Earnings release
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VBI Press Release Exhibit 99.1 VBI Vaccines Announces Second Quarter 2021 Financial Results and Provides Corporate Update Hepatitis B ( HBV ) : FDA and EMA regulatory review of VBI's 3 - antigen prophylactic HBV vaccine candidate ongoing - U.S. PDUFA target action date November 30 , 2021 COVID - 19 : Expected Q3 2021 initiation of the next phase of development of VBI - 2905 Beta variant , including both one - dose booster and two dose regimens , for seropositive and seronegative individuals , respectively Glioblastoma ( GBM ) : Expected Q4 2021 initiation of a randomized , controlled clinical study with registration potential $ 135.0 million in cash and cash equivalents at the end of Q2 2021 CAMBRIDGE , Mass . ( August 2 , 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 second quarter ending June 30 , 2021 and provided a corporate update . Jeff Baxter , VBI's President and CEO commented : “ The second quarter of 2021 was a data - rich period for the Company , with positive results across our lead programs , leading to meaningful advancement of our pipeline . As a result of the encouraging data reported in Q2 , the FDA granted Fast Track Designation for VBI - 1901 in recurrent GBM , we demonstrated the potency of the eVLP particulate delivery platform against COVID - 19 , supporting the assessment of our COVID - 19 Beta variant vaccine candidate in the next phase of development , and we initiated a first - in - class Phase 2 combination study assessing a potential functional cure regimen for chronic HBV infection . Additionally , as we advance towards our PDUFA target action date for our 3 - antigen prophylactic HBV vaccine candidate , we continue to lay the groundwork for the commercial launch , subject to regulatory approvals . The AMA established a unique CPT Code for a 3 - antigen ( S , Pre - S1 , Pre - S2 ) Hepatitis B ( HBV ) Vaccine , a meaningful milestone as it reinforces the scientific differentiation of our candidate and enables a streamlined reimbursement process . At the beginning of the year , we laid out an ambitious and aggressive plan for the development of our pipeline in 2021 , and in the first half of the year we've successfully executed against that plan . We look forward to sharing upcoming data and regulatory milestones as we move into the second half of 2021. " Q2 2021 Key Program Achievements and Anticipated Upcoming Milestones Hepatitis B ( HBV ) 3 - Antigen HBV Prophylactic Vaccine Candidate • • 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 , following acceptance of Marketing Authorization Application ( MAA ) filing in December 2020 July 2021 : The American Medical Association ( AMA ) Current Procedural Terminology ( CPT® ) Panel established a unique CPT code for a 3 - antigen ( S , Pre - S1 , Pre - S2 ) Hepatitis B ( HBV ) vaccine , under which VBI's vaccine candidate will be reported if approved Submissions to United Kingdom Medicines and Healthcare products Regulatory Agency ( MHRA ) and to Health Canada are in process and are expected to be completed in 2021 VBI - 2601 ( BRII - 179 ) : HBV Immunotherapeutic Candidate • April and June 2021 : Complete Phase 1b / 2a study dataset announced - EASL presentation selected for inclusion in the “ Best of the International Liver Congress " summary , highlighting the most noteworthy contributions to the scientific program . Data demonstrated : о VBI - 2601 ( BRII - 179 ) induced both B cell ( antibody ) and T cell responses in chronically - infected HBV patients and was well - tolerated with no safety signals observed Evidence to support further clinical evaluation of VBI - 2601 ( BRII - 179 ) as an immunomodulator in combination with other treatment modalities as a potential functional cure for chronic HBV infection • April 2021 : Phase 2 combination study of VBI - 2601 ( BRII - 179 ) and BRII - 835 ( VIR - 2218 ) , Vir Biotechnology's investigational HBV - targeting siRNA , initiated by partner , Brii Biosciences ( Brii Bio ) COVID - 19 & Coronaviruses VBI - 2900 : eVLP Coronavirus Vaccine Program • June 2021 : Initial positive Phase 1 data of VBI - 2902 announced , demonstrating that a 5µg dose , which expresses an optimized form of the SARS - CoV - 2 spike antigen and is adjuvanted with aluminum phosphate , was generally well - tolerated and elicited a potent immune response significantly higher than that seen in human convalescent sera . Notably : о Safety and tolerability : VBI - 2902 was well - tolerated with no safety signals observed , and no increase in reactogenicity with subsequent doses Neutralizing titers : After two doses , VBI - 2902 induced neutralization titers in 100 % of participants , with 4.3x the geometric mean titer ( GMT ) compared to convalescent sera Antibody binding titers : After two doses , VBI - 2902 induced antibody binding titers in 100 % of participants , with peak antibody binding GMT of 1 : 4,047 - 5.0x the GMT compared to convalescent sera Q3 2021 As a result of this platform - validating initial data , and in response to the increased circulation of COVID - 19 variants , the next phase of the ongoing adaptive Phase 1/2 study , expected to initiate in Q3 2021 , will assess VBI - 2905 , VBI's eVLP vaccine candidate directed against the COVID - 19 Beta variant H1 2022 : Expected initiation of the first clinical study of VBI's multivalent vaccine candidate , designed to increase the breadth of protection against known and emerging variants of COVID - 19 Glioblastoma ( GBM ) VBI - 1901 : Cancer Vaccine Immunotherapeutic Candidate • June 2021 : Positive data from Phase 2a ( Part B ) of ongoing Phase 1 / 2a study presented at ASCO , including : о о VBI - 1901 + GM - CSF study arm : • 6 - month and 12 - month OS : 80 % ( n = 8 / 10 ) and 60 % ( n = 6 / 10 ) , compared to historical controls of 60 % and 30 % ¹ , respectively 2 durable partial responses ( ≥50 % tumor reduction ) and 2 stable disease observations - 40 % disease control rate VBI - 1901 + GSK's AS01² adjuvant system study arm 6 - month OS : 89 % ( n = 8 / 9 ) ; 12 - month OS timepoint not yet reached