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BiondVax Welcomes New Chairman of the Board and Announces Second Quarter 2019 Financial Results

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JERUSALEM, Aug. 28, 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 the appointment of a new Chairman of the Board of Directors and financial results for the quarter ended June 30, 2019.

BiondVax Pharmaceuticals Logo (PRNewsfoto/Biondvax Pharmaceuticals Ltd)

Mr. Mark Germain, who has served as BiondVax's Vice Chairman of the Board of Directors since June 2018, has been appointed Chairman, effective September 30, 2019. Based in New York, and having served as founder, director, chairman of the board, and/or investor in over twenty biotech companies, and with experience assisting in arranging corporate partnerships, acquiring technology, entering mergers and acquisitions, and executing financings, Mr. Germain is well suited to help guide BiondVax's ongoing corporate development. Among his current positions, Mr. Germain is a Managing Director at The Aentib Group, a boutique merchant bank, and serves as a director on the board of the Israeli company Pluristem Therapeutics Inc. (NASDAQ:PSTI). Professor Avner Rotman, who has served as BiondVax's Chairman since 2005, will continue to serve as a Director.

Mr. Mark Germain commented: "It has been a great pleasure to work with Ron and his team this past year, and the rest of the board, and I'm honored to be elected Chairman at this exciting time for the company. Recent events have positioned BiondVax to become a successful manufacturer and marketer of its M-001 universal flu vaccine candidate. In July we closed on a financing of US$20M predominantly supported by our largest shareholder, Marius Nacht, bringing his ownership in the company to approximately 42%. This financing, the 24 million Euros made available by the European Investment Bank, and other resources now provide us with the means to complete our Phase 3 pivotal trial (with a total of approximately 12,000 participants), scale up manufacturing and begin preparation for commercialization."

Dr. Ron Babecoff, BiondVax's President and CEO, commented, "I have had the pleasure of working closely with Mark Germain since he joined our Board of Directors last year. I am confident that his experience and knowledge of the pharmaceutical ecosystem, in addition to his relevant international connections, will prove beneficial as we progress through our ongoing pivotal clinical efficacy Phase 3 trial, and upscale production capacity in our manufacturing facility."

Continuing, Babecoff noted, "Over Professor Rotman's term as Chairman, BiondVax has grown from a preclinical company to a Nasdaq-listed company. On a personal note, I wish to thank Avner for his leadership, guidance, and support that helped me and the company navigate through the many challenges we encountered over the years."

Second Quarter 2019 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.566 (NIS/$US) as at June 30, 2019.

  • Second quarter operating expenses were NIS 19.7m ($5.5m) compared with NIS 30.7m for the second quarter of 2018;
  • Second quarter R&D expenses amounted to NIS 15.2m ($4.3m) compared with NIS 29.2m for the second quarter of 2018;

As of June 30, 2019, BiondVax had cash and cash equivalents of NIS 33.9 million ($9.5 million) as compared to NIS 75.9m as of December 31, 2018. Expenses are 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 commercial manufacturing facility. These figures do not include the $20 million raised in a rights offering that concluded near the beginning of Q3 in July 2019.

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 per share data

*)  Represents an amount lower than NIS 1.









Convenience translation



December 31,


June 30,


June 30,



2018


2018


2019


2019



Audited


Unaudited


Unaudited



N I S


U.S. dollars

CURRENT ASSETS:









Cash and cash equivalents


75,883


37,128


33,916


9,511

Other receivables


965


4,067


1,258


353












76,848


41,195


35,174


9,864

LONG‑TERM ASSETS:









Property, plant and equipment


28,249


18,793


32,475


9,107

Right-of-use assets


-


-


7,610


2,134

Other long term assets


740


880


510


143












28,989


19,673


40,595


11,384












105,837


60,867


75,769


21,248

CURRENT LIABILITIES:









Trade payables


20,723


1,323


7,977


2,237

Operating lease liability


-


-


686


192

Other payables


1,076


780


1,348


378












21,799


2,103


10,011


2,807

LONG‑TERM LIABILITIES:









Liability in respect of government grants


14,643


12,790


14,621


4,100

Operating lease liabilities


-


-


7,076


1,985

Loan from others


94,360


20,710


110,971


31,119

Warrants


6,168


8,475


5,517


1,548

Severance pay liability, net


82


79


86


24












115,253


42,054


138,271


38,776

SHAREHOLDERS' EQUITY:









Ordinary shares of NIS 0.0000001 par value:









Authorized: 391,000,000 shares as of June 30, 2019, 
     2018 (unaudited) and December 31, 2018; Issued 
     and Outstanding: 261,754,119, 261,419,599 and 
     261,419,599 as of June 30, 2019, 2018 (unaudited) 
     and December 31, 2018, respectively


*) -


*)   -


*)   -


*)   -

Share premium


179,929


179,821


185,454


52,006

Accumulated deficit


(211,144)


(163,110)


(257,967)


(72,341)












(31,215)


16,711


(72,513)


(20,335)












105,837


60,868


75,769


21,248

 

 

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,



2018


2018


2019


2018


2019


2019



Audited

Unaudited


Unaudited



N I S


U.S. dollars



(In thousands, except per share data)

Operating expenses:


Research and development, net of participations


71,913


29,205


15,172


40,950


20,904


5,862

Marketing, general and administrative


5,154


1,445


4,518


2,329


5,951


1,669














Total operating expenses


77,067


30,650


19,690


43,279


26,855


7,531














Operating loss


(77,067)


(30,650)


(19,690)


(43,279)


(26,855)


(7,531)














Financial income


2,936


6,386


-


6,386


24


7

Financial expense


(13,596)


(1,227)


(27,699)


(2,800)


(19,992)


(5,606)














Total finance (expense) income, net


(10,660)


5,159


(27,699)


3,586


(19,968)


(5,599)














Net loss                                                           


(87,727)


(25,491)


(47,389)


(39,693)


(46,823)


(13,130)














Basic and diluted net loss per share (NIS)


(0.34)


(0.10)


(0.18)


(0.15)


(0.18)


(0.05)


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


 

 

261,419,599


261,419,599


261,482,786


261,419,599


261,435,179


261,435,179

 

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

 

BVXV)." alt="Mark Germain, Chairman of the Board of Directors, BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV).">

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SOURCE BiondVax Pharmaceuticals Ltd.

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