BiondVax Announces First Quarter 2020 Financial Results
JERUSALEM, June 30, 2020 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its first quarter financial results for the quarter ended March 31, 2020.
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First Quarter 2020 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.57 (NIS/$US) as at March 31, 2020.
Total operating expenses for the first quarter were NIS 20.0 million (approximately $5.6 million) compared with NIS 7.1 million for the first quarter of 2019.
-- R&D expenses for the first quarter amounted to NIS 19 million
(approximately $5.3 million) compared with NIS 5.7 million for the first
quarter of 2019.
-- Net loss for the first quarter was NIS 3.7 million (approximately $1.0
million) compared to net income of NIS 566 thousand for the first
quarter of 2019.
The increase in total operating expenses compared to the first quarter of 2019 was primarily due to expenses related to the ongoing Phase 3 trial and scale-up at our manufacturing facility.
As of March 31, 2020, BiondVax had cash and cash equivalents of NIS 42.5 million (approximately $11.9 million) compared to NIS 72.4 million as of December 31, 2019.
*Tables to follow*
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 seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 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. 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 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, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; 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 U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional 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, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov. 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,
2019 2019 2020 2020
---
Audited Unaudited
Unaudited
N I S
U.S. dollars
CURRENT LIABILITIES:
Trade payables 17,062 15,249 3,278 919
Operating lease liabilities 694 676 684 192
Other payables 1,203 1,275 807 226
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18,959 17,200 4,769 1,337
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LONG-TERM LIABILITIES:
Liability in respect of government grants 14,812 14,568 12,991 3,644
Operating lease liabilities 6,809 7,247 6,641 1,863
Loan from others 123,780 88,792 117,784 33,039
Warrants 16,354 2,059 6,861 1,925
Severance pay liability, net 89 84 90 25
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161,844 112,750 144,367 40,496
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SHAREHOLDERS' EQUITY:
Ordinary shares of NIS 0.0000001 par
*) -
*) -
*) -
*) -
value: Authorized: 600,000,000 shares at
March 31, 2020 (unaudited) and at
391,000,000 shares at March 31, 2019
(unaudited) and December 31, 2019;
Issued and outstanding: 410,213,977
shares at March 31, 2020 (unaudited),
261,419,599 shares at March 31, 2019
(unaudited) and 402,351,657 shares at
December 31, 2019
Share premium 73,867 179,987 262,729 73,697
Accumulated deficit (92,690) (210,578) (324,033) (90,893)
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(18,823) (30,591) (61,304) (17,196)
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33,493 99,359 87,832 24,637
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STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
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In thousands, except share and per share data
Convenience
translation
Three months
Year ended Three months ended ended
December 31, March 31, March 31,
2019 2019 2020 2020
Audited Unaudited Unaudited
NIS U.S. dollars
Operating expenses:
Research and development, net of 68,645 5,732 19,068 5,348
participations
Marketing, general and administrative 9,706 1,433 981 275
Total operating expenses 78,351 7,165 20,049 5,623
Operating loss (78,351) (7,165) (20,049) (5,623)
Financial income 4 9,754 16,502 4,629
Financial expense (30,847) (2,023) (148) (42)
Net income (loss) and total (109,194) 566 (3,695) (1,036)
comprehensive income (loss)
Basic and Diluted net income (loss) (0.33) 0.002 (0.01) (0.002)
per share
Weighted average number of shares 326,651,721 261,419,599 408,596,752 408,596,752
outstanding used to compute basic
and diluted income (loss) per share
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Contact Details
Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
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SOURCE BiondVax Pharmaceuticals Ltd.
