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CAMBRIDGE, Mass., May 01, 2019 (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 first quarter ending March 31, 2019, and highlighted progress of the company’s pipeline.
“2019 has the potential to be a transformative year for VBI, marked by clinical milestones across all four of our lead programs, and as such, the first quarter of 2019 was characterized by intense focus on the execution of our ongoing clinical programs,” said Jeff Baxter, President and CEO, VBI Vaccines Inc. “In April 2019, all subjects in the Sci-B-Vac® pivotal Phase 3 PROTECT study completed clinical visits, including follow-up visits for safety, which confirms the timeline to top-line data. This data read-out is the most significant clinical milestone in the history of VBI and we remain diligently focused and excited as we advance towards the data read-out, expected mid-year this year, 2019.”
Recent Highlights and Upcoming Milestones
Sci-B-Vac®: Trivalent Prophylactic Hepatitis B Vaccine
Sci-B-Vac® is currently being evaluated in a global, pivotal Phase 3 clinical program, the results of which are intended to support future regulatory and marketing authorization submissions in the U.S., Europe, and Canada. The program consists of two concurrent Phase 3 studies – PROTECT and CONSTANT.
PROTECT: 2-arm safety and immunogenicity study in approximately 1,500 adults age 18 and older
CONSTANT: 4-arm lot-to-lot consistency study in approximately 2,850 subjects
VBI-1901 – Glioblastoma (GBM) Immunotherapeutic
VBI-1901 is currently being evaluated in a two-part Phase 1/2a study in recurrent GBM patients.
PART A: Dose-escalation phase designed to evaluate the safety, tolerability, and to define the optimal therapeutic dose level of VBI-1901
PART B: Subsequent extension phase with a narrower enrollment criteria, designed to more clearly assess immunologic responses and the correlation with tumor and clinical responses, based on MRIs and survival data
VBI-2601 – Hepatitis B Immunotherapeutic
VBI-1501 – Prophylactic Cytomegalovirus (CMV) Vaccine
First Quarter 2019 Financial Results
About VBI Vaccines Inc.
VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI is advancing the prevention and treatment of hepatitis B, with the only commercially-approved trivalent hepatitis B vaccine, Sci-B-Vac®, which is approved for use in Israel and 10 other countries and is currently in a Phase 3 study in the U.S., Europe, and Canada, and with an immunotherapeutic in development for a functional cure for chronic hepatitis B. VBI’s eVLP Platform technology allows for the development of enveloped virus-like particle (eVLP) vaccines that closely mimic the target virus to elicit a potent immune response. Integrating its cytomegalovirus (CMV) expertise with the eVLP platform technology, VBI’s lead eVLP vaccine candidates include a prophylactic CMV vaccine candidate and a therapeutic glioblastoma (GBM) vaccine candidate. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.
Website Home: http://www.vbivaccines.com/
News and Insights: http://www.vbivaccines.com/wire/
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 25, 2019, and filed with the Canadian security authorities at sedar.com on February 25, 2019, 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|
|March 31, 2019||December 31, 2018|
|Cash and cash equivalents||$||43,308||$||59,270|
|Prepaid expenses and other current assets||1,405||1,550|
|Total current assets||45,796||61,731|
|Property and equipment, net||9,944||8,525|
|Intangible assets, net||59,465||58,249|
|Other non-current assets||2,600||835|
|Total non-current assets||80,447||75,874|
|Liabilities and stockholder’s equity|
|Other current liabilities||17,339||17,322|
|Total current liabilities||22,993||23,377|
|Total non-current liabilities||16,555||16,095|
|Total stockholders' equity||86,695||98,133|
|Total liabilities and stockholders' equity||126,243||137,605|
|VBI Vaccines Inc. and Subsidiaries|
|Condensed Consolidated Statement of Operations and Comprehensive Loss|
|(In Thousands Except Per Share Amounts)|
|For the Three Months Ended March 31|
|Cost of revenue||988||1,413|
|Research and development||9,227||6,964|
|General and administrative||3,964||3,425|
|Total operating expenses||14,179||11,802|
|Loss from operations||(13,819||)||(11,624||)|
|Interest income (expense), net||(480||)||(539||)|
|Foreign exchange gain (loss)||(307||)||(88||)|
|Loss before income taxes||(14,606||)||(12,251||)|
|Income tax benefit||-||-|
|Basic and diluted net loss per share||$||(0.15||)||$||(0.19||)|
|Weighted-average number of shares used to compute basic and diluted net loss per share||97,481,625||64,179,605|
| 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