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VBI Press Release VBI Vaccines Announces Third Quarter 2021 Financial Results and Provides Corporate Update Exhibit 99.1 - Hepatitis B ( HBV ) : • • • Prophylactic FDA and EMA regulatory review of VBI's 3 - antigen prophylactic HBV vaccine candidate ongoing – U.S. PDUFA target action date November 30 , 2021 On November 3 , the CDC's ACIP unanimously passed a universal HBV vaccination recommendation for all adults age 19-59 , and for adults age 60+ with risk factors for infection Therapeutic : Top - line interim data from Phase 2 combination study of VBI - 2601 ( BRII - 179 ) and BRII - 835 ( VIR - 2218 ) expected H2 2022 - study run by partner , Brii Biosciences COVID - 19 : Initial Phase 1b data expected Q1 2022 assessing VBI - 2905 as a single - dose booster in previously immunized adults Glioblastoma ( GBM ) : Next phase of development expected to assess VBI - 1901 in both primary and recurrent GBM patients , with registration potential - enrollment of additional recurrent patients expected to initiate Q1 2022 $ 137.5 million in cash and cash equivalents at the end of Q3 2021 CAMBRIDGE , Mass . ( November 8 , 2021 ) - 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 . Jeff Baxter , VBI's President and CEO commented : “ The third quarter of 2021 was a notably busy and productive time as we support the ongoing regulatory reviews of our prophylactic 3 - antigen HBV vaccine candidate , prepare for the potential launch of this candidate in the U.S. , Europe , and Canada , and advance both our immunotherapeutic vaccine candidates against GBM and chronic HBV , as well as our coronavirus pipeline , with the objective of creating vaccines that provide long - term breadth of protection with good safety and tolerability profiles . We look forward to sharing data and updates from the various milestones expected over the next six months across our portfolio . The public health space is constantly evolving , evidenced by the renewed focus on prevention of HBV with the recently revised adult vaccination guidelines , plus the mutational evolution of COVID - 19 with new and emerging variants . We are working hard to address significant and relevant unmet medical and public health needs , we believe this dedication and focus on successfully achieving these fundamentals will drive shareholder value . " Recent Accomplishments and Key Anticipated Upcoming Milestones Hepatitis B ( HBV ) 3 - Antigen HBV Prophylactic Vaccine Candidate • • Commercial preparations are ongoing and continue to ramp - up in anticipation of potential regulatory approvals November 3 , 2021 : the CDC's Advisory Committee on Immunization Practices ( ACIP ) unanimously voted to change the adult recommendations for HBV vaccination from risk based in all ages to a universal recommendation for adults age 19-59 , keeping risk - based recommendations for adults age 60+ November 30 , 2021 : U.S. Prescription Drug User Fee Act ( PDUFA ) target action date set by U.S. Food and Drug Administration ( FDA ) • European Medicines Agency ( EMA ) regulatory review ongoing Submissions to United Kingdom Medicines and Healthcare products Regulatory Agency ( MHRA ) and Health Canada are in process and are expected to complete in 2022 VBI - 2601 ( BRII - 179 ) : HBV Immunotherapeutic Candidate • H2 2022 : Top - line interim clinical data expected from Phase 2 combination study of VBI - 2601 ( BRII - 179 ) and BRII - 835 ( VIR - 2218 ) , Vir Biotechnology's investigational HBV- targeting siRNA ; study conducted by partner , Brii Biosciences ( Brii Bio ) COVID - 19 & Coronaviruses VBI - 2900 eVLP Coronavirus Vaccine Program • September 2021 Initiation of Phase 1b study of VBI - 2905 , VBI's eVLP vaccine candidate targeting the Beta variant , as both a single - dose booster in adults previously vaccinated with a full course of messenger RNA ( mRNA ) vaccine , and as a two - dose regimen in unvaccinated adults • Q1 2022 : Initial data expected from one - dose booster study arm , in previously vaccinated adults , in ongoing Phase 1b study Mid - year 2022 : Expected initiation of the first clinical study of VBI's trivalent pan - coronavirus vaccine candidate , VBI - 2901 , designed to increase the breadth of immunity against emerging COVID - 19 variants and betacoronviruses Glioblastoma ( GBM ) VBI - 1901 : Cancer Vaccine Immunotherapeutic Candidate Based on data seen to - date , we anticipate assessing VBI - 1901 in randomized , controlled clinical studies in both primary and recurrent GBM patients as part of the next phase of development • Q1 2022 : Expected initiation of enrollment of expanded number of patients in ongoing study in recurrent GBM , subject to discussions with FDA , increasing study size and adding a control arm to support the potential for accelerated approval based on tumor response data and improvement in overall survival • Mid - year 2022 : Expected initiation of a randomized , controlled clinical study with registration potential in primary GBM patients , subject to discussions with FDA Recent Publications • May 2021 : The Lancet Infectious Diseases publication of data from PROTECT – Phase 3 immunogenicity and safety study assessing VBI's 3 - antigen HBV vaccine candidate compared to Engerix - BⓇ in adults age 18 and older . Link to publication can be found here . • • . June 2021 : Vaccine publication of data from a Phase 3 immunogenicity and safety study , conducted in Vietnam and completed in 2007 , assessing VBI's 3 - antigen HBV vaccine candidate in healthy Asian adults . Link to publication can be found here . July 2021 : Vaccine publication of data from VBI - 2902a preclinical and challenge COVID - 19 studies . Link to publication can be found here . September 2021 : JHEP Reports , an open access companion title to Journal of Hepatology , publication of data from the recently completed Phase 1a / 2b study of VBI - 2601 ( BRII - 179 ) in adults with chronic HBV . Link to publication can be found here . • September 2021 : bioRxiv publication of preclinical and challenge COVID - 19 data from VBI - 2902 , VBI - 2905 , and VBI - 2901 demonstrating broadened immunity against COVID - 19 variants . Link to publication can be found here . October 2021 : The Journal of the American Medical Association Network Open publication of data from CONSTANT - Phase 3 lot - to - lot consistency and immunogenicity study assessing VBI's 3 - antigen HBV vaccine candidate in adults age 18-45 . Link to publication can be found here .