BiondVax Announces First Quarter 2019 Financial Results
JERUSALEM, May 30, 2019 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: 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, 2019.
First Quarter 2019 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, 2019.
-- First quarter operating expenses were NIS 7.1m ($1.97m) compared with
NIS 12.6m for the first quarter of 2018;
-- First quarter R&D expenses amounted to NIS 5.7m ($1.58m) compared with
NIS 11.7m for the first quarter of 2018;
As of March 31, 2019, BiondVax had cash and cash equivalents of NIS 57.5 million ($15.8 million) as compared to NIS 75.8 million as of December 31, 2018. The decrease is attributable to execution of planned ongoing operations related to the ongoing pivotal, clinical efficacy, Phase 3 trial of the Company's M-001 Universal Flu Vaccine candidate.
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-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate 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 clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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 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; 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 resources 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, 2018 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. We undertake no obligation to revise or update any forward-looking statement for any reason.
BALANCE SHEETS
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In thousands, except share and per share data
Convenience
translation
December 31, March 31, March 31,
2018 2018 2019 2019
Audited Unaudited Unaudited
N I S U.S. dollars
CURRENT ASSETS:
Cash and cash equivalents 75,883 55,675 57,532 15,840
Other receivables 965 2,975 1,854 511
76,848 58,650 59,386 16,351
LONG?TERM ASSETS:
Property, plant and equipment 28,249 12,537 31,417 8,650
Right-of-use assets 7,845 2,160
Other long term assets 740 880 711 196
28,989 13,417 39,973 11,006
105,837 72,067 99,359 27,357
CURRENT LIABILITIES:
Trade payables 20,723 8,526 15,249 4,199
Operating lease liability 676 186
Other payables 1,076 768 1,275 351
21,799 9,294 17,200 4,736
LONG?TERM LIABILITIES:
Liability in respect of government grants 14,643 11,252 14,568 4,011
Operating lease liabilities 7,247 1,995
Loan from others 94,360 88,792 24,447
Warrants 6,168 9,315 2,059 567
Severance pay liability, net 82 78 84 23
115,253 20,645 112,750 31,044
SHAREHOLDERS' EQUITY:
Ordinary shares of NIS 0.0000001 par value:
Authorized: 391,000,000 shares as of March 31, 2019,
*) -
*) -
*) -
*) -
2018 (unaudited) and December 31, 2018; Issued and
Outstanding: 261,419,599 shares as of March 31, 2019,
2018 (unaudited) and December 31, 2018
Share premium 179,929 179,747 179,987 49,556
Accumulated deficit (211,144) (137,619) (210,578) (57,979)
(31,215) 42,128 (30,591) (8,423)
105,837 72,067 99,359 27,357
STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
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In thousands, except share and per share data
Convenience
translation
Year ended Three months ended Three months
December 31, March 31, ended
March 31,
2018 2018 2019 2019
Audited Unaudited Unaudited
NIS U.S. dollars
Operating expenses:
Research and development, net of participations 71,913 11,745 5,732 1,578
Marketing, general and administrative 5,154 884 1,433 395
Total operating expenses 77,067 12,629 7,165 1,973
Operating loss (77,067) (12,629) (7,165) (1,973)
Financial income 2,936 9,754 2,685
Financial expense (13,596) (1,573) (2,023) (557)
Net income (loss) (87,727) (14,202) 566 156
(0.34) (0.05) 0.002 0.001
Basic and Diluted net income (loss) per share
Weighted average number of shares outstanding 261,419,599 261,419,599 261,419,599 261,419,599
used to compute basic and diluted income (loss)
per share
Contact Details
Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
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SOURCE BiondVax Pharmaceuticals Ltd.
