- Successful completion of the pivotal Phase 3 program for Sci-B-Vac®, on-track for submission of regulatory approval applications in the U.S., Europe, and Canada expected to begin in Q4 2020
- Announcement of pan-coronavirus vaccine candidate targeting COVID-19, SARS, and MERS – human clinical study material expected to be available in Q4 2020
- Expanded immunologic, tumor, and clinical data from recurrent GBM Phase 2a clinical study of VBI-1901 expected mid-year and Q4 2020
- Human proof-of-concept data from Phase 1b/2a study of hepatitis B immunotherapeutic, VBI-2601, expected H2 2020
- Net cash proceeds of approximately $54 million added to balance sheet from underwritten public offering in April 2020
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, 2020 and provided a corporate update.
President and CEO, Jeff Baxter, commented, "The last several months have brought unprecedented public health and societal challenges. Science and technology are at the forefront of everyone's mind, and since the outbreak of COVID-19 there has been a renewed interest in the vaccine space. An effective COVID-19 vaccine is vital to enabling the return to normalcy. We need the collaboration of many great minds to solve this crisis, and we are aggressively working to be part of the solution with our recently announced pan-coronavirus vaccine candidate. Our candidate, VBI-2901, co-expresses SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins in a multivalent construct that could allow for the production of broadly reactive antibodies, which may also offer potential protection from mutated strains of COVID-19 that may emerge over time. In collaboration with the National Research Council of Canada (NRC), we are evaluating and selecting the optimal vaccine candidate, with the goal of having clinical study material available in Q4 2020. Additionally, we aim to provide periodic updates on the candidate development throughout 2020.
"In this time of heightened public health focus and awareness, we continue to fire on all cylinders as we work to address other significant public health needs. Following the successful completion of the pivotal Phase 3 program for Sci-B-Vac®, our tri-antigenic prophylactic hepatitis B vaccine, we are working with the FDA, EMA, and Health Canada to prepare for submissions of regulatory approval applications in the U.S., Europe, and Canada, beginning in the fourth quarter of 2020. Additionally, the clinical trials for our hepatitis B immunotherapeutic and our glioblastoma (GBM) cancer vaccine immunotherapeutic candidates have not yet been materially impacted by the COVID-19 pandemic and are currently on-track for their respective clinical data readouts expected later in 2020.
"We have been working hard to ensure the safety and health of all employees while also continuing to achieve key program milestones. This balance has required tremendous dedication, flexibility, and communication from every member of the VBI team. With net proceeds of approximately $54 million from our recent equity raise added to the balance sheet, we believe we are now well-positioned to capitalize on the growth and value-driving opportunities ahead."
Recent Highlights and Upcoming Program Milestones
Equity Financing
- April 2020: $57.5 million of gross proceeds raised in an underwritten public offering, resulting in net cash proceeds to the company of approximately $54 million.
Appointment of New Board Member
- March 2020: Damian Braga, former Senior Vice President, Global Commercial Operations and President, U.S. and the Americas, of Sanofi Pasteur, joined VBI's Board of Directors.
Sci-B-Vac®: Tri-antigenic Prophylactic Hepatitis B (HBV) Vaccine
VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate
- H2 2020: Initial human proof-of-concept data expected from Phase 1b/2a study.
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate
VBI-2901: Trivalent Prophylactic Pan-Coronavirus Candidate
First Quarter 2020 Financial Results
About VBI Vaccines Inc.
Cautionary Statement on Forward-looking Information
View source version on businesswire.com: https://www.businesswire.com/news/home/20200506005032/en/
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