VBI Vaccines has filed operational and financial results for the three- and nine-month periods ended September 30th, 2014 on Form 10-Q with the U.S. Securities and Exchange Commission ("SEC"). The Quarterly Report on Form 10-Q is available on the SEC's website at http://www.sec.gov and on VBI's website at http://ir.vbivaccines.com under "SEC Filings."
"The third quarter was transformative for VBI," said Jeff Baxter, VBI's President and CEO. "In addition to raising new capital, resulting in a strong cash position, and making our NASDAQ debut, it marked a period of focused progress across our two vaccine platforms. Our lead candidate, an innovative eVLP-based CMV vaccine, VBI-1501A, has progressed in line with our target milestones. Over the next twelve months, we plan to prepare several batches of VBI-1501A for toxicology studies and for our Phase I clinical trial, which is scheduled to start in Q4 2015."
VBI is developing a prophylactic vaccine to prevent Cytomegalovirus (CMV) infection. CMV is a leading cause of prenatal developmental delays. Based on strong preclinical data, VBI has initiated work for GMP manufacturing of its lead candidate for use in formal preclinical and Phase I trials. Phase I data is expected in 2016, at which time VBI expects to demonstrate safety, tolerability, and also immunological proof of concept in humans.
Third Quarter Highlights
- Completed initial listing on NASDAQ.
- Consummated two equity private placements for gross proceeds of $16.25M.
- Obtained a senior secured term loan facility for up to $6M, of which VBI was able to draw down $3M in the third quarter.
- Developed and scaled-up methods for the manufacture and purification of VBI-1501A with GMP sub-contractors.
- Engaged regulatory advisors and continued preparation of documents supporting the IND filing of VBI-1501A.