BiondVax Announces Third Quarter 2019 Financial Results and Business Update
JERUSALEM, Nov. 26, 2019 /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 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.
-- Third quarter operating expenses were NIS 18.9m ($5.4m) compared with NIS 5.8m for the third quarter of 2018; -- Third quarter R&D expenses amounted to NIS 16.1m ($4.6m) compared with NIS 4.3m for the third quarter of 2018;
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.
Recent Business highlights:
-- $20 million was raised in a shareholder rights offering that concluded in July 2019. As a consequence of the offering and an associated option to purchase ordinary shares that were not purchased by other shareholders in the offering, Angels Investments in High Tech Ltd., wholly owned by Marius Nacht, lead investor of the aMoon Fund, held approximately 42% of outstanding BiondVax shares. -- Mr. Mark Germain was appointed Chairman of BiondVax's Board of Directors, effective September 30, 2019. -- In October 2019, BiondVax received EUR4 million from the European Investment Bank (EIB). These funds are the final tranche of the previously announced co-financing agreement signed in June 2017 and extended in April 2019 from EUR20 million to EUR24 million. -- Laboratory work for the primary and secondary outcome measures in the NIAID-sponsored Phase 2 clinical trial in the USA is now complete and the analysis is ongoing. Results are expected in Q2 2020. -- Enrollment and randomization of 12,463 participants was successfully completed in the pivotal, clinical efficacy, Phase 3 trial of BiondVax's M-001 Universal Influenza Vaccine candidate.
** 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 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 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.
BALANCE SHEETS --- 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-use 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 lower than NIS 1.
STATEMENTS OF COMPREHENSIVE LOSS --- In thousands, except share and per share data Convenience translation Year ended Three months ended Nine months ended Nine months December 31, September 30, September 30, 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 71,913 4,347 16,133 45,297 37,037 10,637 participations 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 (0.34) (0.01) (0.05) (0.16) (0.23) (0.07) NIS) Weighted average number of shares 261,419,599 261,419,599 377,899,911 261,419,599 290,794,601 290,794,601 outstanding used to compute basic and diluted loss per share
Contact Details:
Joshua E. Phillipson
+972-8-930-2529
j.phillipson@biondvax.com
View original content to download multimedia:http://www.prnewswire.com/news-releases/biondvax-announces-third-quarter-2019-financial-results-and-business-update-300965320.html
SOURCE BiondVax Pharmaceuticals Ltd.