VBI Vaccines, Inc. New Stock Price, News & Analysis

VBI Vaccines announced the initiation of a second Phase 2a/2b clinical study for VBI-2601 (BRII-179) targeting chronic hepatitis B (HBV) as an add-on therapy to existing treatments. The trial, conducted in collaboration with Brii Biosciences, will enroll 600 patients in China, with initial data expected in H1 2023. The study aims to improve treatment outcomes for the roughly 290 million people globally infected with HBV, seeking to enhance current functional cure rates of approximately 9%.

VBI Vaccines Inc. (NASDAQ: VBIV) filed a New Drug Submission to Health Canada for its 3-antigen hepatitis B vaccine, aiming for approval in Canada. This vaccine targets all hepatitis B virus subtypes and is already approved in the U.S. as PreHevbrio™. The CEO, Jeff Baxter, emphasized the commitment to collaboration with Health Canada for review. Hepatitis B poses a significant global health risk, affecting over 290 million people. The vaccine's unique formulation is expected to enhance treatment options for adults at risk of hepatitis B infection.

VBI Vaccines Inc. announced updated 12-month and 18-month overall survival data from its Phase 2a study of VBI-1901, a cancer vaccine targeting recurrent glioblastoma (GBM). The data showed a significant improvement in overall survival compared to historical controls, with some patients experiencing up to 93% tumor reduction. The company plans to expand the study to support an application for accelerated approval, with new trials anticipated in Q1 2022 for recurrent GBM and mid-2022 for primary GBM. These results suggest promising efficacy and a need for innovative therapies in GBM treatment.

VBI Vaccines Inc. announced FDA approval for PreHevbrio™, the only 3-antigen hepatitis B vaccine for adults in the U.S. This vaccine targets all known hepatitis B virus subtypes and is indicated for adults aged 18 and older. The approval stems from two Phase 3 clinical studies demonstrating superior seroprotection rates compared to existing vaccines. PreHevbrio is expected to be commercially available in Q1 2022. VBI is also pursuing approvals in Europe and Canada. A shareholder conference call is scheduled for December 1, 2021.

VBI Vaccines Inc. (Nasdaq: VBIV) announced that CEO Jeff Baxter will participate in an analyst-led fireside chat at the Jefferies London Healthcare Conference on November 17, 2021, at 12:20 PM GMT / 7:20 AM ET. The discussion will be moderated by Kelechi Chikere, Ph.D. A live webcast will be available via VBI's Investors page and a replay will be archived post-event. VBI focuses on developing vaccines targeting significant diseases using innovative virus-like particle technology.

VBI Vaccines Inc. (Nasdaq: VBIV) reported its Q3 2021 financial results, noting a cash position of $137.5 million. The company is advancing its 3-antigen HBV vaccine, with a PDUFA target action date set for November 30, 2021, following a shift to universal HBV vaccination recommendations by the CDC. VBI also anticipates interim data for its HBV immunotherapeutic candidate and COVID-19 vaccine in H2 2022. Revenue decreased to $0.1 million, while net loss grew to $15.8 million, driven by increased G&A expenses and R&D investments.

VBI Vaccines Inc. (NASDAQ: VBIV) has announced that its abstract on the pivotal Phase 3 study PROTECT for its 3-antigen hepatitis B vaccine has been accepted for e-poster presentation at the American Association for the Study of Liver Diseases meeting from November 12-15, 2021. The study shows immune response data comparing their vaccine to a single-antigen HBV vaccine. This vaccine, approved in Israel, targets the significant global health threat of hepatitis B, which affects over 290 million individuals worldwide and causes about 900,000 deaths annually due to related complications.

VBI Vaccines Inc. announced the successful results of its Phase 3 CONSTANT study for its 3-antigen hepatitis B vaccine candidate in adults aged 18-45. The study involved 2,838 participants and demonstrated higher seroprotection rates (90.4% vs. 51.6% after two doses) compared to the single-antigen Engerix-B®. Furthermore, the immune response was significantly stronger, with anti-HBs concentrations being over 7.5 times higher post-vaccination. Importantly, no safety signals were observed, enhancing the vaccine's safety profile. These results support regulatory submissions in North America and Europe.

VBI Vaccines Inc. (Nasdaq: VBIV) announced participation in analyst-led fireside chats at two upcoming investor conferences. The first is the Guggenheim 2nd Annual Vaccines & Infectious Disease Conference on October 5, 2021, at 10:30 AM ET, featuring Evan Wang. The second is the H.C. Wainwright 2nd Annual HBV Conference on October 13, 2021, at 4 PM ET, featuring Patrick Trucchio. Live webcasts will be available on VBI's investor page, with replays archived afterward. VBI focuses on innovative vaccines for infectious diseases and cancers.