0001213900-21-063101.txt : 20211202 0001213900-21-063101.hdr.sgml : 20211202 20211202161511 ACCESSION NUMBER: 0001213900-21-063101 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 9 CONFORMED PERIOD OF REPORT: 20211202 FILED AS OF DATE: 20211202 DATE AS OF CHANGE: 20211202 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: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37353 FILM NUMBER: 211466776 BUSINESS ADDRESS: STREET 1: JERUSALEM BIOPARK, 2ND FLOOR STREET 2: HADASSAH EIN KEREM CAMPUS CITY: JERUSALEM STATE: L3 ZIP: 00000 BUSINESS PHONE: 972-8-9302529 MAIL ADDRESS: STREET 1: JERUSALEM BIOPARK, 2ND FLOOR STREET 2: HADASSAH EIN KEREM CAMPUS CITY: JERUSALEM STATE: L3 ZIP: 00000 6-K 1 ea151533-6k_biondvax.htm FORM 6-K

 

 

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 November 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 November 30, 2021, BiondVax Pharmaceuticals Ltd. issued a press release announcing third quarter 2021 financial results.

Exhibit Index

Exhibit No.   Description
     
99.1   Press Release dated November 30, 2021
99.2   BiondVax Pharmaceuticals Ltd. unaudited interim financial statements for the period ending September 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).

 

 

 

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: December 2, 2021 By: /s/ Amir Reichman
    Amir Reichman
    Chief Executive Officer

 

 

 

EX-99.1 2 ea151533ex99-1_biondvax.htm PRESS RELEASE DATED NOVEMBER 11, 2021

Exhibit 99.1

 

 

 

BiondVax announces Third Quarter 2021 Financial Results and Provides Business Update

 

 

Jerusalem, Israel – November 30, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), which focuses on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today published its third quarter financial results for the quarter ended September 30, 2021 and provided a business update.

 

Business Update

·As recently announced, BiondVax signed a term sheet with the world-renowned Max Planck Society (MPG) and the University Medical Center Göttingen (UMG), Germany, for a broad strategic collaboration for the creation of an innovative VHH-antibody (VHH-Ab) pipeline.
·VHH antibodies exhibit distinct advantages over monoclonal antibodies for a number of disease conditions. The collaboration with MPG and UMG would focus on large addressable markets, with known and validated drug targets (thereby shortening development timelines and lowering risk), and where the VHH-Ab advantages have the potential to capture significant market share. Scientists at MPG and UMG are among the leaders worldwide in designing VHH-Abs with superior specificity and binding affinity, traits which can increase efficacy, reduce side effects, and at a lower cost than currently available monoclonal antibodies. In addition, the small size and thermostability of VHH-Abs allows treatment through inhalation, intradermal and other favorable routes of administration and without the need for enhanced cold chain storage and transport. Together, these attributes have the potential to create significant competitive advantages.
·Manufacturing preparations underway: To accelerate development timelines, BiondVax has initiated preparations for the manufacturing of VHH-Abs at the Company’s GMP biologics manufacturing facility in Jerusalem. Furthermore, BiondVax’s current and 2022 planned activities, such as setting-up equipment, developing analytical methods, and training staff, will be oriented toward all VHH-antibody production arising out of the collaboration.
·COVID-19 variants of concern: Max Planck’s currently developed VHH-Ab has demonstrated superior neutralization of all major Variants of Concern (VoC), including Delta. The COVID-19 license agreement between BiondVax and Max Planck will also include an accompanying research collaboration agreement that provides BiondVax with exclusive access to ongoing life-cycle improvements of the COVID-19 VHH-Abs for emerging VoCs including Omicron.
·The European Investment Bank (EIB) has indicated that it supports BiondVax’s new strategic turnaround plans. The parties are currently in discussions to renegotiate the terms of the EIB’s €24 million loan to BiondVax in a manner that would serve both parties’ long-term interests. BiondVax will update its shareholders regarding terms of such negotiations if and once the parties reach an agreement.
·The Annual General Meeting (AGM) of Shareholders of the Company will be held on December 27, 2021. Resolutions to be voted upon at the AGM include the election to the Company’s Board of Directors of Jay Green, former Senior Vice President Finance and CFO of GlaxoSmithKline plc (NYSE: GSK) global vaccine business. Further information about the AGM, including a link to the Proxy Statement and voting card, are available on the SEC website at https://www.sec.gov/Archives/edgar/data/0001611747/000121390021060974/ea151013-6k_biondvaxpharma.htm. Shareholders are invited to contact their broker for voting procedures.

 

 


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

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

 

   

Amir Reichman, BiondVax’s CEO, stated, “The innovative VHH-antibody platform, combined with our agile manufacturing capabilities and planned ongoing collaboration with Max Planck, will enable us to respond quickly to new COVID variants of concern, including Omicron. By preparing now to manufacture batches in-house for preclinical studies, we are streamlining manufacturing for clinical and commercial batches of therapies for known and emerging COVID-19 variants, as well as for the anticipated psoriasis, asthma, macular degeneration, and psoriatic arthritis VHH-antibody therapies. BiondVax is in the process of a transformative turnaround, and we are working with urgency to bring VHH-antibody therapies with compelling commercial potential that address important healthcare needs to the market.

 

Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.229 (NIS/$US), the rate as of the close of business on September 30, 2021.

·R&D expenses for the three months ended September 30, 2021 decreased to NIS 2.0 million ($0.6 million) from NIS 12.6 million for the three months ended September 30, 2020. This decrease was primarily attributable to expenses related to a Phase 3 clinical trial and related operations at our biologics manufacturing facility that took place during Q3 2020. As previously reported, the trial concluded in Q4 2020.
·Marketing, general and administrative expenses for the three months ended September 30, 2021 decreased to NIS 6.2 million ($1.9 million) from NIS 7.3 million for the three months ended September 30, 2020. This decrease of NIS 1.1 million ($0.34 million) was primarily due to a decrease of NIS 0.4 million in salary and salary related expenses, decrease of NIS 1.6 million in share-based payments expenses offset with increased professional expenses of NIS 0.7 million.
·Operating expenses for the three months ended September 30, 2021 were NIS 8.2 million ($2.5 million) compared with NIS 20.0 million for the three months ended September 30, 2020.

 

As of September 30, 2021, BiondVax had cash and cash equivalents of NIS 34.6 million ($10.7 million) as compared to NIS 39.9 million as of June 30, 2021.

 

Unaudited Q3 financial results will be submitted to the Securities and Exchange Commission. A summary is included in the tables below.

 

About BiondVax

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms. www.biondvax.com.

 

Contact Details

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

Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.com

 

 


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

Telephone: +972-8-9302529 ● Fax: +972-8-9302531 ● www.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. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements regarding execution of a definitive agreement with the Max Planck Society and the University Medical Center Göttingen; the therapeutic and commercial potential of VHH antibodies and agreement with EIB regarding the restructuring of the loan from EIB. 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 will not execute a definitive agreement with the Max Planck Society and the University Medical Center Göttingen; the risk that the therapeutic and commercial potential of VHH antibodies will not be met; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from EIB; 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

 

 

BALANCE SHEETS

In thousands, except share and per share data 

 

   Convenience 
   Translation 
   December 31,   September 30,   September 30, 
   2020   2020   2021   2021 
   Audited   Unaudited   Unaudited 
         N I S         U.S. dollars 
CURRENT ASSETS:                    
Cash and cash equivalents   9,421    24,774    34,672    10,738 
Other receivables   1,204    2,930    1,426    442 
                     
    10,625    27,704    36,098    11,180 
LONG-TERM ASSETS:                    
Property, plant and equipment   39,607    39,889    38,607    11,956 
Right-of-use assets   6,206    6,433    5,874    1,819 
Other long-term assets   473    891    446    138 
                     
    46,286    47,213    44,927    13,913 
                     
    56,911    74,917    81,025    25,093 
CURRENT LIABILITIES:                    
Trade payables   1,868    8,213    3,313    1,026 
Operating lease liabilities   654    653    777    241 
Loan from others   60,421    -    64,488    19,972 
Other payables   1,246    2,289    1,693    524 
                     
    64,189    11,155    70,271    21,763 
LONG-TERM LIABILITIES:                    
Operating lease liabilities   6,088    6,268    5,905    1,829 
Loan from others   -    59,242    -    - 
Other payables   1,135    -    568    176 
Severance pay liability, net   95    93    95    29 
                     
    7,318    65,603    6,568    2,034 
SHAREHOLDERS' EQUITY:                    
Ordinary shares of no par value: Authorized: 1,800,000,000 shares at September 30, 2021 (unaudited) and 600,000,000 shares at September 30, 2020 (unaudited) and at December 31, 2020; Issued and outstanding: 573,285,824 shares at September 30, 2021 (unaudited), 460,822,640 shares at September 30, 2020 (unaudited) and 461,285,824 shares at December 31, 2020   *)-    *)-    *)-    *)- 
Share premium   310,197    308,855    358,204    110,933 
Accumulated deficit   (324,793)   (310,696)   (354,018)   (109,637)
                     
    (14,596)   (1,841)   4,186    1,296 
    56,911    74,917    81,025    25,093 

  

*)Represents less than NIS\USD 1.

 

 

 


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

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

 

  

STATEMENTS OF COMPREHENSIVE LOSS

In thousands, except share and per share data

 

       Convenience translation 
   Year ended December 31,   Three months ended September 30,   Nine months ended September 30,   Nine months  ended September 30, 
   2020   2020   2021       2021   2021 
   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    12,579    2,024    43,595    6,677    2,068 
Marketing, general and administrative   16,687    7,303    6,201    12,423    17,208    5,329 
Other income   (75,484)   (75,485)   -    (75,485)   -    - 
                               
Total operating expenses (income)   (7,334)   (55,603)   8,225    (19,467)   23,885    7,397 
                               
Operating income (loss)   7,334    55,603    (8,225)   19,467    (23,885)   (7,397)
                               
Financial income   3,843    -    1,980    5,034    2,802    868 
  Financial expense   (15,632)   (288)   (2,801)   (14,859)   (8,142)   (2,522)
                               
Net  Income (loss)   (4,455)   55,315    (9,046)   9,642    (29,225)   (9,051)
                               
Basic net income (loss) per share (NIS)   (0.01)   0.12    (0.02)   0.02    (0.05)   (0.02)
Diluted net income (loss) per share (NIS)   (0.01)   0.10    (0.02)   0.02    (0.05)   (0.02)
                               
Weighted average number of shares outstanding used to compute basic and diluted loss per share   443,260,878    461,046,640    573,205,607    437,381,202    559,239,052    559,239,052 
Weighted average number of shares outstanding used to compute diluted income (loss) per share   443,260,878    538,495,403    573,205,607    497,489,765    559,239,052    559,239,052 

 

 

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

 

 

 

 

 

EX-99.2 3 ea151533ex99-2_biondvax.htm BIONDVAX PHARMACEUTICALS LTD. UNAUDITED INTERIM FINANCIAL STATEMENTS FOR THE PERIOD ENDING SEPTEMBER 30, 2021

Exhibit 99.2

 

BIONDVAX PHARMACEUTICALS LTD.

 

INTERIM FINANCIAL STATEMENTS

 

AS OF SEPTEMBER 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

 

               Convenience 
               Translation 
               (Note 2c) 
   December 31,   September 30,   September 30, 
   2020   2020   2021   2021 
   Audited   Unaudited   Unaudited 
       N I S   U.S. dollars 
CURRENT ASSETS:                
Cash and cash equivalents   9,421    24,774    34,672    10,738 
Other receivables   1,204    2,930    1,426    442 
                     
    10,625    27,704    36,098    11,180 
LONG-TERM ASSETS:                    
Property, plant and equipment   39,607    39,889    38,607    11,956 
Right-of-use assets   6,206    6,433    5,874    1,819 
Other long-term assets   473    891    446    138 
                     
    46,286    47,213    44,927    13,913 
                     
    56,911    74,917    81,025    25,093 

 

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

 

               Convenience 
               Translation 
               (Note 2c) 
   December 31   September 30,   September 30, 
   2020   2020   2021   2021 
   Audited   Unaudited   Unaudited 
       N I S   U.S. dollars 
CURRENT LIABILITIES:                
Trade payables   1,868    8,213    3,313    1,026 
Operating lease liabilities   654    653    777    241 
Loan from others   60,421    -    64,488    19,972 
Other payables   1,246    2,289    1,693    524 
                     
    64,189    11,155    70,271    21,763 
LONG-TERM LIABILITIES:                    
Operating lease liabilities   6,088    6,268    5,905    1,829 
Loan from others   -    59,242    -    - 
Other payables   1,135    -    568    176 
Severance pay liability, net   95    93    95    29 
                     
    7,318    65,603    6,568    2,034 
SHAREHOLDERS’ EQUITY:                    
Ordinary shares of no par value: Authorized: 1,800,000,000 shares at September 30, 2021 (unaudited) and 600,000,000 shares at September 30, 2020 (unaudited) and at December 31, 2020; Issued and outstanding: 573,285,824 shares at September 30, 2021 (unaudited), 460,822,640 shares at September 30, 2020 (unaudited) and 461,285,824 shares at December 31, 2020   -*)   -*)   -*)   -*)
Share premium   310,197    308,855    358,204    110,933 
Accumulated deficit   (324,793)   (310,696)   (354,018)   (109,637)
                     
    (14,596)   (1,841)   4,186    1,296 
                     
    56,911    74,917    81,025    25,093 

 

*)Represents less than NIS\USD 1.

 

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

 

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

September 30,

  

Nine months ended

September 30,

  

Nine months

ended

September 30,

 
   2020   2020   2021   2020   2021   2021 
   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    12,579    2,024    43,595    6,677    2,068 
Marketing, general and administrative   16,687    7,303    6,201    12,423    17,208    5,329 
Other income   (75,484)   (75,485)   -    (75,485)   -    - 
                               
Total operating expenses (income)   (7,334)   (55,603)   8,225    (19,467)   23,885    7,397 
                               
Operating income (loss)   7,334    55,603    (8,225)   19,467    (23,885)   (7,397)
                               
Financial income   3,843    -    1,980    5,034    2,802    868 
 Financial expense   (15,632)   (288)   (2,801)   (14,859)   (8,142)   (2,522)
                               
Net  Income (loss)   (4,455)   55,315    (9,046)   9,642    (29,225)   (9,051)
                               
Basic net income (loss) per share (NIS)   (0.01)   0.12    (0.02)   0.02    (0.05)   (0.02)
Diluted net income (loss) per share (NIS)   (0.01)   0.10    (0.02)   0.02    (0.05)   (0.02)
                               
Weighted average number of shares outstanding used to compute basic and diluted loss per share   443,260,878    461,046,640    573,205,607    437,381,202    559,239,052    559,239,052 
Weighted average number of shares outstanding used to compute diluted income (loss) per share   443,260,878    538,495,403    573,205,607    497,489,765    559,239,052    559,239,052 

 

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   -    -    (29,225)   (29,225)
Issuance of shares, net   -    41,448    -    41,448 
Share-based compensation   -    6,559    -    6,559 
                     
Balance as of September 30, 2021   -*)   358,204    (354,018)   4,186 
                     
Balance as of September 30, 2021 (convenience translation into U.S. dollars (see Note 2c)   -*)   110,933    (109,637)   1,296 

 

   Share capital   Share premium  

Accumulated

deficit

  

Total

deficiency

 
   Unaudited 
   NIS in thousands 
                 
Balance as of July 1, 2021   -*)   356,358    (344,972)   11,386 
                     
Issuance expenses   -    (681)   -    (681)
Total comprehensive loss   -    -    (9,046)   (9,046)
Share-based compensation   -    2,527    -    2,527 
                     
Balance as of September 30, 2021   -*)   358,204    (354,018)   4,186 
                     
Balance as of September 30, 2021 (convenience translation into U.S. dollars (see Note 2c)   -*)   110,933    (109,637)   1,296 

 

*)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 income   -    -    9,642    9,642 
Exercise of warrants   -    45,274    -    45,274 
Exercise of options   -    166    -    166 
Share-based compensation   -    8,130    -    8,130 
                     
Balance as of September 30, 2020   -*)   308,855    (310,696)   (1,841)
                     
Balance as of September 30, 2020 (convenience translation into U.S. dollars (see Note 2c)   -*)   95,650    (96,220)   570 

 

   Share capital   Share premium  

Accumulated

deficit

  

Total

deficiency

 
   Unaudited 
   NIS in thousands 
                 
Balance as of July 1, 2020   -*)   304,089    (366,011)   (61,922)
                     
Total comprehensive loss   -    -    55,315    55,315 
Exercise of warrants   -    166    -    166 
Share-based compensation   -    4,600    -    4,600 
                     
Balance as of September 30, 2020   -*)   308,855    (310,696)   (1,841)
                     
Balance as of September 30, 2020 (convenience translation into U.S. dollars (see Note 2c)   -*)   95,650    (96,220)   570 

 

*)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)   -*)   95,065    (100,586)   5,521 

 

*)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

September 30,

  

Nine months ended

September 30,

  

Nine months

ended

September 30,

 
   2020   2020   2021   2020   2021   2021 
   Audited   Unaudited   Unaudited 
   N I S   U.S. dollars 
Cash flows from operating activities:                        
Net income (loss)   (4,455)   55,315    (9,046)   9,642    (29,225)   (9,051)
                               
Adjustments to reconcile net income (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    626    612    1,830    1,821    564 
Net financial expenses (income)   12,940    285    (1,803)   13,347    (2,274)   (704)
Capital gain   (160)   -    -    (160)   -    - 
Incease (decrease) in liability with respect to loans from others   (63,359)   (62,799)   240    (64,538)   4,067    1,260 
Decrease in liability with respect to government grants   (14,812)   (12,686)   -    (14,812)   -    - 
Share-based compensation   9,472    4,600    2,527    8,130    6,559    2,030 
Change in employee benefit liabilities, net   6    1    -    4    -    - 
    (53,477)   (69,973)   1,576    (56,199)   10,173    3,150 
Changes in asset and liability items:                              
Decrease (increase) in other receivables   (548)   (463)   1,215    (2,274)   (252)   (78)
Increase (decrease) in trade payables   (15,194)   4,143    678    (8,849)   1,445    447 
Increase (decrease)  in short- and long-term other payables   1,178    681    (614)   1,086    (121)   (37)
                               
    (14,564)   4,361    1,279    (10,037)   1,072    332 
Cash paid and received during the year for:                              
Interest paid   (45)   (15)   4    (39)   19    6 
Interest received   2    -    -    1    -    - 
                               
    (43)   (15)   4    (38)   19    6 
                               
Net cash flows used in operating activities   (72,539)   (10,312)   (6,187)   (56,632)   (17,961)   (5,563)

 

*)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

September 30,

  

Nine months ended

September 30,

  

Nine months

ended

September 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)   (3,348)   (4)   (6,035)   (132)   (41)
Proceeds from sale of property and equipment   160    -    -    160    -    - 
 Increase (decrease) in other long term assets   37    -    (9)   (381)   27    8 
                             - 
Net cash used in investing activities   (5,935)   (3,348)   (13)   (6,256)   (105)   (33)
                               
Cash Flows from Financing Activities:                              
                               
Repayment of operating lease liabilities   (1,240)   (306)   (307)   (928)   (930)   (288)
Proceeds from exercise of options to employees   166    166    -    166    -    - 
Proceeds from exercise of warrants to public   14,790    -    -    14,790    -    - 
Proceeds from issuance of shares, net of issuance costs   -    -    (681)   -    41,448    12,836 
                               
Net cash provided by (used in) financing activities   13,716    (140)   (988)   14,028    40,518    12,548 
                               
Exchange differences on balances of cash and cash equivalents   1,712    (178)   1,977    1,168    2,799    868 
                               
Increase (decrease) in cash and cash equivalents   (63,046)   (13,978)   (5,211)   (47,692)   25,251    7,820 
Balance of cash and cash equivalents at the beginning of the period   72,467    38,752    42,506    72,467    9,421    2,918 
                               
Balance of cash and cash equivalents at the end of the period   9,421    24,774    34,672    24,775    34,672    10,738 
                               
Non cash financing activities                              
                               
Exercise of warrants to the public   30,484    -    -    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 September 30, 2021, the EIB loan balance is $19,971 (approximately NIS 64,488).

 

h.In the nine months ended September 30, 2021, the Company incurred a loss of NIS 29,225 ($ 9,051) and negative cash flows from operating activities of NIS 17,961 ($ 5,563) and it has an accumulated deficit of NIS 354,018 ($ 109,637) 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 September 30, 2021 and for the nine months then ended have been translated into dollars using the representative exchange rate as of that date ($ 1 =  NIS 3.229). 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 September 30, 2021, and for the three and nine 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 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.

b.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 $12,836 (approximately NIS 41,448).

c.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 5: SUBSEQUENT EVENTS

 

a.On October 19, 2021 the company signed a term sheet that includes binding financial terms of contemplated definitive agreements with the Max Planck Society and the University Medical Center Göttingen in Germany, including an exclusive worldwide licensing of novel COVID-19 VHH antibody candidates. The parties intend to enter into a 5-year strategic research collaboration including an option for BiondVax to license innovative VHH antibodies. Frequently referred to as nanobodies, VHH antibodies have the potential to serve as therapeutics and diagnostics for many diseases. The transaction is subject to execution of definitive agreements.

 

Binding terms of the term sheet, which would be included in the definitive agreements, include upfront, milestone and royalty-based cash and stock payments by BiondVax to MPG and UMG. The parties aim to complete definitive agreements by late January, although there is no guarantee if and when the parties will execute the definitive agreements.

 

b.The European Investment Bank (EIB) has indicated that it supports BiondVax’s new strategic turnaround plans. The parties are currently in discussions to renegotiate the terms of the EIB’s €24 million loan to BiondVax in a manner that would serve both parties’ long-term interests. BiondVax will update its shareholders regarding terms of such negotiations if and once the parties reach an agreement.

 

- - - - - - - - - - -

 

 

F-13

 

 

 

 

 

 

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