BiondVax Announces Second Quarter 2018 Financial Results
JERUSALEM, Aug. 22, 2018 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a Phase 3 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, 2018.
Second Quarter 2018 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.65 (NIS/$US) as at June 30, 2018.
- Second quarter operating expenses were NIS 30.6m ($8.4m) compared with NIS 2.59m for the second quarter of 2017;
- Second quarter R&D expenses amounted to NIS 29.2m ($8m) compared with NIS 2m for the second quarter of 2017;
As of June 30, 2018, BiondVax had cash and cash equivalents of NIS 37.1 million ($10.1 million) as compared to NIS 36.6m as of March 30, 2018. Expenses are related to execution of planned ongoing operations including the launch of a pivotal, clinical efficacy, Phase 3 trial of the Company's M-001 Universal Flu Vaccine candidate, and construction of a mid-size commercial manufacturing facility.
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-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. 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 prosecution and outcome of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of the new manufacturing facility its products; 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 United States Food and Drug Administration or equivalent foreign regulatory agencies; 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, 2017 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. We undertake no obligation to revise or update any forward-looking statement for any reason.
** Tables to Follow **
BALANCE SHEETS
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In thousands, except per share data
Convenience
translation
-----------
December 31, June 30, June 30,
--------
2017 2017 2018 2018
---- ---- ---- ----
Audited Unaudited Unaudited
------- --------- ---------
N I S U.S. dollars
----- ------------
CURRENT ASSETS:
Cash and cash equivalents 71,382 31,334 37,128 10,172
Marketable securities - 4,067 -
Short-term deposits - 1,200 - -
Other receivables 3,923 2,812 4,067 1,114
----- ----- ----- -----
75,305 39,413 41,195 11,286
------ ------ ------ ------
LONG?TERM ASSETS:
Property, plant and equipment 5,510 1,233 18,793 5,149
Other long term assets 880 505 880 241
--- --- --- ---
6,390 1,738 19,673 5,390
----- ----- ------ -----
81,695 41,151 60,868 16,676
====== ====== ====== ======
CURRENT LIABILITIES:
Trade payables 6,223 1,188 1,323 363
Other payables 660 664 780 214
--- --- --- ---
6,883 1,852 2,103 577
----- ----- ----- ---
LONG?TERM LIABILITIES:
Liability in respect of government grants 10,300 - 12,790 3,504
Loan from others - - 20,710 5,674
Warrants 8,177 18,231 8,475 2,322
Severance pay liability, net 83 79 79 22
--- --- --- ---
18,560 18,310 42,054 11,522
------ ------ ------ ------
SHAREHOLDERS' EQUITY:
Ordinary shares of NIS 0.0000001 par value:
Authorized: 391,000,000 shares as of June 30, *) - *) - *) - *) -
2018, 2017 (unaudited) and December 31,
2017; Issued and Outstanding: 261,419,599,
179,595,199 and 261,419,599 shares respectively
Share premium 179,669 132,824 179,821 49,265
Options - 533 - -
Other comprehensive income - 2 - -
Accumulated deficit (123,417) (112,370) (163,110) (44,688)
56,252 20,989 16,711 4,577
------ ------ ------ -----
81,695 41,151 60,868 16,676
====== ====== ====== ======
*) 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
December 31, June 30, June 30, ended
June 30,
2017 2017 2018 2017 2018 2018
---- ---- ---- ---- ---- ----
Unaudited Unaudited
--------- ---------
N I S U.S. dollars
----- ------------
(In thousands, except per share data)
Operating expenses:
Research and development, net of participations 18,777 2,022 29,205 3,896 40,950 11,219
Marketing, general and administrative 4879 569 1,445 1,663 2,329 638
---- --- ----- ----- ----- ---
Total operating expenses 23,656 2,591 30,650 5,559 43,279 11,857
------ ----- ------ ----- ------ ------
Operating loss (23,656) (2,591) (30,650) (5,559) (43,279) (11,857)
------- ------ ------- ------ ------- -------
Financial income 18 5 6,386 13 6,386 1,255
Financial expense (10,913) (9,086) (1,227) (17,958) (2,800) (273)
0
Total finance (expense) income, net (10,895) (9,081) 5,159 (17,945) 3,586 982
------- ------ ----- ------- ----- ---
Net loss (34,551) (11,672) (25,491) (23,504) (39,693) (10,875)
======= ======= ======= ======= ======= =======
Other comprehensive loss:
Items to be reclassified to profit or loss in subsequent periods:
Loss from available-for-sale financial assets (4) - (4) - -
(6)
---
Total comprehensive loss (34,557) (11,676) (25,491) (23,508) (39,693) (10,875)
======= ======= ======= ======= ======= =======
Basic and diluted net loss per share (NIS) (0.17) (0.07) (0.10) (0.14) (0.15) (0.04)
===== ===== ===== ===== ===== =====
Weighted average number of shares 175,809,413 261,419,599 169,182,101 261,419,599 261,419,599
outstanding used to compute basic and
diluted loss per share
201,030,768
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Contact Details
Joshua Phillipson
+972 8 930 2529
j.phillipson@biondvax.com
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SOURCE BiondVax Pharmaceuticals Ltd.
Company Codes: NASDAQ-SMALL:BVXV, OTC-PINK:BVAXF, TelAviv:BNDX, TelAviv:BVXV