VBI Vaccines, Inc. - Ordinary Shares (VBIV)

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").