BIONDVAX PHARMACEUTICALS LTD 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 41,593 11,452
38,357
======
*) Represents an amount lower than NIS 1.
STATEMENTS OF COMPREHENSIVE INCOME
----------------------------------
In thousands, except per share data
Convenience
translation
-----------
Year ended Three months ended Three months
December 31, March 31, 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 135,097 135,097 162,481 162,481
outstanding used to compute basic
and diluted loss per share
Contact Details
Joshua Phillipson
Business Development Manager
+972 8 930 2529
j.phillipson@biondvax.com
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SOURCE BiondVax Pharmaceuticals Ltd.
