On May 1, 2019 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, 2019, and highlighted progress of the company’s pipeline (Press release, VBI Vaccines, MAY 1, 2019, View Source [SID1234535495]).

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"2019 has the potential to be a transformative year for VBI, marked by clinical milestones across all four of our lead programs, and as such, the first quarter of 2019 was characterized by intense focus on the execution of our ongoing clinical programs," said Jeff Baxter, President and CEO, VBI Vaccines Inc. "In April 2019, all subjects in the Sci-B-Vac pivotal Phase 3 PROTECT study completed clinical visits, including follow-up visits for safety, which confirms the timeline to top-line data. This data read-out is the most significant clinical milestone in the history of VBI and we remain diligently focused and excited as we advance towards the data read-out, expected mid-year this year, 2019."

Recent Highlights and Upcoming Milestones
Sci-B-Vac: Trivalent Prophylactic Hepatitis B Vaccine
Sci-B-Vac is currently being evaluated in a global, pivotal Phase 3 clinical program, the results of which are intended to support future regulatory and marketing authorization submissions in the U.S., Europe, and Canada. The program consists of two concurrent Phase 3 studies – PROTECT and CONSTANT.

PROTECT: 2-arm safety and immunogenicity study in approximately 1,500 adults age 18 and older

Top-line data, expected mid-year 2019, will include both co-primary endpoints and key secondary endpoints.
Co-primary endpoints: After three doses of Sci-B-Vac vs. three doses of Engerix-B, (i) non-inferiority of seroprotection rates in adults age 18 and older, and (ii) superiority of seroprotection rates in adults over the age of 45.
Secondary endpoints: (i) non-inferiority of seroprotection rates after two doses of Sci-B-Vac vs. three doses of Engerix-B, and (ii) safety and tolerability.
In April 2019, VBI presented data in a poster presentation at The International Liver Congress (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), which support the secondary endpoints in PROTECT. The poster illustrated data from three previously-conducted clinical studies – two randomized Phase 3 studies comparing Sci-B-Vac to Engerix-B conducted in Vietnam and Russia, and one single-arm Phase 4 study conducted in Israel – in subjects aged 18 to 45 years. Data from all three studies demonstrated a clean safety profile for Sci-B-Vac and seroprotection rates of more than 98% after two vaccinations in all subjects receiving Sci-B-Vac.
CONSTANT: 4-arm lot-to-lot consistency study in approximately 2,850 subjects

The primary endpoint is to demonstrate consistency of immune response, measured by geometric mean concentration (GMC), across three independent, consecutively manufactured lots of Sci-B-Vac.
Top-line CONSTANT data is expected around year-end 2019.
VBI-1901 – Glioblastoma (GBM) Immunotherapeutic
VBI-1901 is currently being evaluated in a two-part Phase 1/2a study in recurrent GBM patients.

PART A: Dose-escalation phase designed to evaluate the safety, tolerability, and to define the optimal therapeutic dose level of VBI-1901

Expanded data from Part A of the study was recently selected for poster presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in early June, and will feature expanded immunologic data along with tumor and clinical responses, based on MRIs and survival data, from all three dose cohorts in Part A of the study.
The poster, number 237, will be presented during the Central Nervous System Tumors session on Sunday, June 2, 2019 from 8:00 AM ET to 11:00 AM ET.
PART B: Subsequent extension phase with a narrower enrollment criteria, designed to more clearly assess immunologic responses and the correlation with tumor and clinical responses, based on MRIs and survival data

As announced in April 2019, based on safety and immunogenicity data, the highest dose tested in Part A of the study, 10mcg, has been selected as the optimal dose level to test in Part B of the study.
Enrollment in Part B will be restricted only to those with a first tumor recurrence.
Initiation of enrollment of the 10 patients in Part B of the study is expected mid-year 2019.
VBI-2601 – Hepatitis B Immunotherapeutic
In December 2018, VBI announced a license and collaboration agreement with Brii Biosciences for the development of a functional cure for chronic hepatitis B using VBI-2601, the company’s novel immunotherapeutic candidate formulated to target and enhance B- and T-cell immunity.
In January 2019, VBI initiated pre-clinical studies required to enable initiation of a Phase 2 human proof-of-concept study, which is expected to initiate around year-end 2019.
VBI-1501 – Prophylactic Cytomegalovirus (CMV) Vaccine
In December 2018, VBI announced plans for a Phase 2 dose-ranging study following positive discussions with Health Canada, and the company anticipates similar discussions with the FDA in 2019.
The Phase 2 study is expected to assess the safety and immunogenicity of higher dosages of VBI-1501, up to 20mcg, with study initiation anticipated around the end of 2019.
A toxicology study to support the new dose levels is underway, the results of which are required prior to the start of the Phase 2 study.
First Quarter 2019 Financial Results
Cash Position: VBI ended the first quarter of 2019 with $43.3 million in cash and cash equivalents compared to $59.3 million as of December 31, 2018.
Net Cash Used in Operating Activities: Net cash used in operations for the three months ended March 31, 2019 was $14.0 million compared to $8.6 million for the same period in 2018.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $1.9 million for the three months ended March 31, 2019 compared to $1.0 million for the same period in 2018. The increase in spend is due to the modernization and capacity increase of the company’s manufacturing facility in Rehovot, Israel. The construction and temporary closure of the facility began in Q2 2018 and is now substantially complete. We anticipate being able to recommence operations in the facility by the end of 2019.
Revenue: Revenue in the first quarter of 2019 was $0.4 million, compared to $0.2 million for the same period in 2018. The increase was primarily due to R&D service revenues earned pursuant to the therapeutic hepatitis B license and collaboration agreement with Brii Biosciences, offset by a slight decrease in named-patient sales of Sci-B-Vac in Europe.
Research and Development (R&D): R&D expenses were $9.2 million for the first quarter of 2019, compared to $7.0 million for the same period in 2018. The increase was primarily due to the advancement of the Phase 3 program for Sci-B-Vac and the Phase 1/2a clinical study for VBI-1901 in recurrent GBM patients.
General and Administrative (G&A): G&A expenses were $4.0 million for the first quarter of 2019, compared to $3.4 million for the same period in 2018. The increase was primarily due to increased human resource expenses, the allocation of certain cost of revenues related to the temporary Rehovot facility closure, and pre-commercialization costs for Sci-B-Vac.
Net Loss: Net loss and net loss per share for the first quarter of 2019 were $14.6 million and $0.15, respectively, compared to a net loss of $12.3 million and a net loss per share of $0.19 for the first quarter of 2018.