EX-99.1 2 ea165093ex99-1_biondvax.htm PRESS RELEASE DATED AUGUST 25, 2022

Exhibit 99.1

 

 

BiondVax announces Second Quarter 2022 Financial Results and Provides Business Update

 

JERUSALEM, Aug. 25, 2022 /PRNewswire/ -- 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 financial results for the quarter ended June 30, 2022 and provided a business update.

Business Update

 

Development of the NanoAb program is proceeding according to plan. A pilot quantity of the lead NanoAb, a COVID-19 therapy, was manufactured in-house then sent for preclinical inhalation device evaluation and selection of an inhaler for human use.

 

In September 2022, BiondVax plans to initiate an inhalation proof of concept study with its anti-SARS-COV-2 NanoAbs in COVID-19 infected animals with readout expected in November 2022.

 

BiondVax currently holds several anti-SARS-COV-2 NanoAb candidates, generated and initially characterized by Max Planck Institute for Multidisciplinary Sciences in Göttingen together with University Medical Center Göttingen and exclusively licensed from Max-Planck-Innovation GmbH, which demonstrated high affinity to and strong neutralization of COVID-19 VoCs including Omicron BA1&2 and will be testing them in the coming months for neutralization of BA2.75 and BA5.

 

BiondVax received supportive Scientific Advice from the Paul Ehrlich Institute (PEI) for its COVID-19 NanoAb development plans. PEI supported BiondVax’s plan for first-in-human clinical trial to be conducted directly in sick patients as a combined Phase 1/2a, testing both safety and efficacy, thereby shortening BiondVax’s clinical development timelines.

 

As part of their broader research collaboration with BiondVax, the researchers at Max Planck Institute for Multidisciplinary Sciences in Göttingen and University Medical Center Gottingen have been able to successfully isolate new NanoAbs targeting IL-17A/F and other cytokines, which can be used for treatment of other diseases such as psoriasis, psoriatic arthritis, asthma, and macular degeneration. BiondVax has an exclusive option for an exclusive license to further develop and commercialize these drug candidates.

 

Second Quarter 2022 Financial Summary

 

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.5 (NIS/$US), the rate as of the close of business on June 30, 2022.

 

R&D expenses for the three months ended June 30, 2022 were NIS 6.5 million ($1.85 million) compared to NIS 1.9 million for the three months ended June 30, 2021. Total R&D expenses for the six months ended June 30, 2022 were NIS 10.1 million ($2.9 million) compared to NIS 4.6 million for the six months ended June 30, 2021. These increases were primarily due to drug development activities related to the new COVID-19 NanoAb program licensed from Max-Planck-Innovation GmbH in December 2021.

 

 

 

 

Marketing, general and administrative expenses for the three months ended June 30, 2022 were NIS 4.3 million ($1.2 million) compared to NIS 7.0 million for the three months ended June 30, 2021. Total marketing, general and administrative expenses for the six months ended June 30, 2022 were NIS 8.9 million ($2.5 million) compared to NIS 11 million for the six months ended June 30, 2021. These decreases were primarily due to salaries and related expenses of NIS 1.2 million and share based payment of NIS 1 million.

 

Financial expenses for the three months ended June 30, 2022 were NIS 2.1 million ($0.6 million) compared to NIS 3.0 million for the three months ended June 30, 2021. Financial expenses for the six months ended June 30, 2022 were NIS 3.2 million ($1 million) compared to NIS 4.5 million for the six months ended June 30, 2021. These decreases were primarily due to currency exchange differences and EIB loan financial expenses.

 

Total operating expenses for the three months ended June 30, 2022 were NIS 10.8 million ($3.1 million) compared to NIS 8.9 million for the three months ended June 30, 2021. Total operating expenses for the six months ended June 30, 2022 were NIS 19 million ($5.5 million) compared to NIS 15.6 million for the six months ended June 30, 2021. 

 

Net loss for the for the three months ended June 30, 2022 was NIS 12.9 million ($3.7 million) compared to NIS 12.0 million for the three months ended June 30, 2021. Net loss for the six months ended June 30, 2022 was NIS 22.3 million ($6.4 million) compared to NIS 20.2 million for the six months ended June 30, 2021. These increases were primarily due to an increase in R&D expenses, offset by a decrease in marketing, general and administrative expenses as described above.

 

As of June 30, 2022, BiondVax had cash and cash equivalents of NIS 39.5 million ($11.3 million) compared to NIS 54.0 million as of December 31, 2021.

 

Unaudited second quarter 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 beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.

 

Contact Details

 

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

 

Forward Looking Statements

 

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. 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 the timing of future clinical trials, and the therapeutic and commercial potential of NanoAbs. 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 the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; 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; 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 March 25, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.  

 

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BALANCE SHEETS

In thousands, except share and per share data

 

               Convenience 
               Translation 
   December 31,   June 30,   June 30, 
   2021   2021   2022   2022 
   Audited   Unaudited   Unaudited 
   NIS   N I S   U.S. dollars 
CURRENT ASSETS:                
Cash and cash equivalents   54,036    39,883    39,499    11,285 
Other receivables   1,012    2,641    626    179 
                     
Total current assets   55,048    42,524    40,125    11,464 
                     
LONG TERM ASSETS:                    
                     
Property, plant and equipment   38,519    38,979    39,250    11,214 
Right-of-use assets   5,588    6,109    5,227    1,494 
Restricted cash   444    437    484    138 
Other long-term assets   -    -    485    139 
                     
Total non-current assets   44,551    45,525    45,446    12,985 
                     
Total assets   99,599    88,049    85,571    24,449 
                     
LIABILITIES AND SHAREHOLDERS’ EQUITY                    
CURRENT LIABILITIES:                    
                     
Trade payables   3,107    2,635    2,057    588 
Operating lease liabilities   773    764    857    245 
Loan from others   -    64,248    18,706    5,345 
Other payables   3,327    1,739    1,898    542 
                     
Total current liabilities   7,207    69,386    23,518    6,720 
                     
   LONG TERM LIABILITIES:                    
                     
Operating lease liabilities   5,712    6,047    5,536    1,582 
Loan from others   63,252    -    51,954    14,843 
Other payables   -    1,135    -    - 
Severance pay liability, net   95    95    95    27 
                     
Total long-term liabilities   69,059    7,277    57,585    16,452 
                     
SHAREHOLDERS’ EQUITY:                    
Ordinary shares of no par value: Authorized: 1,800,000,000 shares at June 30, 2022, (unaudited) June 30, 2021 (unaudited) and at December 31, 2021; Issued and outstanding: 747,153,064 shares at June 30, 2022 (unaudited), 573,285,824 shares at June 30, 2021 (unaudited) and 739,048,544 shares at December 31, 2021   (*)   (*)   (*)   (*)
Share premium   388,104    356,358    391,507    111,859 
Accumulated deficit   (364,771)   (344,972)   (387,039)   (110,582)
                     
Total Equity   23,333    11,386    4,468    1,277 
                     
Total liabilities and shareholders’ equity   99,599    88,049    85,571    24,449 

 

(*)Represents less than NIS\USD 1.

 

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STATEMENTS OF COMPREHENSIVE LOSS
In thousands, except share and per share data

 

                       Convenience translation 
   Year ended
December 31,
   Three months ended
June 30,
   Six months ended
June 30,
   Six months ended
June 30,
 
   2021   2021   2022   2021   2022   2022 
   Audited   Unaudited   Unaudited 
   N I S   U.S. dollars 
   (In thousands, except per share data) 
Operating expenses:                              
Research and development, net of participations   10,341    1,900    6,495    4,653    10,148    2,900 
Marketing, general and administrative   24,528    7,002    4,286    11,007    8,919    2,548 
Other income   (40)   -    -    -    -    - 
                               
Total operating expenses   34,829    8,902    10,781    15,660    19,067    5,448 
                               
Operating loss   (34,829)   (8,902)   (10,781)   (15,660)   (19,067)   (5,448)
                              
Financial income   5,716    -    1,571    822    2,783    796 
Financial expense   (10,865)   (3,091)   (3,642)   (5,341)   (5,984)   (1,710)
                               
Net loss and total comprehensive loss  (39,978)   (11,993)   (12,852)   (20,179)   (22,268)   (6,362)
                               
Basic and diluted net loss per share   (0.07)   (0.03)   (0.02)   (0.04)   (0.03)   (0.01)
                               
Weighted average number of shares outstanding used to compute basic and diluted loss per share   564,575,9 67    573,205 ,607    746,898,6 71    552,140,0 30    745,817, 220    745,817,2 20   

 

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.

 

 

 

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