August 20, 2020

BiondVax Announces Second Quarter 2020 Financial Results

JERUSALEM, Aug. 20, 2020 /PRNewswire/ — BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing…

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.