VBI Vaccines

VBI Vaccines Inc. was a biopharmaceutical company that developed prophylactic vaccines and immunotherapeutic candidates based on virus-like particle (VLP) science, including a proprietary enveloped VLP (eVLP) platform and a proprietary mRNA-launched eVLP (MLE) platform. Its candidates were designed to mimic the natural presentation of viruses in order to elicit immune responses, and were directed at infectious disease targets such as hepatitis B, COVID-19 and other coronaviruses, cytomegalovirus (CMV) and Zika, as well as at aggressive cancers, notably glioblastoma (GBM) [3][5][6][7].

The company's approved product was PreHevbrio, a recombinant hepatitis B vaccine (marketed in Israel as Sci-B-Vac), approved in the U.S. for prevention of infection caused by all known hepatitis B virus subtypes in adults 18 and older, and approved in the E.U./EEA/U.K. and Canada for active immunization of adults. Clinical-stage programs included VBI-1501, a Phase 1-complete prophylactic CMV eVLP candidate expressing a modified gB-G antigen; VBI-2902, a monovalent COVID-19 eVLP candidate in Phase 1/2; VBI-2905, a Beta-variant monovalent eVLP candidate in Phase 1; VBI-2601 (BRII-179), a Phase 2 hepatitis B immunotherapeutic developed with Brii Biosciences; and VBI-1901, a Phase 2b bivalent eVLP cancer immunotherapeutic candidate expressing the CMV antigens gB and pp65, co-administered with GM-CSF in recurrent GBM. Preclinical programs covered a multivalent pan-coronavirus candidate (VBI-2901), additional multivalent coronavirus candidates, a bivalent Zika candidate (VBI-2501), and undisclosed MLE-platform programs [2].

In 2024 the company entered insolvency. It initiated restructuring proceedings under Canada's Companies' Creditors Arrangement Act on 2024-07-30, obtained provisional relief under Chapter 15 in the U.S. Bankruptcy Court for the District of Delaware, was delisted from Nasdaq, and ultimately agreed to sell substantially all assets to an affiliate of secured creditor and DIP lender K2 HealthVentures. It discontinued operations and recalled all in-expiry PreHevbrio vaccine in November 2024 [0][1][3][6][7].

Business model

VBI operated as a biopharmaceutical developer and commercializer: it advanced proprietary VLP-based vaccine and immunotherapeutic candidates through clinical development toward regulatory approval, commercialized an approved hepatitis B vaccine (PreHevbrio/PreHevbri/Sci-B-Vac) in multiple markets, and out-licensed or partnered selected programs, such as the worldwide license for VBI-2601 granted to Brii Biosciences in July 2023 with an expected sale of the program to Brii Bio [2][3].

Revenue derived from sales of its approved hepatitis B vaccine (PreHevbrio/PreHevbri/Sci-B-Vac) in approved markets, supplemented by partnership and licensing arrangements (for example, the worldwide license of VBI-2601 to Brii Biosciences) and by grant/government and foundation funding for specific programs from the Government of Canada's Strategic Innovation Fund and CEPI [2].

Traction

By 2024 VBI had an approved hepatitis B vaccine in four regulatory jurisdictions, a Phase 2b oncology candidate in recurrent glioblastoma, a Phase 2 hepatitis B immunotherapeutic partnered with and licensed to Brii Biosciences, and multiple Phase 1/1-2 and preclinical candidates. Development funding was received from the Government of Canada's Strategic Innovation Fund and CEPI. Traction reversed in 2024 with financial distress, failure to file interim financial statements for the period ended June 30, 2024, Nasdaq delisting and discontinuation of operations [2][3][6][7].

Latest developments

On 2024-07-30 VBI initiated CCAA restructuring proceedings in the Ontario Superior Court of Justice and received notice of Nasdaq delisting effective 2024-08-08; on 2024-08-02 the U.S. Bankruptcy Court for the District of Delaware granted provisional Chapter 15 relief. Ernst & Young Inc. was appointed Monitor and ran a sale and investment solicitation process. On 2024-08-20 the BCSC issued a failure-to-file cease trade order. On 2024-10-24 VBI and subsidiaries signed an acquisition agreement with K2 VBI Equity Trust, LLC, an affiliate of K2 HealthVentures, covering substantially all assets, with existing equity to be cancelled for no consideration; the Court approved the transaction on 2024-10-31 and it was recognized in the U.S. on 2024-11-20. The stay of proceedings was extended to 2025-01-31. On 2024-11-15 the company issued a voluntary nationwide recall of all in-expiry PreHevbrio vaccine due to discontinuation of operations, and on 2024-12-09 the BCSC partially revoked the cease trade order to permit closing of the transaction [0][1][3][6][7].