VBI Vaccines, Inc. New - VBIV STOCK NEWS

VBI Vaccines Inc. (Nasdaq: VBIV) announced the drawdown of a $12 million second tranche from a debt financing facility with K2 HealthVentures, increasing the total potential funding to $52 million. The second tranche was upsized from the original $10 million due to the achievement of significant clinical milestones, including positive survival data from Phase 2a for VBI-1901 in glioblastoma and proof-of-concept for VBI-2601 in chronic hepatitis B. Two additional tranches of $10 million each are available upon meeting specific conditions.

VBI Vaccines Inc. (Nasdaq: VBIV) announced expanded tumor response and overall survival data from the Phase 2a portion of its ongoing Phase 1/2a study for VBI-1901, a cancer vaccine targeting recurrent glioblastoma (GBM). At the 2021 ASCO Annual Meeting, data revealed a 6-month overall survival (OS) rate of 80% and 89% in two study arms. Notably, historical controls show ~60% OS at 6 months for GBM. The e-poster presentation by Dr. Patrick Y. Wen will provide insights into this promising therapy's potential in a challenging treatment landscape.

VBI Vaccines (Nasdaq: VBIV) announced that results from its pivotal Phase 3 study, PROTECT, for its 3-antigen hepatitis B vaccine were published in The Lancet Infectious Diseases. The study showed a seroprotection rate of 91.4% for VBI's vaccine compared to 76.5% for Engerix-B® at Day 196, and it exceeded pre-set margins for statistical superiority, especially in adults over 45 years. The safety profile was consistent with previous studies, indicating no new safety risks. Regulatory submissions in North America and Europe are ongoing.

VBI Vaccines reported Q1 2021 financial results with notable developments in its pipeline, focusing on hepatitis B, COVID-19, and glioblastoma. The company raised $22.1 million through share issuance, enhancing its cash position to $133.6 million. Revenue decreased to $0.3 million due to reduced R&D services from collaborations. R&D expenses rose to $6.8 million, attributed to COVID-19 vaccine programs. Net loss increased to $17.6 million, with a loss per share of $0.07. Key upcoming milestones include regulatory reviews and clinical data releases throughout 2021.

VBI Vaccines Inc. (Nasdaq: VBIV) has announced the acceptance of two abstracts for presentation at the Canadian Liver Meeting 2021 regarding its Phase 3 program for a 3-antigen prophylactic hepatitis B vaccine. The oral presentation, scheduled for May 4, will be led by VBI’s Chief Medical Officer, Francisco Diaz-Mitoma, discussing superior seroprotection rates of the vaccine. The second abstract will be showcased in the poster gallery. VBI's vaccine, commercially available in Israel, targets hepatitis B, a disease affecting over 290 million globally.

VBI Vaccines Inc. (Nasdaq: VBIV) announced the submission of preclinical data for its enveloped virus-like particle (eVLP) vaccine candidate, VBI-2902, for peer review. The data shows that VBI-2902, expressing a modified SARS-CoV-2 spike protein, elicited a potent neutralizing antibody response and provided significant protection in hamster models infected with COVID-19. Initial Phase 1/2 study in Canada has commenced, with results expected by Q2 2021. The vaccine demonstrates robustness at few doses and without ultra-cold chain requirements.

VBI Vaccines Inc. (Nasdaq: VBIV) announced that CEO Jeff Baxter and CSO David E. Anderson, Ph.D., will present on their coronavirus vaccine candidates at a virtual biotech investor summit on April 28, 2021, at 1:30 PM ET. The event, titled 'Over the Hump: Vaccine Strategies and Preparedness in a Variant World,' will be moderated by National Securities’ Senior Biotechnology Analyst, Cosme Ordonez, M.D., Ph.D. Attendees can access a live webcast and a replay will be available on VBI’s investor webpage.

VBI Vaccines Inc. (Nasdaq: VBIV) announced that its abstract from the PROTECT study, assessing its 3-antigen hepatitis B vaccine, has been accepted for oral presentation at the NFID 2021 Annual Conference on Vaccinology Research. The presentation, titled Higher seroprotection rates (SPR), will take place on April 27, 2021. VBI’s vaccine candidate is the only 3-antigen hepatitis B vaccine approved in Israel, and the Phase 3 study aims to demonstrate superior immunogenicity and safety compared to existing vaccines, addressing a significant global health threat.

Brii Biosciences, Vir Biotechnology, and VBI Vaccines have commenced a Phase 2 clinical trial for BRII-835 (VIR-2218) and BRII-179 (VBI-2601) aimed at treating chronic hepatitis B virus (HBV) infection. This landmark trial investigates the combination of an siRNA targeting HBV and an HBV immunotherapeutic, marking the first clinical evaluation of this dual-action approach. The study is multi-centered across several countries in Asia and Oceania, focusing on safety and efficacy. Leading experts express optimism about achieving a functional cure for HBV through this innovative combination.