• Productive pre-submission meetings with FDA and EMA in May and July 2020 expected to enable filings of regulatory approval applications for Sci-B-Vac® in the U.S., Europe, and Canada beginning Q4 2020
  • Pre-clinical data for VBI-2901, VBI’s coronavirus program, expected to enable selection of clinical candidate(s) in Q3 2020 and the manufacturing of clinical study material, expected in Q4 2020
  • Additional clinical data expected for VBI’s therapeutic hepatitis B program and therapeutic GBM program in the second half of 2020
  • $86 million cash, cash equivalents, and short term investments provides strong financial support for upcoming milestone-rich quarters

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today reported financial results for the second quarter ending June 30, 2020 and provided a corporate update.Jeff Baxter, President and CEO, commented: “The second quarter of 2020 was again a time of unprecedented disruption, with the COVID-19 pandemic continuing to have severe global public health, societal, and economic consequence. We have implemented and maintained measures required to ensure the safety and wellbeing of all our employees, while also continuing to achieve milestones that we hope will enable VBI to contribute meaningfully to public health solutions. As a result of the commitment, dedication, and passion of the entire VBI team, the remainder of 2020 is expected to be a milestone-rich period across our pipeline. To support the ongoing advancement of VBI’s pipeline candidates, we strengthened our balance sheet over the last few months. With $86 million in cash, cash equivalents, and short term investments, we continue to be well-positioned to capitalize on the growth and value-driving opportunities ahead.”

Recent Highlights and Upcoming Program Milestones

Financing

  • April 2020: $57.5 million gross proceeds raised in an underwritten public offering
  • May 2020: Up to $50 million debt financing facility secured with K2 HealthVentures (K2HV), a healthcare-focused specialty finance company
  • May 2020: Repaid $15.3 million of debt to Perceptive Credit Holdings L.P.

Sci-B-Vac: Tri-Antigenic Prophylactic HBV Vaccine

  • May and July 2020: Productive pre-BLA and pre-submission meetings held with the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively
  • Q4 2020: Submission of applications for regulatory approvals in the U.S., Europe, and Canada expected to begin

VBI-1901: Glioblastoma (GBM) Cancer Vaccine Immunotherapeutic Candidate

  • June 2020: Data presented at the 2020 American Association for Cancer Research (AACR) Annual Meeting highlighting:
    • Observation of a confirmed partial response in a patient treated with VBI-1901 + GM-CSF, with recurrent GBM tumor reduction of greater than 50%
    • Evidenced by five out of the six tumor responses seen to-date, identification of a normal baseline CD4+/CD8+ T cell ratio as a promising, potentially predictive biomarker strategy associated with tumor responses
  • Q4 2020: Initial immunologic and tumor response data expected from the Phase 2a VBI-1901 + AS01B study arm
  • Results observed to-date support further clinical development – exploring potential registrational study, expected to initiate in 2021

VBI-2901: Trivalent Prophylactic Pan-Coronavirus Candidate

  • As part of the collaboration with the National Research Council of Canada (NRC), announced in March 2020, a series of three pre-clinical animal models began in Q2 to evaluate:
    • Trivalent vaccine constructs targeting SARS-CoV-2, SARS-CoV, and MERS-CoV vs. monovalent vaccine constructs targeting SARS-CoV-2
    • Multiple different adjuvants
    • Pre-fusion vs. post-fusion spike proteins
  • Q3 2020: Pre-clinical data expected to enable selection of the optimal clinical vaccine candidate(s)
  • Q4 2020: Clinical study materials expected to be available

VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate

  • H2 2020: Initial human proof-of-concept data expected from ongoing Phase 1b/2a study

Formation of Commercial Advisory Board

  • May 2020: To support the Company’s commercial strategy, VBI formed a Commercial Advisory Board consisting of leading experts in public health policy, epidemiology, and vaccine development, with members Damian Braga (Chair), Eddy A. Bresnitz, M.D., M.S.C.E., Michael D. Decker, M.D., M.P.H., and John D. Grabenstein, Ph.D., R.Ph.

Second Quarter 2020 Financial Results

  • Cash Position: VBI ended the second quarter of 2020 with $86.1 million in cash, cash equivalents, and short term investments compared to $44.2 million as of December 31, 2019. Short term investments consist of guaranteed income certificates held with Schedule 1 Canadian banks for maturity terms greater than 3 months, but less than one year from the date of acquisition.
  • Net Cash Used in Operating Activities: Net cash used in operations for the six months ended June 30, 2020 was $15.5 million compared to the $26.3 million for the same period in 2019. The decrease is the result of the completion of the Sci-B-Vac Phase 3 clinical studies, the first of which (PROTECT) was completed in June 2019, the second of which (CONSTANT) was completed in January 2020.
  • Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $0.3 million for the six months ended June 30, 2020 compared to $2.9 million for the same period in 2019. The decrease was due to the completion of the modernization and capacity increase of VBI’s manufacturing facility in Rehovot, Israel, which re-commenced operations in May 2019.
  • Revenue: Revenue in the second quarter of 2020 was $0.2 million compared to $0.6 million for the same period in 2019. The decrease was due to a decrease in product revenue of Sci-B-Vac on a named-patient basis during the three months ended June 30, 2020 compared to the three months ended June 30, 2019. The decrease was also related to a decrease in R&D services revenue for VBI-2601 following the initiation of the clinical study in November 2019 as part of the ongoing collaboration with the Brii Biosciences.
  • Cost of Revenues: Cost of revenues was $2.1 million for the second quarter of 2020 compared to $2.4 million for the same period in 2019. This slight decrease is due to lower costs related to R&D services revenue.
  • Research and Development (R&D): R&D expenses were $2.4 million for the second quarter of 2020, compared to $7.4 million for the same period in 2019. The decrease in R&D expenses is the result of the completion of the Sci-B-Vac Phase 3 studies and is offset by an increase in expenses due to the ongoing Phase 1/2a study of VBI-1901.
  • General and Administrative (G&A): G&A expenses were $3.9 million for the second quarter of 2020, compared to $3.2 million for the same period in 2019. The increase is a result of the increase in pre-commercialization activities for Sci-B-Vac.
  • Net Loss: Net loss and net loss per share for the second quarter of 2020 were $9.5 million and $0.04, respectively, compared to a net loss of $13.2 million and a net loss per share of $0.13 for the second quarter of 2019.