BiondVax Announces Third Quarter 2019 Financial Results and Business Update

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 EUR4 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 EUR20 million to EUR24 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                             Three months ended                        Nine months ended                  
             
             Nine months

                                                                                        December 31,                             September 30,                        September 30,                       
           
             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                                  71,913              4,347            16,133                    45,297         37,037                                                10,637
       participations



              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                          (0.34)            (0.01)           (0.05)                   (0.16)        (0.23)                                               (0.07)
       NIS)






              Weighted average number of shares                            261,419,599        261,419,599       377,899,911               261,419,599    290,794,601                                           290,794,601
       outstanding used to compute basic
       and diluted loss per share

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

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SOURCE BiondVax Pharmaceuticals Ltd.