Articles from VBI Vaccines Inc.

VBI Vaccines Inc. (VBI) is initiating a voluntary nationwide recall of all remaining PreHevbrio® [Hepatitis B Vaccine (Recombinant); NDC 75052-001-10] (“PreHevbrio”) due to the bankruptcy of the company and termination of operations.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided an update on the restructuring proceedings announced on July 30, 2024.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the Ontario Superior Court of Justice (Commercial List) (“Court”) has issued an initial order (“Initial Order”) granting the company protection under the Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C-36, as amended (“CCAA”). The Initial Order provides for, among other things: (i) a stay of proceeding in favour of VBI, (ii) approval of the DIP Loan (as described below), and (iii) the appointment of Ernst & Young Inc. (“EY”) to serve as monitor (“Monitor”) in the Court during the restructuring (“Restructuring Process”).

VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI" or the "Company"), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the voting results from its annual general meeting of shareholders held on June 25, 2024 (the "Meeting").

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced new interim tumor response data from the ongoing randomized, controlled Phase 2b study of VBI-1901, the Company’s immunotherapeutic cancer vaccine candidate, in recurrent glioblastoma (rGBM) patients. These data will be presented in a poster session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on Saturday, June 1, 2024.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that new interim tumor response data from the ongoing randomized, controlled Phase 2b study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), were accepted for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the quarter ended March 31, 2024.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the year ended December 31, 2023.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules of 2,272,728 of its common shares and warrants to purchase up to 2,272,728 common shares, at an offering price of $0.88 per common share and associated warrant. The warrants have an exercise price of $0.76 per share, are exercisable on the date of issuance, and will expire five years following the date of issuance.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that it has entered into definitive agreements for the sale and issuance of 2,272,728 common shares (or pre-funded warrants in lieu thereof) of VBI at an offering price of $0.88 per common share (or per pre-funded warrant in lieu thereof), in a registered direct offering priced at-the-market under the Nasdaq rules. In a concurrent private placement, VBI will issue unregistered warrants to purchase up to 2,272,728 common shares. The warrants have an exercise price of $0.76 per share, will be exercisable on the date of issuance, and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about April 11, 2024, subject to the satisfaction of customary closing conditions.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will present early tumor response data from the ongoing Phase 2b study of VBI-1901, VBI’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (rGBM) at the World Vaccine Congress Washington at 1:10pm ET on April 3, 2024. The multi-center, randomized, controlled, open-label study has been designed to evaluate overall survival, tumor response rates, and safety and tolerability of VBI-1901 as a monotherapy in rGBM patients.

VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI” or the “Company”), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that it has expanded its collaboration with the government of Canada, supported by a funding contribution from the government’s Strategic Innovation Fund (SIF). Under the new agreement, the remaining CAD$28 million of funding available under the previously committed CAD$56 million will be directed toward the development of VBI’s proprietary MLE platform, a next-generation version of the Company’s particulate, enveloped virus-like particle (“eVLP”) vaccine technology that enables the coding of eVLPs using messenger RNA (“mRNA”). In preclinical studies, VBI’s MLE candidates generated strong B-cell and T-cell signals compared to those seen with other mRNA vaccines tested. The technology platform also offers potential for streamlined manufacturing timelines, similar to other mRNA vaccines.

VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI” or the “Company”), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced agreements whereby Brii Biosciences (“Brii Bio”), subject to certain activities, is expected to: (i) acquire the intellectual property for VBI-2601, VBI’s HBV immunotherapeutic development program, and eliminate payment obligations from the July 2023 agreements between VBI and Brii Bio, (ii) acquire manufacturing capabilities and certain related assets at VBI’s Rehovot, Israel manufacturing facility, and (iii) enter into an exclusive license to develop and commercialize VBI-1901, VBI’s glioblastoma (GBM) immunotherapeutic candidate, in the Asia Pacific region (APAC), excluding Japan. Additionally, subject to certain approvals, VBI and Brii Bio will work together to transfer the manufacturing technologies of VBI-2601 to a site designated by Brii Bio. VBI received $2.5 million of consideration upon signing of definitive documents and is expected to receive up to an additional $30.5 million of consideration, subject to achievement of certain activities, with a target completion date of June 30, 2024.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that additional biomarker data from the Phase 1/2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) patients, were highlighted in a poster presentation at the 28th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), held on Friday, November 17, 2023.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the quarter ended September 30, 2023.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the development of its next-generation mRNA-launched enveloped virus-like particle (eVLP) technology, which expands on the company’s current proprietary eVLP technology by coding the particles in messenger RNA (mRNA). In preclinical studies, VBI’s new mRNA-launched eVLP (MLE) technology has demonstrated an ability to generate stronger B- and T-cell signals than those seen with other mRNA vaccines tested. The MLE technology also has the added benefit of streamlined and accelerated chemistry, manufacturing, and control (CMC) processes and manufacturing timelines, similar to other known mRNA vaccine production platforms.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced interim data from the Phase 1 clinical study of its multivalent pan-coronavirus vaccine candidate, VBI-2901, which expresses the ancestral COVID-19, SARS, and MERS spike antigens. The Phase 1 clinical study enrolled 101 adults, aged 18-64 years who had received either two or three doses of a messenger RNA (mRNA) COVID-19 vaccine licensed by Health Canada, and assessed both one and two dose booster regimens of VBI-2901. Based on interim data, however, peak responses were achieved with only a single 10µg dose of VBI-2901.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the first patients have been dosed in the randomized, controlled Phase 2b study of VBI’s cancer vaccine immunotherapeutic candidate, VBI-1901, in patients with first recurrent glioblastoma (rGBM). The study will assess the safety, tolerability, tumor response rates, and survival following treatment with VBI-1901, as a monotherapy, at 10 leading neuro-oncology centers across the United States.

VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI” or the “Company”) today announced that its strategic hepatitis B (HBV) partner, Brii Biosciences (Brii Bio) (Stock code: 2137.HK), announced topline cohort-level unblinded Week 36 data from interim analysis of a randomized, placebo-controlled and double-blinded Phase 2 study of BRII-179 (VBI-2601), a first-in-class Pre-S1/Pre-S2/S therapeutic vaccine, in combination treatment with pegylated interferon-alpha (PEG-IFNα) in chronic hepatitis B virus (HBV) patients compared with PEG-IFNα only treatment. VBI and Brii Bio reported in previous studies that BRII-179 (VBI-2601) induced broad antibody and T-cell responses against Pre-S1, Pre-S2, and S epitopes in HBV patients. Brii Bio’s detailed press release can be found here: https://www.briibio.com/en/media/press-release/20230906/.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the quarter ended June 30, 2023.

VBI Vaccines Inc. (NASDAQVBIV) (VBI or the Company), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the underwriters of its recent underwritten public offering of common shares and accompanying common warrants to purchase common shares partially exercised their option to purchase an additional 1,536,363 common shares at a public offering price of $1.64 per common share. The aggregate gross proceeds from this exercise were approximately $2.5 million, resulting in total gross proceeds of $23.5 million from the underwritten public offering and the previously completed concurrent registered direct offering, before deducting the underwriting discounts, commissions, and estimated offering expenses. The partial option exercise closed on July 21, 2023.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that PreHevbri® [Hepatitis B vaccine (recombinant, adsorbed)] is now available in the Netherlands and Belgium for active immunization against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. It can be expected that hepatitis D will also be prevented by immunization with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. As part of the marketing and distribution partnership announced in September 2022, PreHevbri will be available in the Netherlands and Belgium through Valneva’s existing commercial infrastructure and distribution networks.

VBI Vaccines Inc. (NASDAQVBIV) (VBI or the Company), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the pricing of its previously announced underwritten public offering of 10,909,091 common shares and accompanying common warrants to purchase up to 10,909,091 common shares, and its concurrent registered direct offering of 1,818,182 common shares and accompanying common warrants to purchase up to 1,818,182 common shares, at a combined public offering price of $1.65 per share and accompanying common warrant. The accompanying common warrants have an exercise price of $1.65 per share and expire five years from the date of issuance. VBI also granted the underwriters a 30-day option to purchase up to an additional 1,636,363 common shares and/or common warrants to purchase up to 1,636,363 common shares offered in the underwritten public offering. The gross proceeds from the underwritten public offering, before deducting underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $18 million, excluding any exercise of the underwriters’ option to purchase additional common shares and/or common warrants to purchase common shares, and the gross proceeds from the concurrent registered direct offering are expected to be approximately $3 million. All of the securities to be sold in the offerings are being offered by VBI. The offerings are expected to close on or about July 10, 2023, subject to satisfaction of customary closing conditions.

VBI Vaccines Inc. (NASDAQVBIV) (“VBI” or the “Company”), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that it has commenced an underwritten public offering and a registered direct offering of its common shares and accompanying common warrants to purchase its common shares. VBI also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of common shares and/or common warrants offered in the public offering. Both offerings are subject to market and other conditions and there can be no assurance as to whether or when the offerings may be completed, or as to the actual size or terms of the offerings. All of the securities to be sold in the offerings are being offered by VBI.

VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI” or the “Company”), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the expansion of its hepatitis B (HBV) partnership with Brii Biosciences (“Brii Bio”) (Stock code: 2137.HK). Through two license and collaboration agreements, Brii Bio expanded its exclusive license to VBI-2601 (BRII-179), VBI’s HBV immunotherapeutic candidate, to global rights and acquired an exclusive license for PreHevbri, VBI’s 3-antigen hepatitis B vaccine, in the Asia Pacific region (APAC).

VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI" or the "Company"), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the voting results from its annual general meeting of shareholders held on June 23, 2023 (the "Meeting").

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that PreHevbri® [Hepatitis B vaccine (recombinant, adsorbed)] is now available in the United Kingdom (“U.K.”) for active immunization against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. It can be expected that hepatitis D will also be prevented by immunization with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. As part of the marketing and distribution partnership announced in September 2022, PreHevbri will be available in the U.K. through Valneva’s existing commercial infrastructure and distribution networks.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that an abstract highlighting T-cell responses and durability of immune responses following vaccination with VBI’s 3-antigen hepatitis B (HBV) vaccine, PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], has been accepted for poster presentation at The International Liver Congress™ 2023 (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), taking place June 21-24.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the quarter ended March 31, 2023.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that Vaughn B. Himes, Ph.D., Chief Technical Officer of Seagen Inc., has joined VBI’s Board of Directors. Dr. Himes has a 30+-year successful track record in biotechnology strategic direction and change management, driving value creation and growth at both small and large biopharmaceutical companies.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced plans to focus the Company’s efforts on the fight against hepatitis B (HBV), concentrating on broadening access to VBI’s FDA-approved 3-antigen HBV vaccine for adults, PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], and advancing its HBV immunotherapeutic candidate, VBI-2601, which has the potential to be part of a functional cure regimen for chronic HBV patients.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the year ended December 31, 2022.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that Jeff Baxter, VBI’s President and CEO, and David E. Anderson, VBI’s Chief Scientific Officer, will discuss the company’s hepatitis B (HBV) portfolio with covering analyst, Steven Seedhouse, Ph.D., from Raymond James & Associates, Inc. The discussion will take place during a fireside chat at 1:00 PM ET on Tuesday, February 28, 2023.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced interim data from the Phase 2 study evaluating the combination of VBI-2601 (BRII-179), VBI’s HBV immunotherapeutic candidate, and BRII-835 (VIR-2218), an HBV-targeting siRNA candidate, in chronically infected HBV patients. The data, which will be featured in an oral presentation at APASL on February 18, 2023, demonstrated that the combination therapy was generally well-tolerated, restored strong anti-HBsAg antibody responses, and led to improved HBsAg-specific T-cell responses, when compared to BRII-835 alone. Notably, in two participants who received the combination therapy, maximum reductions in HBsAg to an undetectable level or to the lower limit of quantification (LLOQ) were achieved by Week 40, which were associated with robust HBV-specific antibody and T-cell responses.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that Health Canada has approved PreHevbrio™ [3-antigen Hepatitis B Vaccine (Recombinant)] for active immunization against infection caused by all known subtypes of hepatitis B (HBV) virus in adults 18 years of age and older. It can be expected that hepatitis D will also be prevented by immunization with PreHevbrio as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

The Coalition for Epidemic Preparedness Innovations (CEPI) is expanding its world-leading portfolio of potential variant-proof coronavirus vaccines in a deal with VBI Vaccines Inc. (Nasdaq: VBIV) to advance the development of multivalent coronavirus shots that could be deployed against COVID-19 as well as a future ‘Coronavirus X’.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that additional biomarker data from the Phase 1/2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), were presented at the 27th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), on Friday, November 18, 2022.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that members of the management team will participate in analyst-led fireside chats at the following investor conferences:

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that its abstract highlighting data from the ongoing Phase 2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), was accepted for poster presentation at the 27th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO), taking place November 16-20, 2022.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced financial results for the third quarter ended September 30, 2022, and provided a corporate update.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that Jeff Baxter, VBI’s President and CEO, and David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will participate in an analyst-led fireside chat at the H.C. Wainwright 3rd Annual Hepatitis B Virus (HBV) Conference on Tuesday, October 18, 2022.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, and Agenus (NASDAQAGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, today announced a collaboration to evaluate the combination of VBI-1901, VBI’s cancer vaccine immunotherapeutic, and balstilimab, Agenus’ monoclonal antibody (mAb) targeting the programmed death receptor-1 (PD-1) protein, in primary glioblastoma (GBM) patients as part of the adaptive platform trial, INSIGhT. Under the agreement, VBI will be the study sponsor and will be responsible for operational execution of the combination trial, and Agenus will provide drug supply and scientific support.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the initiation of enrollment in the Phase 1 clinical study of VBI-2901, a multivalent enveloped virus-like particle (eVLP) coronavirus vaccine candidate expressing the full-length spike proteins from the SARS-CoV-1 (SARS), SARS-CoV-2 (COVID-19), and MERS-CoV (MERS) viruses.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that data from the physician-initiated compassionate use of VBI’s 3-antigen hepatitis B vaccine in four adults chronically infected with hepatitis B virus (HBV) were presented in a poster session at the 2022 International HBV Meeting in Paris, France, on September 19.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced it has entered into a refinanced and upsized debt facility of up to $100 million with its existing lender, K2 HealthVentures (K2HV), a healthcare-focused specialty finance company.

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) (Valneva) and VBI Vaccines Inc. (Nasdaq: VBIV) (VBI) today announced a partnership in select European markets for the marketing and distribution of PreHevbri® [Hepatitis B vaccine (recombinant, adsorbed)], the only 3-antigen hepatitis B vaccine approved in Europe.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced financial results for the second quarter ending June 30, 2022 and provided a corporate update.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that John Dillman has been appointed as the Company’s Chief Commercial Officer. Mr. Dillman will be responsible for leading VBI’s commercial strategy, sales, and sales operations, including the commercialization of VBI’s 3-Antigen Hepatitis B Vaccine (HBV), PreHevbrio™ [Hepatitis B Vaccine (Recombinant)].

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that new data from a follow-up analysis of a subset of participants from the pivotal Phase 3 study (PROTECT) of the Company’s 3-antigen prophylactic hepatitis B (HBV) vaccine, were presented in an oral presentation at The International Liver Congress™ 2022 (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), which took place on June 26, 2022.

VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI" or the "Company"), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the voting results from its annual general meeting of shareholders held on June 22, 2022 (the "Meeting").

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for VBI-1901, a bivalent gB/pp65 immunotherapeutic vaccine candidate for the treatment of glioblastoma (GBM). In June 2021, the FDA also granted Fast Track Designation for VBI-1901 for the treatment of recurrent GBM in patients with first tumor recurrence.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that Jeff Baxter, VBI’s President and CEO, will participate in an analyst-led fireside chat at the Jefferies Healthcare Conference on Wednesday, June 8, 2022.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that new tumor response and overall survival (OS) data from the ongoing Phase 2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (GBM) was presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting on June 5. The expanded Phase 2a data were selected for presentation in both a poster session and a poster discussion session.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for PreHevbri™ [Hepatitis B vaccine (recombinant, adsorbed)] for active immunisation against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. It can be expected that hepatitis D will also be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that an abstract highlighting long-term durability of immune response data following vaccination with VBI’s 3-antigen hepatitis B (HBV) vaccine has been accepted for oral presentation at The International Liver Congress™ 2022 (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), taking place June 22-26, 2022.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that health economics and outcomes research (HEOR) comparing the cost-effectiveness of the Company’s 3-antigen hepatitis B vaccine (HBV), PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], to a single-antigen HBV vaccine, Engerix-B®, among adults in the U.S. was presented in a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2022 meeting held on May 15-18, 2022.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced financial results for the first quarter ending March 31, 2022 and provided a corporate update.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the European Commission (EC) has granted Marketing Authorisation for PreHevbri™ [Hepatitis B vaccine (recombinant, adsorbed)] for active immunisation against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. It can also be expected that hepatitis D will be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. The use of PreHevbri should be in accordance with official recommendations. PreHevbri contains the full antigenic composition of the hepatitis B virus surface antigen, including the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the European Union (EU) and in the European Economic Area (EEA) countries – Iceland, Liechtenstein, and Norway.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that tumor response and overall survival data from the ongoing Phase 2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), was accepted for presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced updated clinical and preclinical data from its coronavirus program, VBI-2900.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] is now available in the United States for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older. PreHevbrio was approved by the U.S. Food and Drug Administration (FDA) on November 30, 2021, and is the only approved 3-antigen HBV vaccine for adults.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that Jeff Baxter, VBI’s President and CEO, will participate in an analyst-led fireside chat at the 32nd Annual Oppenheimer Healthcare Conference on Wednesday, March 16, 2022.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion for VBI’s 3-antigen hepatitis B (HBV) vaccine, under the brand name PreHevbri™ [Hepatitis B vaccine (recombinant, adsorbed)]. The CHMP recommends PreHevbri for active immunization against infection caused by all known subtypes of the hepatitis B virus in adults.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that, following discussion at this afternoon’s meeting of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] now joins the list of recommended products for prophylactic adult vaccination against hepatitis B (HBV) infection. This recommendation follows the approval of PreHevbrio by the U.S. Food and Drug Administration (FDA) on November 30, 2021.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that David E. Anderson, Ph.D, VBI’s Chief Scientific Officer, will present an overview of VBI-1901, the Company’s cancer immunotherapeutic for the treatment of glioblastoma (GBM), at B. Riley’s Oncology Investor Conference. During his presentation, Dr. Anderson will highlight data from the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent GBM patients.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the first patient has been dosed in a second Phase 2a/2b clinical study evaluating VBI-2601 (BRII-179), an immunotherapeutic candidate targeting chronic hepatitis B virus (HBV). This newly announced Phase 2 study will assess VBI-2601 as an add-on therapy to the standard-of-care, nucleos(t)ide reverse transcriptase inhibitor (Nrtl) and pegylated interferon (PEG-IFN-α) therapy, which currently has a functional cure rate of approximately 9%1. A functional cure for chronic HBV infection is defined as achievement of undetectable HBV surface antigen (HBsAg) levels and sustained suppression of HBV DNA. As previously announced in April 2021, VBI-2601 is also being assessed in an additional Phase 2 study as part of a combination regimen with BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) targeting HBV.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the filing of a New Drug Submission (NDS) to Health Canada for the Company’s 3-antigen prophylactic hepatitis B vaccine candidate, seeking approval in Canada for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will present updated 12-month and 18-month overall survival (OS) data from the Phase 2a study investigating VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate targeting recurrent glioblastoma (GBM), at the World Vaccine & Immunotherapy Congress at 3:10 PM PT / 6:10 PM ET on December 1, 2021.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the U.S. Food and Drug Administration (FDA) has approved PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older. PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that Jeff Baxter, President and CEO, will participate in an analyst-led fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 17 at 12:20 PM GMT / 7:20 AM ET.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today reported financial results for the third quarter ending September 30, 2021 and provided a corporate update.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that its abstract highlighting data from PROTECT, the pivotal Phase 3 immunogenicity and safety study of its 3-antigen prophylactic hepatitis B (HBV) vaccine, was accepted for e-poster presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting®, to be held November 12-15, 2021.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that results from the pivotal Phase 3 study, CONSTANT, of VBI’s prophylactic 3-antigen hepatitis B (HBV) vaccine candidate in adults age 18-45 were published in The Journal of the American Medical Association Network Open. The study was designed to demonstrate manufacturing equivalence of three lots of VBI’s HBV vaccine candidate, as well as to evaluate immunogenicity of VBI’s 3-antigen HBV vaccine candidate compared to a single-antigen HBV vaccine, Engerix-B®, after two and three doses, and safety and reactogenicity. Together with results from the first pivotal Phase 3 study, PROTECT, these results formed the basis for the regulatory submissions of VBI’s 3-antigen HBV vaccine candidate in the U.S., Europe, and Canada.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that members of the management team will participate in analyst-led fireside chats at the following upcoming investor conferences:

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced positive results from multiple preclinical studies against several COVID-19 variants of concern as well as the initiation of dosing in the Phase 1b portion of the ongoing clinical study of VBI’s SARS-CoV-2 vaccine candidates in approximately 80 adults age 18-54.