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      BiondVax Provides Second Quarter 2017 Financial Results and Update


      News provided by

      Biondvax Pharmaceuticals Ltd

      Aug 31, 2017, 07:30 ET

      Share this article

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      NESS ZIONA, Israel, Aug. 31, 2017 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) (TASE: BVXV), a 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, 2017 and provided a business update.

      Dr. Ron Babecoff, BiondVax's CEO, commented, "This quarter's significant achievements including the €20 million EIB funding and positive Phase 2b clinical trial results enable us continue towards launching our Phase 3 program and constructing our mid-size manufacturing facility towards commercialization."

      Second Quarter 2017 Financial Summary

      Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.496 (NIS/$US) as at June 30, 2017.

      • Second quarter operating expenses were NIS 2.59m ($742,000) compared with NIS 2.47m for the second quarter of 2016;
      • Second quarter R&D expenses amounted to NIS 2.02m ($579,000) compared with NIS 1.48m for the second quarter of 2016;

      As of June 30, 2017, BiondVax had cash and cash equivalents, short-term investments and marketable securities of NIS 36.6m ($10.5m) as compared to NIS 34.8m as of March 31, 2017. In the first half of 2017, the Company issued to investors approximately 6.7 million ordinary shares which is equivalent to 167 thousand NASDAQ listed ADSs, raising approximately $1.23 million.

       Recent Corporate Update

      • BiondVax reported statistically significant positive results from the European Phase 2b clinical trial of M-001. Both endpoints, safety and influenza-specific cellular immune responses were achieved. Details: http://www.biondvax.com/2017/07/biondvax-reports-positive-phase-2b-clinical-trial-results-for-its-universal-flu-vaccine/.
      • BiondVax signed a significant €20 million (approximately $US 22 million) non-dilutive funding agreement with the European Investment Bank (EIB). Details: http://www.biondvax.com/2017/06/european-investment-bank-eib-supports-late-stage-development-and-production-of-biondvaxs-universal-flu-vaccine-candidate-under-horizon-2020-initiative/.
      • Planning for construction of a mid-sized facility, planned to have capacity to annually produce tens of millions of doses of M-001 either in single-dose syringe or in bulk, is ongoing. A lease agreement was recently signed. Details: http://www.biondvax.com/2017/07/biondvax-signs-lease-agreement-for-mid-size-commercial-facility-to-manufacture-universal-flu-vaccine/.
      • The Israel Innovation Authority (IIA), formerly known as the Office of the Chief Scientist, agreed to fund up to 40% of a NIS 2.7 million (approximately US$ 750,000) budget towards ongoing development of M-001. Details: http://www.biondvax.com/2017/08/biondvax-receives-additional-grant-funding/.

      About BiondVax

      BiondVax is a biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax's proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded onNASDAQ: BVXV and TASE: BVXV. For more information, 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 risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated  Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, 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, 2016 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.

      ** Tables to Follow **


      BALANCE SHEETS

      In thousands, except per share data










      Convenience
      translation



      December 31,


      June 30,


      June 30,



      2016


      2016


      2017


      2017



      Audited


      Unaudited


      Unaudited



      N I S


      U.S. dollars




      CURRENT ASSETS:









      Cash and cash equivalents


      15,705


      15,084


      31,334


      8,963

      Marketable securities


      2,017


      2,017


      4,067


      1,163

      Short-term deposits


      7,602


      11,503


      1,200


      343

      Other receivables


      815


      3,188


      2,812


      804












      26,139


      31,792


      39,413


      11,273

      LONG‑TERM ASSETS:









      Marketable securities


      2,050


      2,049


      -


      -

      Property, plant and equipment


      1,443


      1,746


      1,233


      353

      Other long term assets


      478


      490


      505


      144












      3,971


      4,285


      1,738


      497












      30,110


      36,077


      41,151


      11,770

      CURRENT LIABILITIES:









      Trade payables


      686


      457


      1,188


      340

      Other payables


      689


      697


      664


      190












      1,375


      1,154


      1,852


      530

      LONG‑TERM LIABILITIES:









      Options


      3,043


      4,923


      18,231


      5,215

      Severance pay liability, net


      76


      72


      79


      22












      3,119


      4,995


      18,310


      5,237










      SHAREHOLDERS' EQUITY (DEFICIT):









      Ordinary shares of NIS 0.0000001 par value:









       Authorized: 391,000,000 shares as of
        June 30, 2017, 2016 (unaudited) and
        December 31, 2016; Issued and
        Outstanding: 179,595,199, 135,097,367
        and 135,097,367 shares respectively


      *) -


      *)   -


      *)   -


      *)   -

      Share premium


      113,041


      111,458


      132,824


      37,993

      Options


      1,435


      2,536


      533


      152

       Other comprehensive income


      6


      7


      2


      *)   -

      Accumulated deficit


      (88,866)


      (84,073)


      (112,370)


      (32,142)












      25,616


      29,928


      20,989


      6,003



      30,110


      36,077


      41,151


      11,770










      *) Represents an amount lower than NIS 1.

                                                                                                                                                                                                                            

      STATEMENTS OF COMPREHENSIVE INCOME

      In thousands, except per share data










      Convenience










      translation





      Year ended


      Three months ended


      Six months ended


      Six months

      ended




      December 31,


      June 30


      June 30


      June 30




      2016


      2016


      2017


      2016

      2017


      2017






      Unaudited


      Unaudited




      N I S


      U.S. dollars




      (In thousands, except per share data)


      Operating expenses:














      Research and development, net of participations


      7,794


      1,478


      2,022


      3,541


      3,896


      1,114


      Marketing, general and administrative


      4,106


      999


      569


      1,770


      1,663


      476
















      Total operating expenses


      11,900


      2,477


      2,591


      5,311


      5,559


      1,590
















      Operating loss


      (11,900)


      (2,477)


      (2,591)


      (5,311)


      (5,559)


      (1,590)
















      Financial income


      75


      252


      5


      49


      13


      4


      Financial expense


      (303)


      (6)


      (930)


      (200)


      (1,997)


      (571)


      Financial  income (expenses) due to revaluation of options


      2,944


      (383)


      (8,156)


      1,071


      (15,961)


      (4,566)
















      Total finance (expense) income, net


      2,716


      (138)


      (9,081)


      920


      (17,945)


      (5,133)
















      Net loss 


      (9,184)


      (2,615)


      (11,672)


      (4,39(1


      (23,504)


      (6,723)
















      Other comprehensive income (loss):














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














      Gain (loss) from available-for-sale financial assets


      (6)


      (7)


      (4)


      (5)


      (4)


      (1)
















      Total comprehensive loss


      (9,190)


      (2,622)


      (11,676)


      (4,396)


      (23,508)


      (6,724)
















      Basic and diluted net loss per share (NIS)


      (0.07)


      (0.02)


      (0.07)


      (0.03)


      (0.14)


      (0.04)
















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


      135,097,367


      135,097,367


      175,809,413


      135,097,367


      169,182,101


      169,182,101
















                     

      Contact Details

      Joshua Phillipson
      Business Development
      +972 8 930 2529
      [email protected]   

                                                                                       

      SOURCE Biondvax Pharmaceuticals Ltd

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