UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549

 

Form 6-K/A

 

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 2023

 

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 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 ☐

 

 

 

 

 

 

Explanatory Note

 

This Amendment No. 1 to the Report on Form 6-K, originally filed with the Securities and Exchange Commission on August 11, 2023, is being filed solely for the purposes of furnishing unaudited interim condensed consolidated financial statements as of June 30, 2023, and incorporating certain exhibits into registration statements of the registrant.

 

This Report on Form 6-K (including the text under “Second Quarter 2022 Financial Summary” in Exhibit 99.1, and Exhibit 99.2) is hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-271293 and File No. 333-239344), Form F-1 (File No. 333-267648) and Form F-3 (File No. 333-240189), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

Exhibit No.     Description
     
99.1   Press Release, dated August 11, 2023.
99.2   Unaudited Interim Condensed Consolidated Financial Statements as of June 30, 2023.

 

1

 

 

SIGNATURE

 

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.
   
  By: /s/ Amir Reichman
    Amir Reichman
    Chief Executive Officer

 

August 14, 2023

 

 

2

 

 

Exhibit 99.1

 

 

 

BiondVax Reports Second Quarter Financial Results and Provides Business Update

 

Jerusalem, Israel – Aug. 11, 2023 – via IBN - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, announces the publication today of its financial results for the second quarter ended June 30, 2023, and provided a business update.

 

Second Quarter 2023 Financial Summary

 

R&D expenses for the three months ended June 30, 2023, amounted to $1.45 million compared with $1.97 million for the three months ended June 30, 2022.

 

Marketing, general and administrative expenses for the three months ended June 30, 2023, amounted to $1.14 million compared with $1.29 million for the three months ended June 30, 2022.

 

Total operating expenses for the three months ended June 30, 2023, amounted to $2.56 million compared with $3.26 million for the three months ended June 30, 2022.

 

Financial (loss) income for the three months ended June 30, 2023, amounted to $1.16 million loss compared with $0.28 million income for the three months ended June 30, 2022.

 

Net loss for the three months ended June 30, 2023, amounted to $3.76 million compared with $2.98 million for the three months ended June 30, 2022.

 

As of June 30, 2023, BiondVax had cash and cash equivalents of $7.6 million as compared to $14.2 million as of December 31, 2022. In the six months ended June 30, 2023, BiondVax had an operating loss of $7.3 million and negative cash flows from operating activities of $5.9 million. BiondVax’s current operating budget includes various assumptions concerning the level and timing of cash receipts and cash outlays for operating expenses and capital expenditures, including a cost-savings plan. BiondVax is planning to finance its operations from its existing working capital resources and additional sources of capital and financing with respect to which the Company has initiated actions. However, there is no assurance that additional capital and/or financing will be available to BiondVax, and even if available, whether it will be on terms acceptable to BiondVax or in amounts required. Accordingly, BiondVax’s board of directors approved the cost-savings plan mentioned above, to be implemented if and as required, in whole or in part, at its discretion, to allow BiondVax to continue its operations and meet its cash obligations. The cost-savings plan consists of cutting expenditures by means of further efficiencies and synergies, which include mainly the reduction in headcount and postponing or cancelling capital expenditures that would not be required for the implementation of the revised business plan. BiondVax’s Board of Directors believes that BiondVax’s existing financial resources, potential successful capital raisings and its current operating plans (including the possible disposition of assets outside the ordinary course of business) and restructuring of debt, along with the effects of the cost-savings plan, may be adequate to satisfy its expected liquidity requirements for a period of at least twelve months from the date hereof, although there is no guarantee.

 

BiondVax’s unaudited financial results will be submitted to the Securities and Exchange Commission on Form 6-K. A summary of such results is included in the tables below.

 

 

 

 

Business Update

 

CDMO:

 

oAs announced previously, BiondVax has decided to leverage its aseptic manufacturing site and laboratories by creating a CDMO business unit in parallel to its innovative R&D business unit. The CDMO business unit offers biological drug development services with a focus on preclinical and small clinical stage biopharmaceutical companies. These companies tend to have limited capital and require cost effective drug development services that can be executed in very short timelines. These companies also typically lack the resources required to build their own laboratories and production lines for biological drug development. They also often encounter challenges working with large CDMOs due to the relatively high costs, long timelines and lack of agility in their processes. To overcome these challenges, preclinical and small clinical stage companies may outsource product development to a boutique CDMO such as the one owned by BiondVax. In particular, BiondVax’s CDMO business unit allows clients to leverage BiondVax’s expertise in process development, optimization, scale-up, GMP manufacturing for clinical trials, and navigating complex regulatory frameworks. Additional information is available at www.biondvax.com/cdmo.

 

Pipeline Development:

 

oIn June 2023, BiondVax signed an exclusive license agreement with Max Planck Innovation for development and commercialization of a novel anti-IL-17 NanoAb (VHH antibody) for treatment of autoimmune and inflammatory diseases including psoriasis. We are aggressively advancing the NanoAb preclinical development and expect the IL-17 NanoAb to enter clinical testing in 2024.

 

oBiondVax is pursuing a strategic partnership for its COVID-19 self-administered inhaled NanoAb therapeutic/prophylactic which demonstrated highly promising in vivo results in animals.

 

oNanoAbs for treatment of additional autoimmune diseases such as asthma and wet AMD are being developed at Max Planck and University Medical Center Göttingen as part of their research collaboration agreement with BiondVax. BiondVax holds exclusive options for exclusive licenses at pre agreed financial terms for each of the resulting nanoAbs.

 

About BiondVax

 

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. 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 beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.

 

Company Contact Details

 

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

 

2

 

 

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 cash liquidity, strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. 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, and the risk that BiondVax may not be able to execute its operating plan; the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical trials data for NanoAbs, if any; the risk that our business strategy may not be successful; the risk that the European Investment Bank (EIB) may accelerate the loans under its finance contract with BiondVax; risks relating to the SARS-CoV-2 (COVID-19) virus; 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 10-K filed with the Securities and Exchange Commission on April 17, 2023. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason. 

 

Wire Service Contact:

 

IBN

Los Angeles, California

www.InvestorBrandNetwork.com

310.299.1717 Office

Editor@InvestorBrandNetwork.com

 

3

 

 

 

CONDENSED BALANCE SHEETS (Unaudited)

U.S. dollars in thousands (except share and per share data)

 

   June 30,   December 31, 
   2023   2022 
   Unaudited   Audited 
ASSETS        
         
CURRENT ASSETS:        
Cash and cash equivalents  $7,506   $14,075 
Restricted cash   126    140 
Prepaid expenses and other receivables   138    155 
           
Total current assets   7,770    14,370 
           
NON-CURRENT ASSETS:          
Property, plant and equipment, net   10,802    11,245 
Operating lease right-of-use assets   1,325    1,452 
           
Total non-current assets   12,127    12,697 
           
Total assets  $19,897   $27,067 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY          
           
CURRENT LIABILITIES:          
Trade payables  $651   $716 
Operating lease liabilities   394    382 
Other payables   843    1,240 
           
Total current liabilities   1,888    2,338 
           
NON-CURRENT LIABILITIES:          
Warrants liability   902    5,329 
Loan from others   23,292    20,082 
Non-current operating lease liabilities   927    1,078 
           
Total non-current liabilities   25,121    26,489 
           
CONTINGENT LIABILITIES AND COMMITMENTS          
           
SHAREHOLDERS’ EQUITY (DEFICIT):          
Ordinary shares of no par value: Authorized: 20,000,000,000 shares at June 30, 2023 and at December 31, 2022; Issued and outstanding 1,453,970,784 shares at June 30, 2023 and 989,290,784 shares at December 31, 2022   -    - 
Additional paid-in capital   117,740    116,082 
Accumulated deficit   (123,112)   (115,835)
Accumulated other comprehensive loss   (1,740)   (2,007)
           
Total shareholders’ deficit   (7,112)   (1,760)
           
Total liabilities and shareholders’ deficit  $19,897   $27,067 

 

4

 

 

CONDENSED STATEMENTS OF OPERATIONS (Unaudited)

U.S. dollars in thousands (except share and per share data)

 

   Three months ended
June 30,
   Six months ended
June 30,
 
   2023   2022   2023   2022 
   Unaudited 
                 
Research and development expenses, net  $1,454   $1,974   $3,449   $3,137 
Marketing, general and administrative   1,141    1,289    2,332    2,741 
                     
Total operating loss   2,595    3,263    5,781    5,878 
                     
Financial loss (income), net   1,167    (280)   1,496    (420)
                     
Net loss  $3,762   $2,983   $7,277   $5,458 
                     
Net loss per share attributable to ordinary shareholders, basic and diluted   (0.003)   (0.004)   (0.006)   (0.01)
                     
Basic and diluted net loss per share                    
Weighted average number of shares used for computing basic and diluted net loss per share   1,351,850,046    746,898,671    1,322,019,241    745,817,220 

 

 

5

 

 

CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited)

U.S. dollars in thousands (except share and per share data)

 

  

Three months ended
June 30,

   Six months ended
June 30,
 
   2023   2022   2023   2022 
   Unaudited 
                 
Net loss   (3,762)   (2,983)   (7,277)   (5,458)
                     
Other comprehensive (income) loss:                    
Foreign currency translation adjustments   151    (13)   267    (47)
                     
Total comprehensive loss  $3,611   $(2,996)  $7,010   $(5,505)

 

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

 

 

6

 

 

 

Exhibit 99.2

 

BIONDVAX PHARMACEUTICALS LTD.

 

FINANCIAL STATEMENTS

 

AS OF JUNE 30, 2023

 

U.S. DOLLARS IN THOUSANDS

 

Unaudited

 

INDEX

 

  Page
   
Condensed Balance Sheets 2 – 3
   
Condensed Statements of Operations 4
   
Condensed Statements of Comprehensive Loss 5
   
Condensed Statements of Changes in Shareholders’ Equity 6
   
Condensed Statements of Cash Flows 8 – 9
   
Notes to the condensed Financial Statements 10 – 15

 

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

 

- 1 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

CONDENSED BALANCE SHEETS (Unaudited)

U.S. dollars in thousands (except share and per share data)

 

   June 30,   December 31, 
   2023   2022 
   Unaudited   Audited 
ASSETS          
           
CURRENT ASSETS:          
Cash and cash equivalents  $7,506   $14,075 
Restricted cash   126    140 
Prepaid expenses and other receivables   138    155 
           
Total current assets   7,770    14,370 
           
NON-CURRENT ASSETS:          
Property, plant and equipment, net   10,802    11,245 
Operating lease right-of-use assets   1,325    1,452 
           
Total non-current assets   12,127    12,697 
           
Total assets  $19,897   $27,067 

 

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

 

- 2 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

CONDENSED BALANCE SHEETS (Unaudited)

U.S. dollars in thousands (except share and per share data)

  

   June 30,   December 31, 
   2023   2022 
   Unaudited   Audited 
LIABILITIES AND SHAREHOLDERS’ EQUITY        
         
CURRENT LIABILITIES:        
Trade payables  $651   $716 
Operating lease liabilities   394    382 
Other payables   843    1,240 
           
Total current liabilities   1,888    2,338 
           
NON-CURRENT LIABILITIES:          
Warrants liability   902    5,329 
Loan from others   23,292    20,082 
Non-current operating lease liabilities   927    1,078 
           
Total non-current liabilities   25,121    26,489 
           
CONTINGENT LIABILITIES AND COMMITMENTS   
 
    
 
 
           
SHAREHOLDERS’ EQUITY (DEFICIT):          
Ordinary shares of no par value: Authorized: 20,000,000,000 shares at June 30, 2023 and at December 31, 2022; Issued and outstanding 1,453,970,784 shares at June 30, 2023 and 989,290,784  shares at December 31, 2022   -    - 
Additional paid-in capital   117,740    116,082 
Accumulated deficit   (123,112)   (115,835)
Accumulated other comprehensive loss   (1,740)   (2,007)
           
Total shareholders’ deficit   (7,112)   (1,760)
           
Total liabilities and shareholders’ deficit  $19,897   $27,067 

 

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

 

- 3 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

CONDENSED STATEMENTS OF OPERATIONS (Unaudited)

U.S. dollars in thousands (except share and per share data)

 

   Three months ended
June 30,
   Six months ended
June 30,
 
   2023   2022   2023   2022 
   Unaudited 
                 
Research and development expenses, net  $1,454   $1,974   $3,449   $3,137 
Marketing, general and administrative   1,141    1,289    2,332    2,741 
                     
Total operating loss   2,595    3,263    5,781    5,878 
                     
Financial loss (income), net   1,167    (280)   1,496    (420)
                     
Net loss  $3,762   $2,983   $7,277   $5,458 
                     
Net loss per share attributable to ordinary shareholders, basic and diluted   (0.003)   (0.004)   (0.006)   (0.01)
                     
Basic and diluted net loss per share                    
Weighted average number of shares used for computing basic and diluted net loss per share   1,351,850,046    746,898,671    1,322,019,241    745,817,220 

 

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

 

- 4 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited)

U.S. dollars in thousands (except share and per share data)

 

  

Three months ended
June 30,

   Six months ended
June 30,
 
   2023   2022   2023   2022 
   Unaudited 
                 
Net loss   (3,762)   (2,983)   (7,277)   (5,458)
                     
Other comprehensive (income) loss:                    
Foreign currency translation adjustments   151    (13)   267    (47)
                     
Total comprehensive loss  $3,611   $(2,996)  $7,010   $(5,505)

 

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

 

- 5 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (Unaudited)

U.S. dollars in thousands (except share and per share data)

 

   Three months ended June 30, 2023 
   Ordinary shares   Additional paid-in   Accumulated
comprehensive
   Accumulated   Total shareholders’ 
   Number   Amount   capital    loss   deficit   equity 
                         
Balance as of March 31, 2023   1,313,623,184   $
-
   $116,431   $      (1,891)  $(119,350)  $(4,810)
                               
Exercise of warrants   140,015,200    
-
    704    
-
    
-
    704 
Vested RSU’s   332,400    
-
    
-
    
-
    
-
    
-
 
Issuance of warrants   
-
         398              398 
Share-based compensation   
-
    
-
    207    
-
    
-
    207 
Other comprehensive income   -    
-
    
-
    151    
-
    151 
Net loss   -    
-
    
-
    
-
    (3,762)   (3,762)
                               
Balance as of June 30, 2023   1,453,970,784   $            -   $117,740   $(1,740)  $(123,112)   (7,112)

 

   Six months ended June 30, 2023 
   Ordinary shares   Additional paid-in   Accumulated
comprehensive
   Accumulated   Total shareholders’ 
   Number   Amount   capital    loss   deficit   equity 
                         
Balance as of January 1, 2023   989,290,784   $
-
   $116,082   $(2,007)  $(115,835)  $(1,760)
                               
Exercise of warrants   464,015,200    
-
    801    
-
    
-
    801 
Vested RSU’s   664,800    
-
    
-
    
-
    
-
    
-
 
Issuance of warrants   
-
         398              398 
Share-based compensation   
-
    
-
    459    
-
    
-
    459 
Other comprehensive income   -    
-
    
-
    267    
-
    267 
Net loss   -    
-
    
-
    
-
    (7,277)   (7,277)
                               
Balance as of June 30, 2023   1,453,970,784   $           -   $117,740   $(1,740)  $(123,112)   (7,112)

 

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

 

- 6 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (Unaudited)

U.S. dollars in thousands (except share and per share data)

 

   Three months ended June 30, 2022 
   Ordinary shares   Additional paid-in   Accumulated
comprehensive
   Accumulated   Total shareholders’ 
   Number   Amount   capital    loss   deficit   equity 
                         
Balance as of March 31, 2022   745,048,544    
-
    113,777    (2,089)   (112,514)   (862)
                               
Expiration of employees options        
-
    152    
-
    
-
    152 
Share-based compensation   
-
         406    
-
    
-
    406 
Vested RSU’s   2,104,520    
-
    
-
    
-
    
-
    
-
 
Other comprehensive loss   -    
-
    
-
    (13)   
-
    (13)
Net loss   -    
-
    
-
    
-
    (2,983)   (2,983)
                               
Balance as of June 30, 2022   747,153,064   $        -   $114,335   $(2,102)  $(115,497)  $3,264 

 

   Six months ended June 30, 2022 
   Ordinary shares   Additional paid-in   Accumulated
comprehensive
   Accumulated   Total shareholders’ 
   Number   Amount   capital    loss   deficit   equity 
                         
Balance as of January 1, 2022   739,048,544    
-
    113,076    (2,055)   (110,039)   982 
                               
Issuance of shares, net of issuance costs of $6   6,000,000    
-
    216    
-
    
-
    216 
Vested RSU’s   2,104,520    
-
    
-
    
-
    
-
    
-
 
Expiration of employees options        
-
    152    
-
    
-
    152 
Share-based compensation   
-
         891    
-
    
-
    891 
Other comprehensive loss   -    
-
    
-
    (47)   
-
    (47)
Net loss   -    
-
    
-
    
-
    (5,458)   (5,458)
                               
Balance as of June 30, 2022   747,153,064   $        -   $114,335   $(2,102)  $(115,497)  $3,264 

 

- 7 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)

U.S. dollars in thousands (except share and per share data)

 

   Six months ended
June 30,
 
   2023    2022 
   Unaudited    Unaudited 
Cash flows from operating activities:        
         
Net loss  $(7,277)  $(5,458)
           
Adjustments to reconcile net loss to net cash used in operating activities:          
           
Depreciation of property, plant and equipment   285    279 
Expense of in-process research and development   
-
    179 
Financial expenses related to loan from others   4,321    
-
 
Share-based compensation   452    870 
Decrease in other receivables   8    115 
Warrants revaluation   (3,333)   
-
 
Changes in operating lease right-of-use assets   (16)   (10)
Increase in trade payables   (31)   (317)
Changes in operating lease liabilities   3    9 
(Decrease) increase in other payables   (347)   (437)
           
Net cash used in operating activities   (5,935)   (4,770)
           
Cash flows from investing activities:          
           
Purchase of property, plant and equipment   (383)   (486)
           
Net cash used in investing activities  $(383)  $(486)

 

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

 

- 8 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

CONDENSED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands (except share and per share data) 

 

   Six months ended
June 30,
 
   2023   2022 
   Unaudited   Unaudited 
         
Cash flows from financing activities:        
         
   $-   $- 
           
Net cash provided by financing activities   -    - 
           
Effect of exchange rate changes on cash, cash equivalents and restricted cash   (265)   (839)
           
Decrease in cash, cash equivalents and restricted cash   (6,583)   (6,095)
Cash, cash equivalents and restricted cash at the beginning of the period   14,215    17,518 
           
Cash, cash equivalents and restricted cash at the end of the period  $7,632   $11,423 
           
Supplementary disclosure of cash flows activities:          
           
(1) Cash paid during the year for:          
           
Interest  $725   $- 
           
(2) Non-cash transactions:          
           
Issuance of warrants   398    - 
           
Exercise of warrants liability to equity  $801   $- 
           
Reconciliation of cash, cash equivalents and restricted cash:          
           
Cash and cash equivalents  $7,506   $11,285 
Restricted cash   126    138 
           
Cash, cash equivalents and restricted cash  $7,632   $11,423 

 

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

 

- 9 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

 

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

 

NOTE 1:- GENERAL

 

a.Biondvax Pharmaceuticals Ltd. (the “Company”), is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. The Company was incorporated on July 21, 2003 in Israel, and started its activity on March 31, 2005. The Company’s principal executive offices, manufacturing site and R&D laboratories are located at Jerusalem, Israel.

 

b.On December 22, 2021, the Company signed an exclusive, worldwide, license agreement with the Max Planck Society (“MPG”), the parent organization of the Max Planck Institute for Multidisciplinary Sciences, and the University Medical Center Göttingen (“UMG”), both in Germany, for the development and commercialization of an innovative Covid-19 NanoAb therapy and an accompanying research collaboration agreement with MPG and UMG in support of the abovementioned development of a COVID-19 NanoAb. The agreements became effective January 1, 2022 and provide for an upfront payment, development and sales milestones, and royalties based on sales and sharing of sublicense revenues.

 

c.On February 7, 2022 the Company issued 15,000 ADSs (6,000,000 shares) to Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. under our exclusive, worldwide, License Agreement with MPG and UMG pursuant to Regulation S under the Securities Act.

 

d.On March 23, 2022, the Company executed an additional research collaboration agreement (RCA) with MPG and UMG covering discovery, selection and characterization of NanoAbs for several other disease indications with large and growing markets that leverage their unique and strong binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration. These targets are the basis for validated and currently marketed monoclonal antibodies, including for conditions such as psoriasis, asthma, macular degeneration, and psoriatic arthritis. According to the contract, BiondVax will have an exclusive option for exclusive license agreement for the development and commercialization of each of the NanoAbs covered by the agreement with MPG and UMG.

 

e.As of June 30, 2023, the Company’s cash and cash equivalents totaled $7,632. In the six months ended June 30, 2023, the Company had an operating loss of $7,277 and negative cash flows from operating activities of $5,935. The Company’s current operating budget includes various assumptions concerning the level and timing of cash receipts and cash outlays for operating expenses and capital expenditures, including a cost saving plan. The Company is planning to finance its operations from its existing working capital resources and additional sources of capital and financing that are in the advanced planning phase. However, there is no assurance that additional capital and/or financing will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or in amounts required. Accordingly, the Company’s board of directors approved a cost saving plan, to be implemented if and as required, in whole or in part, at its discretion, to allow the Company to continue its operations and meet its cash obligations. The cost saving plan consists of cutting expenditures by means of further efficiencies and synergies, which include mainly the following steps: reduction in headcount and postponing or cancelling capital expenditures that would not be required for the implementation of the revised business plan. Nevertheless, the Company and the board of directors believe that its existing financial resources, potential successful capital raising exercises and its operating plans, including the possible disposition of assets outside the ordinary course of business, restructuring of debt, along with the effects of the cost-saving plan, may be adequate to satisfy its expected liquidity requirements for a period of at least twelve months from the end of the filing date.

 

- 10 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

 

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

 

NOTE 2:- LOAN FROM OTHERS

 

a.On June 19, 2017, the Company entered into a Finance Contract with the European Investment bank (EIB) for a total amount of approximately $22,422 (€ 20,000) and up to 50% of the Company’s expected cost of developing and marketing the Company’s product candidate, M-001. In addition, as a repayment feature, the 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 its financing.

 

During 2018, the Company received approximately $23,599 (€ 20,000) in two tranches of approximately $7,080 (€ 6,000) and the third tranche of approximately $9,439 (€ 8,000).

 

In the event the Company elects to prepay the EIB financing, or in the event the EIB shall demand prepayment following certain events, including a change of control, senior management changes or merger events, the Company shall be required to pay the EIB the principal amount of the tranches already paid, or the Prepayment Amount, plus the greater of:

 

(i)the amount, as determined by the EIB required in order for the EIB to realize an internal rate of return on the relevant amount prepaid of 20%; and

 

(ii)the Prepayment Amount.

 

The Finance Contract also stipulates that in the event the EIB demands prepayment of the loan due to any prepayment event to non-EIB lenders, the Company shall be obligated to pay the Prepayment Amount plus an additional reduced amount. In addition, and as consideration for the EIB financing, the EIB shall be entitled to 3% of any annual M-001 sales revenues.

 

b.On April 22, 2019, the Committee of the EIB Bank agreed to expand the 2017 financing agreement to the Company by an additional approximately $4,502 (€ 4,000) to a total of approximately $27,013 (€ 24,000). An amendment to that effect was signed in June 2019 (the “Amendment”). Those funds were received in October 2019 and were used in support of the pivotal, clinical efficacy, Phase 3 trial of BiondVax’s M-001 Universal Flu Vaccine candidate in Europe that was ongoing at that time.

 

According to the Amendment, as repayment features, the EIB is entitled to receive the higher between 3% of any M-001 sales revenues for a period of twelve years or realizing a cash-on-cash multiple of 2.8 times its financing.

 

- 11 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

 

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

 

NOTE 2:- LOAN FROM OTHERS (Cont.)

 

c.On October 23, 2020, the Company announced Phase 3 clinical trial results of the 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.

 

As a result of the Phase 3 clinical trial failure, Company’s management believes that there will be no revenues from the M-001 product. Therefore, most likely, there will be no royalty payments to EIB.

 

Under the Finance Contract, the EIB may accelerate all loans extended thereunder if an event of default has occurred, which includes, amongst other things, an event of default arising from the occurrence of a material adverse change, defined as any event or change of condition, which in the opinion of the EIB, has a material adverse effect on: our ability to perform our obligations under the Finance Documents; our business, operations, property, condition (financial or otherwise) or prospects; or the rights or remedies of the EIB under the Finance Contract, amongst other things. If the EIB determines that an event of default has occurred, it could accelerate the amounts outstanding under the Finance Contract, making those amounts immediately due and payable.

 

In accordance with the EIB loan agreement, and due to the above, the Company was required to pay the EIB the principal amount of the tranches already loaned by the EIB to the Company within five years of the date of each tranche of the loan. On December 31, 2020, the Company re-evaluated the loan in the sum of $29,443. As a result, the Company recorded an amount of $6,162 as revaluation income of the EIB loan in 2020.

 

On January 26, 2021, the EIB notified the Company that they welcome the Company’s efforts to secure future equity financing in an amount not less than $2,000 in order to enable the Company to pursue new business opportunities, strengthen the Company’s balance sheet and invest in growth. Thus, within that context, the EIB wrote in their letter that they will not consider the failure of the Company’s pivotal phase 3 trial for M-001 to meet the primary and secondary efficacy endpoints as a trigger for prepayment of a loan extended under the Finance Contract. However, the EIB cautioned the Company 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.

 

d.On August 9, 2022, the Company signed a loan restructuring agreement with the EIB for the new terms of its outstanding approximately $24,554 (€ 24,000) loan to the Company. The new terms include:

 

1.An extension of the maturity dates from 2023 (approximately $20,462) and 2024 (approximately $4,092) until December 31, 2027.

 

2.Interest on the Loan will begin to accrue starting January 1, 2022, at an annual rate of 7%. The interest payments will be deferred until the new maturity date and will be added to the principal balance at the end of each year during the loan period.

 

- 12 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

 

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

 

NOTE 2:- LOAN FROM OTHERS (Cont.)

 

3.An amount of $ 900 (approximately € 880) were paid by BiondVax on August 15, 2022, shortly after the execution of the relevant amendment letter with the EIB and was applied to reduce the outstanding loan. Going forward 10% of any capital raises until maturity will be used to further repay the Loan principal including any outstanding accrued interest.

 

4.If the Company sales exceed approximately $5,332 (€ 5,000), 3% of the revenues will be paid to the EIB as royalties until the EIB receives (from the Loan repayment, inter alia the interest and the royalties) the higher of (i) a total of 2.8 times the original approximately $25,596 (€ 24,000) principal (as provided in the original Loan agreement) and (ii) 20% IRR on the principal.

 

5.In case the Company decides to discharge all liabilities under the finance contract, inter alia payments of the variable remuneration, the Company would need to repay to the EIB an indemnity amount in addition to the Loan principal and the accrued interest. The indemnity amount will be calculated such that the EIB receives an additional payment equal to the greater of (i) the prepayment amount (i.e. twice the prepayment amount in the aggregate) and (ii) the amount required to realize 20% IRR on the prepayment amount at the time of prepayment.

 

The Company recorded the cash received in each tranche and a corresponding liability to repay the cash. The Company evaluates the estimated cash flows from the EIB loan at each reporting period. When the estimated cash flows change from the estimates used as of the date on which the EIB loan was issued, the EIB loan’s carrying amount is adjusted to an amount equal to the present value of the estimated remaining future payments, discounted by using the original effective interest rate. The adjustment to the carrying amount is recognized in earnings as an adjustment to interest expenses, in the period in which the change in estimate occurred.

 

On December 31, 2022 as a result of the loan restructure, the Company recorded an amount of $ 7,168 under finance income. Interest expense related to the EIB loan were $87.

 

On February 16, 2023, $725 was paid to the EIB as part of the loan restructure agreement.

 

For the six-months ended at June 30, 2023 the company recorded $4,321 under finance expenses due to the loan revaluation.

 

As of June 30, 2023, the outstanding principal amount related to the EIB loan in nominal terms is $ 26,065.

 

- 13 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

 

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

 

NOTE 3:- CONTINGENT LIABILITIES AND COMMITMENTS

 

Since 2006, the Company received approximately $5,830 in grants from the Israeli Innovation Authority (IIA), formerly known as the Office of the Chief Scientist. The grants were for research and development of M-001.

 

In return for those grants, the Company undertook to pay royalties amounting to 3%-5% on the revenues derived from sales of products or services developed in whole or in part using these grants. The maximum aggregate royalties paid generally cannot exceed 100% of the grants received by the Company, plus annual interest generally equal to the 12-month LIBOR applicable to dollar deposits, as published on the first business day of each calendar year. The maximum royalty amounts payable by the Company as of June 30, 2023 is approximately $ 5,830 which represents the total gross amount of grants actually received by the Company from the IIA including accrued interest. As of June 30, 2023, the Company had not paid any royalties to the IIA.

 

In light of the Phase 3 clinical trial results (see also Note 3.c above), the Company does not currently expect any revenues from M-001 and therefore does not currently expect to make any royalty payments to the IIA. Therefore, the Company does not record a liability for amounts received from IIA. As previously discussed, in the event of failure of a project that was partly financed by the IIA, the Company is not obligated to pay any royalties or repay the amounts received.

 

The Company is also subject to various other restrictions pursuant to the grant, including limitations on transferring IP developed with grant funds. In light of the Company’s new strategy, it does not expect these restrictions to be material to its ongoing operations.

 

NOTE 4:- SHAREHOLDERS’ EQUITY

 

a.On December 20, 2022, the Company closed an underwritten public offering with gross proceeds to the Company of $8,000,000, before deducting underwriting discounts and other expenses payable by the Company. The offering consisted of 1,600,000 units and pre-funded units. Each unit consisted of one American Depositary Share (“ADS”) and two warrants, each to purchase one ADS, and each pre-funded unit consisted of one pre-funded warrant to purchase one ADS and two warrants each to purchase one ADS. One of the warrants will expire three years from the date of issuance, and the other warrant will expire one year from the date of issuance and may be exercised for half an ADS on or prior to six (6) months following the original issuance for no additional consideration. Each ADS (or pre-funded warrant) was sold together with two warrants at a combined purchase price of $5.00 per unit (or $4.99 per pre-funded unit after reducing $0.01 attributable to the exercise price of the pre-funded warrants). Each ADS represents 400 of our ordinary shares, no par value per share. The Company received a net sum of $7,231 after deduction of underwriter discounts and issuance expenses of $769. The warrants were classified as liabilities, initially and subsequently measured at fair value through earnings pursuant to ASC 480 as the warrants are not considered indexed to the Company’s own shares.

 

b.On January 5, 2023, the Company issued 810,000 ADSs (324,000,000 shares) as a result of warrant exercises.

 

c.During June, 2023, the Company issued 350,038 ADSs (140,015,200 shares) as a result of warrant exercises.

 

- 14 -

 

 

BIONDVAX PHARMACEUTICALS LTD.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

 

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

 

NOTE 5:- SHARE-BASED COMPENSATION

 

a.Option plans:

 

Options granted under the Company’s 2005 Israeli Share Option Plan (“Plan”) were exercisable in accordance with the terms of the Plan, within 10 years from the date of grant, against payment of an exercise price. The options generally vest over a period of three or four years.

 

In March 2018, the Company’s Board of Directors approved the adoption of the Company’s 2018 Israeli Share Option Plan (“2018 Plan”) for the grant of options and restricted shares (“RSU”) to employees, directors and service providers. The options are exercisable within 10 years from the date of grant, against payment of the exercise price, in accordance with the terms of the 2018 Plan. The options generally vest over a period of three or four years.

 

There were no option grants during the six months ended June 30, 2023.

 

b.The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the six months ended June 30, 2023 and 2022 is comprised as follows:

 

  

Six months ended
June 30,

 
   2023   2022 
   Unaudited   Unaudited 
         
Research and development expenses  $57   $44 
Marketing, general and administrative expenses   395    826 
Total share-based compensation  $452   $870 

 

During the six months ended June 30, 2023, the company granted 126,931 RSU’s to employees and officers. These RSU’s vest over three years and the fair value of said grant was $280.

 

As of June 30, 2023, there are $463 of total unrecognized costs related to share-based compensation that is expected to be recognized over a period of up to four years.

 

The fair value of the granted RSUs was determined based on the stock marketprice of the Company’s ADS on the day of grant.

 

 

- 15 -

 

 

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v3.23.2
Document And Entity Information
6 Months Ended
Jun. 30, 2023
Document Information Line Items  
Entity Registrant Name BIONDVAX PHARMACEUTICALS LTD.
Document Type 6-K/A
Current Fiscal Year End Date --12-31
Amendment Flag true
Amendment Description This Amendment No. 1 to the Report on Form 6-K, originally filed with the Securities and Exchange Commission on August 11, 2023, is being filed solely for the purposes of furnishing unaudited interim condensed consolidated financial statements as of June 30, 2023, and incorporating certain exhibits into registration statements of the registrant.This Report on Form 6-K (including the text under “Second Quarter 2022 Financial Summary” in Exhibit 99.1, and Exhibit 99.2) is hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-271293 and File No. 333-239344), Form F-1 (File No. 333-267648) and Form F-3 (File No. 333-240189), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
Entity Central Index Key 0001611747
Document Period End Date Jun. 30, 2023
Document Fiscal Year Focus 2023
Document Fiscal Period Focus Q2
Entity File Number 001-37353
v3.23.2
Condensed Balance Sheets (Unaudited) - USD ($)
$ in Thousands
Jun. 30, 2023
Dec. 31, 2022
CURRENT ASSETS:    
Cash and cash equivalents $ 7,506 $ 14,075
Restricted cash 126 140
Prepaid expenses and other receivables 138 155
Total current assets 7,770 14,370
NON-CURRENT ASSETS:    
Property, plant and equipment, net 10,802 11,245
Operating lease right-of-use assets 1,325 1,452
Total non-current assets 12,127 12,697
Total assets 19,897 27,067
CURRENT LIABILITIES:    
Trade payables 651 716
Operating lease liabilities 394 382
Other payables 843 1,240
Total current liabilities 1,888 2,338
NON-CURRENT LIABILITIES:    
Warrants liability 902 5,329
Loan from others 23,292 20,082
Non-current operating lease liabilities 927 1,078
Total non-current liabilities 25,121 26,489
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY (DEFICIT):    
Ordinary shares of no par value: Authorized: 20,000,000,000 shares at June 30, 2023 and at December 31, 2022; Issued and outstanding 1,453,970,784 shares at June 30, 2023 and 989,290,784 shares at December 31, 2022
Additional paid-in capital 117,740 116,082
Accumulated deficit (123,112) (115,835)
Accumulated other comprehensive loss (1,740) (2,007)
Total shareholders’ deficit (7,112) (1,760)
Total liabilities and shareholders’ deficit $ 19,897 $ 27,067
v3.23.2
Condensed Balance Sheets (Unaudited) (Parentheticals) - $ / shares
Jun. 30, 2023
Dec. 31, 2022
Statement of Financial Position [Abstract]    
Ordinary shares, no par value (in Dollars per share) $ 0 $ 0
Ordinary shares, authorized 20,000,000,000 20,000,000,000
Ordinary shares, issued 1,453,970,784 989,290,784
Ordinary shares, outstanding 1,453,970,784 989,290,784
v3.23.2
Condensed Statements of Operation (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Income Statement [Abstract]        
Research and development expenses, net $ 1,454 $ 1,974 $ 3,449 $ 3,137
Marketing, general and administrative 1,141 1,289 2,332 2,741
Total operating loss 2,595 3,263 5,781 5,878
Financial loss (income), net 1,167 (280) 1,496 (420)
Net loss $ 3,762 $ 2,983 $ 7,277 $ 5,458
Net loss per share attributable to ordinary shareholders, basic (in Dollars per share) $ (0.003) $ (0.004) $ (0.006) $ (0.01)
Basic and diluted net loss per share        
Weighted average number of shares used for computing basic net loss per share (in Shares) 1,351,850,046 746,898,671 1,322,019,241 745,817,220
v3.23.2
Condensed Statements of Operation (Unaudited) (Parentheticals) - $ / shares
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Income Statement [Abstract]        
Net loss per share attributable to ordinary shareholders, diluted $ (0.003) $ (0.004) $ (0.006) $ (0.01)
Weighted average number of shares used for computing diluted net loss per share (in Shares) 1,351,850,046 746,898,671 1,322,019,241 745,817,220
v3.23.2
Condensed Statements of Comprehensive Loss (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Statement of Comprehensive Income [Abstract]        
Net loss $ (3,762) $ (2,983) $ (7,277) $ (5,458)
Other comprehensive (income) loss:        
Foreign currency translation adjustments 151 (13) 267 (47)
Total comprehensive loss $ 3,611 $ (2,996) $ 7,010 $ (5,505)
v3.23.2
Condensed Statements of Changes in Shareholders’ Equity (Unaudited) - USD ($)
$ in Thousands
Ordinary shares
Additional paid-in capital
Accumulated comprehensive loss
Accumulated deficit
Total
Balance at Dec. 31, 2021 $ 113,076 $ (2,055) $ (110,039) $ 982
Balance (in Shares) at Dec. 31, 2021 739,048,544        
Issuance of shares, net of issuance costs of $6 216 216
Issuance of shares, net of issuance costs of $6 (in Shares) 6,000,000        
Vested RSU’s
Vested RSU’s (in Shares) 2,104,520        
Expiration of employees options 152 152
Share-based compensation   891 891
Share-based compensation (in Shares)        
Other comprehensive income (loss) (47) (47)
Net loss (5,458) (5,458)
Balance at Jun. 30, 2022 114,335 (2,102) (115,497) 3,264
Balance (in Shares) at Jun. 30, 2022 747,153,064        
Balance at Mar. 31, 2022 113,777 (2,089) (112,514) (862)
Balance (in Shares) at Mar. 31, 2022 745,048,544        
Vested RSU’s
Vested RSU’s (in Shares) 2,104,520        
Expiration of employees options 152 152
Share-based compensation   406 406
Share-based compensation (in Shares)        
Other comprehensive income (loss) (13) (13)
Net loss (2,983) (2,983)
Balance at Jun. 30, 2022 114,335 (2,102) (115,497) 3,264
Balance (in Shares) at Jun. 30, 2022 747,153,064        
Balance at Dec. 31, 2022 116,082 (2,007) (115,835) (1,760)
Balance (in Shares) at Dec. 31, 2022 989,290,784        
Exercise of warrants 801 801
Exercise of warrants (in Shares) 464,015,200        
Vested RSU’s
Vested RSU’s (in Shares) 664,800        
Issuance of warrants   398     398
Issuance of warrants (in Shares)        
Share-based compensation 459 459
Share-based compensation (in Shares)        
Other comprehensive income (loss) 267 267
Net loss (7,277) (7,277)
Balance at Jun. 30, 2023 117,740 (1,740) (123,112) (7,112)
Balance (in Shares) at Jun. 30, 2023 1,453,970,784        
Balance at Mar. 31, 2023 116,431 (1,891) (119,350) (4,810)
Balance (in Shares) at Mar. 31, 2023 1,313,623,184        
Exercise of warrants 704 704
Exercise of warrants (in Shares) 140,015,200        
Vested RSU’s
Vested RSU’s (in Shares) 332,400        
Issuance of warrants   398     398
Issuance of warrants (in Shares)        
Share-based compensation 207 207
Share-based compensation (in Shares)        
Other comprehensive income (loss) 151 151
Net loss (3,762) (3,762)
Balance at Jun. 30, 2023 $ 117,740 $ (1,740) $ (123,112) $ (7,112)
Balance (in Shares) at Jun. 30, 2023 1,453,970,784        
v3.23.2
Condensed Statements of Changes in Shareholders’ Equity (Unaudited) (Parentheticals)
$ in Thousands
6 Months Ended
Jun. 30, 2022
USD ($)
Statement of Stockholders' Equity [Abstract]  
Issuance of shares, net of issuance costs $ 6
v3.23.2
Condensed Statements of Cash Flows - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Statement of Cash Flows [Abstract]    
Net loss $ (7,277) $ (5,458)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation of property, plant and equipment 285 279
Expense of in-process research and development 179
Financial expenses related to loan from others 4,321
Share-based compensation 452 870
Decrease in other receivables 8 115
Warrants revaluation (3,333)
Changes in operating lease right-of-use assets (16) (10)
Increase in trade payables (31) (317)
Changes in operating lease liabilities 3 9
(Decrease) increase in other payables (347) (437)
Net cash used in operating activities (5,935) (4,770)
Cash flows from investing activities:    
Purchase of property, plant and equipment (383) (486)
Net cash used in investing activities (383) (486)
Cash flows from financing activities:    
Proceeds from issuance of common stock
Net cash provided by financing activities
Effect of exchange rate changes on cash, cash equivalents and restricted cash (265) (839)
Decrease in cash, cash equivalents and restricted cash (6,583) (6,095)
Cash, cash equivalents and restricted cash at the beginning of the period 14,215 17,518
Cash, cash equivalents and restricted cash at the end of the period 7,632 11,423
(1) Cash paid during the year for:    
Interest 725
(2) Non-cash transactions:    
Issuance of warrants 398
Exercise of warrants liability to equity 801
Reconciliation of cash, cash equivalents and restricted cash:    
Cash and cash equivalents 7,506 11,285
Restricted cash 126 138
Cash, cash equivalents and restricted cash $ 7,632 $ 11,423
v3.23.2
General
6 Months Ended
Jun. 30, 2023
General [Abstract]  
GENERAL

NOTE 1:- GENERAL

 

a.Biondvax Pharmaceuticals Ltd. (the “Company”), is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. The Company was incorporated on July 21, 2003 in Israel, and started its activity on March 31, 2005. The Company’s principal executive offices, manufacturing site and R&D laboratories are located at Jerusalem, Israel.

 

b.On December 22, 2021, the Company signed an exclusive, worldwide, license agreement with the Max Planck Society (“MPG”), the parent organization of the Max Planck Institute for Multidisciplinary Sciences, and the University Medical Center Göttingen (“UMG”), both in Germany, for the development and commercialization of an innovative Covid-19 NanoAb therapy and an accompanying research collaboration agreement with MPG and UMG in support of the abovementioned development of a COVID-19 NanoAb. The agreements became effective January 1, 2022 and provide for an upfront payment, development and sales milestones, and royalties based on sales and sharing of sublicense revenues.

 

c.On February 7, 2022 the Company issued 15,000 ADSs (6,000,000 shares) to Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. under our exclusive, worldwide, License Agreement with MPG and UMG pursuant to Regulation S under the Securities Act.

 

d.On March 23, 2022, the Company executed an additional research collaboration agreement (RCA) with MPG and UMG covering discovery, selection and characterization of NanoAbs for several other disease indications with large and growing markets that leverage their unique and strong binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration. These targets are the basis for validated and currently marketed monoclonal antibodies, including for conditions such as psoriasis, asthma, macular degeneration, and psoriatic arthritis. According to the contract, BiondVax will have an exclusive option for exclusive license agreement for the development and commercialization of each of the NanoAbs covered by the agreement with MPG and UMG.

 

e.As of June 30, 2023, the Company’s cash and cash equivalents totaled $7,632. In the six months ended June 30, 2023, the Company had an operating loss of $7,277 and negative cash flows from operating activities of $5,935. The Company’s current operating budget includes various assumptions concerning the level and timing of cash receipts and cash outlays for operating expenses and capital expenditures, including a cost saving plan. The Company is planning to finance its operations from its existing working capital resources and additional sources of capital and financing that are in the advanced planning phase. However, there is no assurance that additional capital and/or financing will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or in amounts required. Accordingly, the Company’s board of directors approved a cost saving plan, to be implemented if and as required, in whole or in part, at its discretion, to allow the Company to continue its operations and meet its cash obligations. The cost saving plan consists of cutting expenditures by means of further efficiencies and synergies, which include mainly the following steps: reduction in headcount and postponing or cancelling capital expenditures that would not be required for the implementation of the revised business plan. Nevertheless, the Company and the board of directors believe that its existing financial resources, potential successful capital raising exercises and its operating plans, including the possible disposition of assets outside the ordinary course of business, restructuring of debt, along with the effects of the cost-saving plan, may be adequate to satisfy its expected liquidity requirements for a period of at least twelve months from the end of the filing date.
v3.23.2
Loan from Others
6 Months Ended
Jun. 30, 2023
Loan from Others [Abstract]  
LOAN FROM OTHERS

NOTE 2:- LOAN FROM OTHERS

 

a.On June 19, 2017, the Company entered into a Finance Contract with the European Investment bank (EIB) for a total amount of approximately $22,422 (€ 20,000) and up to 50% of the Company’s expected cost of developing and marketing the Company’s product candidate, M-001. In addition, as a repayment feature, the 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 its financing.

 

During 2018, the Company received approximately $23,599 (€ 20,000) in two tranches of approximately $7,080 (€ 6,000) and the third tranche of approximately $9,439 (€ 8,000).

 

In the event the Company elects to prepay the EIB financing, or in the event the EIB shall demand prepayment following certain events, including a change of control, senior management changes or merger events, the Company shall be required to pay the EIB the principal amount of the tranches already paid, or the Prepayment Amount, plus the greater of:

 

(i)the amount, as determined by the EIB required in order for the EIB to realize an internal rate of return on the relevant amount prepaid of 20%; and

 

(ii)the Prepayment Amount.

 

The Finance Contract also stipulates that in the event the EIB demands prepayment of the loan due to any prepayment event to non-EIB lenders, the Company shall be obligated to pay the Prepayment Amount plus an additional reduced amount. In addition, and as consideration for the EIB financing, the EIB shall be entitled to 3% of any annual M-001 sales revenues.

 

b.On April 22, 2019, the Committee of the EIB Bank agreed to expand the 2017 financing agreement to the Company by an additional approximately $4,502 (€ 4,000) to a total of approximately $27,013 (€ 24,000). An amendment to that effect was signed in June 2019 (the “Amendment”). Those funds were received in October 2019 and were used in support of the pivotal, clinical efficacy, Phase 3 trial of BiondVax’s M-001 Universal Flu Vaccine candidate in Europe that was ongoing at that time.

 

According to the Amendment, as repayment features, the EIB is entitled to receive the higher between 3% of any M-001 sales revenues for a period of twelve years or realizing a cash-on-cash multiple of 2.8 times its financing.

 

c.On October 23, 2020, the Company announced Phase 3 clinical trial results of the 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.

 

As a result of the Phase 3 clinical trial failure, Company’s management believes that there will be no revenues from the M-001 product. Therefore, most likely, there will be no royalty payments to EIB.

 

Under the Finance Contract, the EIB may accelerate all loans extended thereunder if an event of default has occurred, which includes, amongst other things, an event of default arising from the occurrence of a material adverse change, defined as any event or change of condition, which in the opinion of the EIB, has a material adverse effect on: our ability to perform our obligations under the Finance Documents; our business, operations, property, condition (financial or otherwise) or prospects; or the rights or remedies of the EIB under the Finance Contract, amongst other things. If the EIB determines that an event of default has occurred, it could accelerate the amounts outstanding under the Finance Contract, making those amounts immediately due and payable.

 

In accordance with the EIB loan agreement, and due to the above, the Company was required to pay the EIB the principal amount of the tranches already loaned by the EIB to the Company within five years of the date of each tranche of the loan. On December 31, 2020, the Company re-evaluated the loan in the sum of $29,443. As a result, the Company recorded an amount of $6,162 as revaluation income of the EIB loan in 2020.

 

On January 26, 2021, the EIB notified the Company that they welcome the Company’s efforts to secure future equity financing in an amount not less than $2,000 in order to enable the Company to pursue new business opportunities, strengthen the Company’s balance sheet and invest in growth. Thus, within that context, the EIB wrote in their letter that they will not consider the failure of the Company’s pivotal phase 3 trial for M-001 to meet the primary and secondary efficacy endpoints as a trigger for prepayment of a loan extended under the Finance Contract. However, the EIB cautioned the Company 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.

 

d.On August 9, 2022, the Company signed a loan restructuring agreement with the EIB for the new terms of its outstanding approximately $24,554 (€ 24,000) loan to the Company. The new terms include:

 

1.An extension of the maturity dates from 2023 (approximately $20,462) and 2024 (approximately $4,092) until December 31, 2027.

 

2.Interest on the Loan will begin to accrue starting January 1, 2022, at an annual rate of 7%. The interest payments will be deferred until the new maturity date and will be added to the principal balance at the end of each year during the loan period.

 

3.An amount of $ 900 (approximately € 880) were paid by BiondVax on August 15, 2022, shortly after the execution of the relevant amendment letter with the EIB and was applied to reduce the outstanding loan. Going forward 10% of any capital raises until maturity will be used to further repay the Loan principal including any outstanding accrued interest.

 

4.If the Company sales exceed approximately $5,332 (€ 5,000), 3% of the revenues will be paid to the EIB as royalties until the EIB receives (from the Loan repayment, inter alia the interest and the royalties) the higher of (i) a total of 2.8 times the original approximately $25,596 (€ 24,000) principal (as provided in the original Loan agreement) and (ii) 20% IRR on the principal.

 

5.In case the Company decides to discharge all liabilities under the finance contract, inter alia payments of the variable remuneration, the Company would need to repay to the EIB an indemnity amount in addition to the Loan principal and the accrued interest. The indemnity amount will be calculated such that the EIB receives an additional payment equal to the greater of (i) the prepayment amount (i.e. twice the prepayment amount in the aggregate) and (ii) the amount required to realize 20% IRR on the prepayment amount at the time of prepayment.

 

The Company recorded the cash received in each tranche and a corresponding liability to repay the cash. The Company evaluates the estimated cash flows from the EIB loan at each reporting period. When the estimated cash flows change from the estimates used as of the date on which the EIB loan was issued, the EIB loan’s carrying amount is adjusted to an amount equal to the present value of the estimated remaining future payments, discounted by using the original effective interest rate. The adjustment to the carrying amount is recognized in earnings as an adjustment to interest expenses, in the period in which the change in estimate occurred.

 

On December 31, 2022 as a result of the loan restructure, the Company recorded an amount of $ 7,168 under finance income. Interest expense related to the EIB loan were $87.

 

On February 16, 2023, $725 was paid to the EIB as part of the loan restructure agreement.

 

For the six-months ended at June 30, 2023 the company recorded $4,321 under finance expenses due to the loan revaluation.

 

As of June 30, 2023, the outstanding principal amount related to the EIB loan in nominal terms is $ 26,065.

v3.23.2
Contingent Liabilities and Commitments
6 Months Ended
Jun. 30, 2023
Contingent Liabilities and Commitments [Abstract]  
CONTINGENT LIABILITIES AND COMMITMENTS

NOTE 3:- CONTINGENT LIABILITIES AND COMMITMENTS

 

Since 2006, the Company received approximately $5,830 in grants from the Israeli Innovation Authority (IIA), formerly known as the Office of the Chief Scientist. The grants were for research and development of M-001.

 

In return for those grants, the Company undertook to pay royalties amounting to 3%-5% on the revenues derived from sales of products or services developed in whole or in part using these grants. The maximum aggregate royalties paid generally cannot exceed 100% of the grants received by the Company, plus annual interest generally equal to the 12-month LIBOR applicable to dollar deposits, as published on the first business day of each calendar year. The maximum royalty amounts payable by the Company as of June 30, 2023 is approximately $ 5,830 which represents the total gross amount of grants actually received by the Company from the IIA including accrued interest. As of June 30, 2023, the Company had not paid any royalties to the IIA.

 

In light of the Phase 3 clinical trial results (see also Note 3.c above), the Company does not currently expect any revenues from M-001 and therefore does not currently expect to make any royalty payments to the IIA. Therefore, the Company does not record a liability for amounts received from IIA. As previously discussed, in the event of failure of a project that was partly financed by the IIA, the Company is not obligated to pay any royalties or repay the amounts received.

 

The Company is also subject to various other restrictions pursuant to the grant, including limitations on transferring IP developed with grant funds. In light of the Company’s new strategy, it does not expect these restrictions to be material to its ongoing operations.

v3.23.2
Shareholders' Equity
6 Months Ended
Jun. 30, 2023
Shareholders' Equity [Abstract]  
SHAREHOLDERS’ EQUITY

NOTE 4:- SHAREHOLDERS’ EQUITY

 

a.On December 20, 2022, the Company closed an underwritten public offering with gross proceeds to the Company of $8,000,000, before deducting underwriting discounts and other expenses payable by the Company. The offering consisted of 1,600,000 units and pre-funded units. Each unit consisted of one American Depositary Share (“ADS”) and two warrants, each to purchase one ADS, and each pre-funded unit consisted of one pre-funded warrant to purchase one ADS and two warrants each to purchase one ADS. One of the warrants will expire three years from the date of issuance, and the other warrant will expire one year from the date of issuance and may be exercised for half an ADS on or prior to six (6) months following the original issuance for no additional consideration. Each ADS (or pre-funded warrant) was sold together with two warrants at a combined purchase price of $5.00 per unit (or $4.99 per pre-funded unit after reducing $0.01 attributable to the exercise price of the pre-funded warrants). Each ADS represents 400 of our ordinary shares, no par value per share. The Company received a net sum of $7,231 after deduction of underwriter discounts and issuance expenses of $769. The warrants were classified as liabilities, initially and subsequently measured at fair value through earnings pursuant to ASC 480 as the warrants are not considered indexed to the Company’s own shares.

 

b.On January 5, 2023, the Company issued 810,000 ADSs (324,000,000 shares) as a result of warrant exercises.

 

c.During June, 2023, the Company issued 350,038 ADSs (140,015,200 shares) as a result of warrant exercises.
v3.23.2
Share-Based Compensation
6 Months Ended
Jun. 30, 2023
Share-Based Compensation [Abstract]  
SHARE-BASED COMPENSATION

NOTE 5:- SHARE-BASED COMPENSATION

 

a.Option plans:

 

Options granted under the Company’s 2005 Israeli Share Option Plan (“Plan”) were exercisable in accordance with the terms of the Plan, within 10 years from the date of grant, against payment of an exercise price. The options generally vest over a period of three or four years.

 

In March 2018, the Company’s Board of Directors approved the adoption of the Company’s 2018 Israeli Share Option Plan (“2018 Plan”) for the grant of options and restricted shares (“RSU”) to employees, directors and service providers. The options are exercisable within 10 years from the date of grant, against payment of the exercise price, in accordance with the terms of the 2018 Plan. The options generally vest over a period of three or four years.

 

There were no option grants during the six months ended June 30, 2023.

 

b.The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the six months ended June 30, 2023 and 2022 is comprised as follows:

 

  

Six months ended
June 30,

 
   2023   2022 
   Unaudited   Unaudited 
         
Research and development expenses  $57   $44 
Marketing, general and administrative expenses   395    826 
Total share-based compensation  $452   $870 

 

During the six months ended June 30, 2023, the company granted 126,931 RSU’s to employees and officers. These RSU’s vest over three years and the fair value of said grant was $280.

 

As of June 30, 2023, there are $463 of total unrecognized costs related to share-based compensation that is expected to be recognized over a period of up to four years.

 

The fair value of the granted RSUs was determined based on the stock marketprice of the Company’s ADS on the day of grant.

v3.23.2
Share-Based Compensation (Tables)
6 Months Ended
Jun. 30, 2023
Share-Based Compensation [Abstract]  
Schedule of Share-Based Compensation Expense Related The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the six months ended June 30, 2023 and 2022 is comprised as follows:
  

Six months ended
June 30,

 
   2023   2022 
   Unaudited   Unaudited 
         
Research and development expenses  $57   $44 
Marketing, general and administrative expenses   395    826 
Total share-based compensation  $452   $870 
v3.23.2
General (Details) - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2023
Feb. 07, 2022
General (Details) [Line Items]    
Share issued (in Shares)   15,000
Cash and cash equivalents $ 7,632  
Operating loss 7,277  
Cash flows from operating activities $ (5,935)  
Max-Planck-Gesellschaft zur Förderung der Wissenschaften [Member]    
General (Details) [Line Items]    
Shares Issued (in Shares)   6,000,000
v3.23.2
Loan from Others (Details)
€ in Thousands, $ in Thousands
1 Months Ended 6 Months Ended
Jan. 02, 2023
Dec. 31, 2022
USD ($)
Jan. 26, 2021
USD ($)
Dec. 31, 2020
USD ($)
Oct. 23, 2020
Apr. 22, 2019
USD ($)
Dec. 31, 2018
USD ($)
Jun. 19, 2017
USD ($)
Jun. 30, 2023
USD ($)
Jun. 30, 2023
EUR (€)
Jun. 30, 2023
EUR (€)
Feb. 26, 2023
USD ($)
Aug. 15, 2022
USD ($)
Aug. 15, 2022
EUR (€)
Aug. 09, 2022
USD ($)
Aug. 09, 2022
EUR (€)
Apr. 22, 2019
EUR (€)
Dec. 31, 2018
EUR (€)
Jun. 19, 2017
EUR (€)
Loan from Others (Details) [Line Items]                                      
Loan from bank             $ 23,599                     € 20,000  
Long term maturities 2023                 $ 20,462                    
Long term maturities 2024                 $ 4,092                    
Annual interest rate percentage 7.00%                                    
Loan paid                         $ 900 € 880          
Capital raises percentage                 10.00% 10.00%                  
Principal amount                 $ 25,596   € 24,000                
Finance income   $ 7,168                                  
Finance expenses                 $ 4,321                    
European Investment bank [Member]                                      
Loan from Others (Details) [Line Items]                                      
Loan from bank               $ 22,422                     € 20,000
Percentage of development and marketing               50.00%                      
Sales revenues, percentage             3.00% 3.00% 3.00% 3.00%                  
Repayment term         5 years     10 years                      
Repayment description               realizing a cash-on-cash multiple of 2.8 times its financing.                      
Rate of return interest percentage             20.00%                     20.00%  
Re-evaluated loan       $ 29,443                              
Revaluation income       $ 6,162                              
Future equity financing     $ 2,000                                
Outstanding loan amount                             $ 24,554 € 24,000      
Loan paid                       $ 725              
Sales exceed                 $ 5,332 € 5,000                  
Debt description                 a total of 2.8 times the original approximately a total of 2.8 times the original approximately                  
Interest expense related   $ 87                                  
Outstanding principal amount                 $ 26,065                    
IRR [Member]                                      
Loan from Others (Details) [Line Items]                                      
Debt instrument percentage                 20.00% 20.00%                  
Prepayment percentage                 20.00% 20.00%                  
2017 Financing Agreement [Member] | European Investment bank [Member]                                      
Loan from Others (Details) [Line Items]                                      
Loan from bank           $ 27,013                     € 24,000    
Sales revenues, percentage           3.00%                          
Repayment term           12 years                          
Repayment description           realizing a cash-on-cash multiple of 2.8 times its financing.                          
Additional loan           $ 4,502                     € 4,000    
Two Tranches [Member]                                      
Loan from Others (Details) [Line Items]                                      
Loan from bank             $ 7,080                     € 6,000  
Third Tranche [Member]                                      
Loan from Others (Details) [Line Items]                                      
Loan from bank             $ 9,439                     € 8,000  
v3.23.2
Contingent Liabilities and Commitments (Details)
$ in Thousands
6 Months Ended
Jun. 30, 2023
USD ($)
Contingent Liabilities and Commitments (Details) [Line Items]  
Grants received (in Dollars) $ 5,830
Grants received percentage 100.00%
Total gross grants (in Dollars) $ 5,830
Minimum [Member]  
Contingent Liabilities and Commitments (Details) [Line Items]  
Pay royalty amount percentage 3.00%
Maximum [Member]  
Contingent Liabilities and Commitments (Details) [Line Items]  
Pay royalty amount percentage (5.00%)
v3.23.2
Shareholders' Equity (Details) - USD ($)
1 Months Ended
Dec. 20, 2022
Jun. 30, 2023
Feb. 07, 2022
Jan. 05, 2022
Shareholders' Equity (Details) [Line Items]        
Gross proceeds (in Dollars) $ 8,000,000      
Offering units 1,600,000      
Expire term 3 years      
Purchase price per unit (in Dollars per share) $ 5      
Prefunded unit (in Dollars per share) 4.99      
Exercise price (in Dollars per share) $ 0.01      
Ordinary shares, issued 400      
Received net amount (in Dollars) $ 7,231      
Issuance expense (in Dollars) $ 769      
Shares, Issued     15,000  
Warrant [Member]        
Shareholders' Equity (Details) [Line Items]        
Expire term 1 year      
Shares, Issued   140,015,200   324,000,000
ADSs [Member] | Warrant [Member]        
Shareholders' Equity (Details) [Line Items]        
Shares, Issued   350,038   810,000
v3.23.2
Share-Based Compensation (Details) - USD ($)
$ in Thousands
1 Months Ended 6 Months Ended
Mar. 18, 2018
Jun. 30, 2023
Share-Based Compensation (Details) [Line Items]    
Exercisable terms Plans 10 years 10 years
RSU’s employees and officers shares (in Shares)   126,931
RSU’s vest over fair value (in Dollars)   $ 280
Share-based compensation unrecognized costs (in Dollars)   $ 463
Expected recognized period   4 years
2005 Israeli Share Option Plan [Member]    
Share-Based Compensation (Details) [Line Items]    
Vested period   3 years
2018 Israeli Share Option Plan [Member]    
Share-Based Compensation (Details) [Line Items]    
Vested period 4 years  
v3.23.2
Share-Based Compensation (Details) - Schedule of Share-Based Compensation Expense Related - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Schedule of Share Based Compensation Expense Related [Abstract]    
Research and development expenses $ 57 $ 44
Marketing, general and administrative expenses 395 826
Total share-based compensation $ 452 $ 870

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