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VBI Vaccines Inc. (NASDAQ: VBIV) is a leading biopharmaceutical company focused on developing next-generation vaccines to meet unmet needs in infectious diseases and immuno-oncology. Headquartered in Cambridge, MA, with research facilities in Ottawa, Canada, VBI is at the forefront of vaccine innovation with two primary platforms.
The first platform, Enveloped Virus-Like Particle (eVLP), enables the design of vaccines that closely mimic the target virus, enhancing their effectiveness. The company's lead eVLP asset is a prophylactic cytomegalovirus (CMV) vaccine, currently advancing with GMP manufacturing for formal preclinical and Phase I trials.
The second platform is a thermostable technology allowing vaccines and biologics to withstand fluctuating temperatures during storage and transport. VBI has completed proof-of-concept thermostability studies on several vaccine and biologic targets, highlighting this platform's potential to improve global vaccine distribution.
VBI's commercial product, Sci-B-Vac, is a hepatitis B (HBV) vaccine approved for adults, children, and newborns. The company's innovations are designed to address significant gaps in the vaccine market, particularly in underserved areas.
Recent achievements include the initiation of GMP manufacturing for its CMV vaccine candidate and successful proof-of-concept studies for its thermostable technology. VBI continues to be a pivotal player in the biopharmaceutical field, dedicated to advancing public health through cutting-edge vaccine solutions.
VBI Vaccines Inc. (Nasdaq: VBIV) has provided an update on its restructuring proceedings announced on July 30, 2024. The U.S. Bankruptcy Court for the District of Delaware granted provisional relief under Chapter 15 of the U.S. Bankruptcy Code on August 2, 2024. A hearing is scheduled to consider the recognition of the Ontario Superior Court of Justice order granting the company protection under the Companies' Creditors Arrangement Act (CCAA).
VBI received notice from Nasdaq that its common shares will be delisted effective August 8, 2024. The company does not plan to appeal this decision. Ernst & Young Inc. has been appointed as Monitor in the CCAA proceedings and the proposed sale and investment solicitation process (SISP).
VBI Vaccines Inc. (Nasdaq: VBIV) has initiated restructuring proceedings under the Companies' Creditors Arrangement Act (CCAA) in Canada. The Ontario Superior Court of Justice has issued an initial order granting the company protection, including a stay of proceedings and approval of a DIP Loan. Ernst & Young Inc. has been appointed as the monitor during the restructuring process.
VBI intends to fund the CCAA process through cash on hand and a DIP Loan from K2 HealthVentures The company plans to seek approval for a sale and investment solicitation process (SISP) to identify potential purchasers of its assets. VBI will also file for Chapter 15 bankruptcy in the US and commence proceedings under Israeli Insolvency Law to protect its subsidiaries and assets in those countries.
As a result, VBI expects its common shares to cease trading on the Nasdaq Capital Market and anticipates ceasing reporting as a public company.
VBI Vaccines announced the results of its annual general meeting of shareholders held on June 25, 2024. The meeting saw representation by 13,879,327 common shares, accounting for 48.39% of the company's outstanding shares. Shareholders voted on eight director nominees, all of whom were re-elected. The votes were as follows: Steven Gillis (80.58% for, 19.42% withheld), Damian Braga (80.35% for, 19.65% withheld), Joanne Cordeiro (83.07% for, 16.93% withheld), Michel De Wilde (79.77% for, 20.23% withheld), Vaughn Himes (83.88% for, 16.12% withheld), Blaine H. McKee (83.12% for, 16.88% withheld), Jeffrey R. Baxter (81.10% for, 18.90% withheld), and Nell Beattie (81.73% for, 18.27% withheld). Additionally, EisnerAmper LLP was appointed as the independent registered public accounting firm until the next annual meeting. More details can be found in the company's SEC and SEDAR filings.
VBI Vaccines shared interim data from the Phase 2b study of its cancer vaccine VBI-1901 in recurrent glioblastoma (rGBM) patients. Results showed a 67% tumor reduction in one patient, with a 43% disease control rate in the treatment group versus 0% in the control group. The FDA has granted Fast Track and Orphan Drug Designations to VBI-1901. Additional data will be available in Q4 2024. The study aims to enroll 60 patients by year-end.
VBI Vaccines announced that new interim tumor response data from its ongoing Phase 2b study of VBI-1901, a cancer vaccine candidate for recurrent glioblastoma (GBM), will be presented at the 2024 ASCO Annual Meeting. The data include updates on patients from the initial evaluation and new patients randomized into the study. The study involves 60 patients, randomized into two arms: VBI-1901 combined with GM-CSF, and standard-of-care treatment. Key endpoints are safety, overall survival, tumor response rate, progression-free survival, immunologic responses, corticosteroid use reduction, and quality of life changes.
VBI Vaccines (NASDAQ: VBIV) reported substantial growth in its first quarter 2024 financial results. Global net revenue for PreHevbrio, their Hepatitis B vaccine, surged 105% year-over-year to $1.0 million. VBI-1901, their cancer vaccine, showed encouraging early data in glioblastoma patients, with more results expected later in 2024. The company expanded its strategic partnership with the Canadian Government to develop its MLE technology, backed by CAD$28 million in funding. Financial highlights include a decrease in cost of revenues to $2.7 million and a reduction in R&D expenses to $2.6 million. Despite net losses, the company reduced its operating cash outflow by 46% year-over-year. SG&A expenses dropped 42% due to organizational changes.
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