NESS ZIONA, Israel, May 30, 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 March 31, 2017 and provided a business update.

First Quarter 2017 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.63 (NIS/$US) as at March 31, 2017.

  • First quarter operating expenses were NIS 2.97m ($817,000) compared with NIS 2.83m for the first quarter of 2016;
  • First quarter R&D expenses amounted to NIS 1.87m ($516,000) compared with NIS 2.06m for the first quarter of 2016;

As of March 31, 2017, BiondVax had cash and cash equivalents, short-term investments and marketable securities of NIS 35 million ($9.6 million) as compared to NIS 27 million as of December 31, 2016. The increase is attributable to a private placement of NIS 10.9 million.

 Recent Corporate Update

  • The European UNISEC consortium sponsored Phase 2b processed the final participant in September. Preliminary safety results were reported in November.[1] Immunogenicity results and statistical analysis are currently being processed by other UNISEC consortium entities.
  • In January, Angels High Tech Investments Ltd. invested NIS 10.9 million, approximately $2.8 million, in exchange for 33.8 million ordinary BiondVax shares on the Tel Aviv Stock Exchange (equivalent to 844,000 NASDAQ listed ADS) at the December 29, 2016 Tel Aviv closing market price. Following the transaction, Angels Investments held 19.99% of all issued and outstanding share capital of the Company.[2]
  • In January, the peer-reviewed journal Vaccine published an article titled, "Back to the future: Immunization with M-001 prior to trivalent influenza vaccine in 2011/12 enhanced protective immune responses against 2014/15 epidemic strain." The article reports that blood plasma samples from people who received M-001 in 2011 (as part of BiondVax's BVX-005 clinical trial in the elderly) showed a five-fold significant increase of protective antibodies against a new epidemic 2014/15 flu strain (A/Swiss) – a strain which did not exist when M-001 was administered to the BVX-005 participants.[3]
  • An article by BiondVax-affiliated authors titled, "Strategy for approving a universal flu vaccine" was published in March in the peer-reviewed journal Future Virology.[4]
  • Also in March, the Company received approval for a grant representing 20% of a NIS 20 million budget from Israel's Ministry of Economy and Industry to build a facility for commercial scale production of its universal flu vaccine candidate.[5]
  • In April, the company presented at the Influenza Vaccines for the World (IVW2017) conference in Switzerland.

 

[1] http://www.biondvax.com/2016/11/biondvax-phase-2b-trial-preliminary-safety-results-the-universal-flu-vaccine-candidate-is-safe-and-well-tolerated/

[2] http://www.biondvax.com/2017/01/biondvax-receives-us-2-8-million-investment-from-angels-high-tech-investments-ltd/

[3] http://www.biondvax.com/2017/01/back-to-the-future-study-published-in-vaccine-journal-indicates-biondvaxs-universal-flu-vaccine-candidate-may-cover-strains-which-dont-yet-exist/

[4] http://www.biondvax.com/2017/03/biondvax-publishes-regulatory-approval-strategy-for-novel-universal-flu-vaccines-in-future-virology-journal/

[5] http://www.biondvax.com/2017/03/biondvax-approved-for-grant-from-israels-ministry-of-economy-and-industry-to-build-facility-for-commercial-scale-production-of-its-universal-flu-vaccine/

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 on NASDAQ: 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,


March 31,


March 31,



2016


2016


2017


2017





Unaudited


Unaudited



N I S


U.S. dollars




CURRENT ASSETS:









Cash and cash equivalents


15,705


29,817


24,020


6,613

Marketable securities


4,067


4,065


4,068


1,120

Short-term deposits


7,602


-


6,751


1,859

Other receivables


815


2,282


4,979


1,371












28,189


36,164


39,818


10,963

LONG‑TERM ASSETS:









Property, plant and equipment


1,443


1,903


1,297


357

Other long term assets


478


290


478


132












1,921


2,193


1,775


489












30,110


38,357


41,593


11,452

CURRENT LIABILITIES:









Trade payables


686


836


752


207

Other payables


689


735


526


145












1,375


1,571


1,278


352

LONG‑TERM LIABILITIES:









Options


3,043


4,540


10,848


2,987

Severance pay liability, net


76


71


76


21












3,119


4,611


10,924


3,008










SHAREHOLDERS' EQUITY (DEFICIT):









Ordinary shares of NIS 0.0000001 par value:









 Authorized: 391,000,000 shares as of
  March 31, 2017, 2016 (unaudited) and
  December 31, 2016; Issued and
  Outstanding: 162,481,153 ,
  135,097,367 and 135,097,367
  shares respectively


*) -


*)   -


*)   -


*)   -

Share premium


113,041


111,083


129,550


35,668

Options


1,435


2,536


533


147

 Other comprehensive income


6


14


6


2

Accumulated deficit


(88,866)


(81,458)


(100,698)


(27,725)












25,616


32,175


29,391


8,092



30,110


 

38,357


41,593


11,452



















*) Represents an amount lower than NIS 1.

      

                                                                                                                                                                                                                      

STATEMENTS OF COMPREHENSIVE INCOME

In thousands, except per share data









Convenience
translation




Year ended

December 31,


Three months ended

March 31,


Three months

ended

March 31, 




2016


2016


2017


2017






Unaudited


Unaudited




NIS


U.S. dollars











Operating expenses:










Research and development, net of participations



7,794


2,063


1,874


516

Marketing, general and administrative



4,106


771


1,094


301











Total operating expenses



11,900


2,834


2,968


817











Operating loss



(11,900)


(2,834)


(2,968)


(817)











Financial income



3,019


1,481


8


2

Financial expense



(303)


(423)


(8,872)


(2,443)











Net loss                                                         



(9,184)


(1,776)


(11,832)


(3,258)











Other comprehensive income (loss):




















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



(6)


2


-


-











Total comprehensive loss



(9,190)


(1,774)


(11,832)


(3,258)











Basic and Diluted net loss per share



(0.07)


(0.01)


(0.07)


(0.02)











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



135,097


135,097


162,481


162,481













 

Contact Details
Joshua Phillipson
Business Development Manager
+972 8 930 2529
j.phillipson@biondvax.com

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SOURCE BiondVax Pharmaceuticals Ltd.

Copyright 2017 PR Newswire

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