Full Press Release Details
Third Quarter 2019 Financial Results and Business Update
Jerusalem, Israel - November
26, 2019 - 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 September 30, 2019.
Third Quarter 2019 Financial Summary
Results are in New Israel Shekels
(NIS) and convenience translation to $US is provided using the exchange rate of 3.482 (NIS/$US) as at September 30, 2019.
Expenses were related to execution
of planned ongoing operations, including the ongoing pivotal, clinical efficacy, Phase 3 trial of the Company's M-001 Universal
Flu Vaccine candidate and construction of a mid-size pilot manufacturing facility.
As of September 30, 2019, BiondVax
had cash and cash equivalents of NIS 75.2 million ($21.6 million) as compared to NIS 33.9
million as of June 30, 2019.
Business highlights:
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.
Joshua E. Phillipson | +972 8 930
2529 | j.phillipson@biondvax.com
Forward Looking Statements
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 publication by NIAID of the results of the NIH/NIAID
conducted Phase 2 clinical trial in the USA; 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.
In thousands, except share and per share data
| Convenience translation | ||||||||||||||||
| December 31, | September 30, | September 30, | ||||||||||||||
| 2018 | 2018 | 2019 | 2019 | |||||||||||||
| Audited | Unaudited | Unaudited | ||||||||||||||
| N I S | U.S. dollars | |||||||||||||||
| CURRENT ASSETS: | ||||||||||||||||
| Cash and cash equivalents | 75,883 | 52,985 | 75,247 | 21,610 | ||||||||||||
| Other receivables | 965 | 2,716 | 1,887 | 542 | ||||||||||||
| 76,848 | 55,701 | 77,134 | 22,152 | |||||||||||||
| LONG-TERM ASSETS: | ||||||||||||||||
| Property, plant and equipment | 28,249 | 24,175 | 34,324 | 9,857 | ||||||||||||
| Right-of-se assets | - | - | 7,371 | 2,117 | ||||||||||||
| Other long term assets | 740 | 888 | 507 | 146 | ||||||||||||
| 28,989 | 25,063 | 42,202 | 12,120 | |||||||||||||
| 105,837 | 80,764 | 119,336 | 34,272 | |||||||||||||
| CURRENT LIABILITIES: | ||||||||||||||||
| Trade payables | 20,723 | 1,732 | 1,552 | 446 | ||||||||||||
| Operating lease liability | - | - | 697 | 200 | ||||||||||||
| Other payables | 1,076 | 981 | 820 | 235 | ||||||||||||
| 21,799 | 2,713 | 3,069 | 881 | |||||||||||||
| LONG-TERM LIABILITIES: | ||||||||||||||||
| Liability in respect of government grants | 14,643 | 12,930 | 14,454 | 4,151 | ||||||||||||
| Operating lease liability | - | - | 6,898 | 1,981 | ||||||||||||
| Loan from others | 94,360 | 42,770 | 108,353 | 31,118 | ||||||||||||
| Warrants | 6,168 | 7,759 | 6,908 | 1,984 | ||||||||||||
| Accrued severance pay, net | 82 | 81 | 87 | 25 | ||||||||||||
| 115,253 | 63,540 | 136,700 | 39,259 | |||||||||||||
| SHAREHOLDERS' EQUITY: | ||||||||||||||||
| Ordinary shares of NIS 0.0000001 par value: | ||||||||||||||||
| Authorized: 600,000,000 shares at September 30, 2019, 2018 (unaudited) and December 31, 2018; Issued and outstanding: 402,351,657, 261,419,599 and 261,41,599 shares at September 30, 2019, 2018 (unaudited) and December 31, 2018, respectively | *)- | *)- | *)- | *)- | ||||||||||||
| Share premium | 179,929 | 179,871 | 256,889 | 73,776 | ||||||||||||
| Accumulated deficit | (211,144 | ) | (165,360 | ) | (277,322 | ) | (79,644 | ) | ||||||||
| (31,215 | ) | 14,511 | (20,433 | ) | (5,868 | ) | ||||||||||
| 105,837 | 80,764 | 119,336 | 34,272 |
*) Represents an amount
STATEMENTS OF COMPREHENSIVE
In thousands, except share and per share data
| Convenience translation | ||||||||||||||||||||||||
| Year ended December 31, | Three months ended September 30, | Nine months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||
| 2018 | 2018 | 2019 | 2018 | 2019 | 2019 | |||||||||||||||||||
| Audited | Unaudited | Unaudited | ||||||||||||||||||||||
| N I S | U.S. dollars | |||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||
| Research and development, net of participations | 71,913 | 4,347 | 16,133 | 45,297 | 37,037 | 10,637 | ||||||||||||||||||
| Marketing, general and administrative | 5,154 | 1,475 | 2,790 | 3,804 | 8,741 | 2,510 | ||||||||||||||||||
| Total operating expenses | 77,067 | 5,822 | 18,923 | 49,101 | 45,778 | 13,147 | ||||||||||||||||||
| Operating loss | (77,067 | ) | (5,822 | ) | (18,923 | ) | (49,101 | ) | (45,778 | ) | (13,147 | ) | ||||||||||||
| Financial income | 2,936 | 3,729 | 169 | 9,817 | 193 | 55 | ||||||||||||||||||
| Financial expense | (13,596 | ) | (157 | ) | (601 | ) | (2,659 | ) | (20,593 | ) | (5,914 | ) | ||||||||||||
| Total financial income (expense), net | (10,660 | ) | 3,572 | (432 | ) | 7,158 | (20,400 | ) | (5,859 | ) | ||||||||||||||
| Loss and total comprehensive loss | (87,727 | ) | (2,250 | ) | (19,355 | ) | (41,943 | ) | (66,178 | ) | (19,006 | ) | ||||||||||||
| Basic and diluted net loss per share (in NIS) | (0.34 | ) | (0.01 | ) | (0.05 | ) | (0.16 | ) | (0.23 | ) | (0.07 | ) | ||||||||||||
| Weighted average number of shares outstanding used to compute basic and diluted loss per share | 261,419,599 | 261,419,599 | 377,899,911 | 261,419,599 | 290,794,601 | 290,794,601 |