On May 1, 2018 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported financial results for the first quarter ending March 31, 2018, and provided a corporate update (Press release, VBI Vaccines, MAY 1, 2018, View Source [SID1234525932]).
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"Following the completion of the $71.9 million financing in October 2017, we have made strong progress across our development programs, highlighted by the recent completion of enrollment of more than 1,600 participants in our Phase 3 PROTECT study of Sci-B-Vac, our Hepatitis B vaccine," said Jeff Baxter, President and CEO of VBI. "With data readouts from both our congenital cytomegalovirus (CMV) and glioblastoma (GBM) programs expected mid-year and in the second half of 2018, respectively, our goal for 2018 is to capitalize on the recent momentum and continue to create value, advancing all three of our lead clinical programs towards significant clinical milestones."
Recent Highlights and Upcoming Milestones
Sci-B-Vac for Hepatitis B
VBI initiated a pivotal Phase 3 clinical program for Sci-B-Vac, the Company’s Hepatitis B vaccine, in December 2017 in the U.S., Europe, and Canada. This program consists of two concurrent Phase 3 studies, the PROTECT study and the CONSTANT study.
The PROTECT study is designed to evaluate the safety and immunogenicity of Sci-B-Vac in more than 1,600 adults. The primary endpoints, which are stratified by age cohort, include assessment of the seroprotection rate after three doses of Sci-B-Vac Engerix-B. The secondary endpoint will evaluate speed to seroprotection, including assessment after two doses of Sci-B-Vac vs. three doses of Engerix-B.
In April 2018, VBI completed enrollment in the PROTECT study.
The CONSTANT study is designed to demonstrate lot-to-lot consistency for immune response in approximately 3,200 adults, as measured by geometric mean concentration (GMC) of antibodies across three independent, consecutively manufactured lots of Sci-B-Vac. The secondary endpoint will evaluate safety of Sci-B-Vac Engerix-B.
Enrollment is ongoing in the CONSTANT study.
Topline data are expected mid-year 2019.
The results from this pivotal Phase 3 program are intended to support future regulatory filings in the U.S., Europe, and Canada.
VBI-1501 for Congenital Cytomegalovirus (CMV)
VBI-1501 is currently being evaluated in a Phase 1 randomized, observer-blind, placebo-controlled study designed to evaluate the safety, tolerability, and immunogenicity of VBI-1501 in 128 CMV-negative, healthy adults.
In July 2017, VBI announced positive interim immunogenicity data from this Phase I study. After two of the three planned vaccinations, antibody responses against the CMV gB antigen were observed with clear evidence of dose-dependent boosting, seroconversion in 100% of subjects who received the highest dose, and clear benefit of the adjuvant alum.
VBI plans to report final safety and immunogenicity data from the study mid-year 2018, which will inform next steps for the clinical development of VBI-1501.
VBI-1901 for Glioblastoma (GBM)
In January 2018, VBI commenced patient dosing in a Phase 1/2a clinical study of VBI-1901 for the treatment of recurrent glioblastoma (rGBM).
The multi-center, open-label, two-part study will enroll up to 28 patients and is designed to evaluate safety, tolerability, and the optimal therapeutic dose level of VBI-1901.
In April 2018, VBI announced that the independent Data and Safety Monitoring Board (DSMB) unanimously recommended continuation of the Phase 1/2a clinical study without modification after review of all safety data from the fully enrolled, low-dose patient cohort.
Following this recommendation, VBI initiated patient enrollment in the intermediate-dose arm of the dose-escalation phase of the study.
Two additional, pre-specified DSMB reviews are planned to occur following the completion of enrollment in the intermediate-dose study arm and the high-dose study arm, respectively.
Extensive biomarker testing and tumor imaging is built into this clinical protocol, such that VBI expects to generate immunologic data that will show whether VBI-1901 is inducing an immune response as expected.
In the second half of 2018, VBI hopes to be able to correlate this immunologic and biomarker data with initial clinical outcomes, and in early 2019, 6-month overall survival (OS) and progression-free survival (PFS) data are expected.
First Quarter 2018 Financial Results
VBI ended the first quarter of 2018 with $58.1 million in cash and cash equivalents compared with $67.7 million as of December 31, 2017. Net cash used in operations for the three months ended March 31, 2018 was $8.6 million.
Revenue for the first quarter of 2018 was $0.2 million, compared with $0.1 million for the same period in 2017. The increase was primarily due to named-patient sales of Sci-B-Vac in Europe.
Research and development expenses were $7.0 million for the first quarter of 2018, as compared to $4.7 million for the same period in 2017. The increase was primarily due to the initiation of the Phase 3 program for Sci-B-Vac and the Phase 1/2a clinical study for VBI-1901 in recurrent GBM patients, but was partially offset by the reduction in research expenses as VBI-1901 moved from pre-clinical activity to clinical activity.
General and administrative expenses were $3.4 million for the first quarter of 2018, as compared to $3.0 million for the same period in 2017. The increase was primarily due to expanded headcount and facilities.
Net loss and net loss per share for the first quarter of 2018 were $12.3 million and $0.19, respectively, compared to a net loss of $8.6 million and a net loss per share of $0.22 for the first quarter of 2017.