On August 2, 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 second quarter ending June 30, 2021 and provided a corporate update (Press release, VBI Vaccines, AUG 2, 2021, View Source [SID1234585517]).
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Jeff Baxter, VBI’s President and CEO commented: "The second quarter of 2021 was a data-rich period for the Company, with positive results across our lead programs, leading to meaningful advancement of our pipeline. As a result of the encouraging data reported in Q2, the FDA granted Fast Track Designation for VBI-1901 in recurrent GBM, we demonstrated the potency of the eVLP particulate delivery platform against COVID-19, supporting the assessment of our COVID-19 Beta variant vaccine candidate in the next phase of development, and we initiated a first-in-class Phase 2 combination study assessing a potential functional cure regimen for chronic HBV infection. Additionally, as we advance towards our PDUFA target action date for our 3-antigen prophylactic HBV vaccine candidate, we continue to lay the groundwork for the commercial launch, subject to regulatory approvals. The AMA established a unique CPT Code for a 3-antigen (S, Pre-S1, Pre-S2) Hepatitis B (HBV) Vaccine, a meaningful milestone as it reinforces the scientific differentiation of our candidate and enables a streamlined reimbursement process. At the beginning of the year, we laid out an ambitious and aggressive plan for the development of our pipeline in 2021, and in the first half of the year we’ve successfully executed against that plan. We look forward to sharing upcoming data and regulatory milestones as we move into the second half of 2021."
Q2 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
July 2021: The American Medical Association (AMA) Current Procedural Terminology (CPT) Panel established a unique CPT code for a 3-antigen (S, Pre-S1, Pre-S2) Hepatitis B (HBV) vaccine, under which VBI’s vaccine candidate will be reported if approved
Submissions to United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) and to Health Canada are in process and are expected to be completed in 2021
VBI-2601 (BRII-179) : HBV Immunotherapeutic Candidate
April and June 2021: Complete Phase 1b/2a study dataset announced – EASL presentation selected for inclusion in the "Best of the International Liver Congress" summary, highlighting the most noteworthy contributions to the scientific program. Data demonstrated:
VBI-2601 (BRII-179) induced both B cell (antibody) and T cell responses in chronically-infected HBV patients and was well-tolerated with no safety signals observed
Evidence to support further clinical evaluation of VBI-2601 (BRII-179) as an immunomodulator in combination with other treatment modalities as a potential functional cure for chronic HBV infection
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, Brii Biosciences (Brii Bio)
COVID-19 & Coronaviruses
VBI-2900 : eVLP Coronavirus Vaccine Program
June 2021: Initial positive Phase 1 data of VBI-2902 announced, demonstrating that a 5µg dose, which expresses an optimized form of the SARS-CoV-2 spike antigen and is adjuvanted with aluminum phosphate, was generally well-tolerated and elicited a potent immune response significantly higher than that seen in human convalescent sera. Notably:
Safety and tolerability: VBI-2902 was well-tolerated with no safety signals observed, and no increase in reactogenicity with subsequent doses
Neutralizing titers: After two doses, VBI-2902 induced neutralization titers in 100% of participants, with 4.3x the geometric mean titer (GMT) compared to convalescent sera
Antibody binding titers: After two doses, VBI-2902 induced antibody binding titers in 100% of participants, with peak antibody binding GMT of 1:4,047 – 5.0x the GMT compared to convalescent sera
Q3 2021 : As a result of this platform-validating initial data, and in response to the increased circulation of COVID-19 variants, the next phase of the ongoing adaptive Phase 1/2 study, expected to initiate in Q3 2021, will assess VBI-2905, VBI’s eVLP vaccine candidate directed against the COVID-19 Beta variant
H1 2022 : Expected initiation of the first clinical study of VBI’s multivalent vaccine candidate, designed to increase the breadth of protection against known and emerging variants of COVID-19
Glioblastoma (GBM)
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate
June 2021: Positive data from Phase 2a (Part B) of ongoing Phase 1/2a study presented at ASCO (Free ASCO Whitepaper), including:
VBI-1901 + GM-CSF study arm:
6-month and 12-month OS: 80% (n=8/10) and 60% (n=6/10), compared to historical controls of 60% and 30%1, respectively
2 durable partial responses (≥ 50% tumor reduction) and 2 stable disease observations – 40% disease control rate
VBI-1901 + GSK’s AS012 adjuvant system study arm:
6-month OS: 89% (n=8/9); 12-month OS timepoint not yet reached
5 stable disease observations – 50% disease control rate
June 2021: FDA Fast Track Designation granted for VBI-1901 + GM-CSF in first recurrent GBM patients
Q4 2021: Expected initiation of a randomized, controlled clinical study with registration potential
Recent Peer-Reviewed Publications
May 2021: The Lancet Infectious Diseases publication of data from PROTECT – Phase 3 immunogenicity and safety study assessing VBI’s 3-antigen HBV vaccine candidate compared to Engerix-B in adults age 18 and older. Link to publication can be found here.
June 2021: Vaccine publication of data from a Phase 3 immunogenicity and safety study, conducted in Vietnam and completed in 2007, assessing VBI’s 3-antigen HBV vaccine candidate in healthy Asian adults. Link to publication can be found here.
July 2021: Vaccine publication of data from VBI-2902a preclinical and challenge COVID-19 studies. Link to publication can be found here.
Additional Corporate Updates
Board Appointment: In July 2021, VBI appointed Linda Bain, CFO of Codiak BioSciences, Inc., to the Company’s Board of Directors
Debt Financing: In May 2021, VBI drew down a $12 million second tranche under its debt financing facility with K2 Healthventures, bringing the amount drawn to-date to $32 million
Second Quarter 2021 Financial Results
Cash Position: VBI ended the second quarter of 2021 with $135.0 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 six months ended June 30, 2021 was $17.4 million, compared to $15.5 million for the same period in 2020. The increase in cash outflows is largely a result of an increase in net loss, offset by the change in operating working capital, notably the cash received in advance from the CEPI funding agreement.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $1.0 million for the six months ended June 30, 2021, compared to $0.3 million for the same period in 2020. The increase is a result of routine purchases of property and equipment in Rehovot, Israel.
Revenue: Revenue in the second quarter of 2021 was $0.1 million, compared to $0.2 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 ending June 30, 2021 compared to the three months ending June 30, 2020.
Cost of Revenues: Cost of revenues was $2.6 million in the second quarter of 2021 as compared to $2.1 million for the same period in 2020. The increase in the cost of revenues was due to increased outsourced testing costs and inventory-related costs incurred in the three months ending June 30, 2021 compared to the same period in 2020.
Research and Development (R&D): R&D expenses for the second quarter of 2021 were $4.6 million compared to $2.4 million in the second quarter of 2020. The increase was a result of increased expenses related to our coronavirus vaccine program, including the Phase 1 clinical study of VBI-2902 and development and manufacture of VBI-2905, offset by government grants and funding arrangements. The increase was also due to an increase in R&D expenses related to the development of our other vaccine candidates, which was offset by a decrease in regulatory costs related to the BLA submission for the 3-antigen prophylactic HBV vaccine candidate that was submitted in 2020.
General and Administrative (G&A): G&A expenses were $9.4 million for the second quarter of 2021, compared to $3.9 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 second quarter of 2021 were $17.5 million and $0.07, respectively, compared to a net loss of $9.5 million and a net loss per share of $0.04 for the second quarter of 2020.