BiondVax Announces Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update

JERUSALEM, June 12, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its fourth quarter and full year financial results for the year ended December 31, 2019 and provided a business update.

Fourth Quarter 2019 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.456 (NIS/$US) as at December 31, 2019.

    --  Total operating expenses were NIS 32.5 million (approximately $9.4
        million) compared with NIS 27.9 million for the fourth quarter of 2018.
    --  R&D expenses for the fourth quarter amounted to NIS 31.6 million ($9.1
        million) compared with NIS 26.6 million for the fourth quarter of 2018.

Full Year 2019 Financial Summary

    --  Total operating expenses for 2019 were NIS 78.3 million ($22.6 million)
        compared with NIS 77 million in 2018.
    --  R&D expenses for 2019 amounted to NIS 68.6 million ($19.8 million)
        compared with NIS 71.9 million in 2018.

As of December 31, 2019, BiondVax had cash and cash equivalents of NIS 72.4 million ($20.9 million) compared to NIS 75.8 million as of December 31, 2018. Complete financial results are available in the Company's annual report on Form 20-F for the year ended December 31, 2019, which is being filed with the Securities and Exchange Commission today.

*Tables to follow*

2019 Highlights and Recent Corporate Update

    --  Pivotal clinical efficacy Phase 3 trial: The pivotal Phase 3 clinical
        trial aims to compare the safety and clinical efficacy of M-001 versus a
        placebo in preventing flu illness (as primary endpoints), and in
        reducing flu illness severity (as a secondary endpoint) from circulating
        influenza strains. Prior to both the 2018/19 and 2019/20 flu seasons, a
        total of over 12,400 adult volunteers aged 50+ (with half aged 65+) in
        seven European countries were enrolled. To date, no serious treatment
        related adverse events have been identified. Monitoring of the trial's
        second cohort (enrolled for the 2019/20 flu season) is nearly complete,
        and the Phase 3 clinical trial results are expected by the end of 2020.
    --  NIH-supported Phase 2 clinical trial: The clinical study report (CSR) of
        the NIH-supported Phase 2 clinical trial was completed earlier this
        week. The CSR concludes that "M-001 was safe in this study" and that
        "M-001 induced significant polyfunctional T cell responses," indicating
        that both primary endpoints of the trial were achieved. The trial in 120
        adult volunteers, supported by the U.S. National Institute of Allergy
        and Infectious Diseases (NIAID), part of the National Institutes of
        Health (NIH), was conducted by several of NIAID's Vaccine Treatment and
        Evaluation Units (VTEUs) in the U.S.
    --  Pilot manufacturing facility: Equipment installation and scale-up in
        BiondVax's pilot manufacturing facility in Jerusalem are in progress.
        The facility has planned annual capacity of up to between 10 and 20
        million doses in bulk.
    --  EUR24 million non-dilutive co-funding: The European Investment Bank
        (EIB) extended the 2017 co-financing agreement from EUR20 million to
        EUR24 million to support construction of BiondVax's pilot manufacturing
        facility in Israel and Phase 3 trial. BiondVax was honored to host Mr.
        Ambroise Fayolle, EIB Vice-President, during his visit to BiondVax in
        June 2019 for a signature event celebrating the extension of the
        financing agreement.
    --  $20 million rights offering: In June and July 2019, BiondVax raised
        approximately US$20 million in a rights offering to existing
    --  Warrant expiration: BiondVax received proceeds of approximately $4.2
        million through exercises of BiondVax warrants between January 1, 2020
        and expiration of the warrants in May 2020.
    --  New Board members: In September 2019, Mr. Mark Germain was appointed
        Chairman of the Board of Directors. In March 2020, Mr. Samuel Moed, Dr.
        Yael Margolin, and Mr. Adi Raviv were elected to the board. Mr. Moed
        recently served as Senior Vice President, Corporate Strategy at Bristol
        Myers Squibb (NYSE: BMY).

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 seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 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. For more information, please visit

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, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; 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 U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional 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, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, We undertake no obligation to revise or update any forward-looking statement for any reason.

Contact Details
Joshua E. Phillipson | +972 8 930 2529 |

              BALANCE SHEETS


              In thousands, except share and per share data



                                                                        December 31, 
          December 31,

                                                                                2018           2019                              2019

                                                                           N I S     
          U.S. dollars

            CURRENT ASSETS:

            Cash and cash equivalents                                        75,883         72,467                            20,968

            Other receivables                                                   965            656                               190

                                                                              76,848         73,123                            21,158

            LONG-TERM ASSETS:

            Property, plant and equipment                                    28,249         34,981                            10,122

            Right-of-use assets                                                             7,136                             2,065

            Other long-term assets                                              740            510                               148

                                                                              28,989         42,627                            12,335

                                                                             105,837        115,750                            33,493


            Trade payables                                                   20,723         17,062                             4,937

            Current maturities of lease liabilities                                           694                               201

            Other payables                                                    1,076          1,203                               348

                                                                              21,799         18,959                             5,486


            Liability in respect of government grants                        14,643         14,812                             4,286

            Lease Liabilities                                                               6,809                             1,970

            Loan from others                                                 94,360        123,780                            35,816

            Warrants                                                          6,168         16,354                             4,732

            Severance pay liability, net                                         82             89                                26

                                                                             115,253        161,844                            46,830


            Ordinary shares of NIS 0.0000001 par value: Authorized:  
           *)   -   
        *)   -                  
            *)   -
    391,000,000 shares at December 31, 2019 and 2018;
    Issued and outstanding: 402,351,657 and 261,419,599,
    shares at of December 31, 2019 and 2018, respectively

            Share premium                                                   179,929        255,285                            73,867

            Accumulated deficit                                           (211,144)     (320,338)                         (92,690)

                                                                            (31,215)      (65,053)                         (18,823)

                                                                             105,837        115,750                            33,493

*) Represents amounts less than NIS\USD 1.



                In thousands, except share and per share data

                                                                                                                                                    Convenience translation

        Year ended               
       Year ended

        December 31,             
       December 31,

                                                                                                           2017              2018        2019                                      2019

         N I S                
       U.S. dollars

              Operating expenses:

              Research and development, net of participations                                           18,777            71,913      68,645                                    19,863

              Marketing, general and administrative                                                      4,879             5,154       9,706                                     2,808

              Total operating expenses                                                                  23,656            77,067      78,351                                    22,671

              Operating loss                                                                          (23,656)         (77,067)   (78,351)                                 (22,671)

              Financial income                                                                              18             2,936           4                                         1

              Financial expense                                                                       (10,913)         (13,596)   (30,847)                                  (8,926)

              Loss                                                                                    (34,551)         (87,727)  (109,194)                                 (31,596)

              Other comprehensive loss:

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

              Loss from available-for-sale marketable                                                      (6)

              Total comprehensive loss                                                                (34,557)         (87,727)  (109,194)                                 (31,596)

              Basic and diluted loss per share                                                          (0.17)           (0.34)     (0.33)                                   (0.09)

               Weighted average number of shares outstanding used to compute basic and diluted loss
                per share                                                                           201,030,768       261,419,599 326,651,721                               326,651,721

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SOURCE BiondVax Pharmaceuticals Ltd.