JERUSALEM, June 30, 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 first quarter financial results for the quarter ended March 31, 2020.

BiondVax Pharmaceuticals logo

First Quarter 2020 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.57 (NIS/$US) as at March 31, 2020.

Total operating expenses for the first quarter were NIS 20.0 million (approximately $5.6 million) compared with NIS 7.1 million for the first quarter of 2019.

  • R&D expenses for the first quarter amounted to NIS 19 million (approximately $5.3 million) compared with NIS 5.7 million for the first quarter of 2019.
  • Net loss for the first quarter was NIS 3.7 million (approximately $1.0 million) compared to net income of NIS 566 thousand for the first quarter of 2019.

The increase in total operating expenses compared to the first quarter of 2019 was primarily due to expenses related to the ongoing Phase 3 trial and scale-up at our manufacturing facility.

As of March 31, 2020, BiondVax had cash and cash equivalents of NIS 42.5 million (approximately $11.9 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.

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



March 31,


March 31,


2019



2019


2020


2020


Audited



Unaudited


Unaudited





N I S


U.S. dollars

CURRENT LIABILITIES:









Trade payables

17,062



15,249


3,278


919

Operating lease liabilities

694



676


684


192

Other payables

1,203



1,275


807


226











18,959



17,200


4,769


1,337

LONG–TERM LIABILITIES:









Liability in respect of government grants

14,812



14,568


12,991


3,644

Operating lease liabilities

6,809



7,247


6,641


1,863

Loan from others

123,780



88,792


117,784


33,039

Warrants

16,354



2,059


6,861


1,925

Severance pay liability, net

89



84


90


25











161,844



112,750


144,367


40,496

SHAREHOLDERS' EQUITY:









   Ordinary shares of NIS 0.0000001 par 
      value: Authorized: 600,000,000 shares at
       March 31, 2020 (unaudited) and at 
      391,000,000 shares at March 31, 2019 
      (unaudited) and December 31, 2019; 
      Issued and outstanding: 410,213,977 
      shares at March 31, 2020 (unaudited), 
      261,419,599 shares at March 31, 2019 
      (unaudited) and 402,351,657 shares at 
      December 31, 2019

*)   -



*)   -


*)   -


*)   -

Share premium

73,867



179,987


262,729


73,697

Accumulated deficit

(92,690)



(210,578)


(324,033)


(90,893)











(18,823)



(30,591)


(61,304)


(17,196)











33,493



99,359


87,832


24,637

 

 



STATEMENTS OF COMPREHENSIVE INCOME (LOSS)


In thousands, except share and per share data











Convenience









translation









Three months



Year ended


Three months ended


ended



December 31,


March 31,


March 31, 



2019


2019


2020


2020



Audited


Unaudited


Unaudited



NIS


U.S. dollars


Operating expenses:









Research and development, net of 
     participations

68,645


5,732


19,068


5,348


Marketing, general and administrative

9,706


1,433


981


275











Total operating expenses

78,351


7,165


20,049


5,623











Operating loss

(78,351)


(7,165)


(20,049)


(5,623)


Financial income

4


9,754


16,502


4,629


Financial expense

(30,847)


(2,023)


(148)


(42)











Net income (loss) and total 
     comprehensive income (loss)      

(109,194)


566


(3,695)


(1,036)


Basic and Diluted net income (loss) 
     per share

(0.33)


0.002


(0.01)


(0.002)











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

326,651,721


261,419,599


408,596,752


408,596,752




















 

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

 

 

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SOURCE BiondVax Pharmaceuticals Ltd.

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