On November 6, 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 third quarter ending September 30, 2019, and provided an update on the Company’s recent and future developments (Press release, VBI Vaccines, NOV 6, 2019, View Source [SID1234550526]).

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"All subjects in the Sci-B-Vac pivotal Phase 3 CONSTANT study have now completed clinical visits, including follow-up visits for safety, a milestone that confirms the timeline to top-line data expected early January 2020," said Jeff Baxter, VBI’s president and CEO. "Further, the third quarter of 2019 saw meaningful progression of our cancer vaccine immunotherapeutic candidate, VBI-1901, with the dosing of the first patient in Part B of the ongoing Phase 1/2a study in recurrent glioblastoma patients, the expanded scope of the study with the clinical collaboration to assess VBI-1901 in combination with GSK’s AS01B adjuvant system, and the presentation of robust additional immunogenicity data from Part A of the study to further correlate the immunologic responses with the tumoral and clinical responses. We also completed an equity raise totaling $37.4 million in net proceeds, strengthening our balance sheet as we enter this period of significant clinical data readouts."

Recent Highlights and Upcoming Milestones

Sci-B-Vac: Trivalent Prophylactic Hepatitis B Vaccine

Presentation of PROTECT Phase 3 Data:

The positive top-line data from the PROTECT Phase 3 study, as announced in June 2019, was presented in a late-breaking oral presentation at ID Week 2019, detailing the robust seroprotection data that showed seroprotection rates (SPR) of Sci-B-Vac compared with Engerix-B were statistically significantly higher in all key subgroup analyses of adults age ≥ 18 years, regardless of age, gender, diabetic status, body mass index, and smoking status.

The data will also be presented in a late-breaker poster presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting on November 11, 2019. This presentation will highlight the immunogenicity and safety data of the study, including the successfully met co-primary endpoints and the rapid and higher SPR and antibody responses to Sci-B-Vac compared with Engerix-B.

CONSTANT Phase 3 Data:

CONSTANT, a second Phase 3 study of Sci-B-Vac enrolling approximately 2,850 subjects, is a double-blind, four-arm, randomized, controlled study designed to demonstrate lot-to-lot consistency for immune responses, as measured by geometric mean concentration (GMC) of antibodies across three independent consecutively-manufactured lots of Sci-B-Vac. In October, all study subjects completed clinical visits, including follow-up visits for safety, confirming the timeline to top-line data which is expected early January 2020.

VBI-1901 – Glioblastoma (GBM) Vaccine Immunotherapeutic Candidate

In September, VBI became the first biopharma company to collaborate with GlaxoSmithKline (GSK) to assess its AS01B adjuvant system as part of a therapeutic cancer vaccine candidate. As part of the collaboration, VBI plans to add an additional study arm to Part B of the ongoing Phase 1/2a clinical study in recurrent GBM. Part B of the study is now planned to be a two-arm, open-label study, enrolling 20 first-recurrent GBM patients to receive VBI-1901 in combination with either GM-CSF, as per Part A of the study, or AS01B as immunomodulatory adjuvants.

New data from Part A, the dose-escalation phase, of the ongoing Phase 1/2a clinical study in recurrent GBM patients was presented at the World Vaccine Congress Europe in October. This data highlighted additional biomarkers – reduction of harmful, immunosuppressive regulatory T-cells (Tregs) and expansion of beneficial CD4+ T-helper cells against both antigens in VBI-1901, gB and pp65 – that strengthen the correlation between the vaccine-induced T-cell responses and the tumoral and clinical responses observed in three out of six (3/6) patients in the high-dose cohort that had evidence of stable disease by magnetic resonance imaging (MRI).

Enrollment of the 10 patients in the VBI-1901 with GM-CSF arm was initiated at the end of July. Initial data is expected to be presented at a medical meeting later this year.

BRII-179 (VBI-2601) – Hepatitis B Immunotherapeutic Candidate

As part of the collaboration with Brii Biosciences (Brii Bio), VBI and Brii Bio plan to initiate the enrollment of a Phase 1b/2a proof-of-concept study in subjects with chronic hepatitis B later in Q4 2019, which would enable an initial human proof-of-concept data readout in the second half of 2020.

Third Quarter 2019 Financial Results

Cash Position: VBI ended the third quarter of 2019 with $53.0 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 nine months ended September 30, 2019 was $40.2 million compared to $38.0 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 $3.5 million for the nine months ended September 30, 2019 compared to $3.6 million for the same period in 2018. This spend is largely related to the completion of the modernization and capacity increase of the facility in Rehovot, Israel. This work began in 2018 and completed on schedule in May 2019, during which period the facility was temporarily closed.
Revenue: Revenue in the third quarter of 2019 was $0.6 million, compared to $0.3 million for the same period in 2018. The increase was primarily due to R&D services revenues earned pursuant to the therapeutic hepatitis B collaboration and license agreement with Brii Biosciences.
Research and Development (R&D): R&D expenses were $5.4 million for the third quarter of 2019, compared to $10.5 million for the same period in 2018. The decrease was primarily due to the decrease in clinical expenses due to the completion of the Sci-B-Vac Phase 3 PROTECT study.
General and Administrative (G&A): G&A expenses were $9.4 million for the third quarter of 2019, compared to $3.5 million for the same period in 2018. The increase was primarily a result of the impairment charge relating to goodwill of $6.3 million offset by a decrease in legal fees and a reduction in public company costs.
Net Loss: Net loss and net loss per share for the third quarter of 2019 were $16.2 million and $0.15, respectively, compared to a net loss of $15.4 million and a net loss per share of $0.24 for the third quarter of 2018.