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BiondVax Announces First Quarter 2019 Financial Results

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JERUSALEM, May 30, 2019 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced its financial results for the quarter ended March 31, 2019.

BiondVax Pharmaceuticals Logo (PRNewsfoto/Biondvax Pharmaceuticals Ltd)

First Quarter 2019 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.63 (NIS/$US) as at March 31, 2019.

  • First quarter operating expenses were NIS 7.1m ($1.97m) compared with NIS 12.6m for the first quarter of 2018;
  • First quarter R&D expenses amounted to NIS 5.7m ($1.58m) compared with NIS 11.7m for the first quarter of 2018;

As of March 31, 2019, BiondVax had cash and cash equivalents of NIS 57.5 million ($15.8 million) as compared to NIS 75.8 million as of December 31, 2018. The decrease is attributable to execution of planned ongoing operations related to the ongoing pivotal, clinical efficacy, Phase 3 trial of the Company's M-001 Universal Flu Vaccine candidate.

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 6 completed Phase 1/2 and Phase 2 clinical trials, covering 698 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. 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, the prosecution and outcome of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of the new manufacturing facility; 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 United States Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise 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, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the Company's periodic filings with the SEC. 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,



2018


2018


2019


2019



Audited


Unaudited


Unaudited



N I S


U.S. dollars

CURRENT ASSETS:









Cash and cash equivalents


75,883


55,675


57,532


15,840

Other receivables


965


2,975


1,854


511












76,848


58,650


59,386


16,351

LONG‑TERM ASSETS:









Property, plant and equipment


28,249


12,537


31,417


8,650

Right-of-use assets


-


-


7,845


2,160

Other long term assets


740


880


711


196












28,989


13,417


39,973


11,006












105,837


72,067


99,359


27,357

CURRENT LIABILITIES:









Trade payables


20,723


8,526


15,249


4,199

Operating lease liability


-


-


676


186

Other payables


1,076


768


1,275


351












21,799


9,294


17,200


4,736

LONG‑TERM LIABILITIES:









Liability in respect of government grants


14,643


11,252


14,568


4,011

Operating lease liabilities


-


-


7,247


1,995

Loan from others


94,360


-


88,792


24,447

Warrants


6,168


9,315


2,059


567

Severance pay liability, net


82


78


84


23












115,253


20,645


112,750


31,044










SHAREHOLDERS' EQUITY:









Ordinary shares of NIS 0.0000001 par value:









 Authorized: 391,000,000 shares as of March 31, 2019,
 2018 (unaudited) and December 31, 2018; Issued and
 Outstanding: 261,419,599 shares as of March 31, 2019,
 2018 (unaudited) and December 31, 2018


*) -


*)   -


*)   -


*)   -

Share premium


179,929


179,747


179,987


49,556

Accumulated deficit


(211,144)


(137,619)


(210,578)


(57,979)












(31,215)


42,128


(30,591)


(8,423)












105,837


72,067


99,359


27,357











 



 

STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

In thousands, except share and per share data





Convenience

translation


Year ended

December 31,


Three months ended

March 31,


Three months

ended

March 31, 


2018


2018


2019


2019


Audited


Unaudited


Unaudited


NIS


U.S. dollars









Operating expenses:








Research and development, net of participations

71,913


11,745


5,732


1,578

Marketing, general and administrative

5,154


884


1,433


395









Total operating expenses

77,067


12,629


7,165


1,973









Operating loss

(77,067)


(12,629)


(7,165)


(1,973)

Financial income

2,936


-


9,754


2,685

Financial expense

(13,596)


(1,573)


(2,023)


(557)









Net income (loss)                           

(87,727)


(14,202)


566


156

 

Basic and Diluted net income (loss) per share

(0.34)


(0.05)


0.002


0.001









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

261,419,599


261,419,599


261,419,599


261,419,599
















 

 

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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