BiondVax Welcomes New Chairman of the Board and Announces Second Quarter 2019 Financial Results
JERUSALEM, Aug. 28, 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 the appointment of a new Chairman of the Board of Directors and financial results for the quarter ended June 30, 2019.
Mr. Mark Germain, who has served as BiondVax's Vice Chairman of the Board of Directors since June 2018, has been appointed Chairman, effective September 30, 2019. Based in New York, and having served as founder, director, chairman of the board, and/or investor in over twenty biotech companies, and with experience assisting in arranging corporate partnerships, acquiring technology, entering mergers and acquisitions, and executing financings, Mr. Germain is well suited to help guide BiondVax's ongoing corporate development. Among his current positions, Mr. Germain is a Managing Director at The Aentib Group, a boutique merchant bank, and serves as a director on the board of the Israeli company Pluristem Therapeutics Inc. (NASDAQ: PSTI). Professor Avner Rotman, who has served as BiondVax's Chairman since 2005, will continue to serve as a Director.
Mr. Mark Germain commented: "It has been a great pleasure to work with Ron and his team this past year, and the rest of the board, and I'm honored to be elected Chairman at this exciting time for the company. Recent events have positioned BiondVax to become a successful manufacturer and marketer of its M-001 universal flu vaccine candidate. In July we closed on a financing of US$20M predominantly supported by our largest shareholder, Marius Nacht, bringing his ownership in the company to approximately 42%. This financing, the 24 million Euros made available by the European Investment Bank, and other resources now provide us with the means to complete our Phase 3 pivotal trial (with a total of approximately 12,000 participants), scale up manufacturing and begin preparation for commercialization."
Dr. Ron Babecoff, BiondVax's President and CEO, commented, "I have had the pleasure of working closely with Mark Germain since he joined our Board of Directors last year. I am confident that his experience and knowledge of the pharmaceutical ecosystem, in addition to his relevant international connections, will prove beneficial as we progress through our ongoing pivotal clinical efficacy Phase 3 trial, and upscale production capacity in our manufacturing facility."
Continuing, Babecoff noted, "Over Professor Rotman's term as Chairman, BiondVax has grown from a preclinical company to a Nasdaq-listed company. On a personal note, I wish to thank Avner for his leadership, guidance, and support that helped me and the company navigate through the many challenges we encountered over the years."
Second Quarter 2019 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.566 (NIS/$US) as at June 30, 2019.
-- Second quarter operating expenses were NIS 19.7m ($5.5m) compared with
NIS 30.7m for the second quarter of 2018;
-- Second quarter R&D expenses amounted to NIS 15.2m ($4.3m) compared with
NIS 29.2m for the second quarter of 2018;
As of June 30, 2019, BiondVax had cash and cash equivalents of NIS 33.9 million ($9.5 million) as compared to NIS 75.9m as of December 31, 2018. Expenses are 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 commercial manufacturing facility. These figures do not include the $20 million raised in a rights offering that concluded near the beginning of Q3 in July 2019.
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 per share data
*) Represents an amount lower than NIS 1.
Convenience translation
December 31, June
30
,
June 30,
2018 2018 2019 2019
Audited Unaudited
Unaudited
N I S
U.S. dollars
CURRENT ASSETS:
Cash and cash equivalents 75,883 37,128 33,916 9,511
Other receivables 965 4,067 1,258 353
76,848 41,195 35,174 9,864
LONG?TERM ASSETS:
Property, plant and equipment 28,249 18,793 32,475 9,107
Right-of-use assets 7,610 2,134
Other long term assets 740 880 510 143
28,989 19,673 40,595 11,384
105,837 60,867 75,769 21,248
CURRENT LIABILITIES:
Trade payables 20,723 1,323 7,977 2,237
Operating lease liability 686 192
Other payables 1,076 780 1,348 378
21,799 2,103 10,011 2,807
LONG?TERM LIABILITIES:
Liability in respect of government grants 14,643 12,790 14,621 4,100
Operating lease liabilities 7,076 1,985
Loan from others 94,360 20,710 110,971 31,119
Warrants 6,168 8,475 5,517 1,548
Severance pay liability, net 82 79 86 24
115,253 42,054 138,271 38,776
SHAREHOLDERS' EQUITY:
Ordinary shares of NIS 0.0000001 par value:
Authorized: 391,000,000 shares as of June 30, 2019,
*) -
*) -
*) -
*) -
2018 (unaudited) and December 31, 2018; Issued
and Outstanding: 261,754,119, 261,419,599 and
261,419,599 as of June 30, 2019, 2018 (unaudited)
and December 31, 2018, respectively
Share premium 179,929 179,821 185,454 52,006
Accumulated deficit (211,144) (163,110) (257,967) (72,341)
(31,215) 16,711 (72,513) (20,335)
105,837 60,868 75,769 21,248
STATEMENTS OF COMPREHENSIVE INCOME
---
In thousands, except per share data
Convenience translation
Year ended Three months ended Six months ended
Six months
December 31, June 30,
June 30,
ended
June 30,
2018 2018 2019 2018 2019 2019
Audited
Unaudited
Unaudited
N I S
U.S. dollars
(In thousands, except per share data)
Operating expenses:
Research and development, net of participations 71,913 29,205 15,172 40,950 20,904 5,862
Marketing, general and administrative 5,154 1,445 4,518 2,329 5,951 1,669
Total operating expenses 77,067 30,650 19,690 43,279 26,855 7,531
Operating loss (77,067) (30,650) (19,690) (43,279) (26,855) (7,531)
Financial income 2,936 6,386 6,386 24 7
Financial expense (13,596) (1,227) (27,699) (2,800) (19,992) (5,606)
Total finance (expense) income, net (10,660) 5,159 (27,699) 3,586 (19,968) (5,599)
Net loss (87,727) (25,491) (47,389) (39,693) (46,823) (13,130)
Basic and diluted net loss per share (NIS) (0.34) (0.10) (0.18) (0.15) (0.18) (0.05)
Weighted average number of shares 261,419,599 261,482,786 261,419,599 261,435,179 261,435,179
outstanding used to compute basic
and diluted loss per share
261,419,599
Contact Details
Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
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SOURCE BiondVax Pharmaceuticals Ltd.
