Globe Newswire 9-Nov-2018 7:00 AM
-- Completion of vaccination and enrollment in Sci-B-Vac® PROTECT and CONSTANT Phase 3 studies, respectively --
-- Encouraging early immunologic data observed in Phase 1/2a study of VBI-1901 for the treatment of recurrent glioblastoma --
CAMBRIDGE, Mass., Nov. 09, 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 third quarter ending September 30, 2018, and provided a corporate update.
"The last few months have seen meaningful progress across our portfolio, marked by achievements in our Sci-B-Vac® Phase 3 studies, PROTECT and CONSTANT, and early data from our Phase 1/2a study of VBI-1901 in recurrent glioblastoma (GBM)," said Jeff Baxter, President and CEO. "We have now completed vaccination and enrollment in the PROTECT and CONSTANT studies, respectively, with an exceptionally low drop-out rate, and no safety signals observed or reported to-date. These accomplishments support the clean safety profile of Sci-B-Vac® and reaffirm the timeline for top-line data from the PROTECT and CONSTANT trials, expected to read out mid-year 2019 and around the 2019 year-end, respectively."
Mr. Baxter continued, "Additionally, we are encouraged by the early immunologic data we've seen from our Phase 1/2a study of VBI-1901 in recurrent glioblastoma (GBM), which has shown evidence of robust boosting of CMV-specific immunity in some subjects in both the low-dose and intermediate-dose cohorts. With the addition of two top neuro-oncology sites, Dana-Farber Cancer Institute and Massachusetts General Hospital, we expect to complete enrollment in the high-dose cohort quickly. Thanks to the dedication and achievements of the entire VBI team, the fundamentals of the company remain strong and on-track as we head into a critical and exciting first half of 2019."
Recent Highlights and Upcoming Milestones
Formation of Three Scientific and Clinical Advisory Boards
Appointment of Chief Financial Officer and Head of Business Development
Sci-B-Vac® for Hepatitis B
VBI-1901 for Glioblastoma (GBM)
VBI-1501 for Congenital Cytomegalovirus (CMV)
Third 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 Sheet|
|September 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||25,986||$||67,694|
|Prepaid expenses and other current assets||3,054||1,944|
|Total current assets||30,160||70,426|
|Property and equipment, net||7,293||2,245|
|Intangible assets, net||61,531||63,336|
|Other non-current assets||1,113||675|
|Liabilities and stockholder's equity|
|Other current liabilities||14,255||11,426|
|Total current liabilities||18,765||13,236|
|Total non-current liabilities||12,931||12,633|
|Total stockholders' equity||77,128||119,787|
|Total liabilities and stockholders' equity||108,824||145,656|
|VBI Vaccines Inc. and Subsidiaries
|Condensed Consolidated Statement of Operations and Comprehensive Loss
|(In Thousands Except Share and Per Share Amounts)
|Three Months Ended September 30||Nine Months Ended September 30|
|Cost of revenue||801||1,334||3,281||3,966|
|Research and development||10,507||5,205||28,385||14,387|
|General and administrative||3,493||2,795||10,904||8,611|
|Total operating expenses||14,801||9,334||42,570||26,964|
|Loss from operations||(14,542||)||(9,141||)||(41,899||)||(26,300||)|
|Interest income (expense), net||(716||)||(742||)||(1,891||)||(2,188||)|
|Foreign exchange gain (loss)||(112||)||81||(560||)||605|
|Loss before income taxes||(15,370||)||(9,802||)||(44,350||)||(27,883||)|
|Income tax benefit||-||-||-||431|
|Basic and diluted net loss per share||$||(0.24||)||$||(0.24||)||$||(0.69||)||$||(0.68||)|
|Weighted-average number of shares used to compute basic and diluted net loss per share||64,383,391||40,229,371||64,274,310||40,115,689|
| Other comprehensive income (loss) -
currency translation adjustments
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
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