11,676)
                               
Exercise of Options   -    3,069    -    -    -    3,069 
Share-based compensation   -    205    -    -    -    205 
                               
Balance as of June 30, 2017   *) -   132,824    533    2    (112,370)   20,989 

 

*) Represents an amount lower than NIS 1.

 

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

 

5 

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

 

  

   Share
capital
   Share premium   Options   Unrealized gain (loss) on available-for-sale financial assets  

Accumulated

deficit

  

Total

Equity

 
   NIS in thousands 
                         
Balance as of January 1, 2017   *) -   113,041    1,435    6    (88,866)   25,616 
                               
Loss   -    -    -    -    (34,551)   (34,551)
Other comprehensive loss   -    -    -    (6)   -    (6)
Total comprehensive loss   -    -    -    (6)   (34,551)   (34,557)
                               
Issuance of ordinary shares, net of issuance costs   *) -   55,692    -     -    -    55,692 
Exercise of employees options   *) -   18    -    -    -    18 
Exercise of options   *) -   8,964    -    -    -    8,964 
Expiration of options series 4   -    902    (902)   -    -    - 
Expiration of options series 5   -    533    (533)   -    -    - 
Share-based compensation   -    519    -    -    -    519 
                               
Balance as of December 31, 2017   *) -   179,669    -    -    (123,417)   56,252 

  

*) Represents an amount lower than NIS 1.

 

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

 

6 

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

STATEMENTS OF CASH FLOWS

  

                      

Convenience translation

(Note 2)

 
  

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) 
                         
Cash flows from operating activities:                        
Net loss   (34,551)   (11,672)   (25,491)   (23,504)   (39,693)   (10,875)
                               
Adjustments to reconcile net loss to net cash used in operating activities:                              
                               
Adjustments to profit and loss items:                              
Depreciation and amortization   440    106    266    255    414    114 
Net financial expenses (income)   10,895    9,080    (6,699)   17,944    (6,077)   (1,665)
Increase in liability with respect to government grants   10,300    -    1,538    -    2,490    682 
Share-based compensation   519    205    74    425    152    41 
Change in employee benefit liabilities, net   7    3    1    3    (4)   (1)
                               
    22,161    9,394    (4,820)   18,627    (3,025)   (829)
Changes in asset and liability items:                              
Increase  in other receivables   (3,108)   (1,332)   (1,092)   (1,014)   (144)   (39)
Increase (decrease) in trade payables   5,537    429    (7,203)   502    (4,900)   (1,342)
Increase (decrease) in other payables   (29)   138    12    (25)   120    33 
                               
    2,400    (765)   (8,283)   (537)   (4,924)   (1,349)
                               
Cash paid and received during the year for:                              
Interest paid   (73)   (7)   (7)   (15)   (12)   (3)
Interest received   13    1    26    9    26    7 
                               
    (60)   (6)   19    (6)   14    4 
                               
Net cash flows used in operating activities   (10,050)   (3,049)   (38,575)   (5,420)   (47,628)   (13,049)

 

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

 

7 

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

STATEMENTS OF CASH FLOWS

 

 

                      

Convenience translation

(Note 2)

 
  

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) 
     
Cash Flows from Investing Activities:                        
                         
Increase in short-term deposits   7,602    5,551    -    6,402    -    - 
Purchase of property and equipment   (4,508)   (42)   (6,522)   (45)   (13,697)   (3,753)
Proceeds from sale of  marketable securities   4,067    -    -    -    -    - 
Increase in other long term assets   (402)   (27)   -    (27)   -    - 
                               
Net cash provided by (used in) investing activities   6,759    5,482    (6,522)   6,330    (13,697)   (3,753)
                               
Cash Flows from Financing Activities:                              
                               
Proceeds from issuance of shares and options, net of issuance costs   55,692    4,482    -    15,387    -    - 
Loan from others             25,272    -    25,272    6,924 
Proceeds from exercise of options to employees   18    -    -    -    -    - 
Proceeds from exercise of options   6,129    1,312         1,312    -    - 
                               
Net cash provided by financing activities   61,839    5,794    25,272    16,699    25,272    6,924 
                               
Exchange differences on balances of cash and cash equivalents   (2,871)   (913)   1,277    (1,980)   1,799    493 
Increase (decrease) in cash and cash equivalents   55,677    7,314    (18,548)   15,629    (34,254)   (9,385)
                               
Balance of cash and cash equivalents at the beginning of the period   15,705    24,020    55,676    15,705    71,382    19,557 
                               
Balance of cash and cash equivalents at the end of the period   71,382    31,334    37,128    31,334    37,128    10,172 

 

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

 

8 

 

  

BIONDVAX PHARMACEUTICALS LTD.

 

NOTES TO 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 immunomodulation therapies for infectious diseases. The Company was incorporated on July 21, 2003 and started its activity on March 31, 2005.

 

b.On June 7, 2007, the Company issued ordinary shares and options on the TASE.

 

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 representing 20% of 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 is product (“the Grant”). The receipt of the Grant is subject to certain terms and conditions, including those outlined under the Israeli Encouragement of Capital Investment Law,1959. The terms and conditions include, inter alia, the following: (a) at least 24% of the investments in the planned manufacturing facility’s fixed assets will be financed by additional share capital; (b) the Company will maintain its intellectual property and manufacturing facility in Israel for a period of at least 10 years.

 

d.On July 20, 2017, the Compnay announced positive results for Phase 2b BVX-007 clinicaltrial, a clinical trial conducted with the collaboration of the European UNISEC consortium to work on promising concepts for a universal influenza vaccine.

 

e.On August 30, 2017, the Company announced that its Board of Directors has decided to voluntarily delist from the Tel Aviv Stock Exchange (TASE), while remaining listed on NASDAQ. The Company announced that the delisting process of BiondVax’s shares from trading on the TASE will take place by the end of 2017. An announcement regarding the delisting procedure and timeline will follow. In addition, during the interim period, BiondVax’s shares will continue to be traded on the TASE. The Company also announced that the Board of Directors has also decided to form a committee to identify a new Chairman of the Board with relevant global experience, to guide the Company through the anticipated upcoming international Phase 3 trials and global commercialization. Professor Avner Rotman will continue to serve as Chairman until a suitable replacement is identified.

 

f.On November 20, 2017, the Company announced the signing of a clinical trial agreement with the National Institute of Allergy and Infection Diseases of the U.S. National Institutes of Health for a Phase 2 clinical trial in the U.S. using BiondVax’s product candidate, M-001.

 

g.On January 22, 2018, the Company signed a letter of intent, or LOI, with a European contract research organization, for the purpose of conducting a phase 3 clinical trial in Europe, planned by the Company to begin prior to the 2018/19 flu season.

 

Under the LOI, the parties are to enter into a master service agreement and work order related to the performance of a phase 3 trial as soon as possible in order to assess the safety and clinical efficacy of BiondVax’s product candidate M-001, a universal influenza vaccine. The LOI includes an upfront fee payable by the Company of €200,000 for start-up activities, as detailed in the LOI. The LOI continues in effect until the earlier of: (1) the end of the one month period following the execution of the LOI or (2) the execution of the master service agreement, unless extended. 

 

On June 18, 2018, the first trach of $7 million received by the Company according to the financing agreement signed in June 2017.

 

9 

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

NOTES TO FINANCIAL STATEMENTS

In thousands (except share and per share data)

 

NOTE 1: GENERAL (Cont.)

  

h.On March 13, 2018, the Company announced the appointment of a contract research organization (CRO) to conduct the first pivotal phase 3 clinical trial of M-001, BiondVax’s universal flu vaccine candidate.

 

i.On March 15, 2018, the Company and the CRO executed a master service agreement and work order. According to the master service agreement, the Company undertakes to pay remuneration as well as to reimburse the CRO for costs incurred as a result of the master service agreement and work orders. The master service agreement shall be in effect as of March 8, 2018 for a period of five years or later, if a work order remains in effect, and until such work order’s completion. The first work order which governs the conduct of the Company’s clinical trial in Europe is scheduled for a total period of 32.5 months. The Company has a right to terminate the master service agreement or the work order by giving a 45 days’ notice or in the event of a material breach.

 

j.In the six months ended June 30, 2018, the Company incurred a loss of NIS 39,693 ($ 10,875) and negative cash flows from operating activities of NIS 47,630 ($ 13,049) and it has an accumulated deficit of NIS 163,110 ($ 44,688) as of that date.

 

To date the Company has not generated any revenues yet and will need additional funds to finance its Phase 3 clinical trials in the future.

 

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

 

The financial statements as of June 30, 2018 and for the six months then ended have been translated into dollars using the representative exchange rate as of that date ($ 1 =  NIS 3.65). 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.

 

10 

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

NOTES TO FINANCIAL STATEMENTS

In thousands (except share and per share data)

 

NOTE 3: SIGNIFICANT ACCOUNTING POLICIES

 

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: SUBSEQUENT EVENT

 

On August 13, 2018 the second trach of $7 million received by the Company according to the financing agreement signed in June 2017 ( see also Note 1g ).

 

- - - - - - - - - - - - - - - - - - - -

 

11 

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