On October 8, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported financial results for the third quarter ending September 30, 2021 and provided a corporate update (Press release, VBI Vaccines, NOV 8, 2021, View Source [SID1234594682]).
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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.
Third Quarter 2021 Financial Results
Cash Position: VBI ended the third quarter of 2021 with $137.5 million in cash, cash equivalents, and short-term investments compared with $93.8 million as of December 31, 2020.
Net Cash Used in Operating Activities: Net cash used in operating activities for the nine months ended September 30, 2021 was $21.4 million, compared to $30.6 million for the same period in 2020. The decrease in cash outflows is largely a result of the change in operating working capital, notably the cash received in advance from the CEPI funding agreement, offset by an increase in net loss.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $1.4 million for the nine months ended September 30, 2021, compared to $0.5 million for the same period in 2020. The increase is a result of routine purchases of property and equipment at our manufacturing facility in Rehovot, Israel.
Revenue: Revenue in the third quarter of 2021 was $0.1 million, compared to $0.3 million for the same period in 2020. The decrease in revenues was due to a decrease in R&D services revenue as part of the collaboration with Brii Bio. Fewer manufacturing and non-clinical research services were done in the three months ending September 30, 2021 compared to the three months ending September 30, 2020.
Cost of Revenues: Cost of revenues was $2.5 million in the third quarter of 2021 as compared to $2.1 million for the same period in 2020. The increase in the cost of revenues was due to increased outsourced testing costs and inventory-related costs incurred in the three months ending September 30, 2021 compared to the same period in 2020.
Research and Development (R&D): R&D expenses for the third quarter of 2021 were $3.0 million compared to $4.5 million in the third quarter of 2020. The decrease was a result of the government grants and funding arrangements, offset by an increase in the costs related to our coronavirus vaccine program, including the Phase 1a and Phase 1b portions of VBI-2902 and VBI-2905, respectively, and development and manufacturing of VBI-2905. The increase was also due to an increase in R&D expenses related to the development of our other vaccine candidates.
General and Administrative (G&A): G&A expenses were $9.7 million for the third quarter of 2021, compared to $5.6 million for the same period in 2020. The increase was a result of the increased commercialization preparation activities related to the 3-antigen prophylactic HBV vaccine candidate in anticipation of potential regulatory approvals, in addition to increased insurance and labor costs.
Net Loss: Net Loss and net loss per share for the third quarter of 2021 were $15.8 million and $0.06, respectively, compared to a net loss of $13.0 million and a net loss per share of $0.06 for the third quarter of 2020.