Loading, Please Wait...
-- Pivotal Phase 3 program for Sci-B-Vac® Hepatitis B vaccine continues to advance towards topline data expected mid-year 2019 --
-- Positive safety and immunogenicity data from Phase 1 study of VBI-1501 for Congenital Cytomegalovirus (CMV) reported in May 2018 --
-- Initial data from Phase 1/2a study of VBI-1901 for the treatment of recurrent glioblastoma (GBM) expected H2 2018 --
CAMBRIDGE, Mass., July 26, 2018 (GLOBE NEWSWIRE) -- VBI Vaccines Inc. (NASDAQ:VBIV) (“VBI”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today reported financial results for the second quarter ending June 30, 2018, and provided a corporate update.
“We continue to make strong progress in all three of our lead clinical programs,” said Jeff Baxter, President and CEO of VBI. “Our pivotal Phase 3 program of Sci-B-Vac®, our hepatitis B vaccine, is advancing well towards topline data from the PROTECT study expected mid-year 2019. Our eVLP technology-based pipeline showed exciting results in the clinic in May, when we reported positive final safety and immunogenicity data from our Phase 1 randomized study of VBI-1501 for CMV. This study was the first in-human study of a vaccine developed with our eVLP technology. We were excited to be able to demonstrate a robust immunologic response at a dose that is one-tenth the amount of other organizations’ CMV vaccine candidates. For our immuno-oncology pipeline, also developed with our eVLP technology, we look forward to reporting initial immunologic data from the Phase 1/2a study of VBI-1901 in recurrent GBM patients, which we expect in the second half of this year.”
Recent Highlights and Upcoming Milestones
Sci-B-Vac ® for Hepatitis B
VBI-1501 for Congenital Cytomegalovirus (CMV)
VBI-1901 for Glioblastoma Multiforme (GBM)
Second Quarter 2018 Financial Results
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI’s first marketed product is Sci-B-Vac®, a hepatitis B (HBV) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac® is approved for use in Israel and 10 other countries. VBI’s eVLP Platform technology enables the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (CMV) and glioblastoma (GBM). VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The company cautions that such statements involve risks and uncertainties that may materially affect the company's results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the company's products. A discussion of these and other factors, including risks and uncertainties with respect to the company, is set forth in the Company's filings with the Securities and Exchange Commission and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 26, 2018, and filed with the Canadian security authorities at sedar.com on February 26, 2018, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
|VBI Vaccines Inc. and Subsidiaries|
|Selected Condensed Consolidated Balance Sheets|
|June 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||41,127||$||67,694|
|Prepaid expenses and other current assets||2,757||1,944|
|Total current assets||44,910||70,426|
|Property and equipment, net||4,738||2,245|
|Intangible assets, net||60,374||63,336|
|Other long-term assets||1,106||675|
|Liabilities and stockholders’ equity|
|Other current liabilities||13,302||11,426|
|Total current liabilities||16,328||13,236|
|Total non-current liabilities||13,565||12,633|
|Total stockholders' equity||89,796||119,787|
|Total liabilities and stockholders' equity||119,689||145,656|
|VBI Vaccines Inc. and Subsidiaries|
|Condensed Consolidated Statements of Operations and Comprehensive Loss|
|(In Thousands Except Per Share Amounts)|
|Three Months Ended June 30||Six Months Ended June 30|
|Cost of revenue||1,067||1,357||2,480||2,632|
|Research and development||10,914||4,528||17,879||9,182|
|General and administrative||3,987||2,771||7,412||5,816|
|Total operating expenses||15,968||8,656||27,771||17,630|
|Loss from operations||(15,734||)||(8,312||)||(27,359||)||(17,159||)|
|Interest income (expense), net||(636||)||(743||)||(1,175||)||(1,447||)|
|Foreign exchange gain (loss)||(361||)||42||(448||)||524|
|Loss before income taxes||(16,731||)||(9,013||)||(28,982||)||(18,082||)|
|Income tax benefit||-||-||-||431|
|Basic and diluted net loss per share||$||(0.26||)||$||(0.22||)||$||(0.45||)||$||(0.44||)|
|Weighted-average number of shares used to
compute basic and diluted net loss per share
|Other comprehensive income (loss) - currency
Nicole Anderson, Communications Executive
Phone: (617) 830-3031 x124
VBI Investor Contact
Chief Business Officer
VBI Media Contact
Burns McClellan, Inc.
Robert Flamm, Ph.D.
Phone: (212) 213-0006