JERUSALEM, Nov. 26, 2019 /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 September 30, 2019.

Third Quarter 2019 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.482 (NIS/$US) as at September 30, 2019.

  • Third quarter operating expenses were NIS 18.9m ($5.4m) compared with NIS 5.8m for the third quarter of 2018;
  • Third quarter R&D expenses amounted to NIS 16.1m ($4.6m) compared with NIS 4.3m for the third quarter of 2018;

Expenses were related to execution of planned ongoing operations, including the ongoing pivotal, clinical efficacy, Phase 3 trial of the Company's M-001 Universal Flu Vaccine candidate and construction of a mid-size pilot manufacturing facility.

As of September 30, 2019, BiondVax had cash and cash equivalents of NIS 75.2 million ($21.6 million) as compared to NIS 33.9 million as of June 30, 2019.

Recent Business highlights:

  • $20 million was raised in a shareholder rights offering that concluded in July 2019. As a consequence of the offering and an associated option to purchase ordinary shares that were not purchased by other shareholders in the offering, Angels Investments in High Tech Ltd., wholly owned by Marius Nacht, lead investor of the aMoon Fund, held approximately 42% of outstanding BiondVax shares.
  • Mr. Mark Germain was appointed Chairman of BiondVax's Board of Directors, effective September 30, 2019.
  • In October 2019, BiondVax received €4 million from the European Investment Bank (EIB). These funds are the final tranche of the previously announced co-financing agreement signed in June 2017 and extended in April 2019 from €20 million to €24 million.
  • Laboratory work for the primary and secondary outcome measures in the NIAID-sponsored Phase 2 clinical trial in the USA is now complete and the analysis is ongoing. Results are expected in Q2 2020.
  • Enrollment and randomization of 12,463 participants was successfully completed in the pivotal, clinical efficacy, Phase 3 trial of BiondVax's M-001 Universal Influenza Vaccine candidate.

 ** 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 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 publication by NIAID of the results of  the NIH/NIAID conducted Phase 2 clinical trial in the USA; 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,


September 30,


September 30,



2018


2018


2019


2019



Audited


Unaudited


Unaudited



N I S


U.S. dollars

CURRENT ASSETS:









Cash and cash equivalents


75,883


52,985


75,247


21,610

Other receivables


965


2,716


1,887


542












76,848


55,701


77,134


22,152

LONG‑TERM ASSETS:









Property, plant and equipment


28,249


24,175


34,324


9,857

Right-of-use assets


-


-


7,371


2,117

Other long term assets


740


888


507


146












28,989


25,063


42,202


12,120












105,837


80,764


119,336


34,272










CURRENT LIABILITIES:









Trade payables


20,723


1,732


1,552


446

Operating lease liability


-


-


697


200

Other payables


1,076


981


820


235












21,799


2,713


3,069


881

LONG‑TERM LIABILITIES:









Liability in respect of government grants


14,643


12,930


14,454


4,151

Operating lease liability


-


-


6,898


1,981

Loan from others


94,360


42,770


108,353


31,118

Warrants


6,168


7,759


6,908


1,984

Accrued severance pay, net


82


81


87


25












115,253


63,540


136,700


39,259

SHAREHOLDERS' EQUITY:









Ordinary shares of NIS 0.0000001 par value:









Authorized: 600,000,000 shares at September 30, 2019, 2018
(unaudited) and December 31, 2018; Issued and outstanding:
402,351,657, 261,419,599 and 261,41,599 shares at
September 30, 2019, 2018 (unaudited) and December 31, 2018,
respectively


*)   -


*)   -


*)   -


*)   -

Share premium


179,929


179,871


256,889


73,776

Accumulated deficit


(211,144)


(165,360)


(277,322)


(79,644)












(31,215)


14,511


(20,433)


(5,868)












105,837


80,764


119,336


34,272

*) Represents an amount lower than NIS 1.

STATEMENTS OF COMPREHENSIVE LOSS

In thousands, except share and per share data









Convenience
translation



Year ended

December 31,


Three months ended

September 30,


Nine months ended

September 30,


Nine months

ended

September 30,



2018


2018


2019


2018


2019


2019



Audited


Unaudited


Unaudited



N I S


U.S. dollars

Operating expenses:


























Research and development, net of 
   participations


71,913


4,347


16,133


45,297


37,037


10,637

Marketing, general and administrative


5,154


1,475


2,790


3,804


8,741


2,510














Total operating expenses


77,067


5,822


18,923


49,101


45,778


13,147














Operating loss


(77,067)


(5,822)


(18,923)


(49,101)


(45,778)


(13,147)














Financial income


2,936


3,729


169


9,817


193


55

Financial expense


(13,596)


(157)


(601)


(2,659)


(20,593)


(5,914)














Total financial income (expense), net


(10,660)


3,572


(432)


7,158


(20,400)


(5,859)














Loss and total comprehensive loss


(87,727)


(2,250)


(19,355)


(41,943)


(66,178)


(19,006)














Basic and diluted net loss per share (in 
   NIS)


(0.34)


(0.01)


(0.05)


(0.16)


(0.23)


(0.07)














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


261,419,599


261,419,599


377,899,911


261,419,599


290,794,601


290,794,601

 

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

 

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SOURCE BiondVax Pharmaceuticals Ltd.


Source: BiondVax Pharmaceuticals Ltd.