Full Press Release Details
Second Quarter 2018 Financial Results
Jerusalem, Israel - August 22, 2018
-- 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.
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.
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.
Joshua E. Phillipson
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 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 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, 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 **
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 |
STATEMENTS OF COMPREHENSIVE
In thousands, except per share data
| Convenience translation | ||||||||||||||||||||||||
| Year ended December 31, | Three months ended June 30, | Six months ended June 30, | Six months 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 | ) | ||||||||||||
| 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 | (6 | ) | (4 | ) | - | (4 | ) | - | - | |||||||||||||||
| 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 outstanding used to compute basic and diluted loss per share | 201,030,768 | 175,809,413 | 261,419,599 | 169,182,101 | 261,419,599 | 261,419,599 |