BiondVax Announces Second Quarter 2020 Financial Results

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its second quarter financial results for the quarter ended June 30, 2020 .

 

JERUSALEM, Aug. 20, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its second quarter financial results for the quarter ended June 30, 2020.

Second Quarter 2020 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.466 (NIS/$US) as at June 30, 2020.

Total operating expenses for the second quarter were NIS 16.0 million (approximately $4.61 million) compared with NIS 19.7 million for the second quarter of 2019.

  • R&D expenses for the second quarter amounted to NIS 11.9 million (approximately $3.4 million) compared with NIS 15.2 million for the second quarter of 2019.
  • Net loss for the second quarter was NIS 42 million (approximately $12.1 million) compared to net loss of NIS 47.4 million for the second quarter of 2019.

The decrease in total operating expenses compared to the second quarter of 2019 was primarily due to fewer costs associated with the nearly complete pivotal Phase 3 trial and completion of construction of the manufacturing facility.

As of June 30, 2020, BiondVax had cash and cash equivalents of NIS 38.7 million (approximately $11.2 million) compared to NIS 72.4 million as of December 31, 2019.

*Tables to follow*

About BiondVax

BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please visit www.biondvax.com.

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

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our  vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.

 

 

BALANCE SHEETS

In thousands, except share and per share data

 
               

Convenience

               

Translation

 

December 31

   


        June 30,

 

June 30,

 

2019

   

2019

 

2020

 

2020

 

Audited

   

Unaudited

 

Unaudited

       

N I S   

 

U.S. dollars

CURRENT ASSETS:

               

Cash and cash equivalents

72,467

   

33,916

 

38,752

 

11,181

Other receivables

656

   

1,258

 

2,467

 

712

                 
 

73,123

   

35,174

 

41,219

 

11,893

LONG–TERM ASSETS:

               

Property, plant and equipment

34,981

   

32,475

 

36,937

 

10,658

Right-of-use assets

7,136

   

7,610

 

6,662

 

1,922

Other long-term assets

510

   

510

 

891

 

257

                 
 

42,627

   

40,595

 

44,490

 

12,837

               

-

 

115,750

   

75,769

 

85,709

 

24,730

                 

CURRENT LIABILITIES:

               

Trade payables

17,062

   

7,977

 

4,070

 

1,174

Operating lease liabilities

694

   

686

 

676

 

195

Other payables

1,203

   

1,348

 

1,609

 

464

                 
 

18,959

   

10,011

 

6,355

 

1,835

LONG–TERM LIABILITIES:

               

Liability in respect of government grants

14,812

   

14,621

 

12,686

 

3,660

Operating lease liabilities

6,809

   

7,076

 

6,457

 

1,863

Loan from others

123,780

   

110,971

 

122,041

 

35,211

Warrants

16,354

   

5,517

 

-

 

-

Severance pay liability, net

89

   

86

 

92

 

26

                 
 

161,844

   

138,271

 

141,276

 

40,760

SHAREHOLDERS' EQUITY:

               

Ordinary shares of no par value: Authorized:
       600,000,000, 391,000,000 and
       600,000,000 shares at June 30, 2020 and
       2019 (unaudited) and December 31, 2019,
       respectively; Issued and outstanding:
       460,822,640, 261,419,599 and
       402,351,657 shares at June 30, 2020 and
       2019 (unaudited) and December 31, 2019,
      respectively

*)   -

   

*)   -

 

*)   -

 

*)   -

Share premium

255,285

   

185,454

 

304,089

 

87,735

Accumulated deficit

(320,338)

   

(257,967)

 

(366,011)

 

(105,600)

                 
 

(65,053)

   

(72,513)

 

(61,922)

 

(17,865)

                 
 

115,750

   

75,769

 

85,709

 

24,730

 

*)            Represents less than NIS\USD 1.

 


 

 

STATEMENTS OF COMPREHENSIVE INCOME (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,

 
   

2019

 

2019

 

2020

 

2019

2020

 

2020

 
   

Audited

 

Unaudited

 

Unaudited

 
   

N I S

 

U.S. dollars

 
   

(In thousands, except per share data)

 

Operating expenses:

                       

Research and development, net of
    participations

 

68,645

 

15,172

 

11,948

 

20,904

 

31,016

 

8,949

 

Marketing, general and administrative

 

9,706

 

4,518

 

4,139

 

5,951

 

5,120

 

1,477

 
                           

Total operating expenses

 

78,351

 

19,690

 

16,087

 

26,855

 

36,136

 

10,426

 
                       

-

 

Operating loss

 

(78,351)

 

(19,690)

 

(16,087)

 

(26,855)

 

(36,136)

 

(10,426)

 

Financial income

 

4

 

-

 

(11,291)

 

24

 

5,211

 

1,503

 

 

Financial expense

 

(30,847)

 

(27,699)

 

(14,600)

 

(19,992)

 

(14,748)

 

(4,255)

 
                           

Net loss 

 

 

(109,194)

 

(47,389)

 

(41,978)

 

(46,823)

 

(46,673)

 

(13,177)

 
                           

Basic and diluted net loss per share
    (NIS)

 

(0.33)

 

(0.18)

 

(0.10)

 

(0.18)

 

(0.11)

 

(0.03)

 
                           

Weighted average number of shares
    outstanding used to compute basic
    and diluted loss per share

 

326,651,721

 

261,482,786

 

433,498,227

 

261,435,179

 

431,485,801

 

431,485,801

 
                           

 

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SOURCE BiondVax Pharmaceuticals Ltd.

 
 
Company Codes: NASDAQ-SMALL:BVXV
 
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