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BiondVax Announces Second Quarter 2018 Financial Results

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BiondVax Announces Second Quarter 2018 Financial Results

PR Newswire

JERUSALEM, Aug. 22, 2018 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV), a Phase 3 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 June 30, 2018.

BiondVax Pharmaceuticals Logo (PRNewsfoto/Biondvax Pharmaceuticals Ltd)

Second Quarter 2018 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.65 (NIS/$US) as at June 30, 2018.

  • Second quarter operating expenses were NIS 30.6m ($8.4m) compared with NIS 2.59m for the second quarter of 2017;
  • Second quarter R&D expenses amounted to NIS 29.2m ($8m) compared with NIS 2m for the second quarter of 2017;

As of June 30, 2018, BiondVax had cash and cash equivalents of NIS 37.1 million ($10.1 million) as compared to NIS 36.6m as of March 30, 2018. Expenses are related to execution of planned ongoing operations including the launch of a pivotal, clinical efficacy, Phase 3 trial of the Company's M-001 Universal Flu Vaccine candidate, and construction of a mid-size commercial manufacturing facility.

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-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating 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 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. 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 involve certain risks and uncertainties 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 its products; 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 resource 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, 2017 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 and the Tel-Aviv Stock Exchange. We undertake no obligation to revise or update any forward-looking statement for any reason.

** Tables to Follow **

 

BALANCE SHEETS

In thousands, except per share data









Convenience
translation



December 31,


June 30,


June 30,



2017


2017


2018


2018



Audited


Unaudited


Unaudited



N I S


U.S. dollars

CURRENT ASSETS:









Cash and cash equivalents


71,382


31,334


37,128


10,172

Marketable securities


-


4,067




-

Short-term deposits


-


1,200


-


-

Other receivables


3,923


2,812


4,067


1,114












75,305


39,413


41,195


11,286

LONG‑TERM ASSETS:









Property, plant and equipment


5,510


1,233


18,793


5,149

Other long term assets


880


505


880


241












6,390


1,738


19,673


5,390












81,695


41,151


60,868


16,676

CURRENT LIABILITIES:









Trade payables


6,223


1,188


1,323


363

Other payables


660


664


780


214












6,883


1,852


2,103


577

LONG‑TERM LIABILITIES:









Liability in respect of government grants


10,300


-


12,790


3,504

Loan from others


-


-


20,710


5,674

Warrants


8,177


18,231


8,475


2,322

Severance pay liability, net


83


79


79


22












18,560


18,310


42,054


11,522

SHAREHOLDERS' EQUITY:









Ordinary shares of NIS 0.0000001 par value:









 Authorized: 391,000,000 shares as of June 30, 
 
2018, 2017 (unaudited) and December 31, 
 2017; Issued and Outstanding: 261,419,599, 
 179,595,199 and 261,419,599 shares respectively


*) -


*)   -


*) -


*) -

Share premium


179,669


132,824


179,821


49,265

Options


-


533


-


-

 Other comprehensive income


-


2


-


-

Accumulated deficit


(123,417)


(112,370)


(163,110)


(44,688)












56,252


20,989


16,711


4,577












81,695


41,151


60,868


16,676


*)            Represents an amount lower than NIS 1.

                                                                                                                                                                                                                      

STATEMENTS OF COMPREHENSIVE INCOME


In thousands, except per share data














Convenience translation




Year ended

December 31,


Three months ended

June 30,


Six months ended

June 30,


Six months

ended

June 30,




2017


2017


2018


2017


2018


2018






Unaudited


Unaudited




N I S


U.S. dollars




(In thousands, except per share data)


Operating expenses:













Research and development, net of   participations


18,777


2,022


29,205


3,896


40,950


11,219


Marketing, general and administrative


4879


569


1,445


1,663


2,329


638
















Total operating expenses


23,656


2,591


30,650


5,559


43,279


11,857
















Operating loss


(23,656)


(2,591)


(30,650)


(5,559)


(43,279)


(11,857)
















Financial income


18


5


6,386


13


6,386


1,255


Financial expense


(10,913)


(9,086)


(1,227)


(17,958)


(2,800)


(273)




0












Total finance (expense) income, net


(10,895)


(9,081)


5,159


(17,945)


3,586


982
















Net loss 


(34,551)


(11,672)


(25,491)


(23,504)


(39,693)


(10,875)
















Other comprehensive loss:














Items to be reclassified to profit or loss in subsequent periods:














Loss from available-for-sale financial assets


 

(6)


(4)


-


(4)


-


-
















Total comprehensive loss


(34,557)


(11,676)


(25,491)


(23,508)


(39,693)


(10,875)
















Basic and diluted net loss per share (NIS)


(0.17)


(0.07)


(0.10)


(0.14)


(0.15)


(0.04)
















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


 

 

201,030,768


175,809,413


261,419,599


169,182,101


261,419,599


261,419,599


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

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SOURCE BiondVax Pharmaceuticals Ltd.

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