On May 10, 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 first quarter ending March 31, 2021 and provided a corporate update (Press release, VBI Vaccines, MAY 10, 2021, View Source [SID1234579598]).

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Jeff Baxter, VBI’s President and CEO commented: "The first quarter of 2021 marked the beginning of a transformational year for VBI with notable developments across our lead pipeline programs targeting hepatitis B (HBV), coronaviruses, including different variants of COVID-19, and glioblastoma (GBM). We continue to support the U.S. and European regulatory bodies in their review of our 3-antigen HBV vaccine candidate, and we look forward to ongoing discussions throughout the year. Additionally, our partnerships have enabled us to aggressively advance our pipeline candidates, including the initiation of a first-in-class Phase 2 combination study assessing a potential functional cure regimen for chronic HBV infection as well as a suite of coronavirus vaccine candidates. Most recently, the partnership we entered into with CEPI supports the development of VBI’s enveloped virus-like particle (eVLP) vaccine candidates against known and emerging variants of COVID-19, including B.1.351, the variant first identified in South Africa. With the strength of these partnerships and our financial position, we believe we are well positioned to meet the numerous regulatory and clinical milestones expected over the coming months."

Q1 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
Submissions to United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) and to Health Canada are in process and are expected to be completed this year
VBI-2601 (BRII-179) : HBV Immunotherapeutic

April 2021: Additional data from Phase 1b/2a study in chronic HBV patients demonstrated robust HBV-specific T cell and antibody responses across all study arms
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 and trial sponsor, Brii Biosciences (Brii Bio)
2021: Complete Phase 1b/2a study dataset targeted for presentation at scientific conference later this year
COVID-19 & Coronaviruses

March 2021: Announcement of partnership with Coalition for Epidemic Preparedness Innovations (CEPI) – CEPI to provide up to $33 million of funding to support development of VBI’s enveloped virus-like particle (eVLP) vaccine candidates against COVID-19 variants of concern
VBI-2902 : Monovalent COVID-19 Vaccine Candidate

Vaccine candidate supported by funding from the Strategic Innovation Fund of the Government of Canada
March 2021: Adaptive Phase 1/2 clinical study initiated in adults in Canada
Q2 2021: Initial data from ongoing Phase 1/2 study expected by the end of the second quarter
VBI-2905 : Monovalent COVID-19 (B.1.351 Variant) Vaccine Candidate

Vaccine candidate supported by funding from CEPI
Mid-year 2021: Phase 1 clinical study expected to initiate
VBI-2901 : Multivalent Pan-Coronavirus Vaccine Candidate

Vaccine candidate supported by funding from the Strategic Innovation Fund of the Government of Canada
H2 2021: Phase 1 clinical study expected to initiate
Glioblastoma (GBM)

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

Q2 2021: Additional data, including tumor response and 6-month and 12-month overall survival data from Phase 2a (Part B) of ongoing Phase 1/2a study expected
Q4 2021: Expected initiation of a randomized, controlled clinical study with the potential to yield registrational data
Financing

Throughout the first quarter of 2021, VBI raised total gross proceeds of $22.1 million, issuing 5.8 million shares at an average price of $3.84 through its Open Market Sales AgreementSM, established July 31, 2020 with Jefferies LLC
First Quarter 2021 Financial Results

Cash Position: VBI ended the first quarter of 2021 with $133.6 million in cash, cash equivalents, and short-term investments compared with $119.1 million as of December 31, 2020.
Net Cash Used in Operating Activities: Net cash used in operating activities for the three months ended March 31, 2021 was $6.6 million, compared to $7.6 million for the same period in 2020. The decrease 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 $0.6 million for the three months ended March 31, 2021, compared to $0.1 million for the same period in 2020. The increase is a result of routine purchases of property and equipment.
Revenue: Revenue in the first quarter of 2021 was $0.3 million, compared to $0.4 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 required in the three months ended March 31, 2021 compared to the three months ended March 31, 2020.
Cost of Revenues: Cost of revenues was $2.4 million in the first quarter of 2021 as compared to $2.6 million for the same period in 2020. The decrease in the cost of revenues was due to the decrease in VBI-2601 R&D services referenced above.
Research and Development (R&D): R&D expenses for the first quarter of 2021 were $6.8 million compared to $3.2 million in the first quarter of 2020. The increase was a result of increased expenses related to our coronavirus vaccine program, which was offset by a decrease in the R&D expenses related to the 3-antigen prophylactic HBV vaccine candidate, the final Phase 3 clinical study of which (CONSTANT) completed in January 2020, and regulatory costs related to the BLA submission for the 3-antigen prophylactic HBV vaccine candidate.
General and Administrative (G&A): G&A expenses were $6.7 million for the first quarter of 2021, compared to $4.1 million for the same period in 2020. The increase was a result of the increased pre-commercialization activities related to the 3-antigen prophylactic HBV vaccine candidate in preparation for potential regulatory approvals, in addition to increased insurance and labor costs.
Net Loss: Net Loss and net loss per share for the first quarter of 2021 were $17.6 million and $0.07, respectively, compared to a net loss of $8.4 million and a net loss per share of $0.05 for the first quarter of 2020.