BiondVax Provides Second Quarter 2017 Financial Results and Update
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 EUR20 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-clini
cal-trial-results-for-its-universal-flu-vaccine/.
-- BiondVax signed a significant EUR20 million (approximately $US 22
million) non-dilutive funding agreement with the European Investment
Bank (EIB). Details:
http://www.biondvax.com/2017/06/european-investment-bank-eib-supports-la
te-stage-development-and-production-of-biondvaxs-universal-flu-vaccine-c
andidate-under-horizon-2020-initiative/.
-- Planning for construction of a mid-sized facility, planned to have
capacity to annually produce tens of millions of doses of M-001 either
in single-dose syringe or in bulk, is ongoing. A lease agreement was
recently signed. Details:
http://www.biondvax.com/2017/07/biondvax-signs-lease-agreement-for-mid-s
ize-commercial-facility-to-manufacture-universal-flu-vaccine/.
-- The Israel Innovation Authority (IIA), formerly known as the Office of
the Chief Scientist, agreed to fund up to 40% of a NIS 2.7 million
(approximately US$ 750,000) budget towards ongoing development of M-001.
Details:
http://www.biondvax.com/2017/08/biondvax-receives-additional-grant-fundi
ng/.
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, 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
------ ------ ------ -----
41,151 11,770
30,110 36,077
====== ======
*) 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 135,097,367 135,097,367 175,809,413 135,097,367 169,182,101 169,182,101
outstanding used to compute basic
and diluted loss per share
Contact Details
Joshua Phillipson
Business Development
+972 8 930 2529
j.phillipson@biondvax.com
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SOURCE Biondvax Pharmaceuticals Ltd
