VBI Vaccines Reports Fourth Quarter and Full Year Financial Results for 2020, Provides Corporate Update and Outlook for 2021

Rhea-AI Summary

VBI Vaccines (Nasdaq: VBIV) reported its financial results for Q4 and the full year 2020, highlighting significant advancements in its vaccine pipeline. The company introduced two new candidates for COVID-19 and is advancing its 3-antigen hepatitis B vaccine candidate, with applications submitted to the FDA and EMA. With $119.1 million in cash as of year-end 2020, VBI is well-positioned for upcoming milestones in 2021, including further clinical studies for its therapeutic vaccine candidates targeting chronic HBV and recurrent glioblastoma.

Positive

• Completed pivotal Phase 3 program for hepatitis B vaccine candidate.
• Submitted BLA and MAA applications, with reviews initiated by the FDA and EMA.
• Partnership with Syneos Health for potential commercialization.
• Strong cash position of $119.1 million to support upcoming milestones.

Negative

• None.

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced financial results for the fourth quarter and twelve months ended December 31, 2020. The Company also provided a corporate update and its outlook for 2021.

Annual Note from Jeff Baxter, President and CEO:

“2020 was, unfortunately, a historic year, marked by unprecedented disruption, with severe public health, societal, and economic consequence. Every single person, worldwide, felt the devastating effects of the ongoing COVID-19 pandemic. Industries and companies went through extraordinary change and, amidst the temporary adjustments, new normals were established. The impact of this pandemic is likely to be felt for years, if not decades, to come.

The events of 2020 led to impressive collaboration, progress, and transformation across the biotechnology industry, governments, and foundations. We added two new vaccine candidates to our pipeline in 2020 – a multivalent pan-coronavirus vaccine candidate, VBI-2901, and a monovalent COVID-19 vaccine candidate, VBI-2902. To support the advancement of these candidates, we received an award from the Strategic Innovation Fund of the Government of Canada and partnered with both the National Research Council of Canada (NRC), Canada’s largest federal R&D organization, and Resilience Biotechnologies, a Contract Development and Manufacturing Organization. The preclinical results of these two candidates continue to excite us and we are working hard to get these candidates into the clinic in forms that are optimized both for clinical outcome and long-term commercial viability. We recognize the possibility that COVID-19, in some form, may be here to stay, especially with the recent emergence of additional variants, and we are committed to the long-term control of known and emerging coronaviruses.

Our 2020 achievements and progress, however, extend well beyond our coronavirus programs. We successfully completed the pivotal Phase 3 program for our 3-antigen prophylactic hepatitis B (HBV) vaccine candidate and submitted applications for approval in the U.S. and Europe. We believe this vaccine candidate has the potential to be a meaningful intervention for adults in the fight against HBV and we look forward to working with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) throughout 2021 as they conduct their review.

In addition to the advancement of these prophylactic vaccine candidates, we continue to see meaningful data generated by the clinical studies of our therapeutic vaccine candidates targeting both chronic HBV infection, VBI-2601, and recurrent glioblastoma (GBM), VBI-1901. With both of these candidates, we are seeking to address diseases that are challenging and aggressive, with few, if any, effective treatment options available to patients. Based on the positive data seen to-date, we and our partners expect to initiate subsequent clinical studies in both indications in 2021.

These achievements are a result of the continued hard work, dedication, and flexibility of every member of the VBI team. Our team remains united across the US, Canada, and Israel in our mission to protect and enhance human life, and we thank our shareholders and partners for their support. With $119.1 million in cash, cash-equivalents, and short-term investments on-hand at the end of 2020, we entered 2021 well-positioned to achieve meaningful milestones across all of our lead pipeline programs over the next 12 months, and beyond.”

Second Half 2020 Key Program Achievements and Projected Upcoming Milestones

3-Antigen Hepatitis B Vaccine Candidate

• November 2020: Biologics License Application (BLA) and Marketing Authorization Application (MAA) submitted to U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively
• December 2020 and February 2021: EMA acceptance of MAA filing, and FDA acceptance of BLA filing, initiating the review process
• December 2020: Announcement of Syneos Health (Syneos) and VBI partnership for commercialization in the U.S., Europe, and Canada, pending regulatory approvals
• November 30, 2021: U.S. Prescription Drug User Fee Act (PDUFA) ta

FAQ

What are the recent achievements of VBI Vaccines in 2020?

VBI Vaccines successfully completed the Phase 3 program for its hepatitis B vaccine candidate and submitted applications to the FDA and EMA.

What is the current cash position of VBI Vaccines?

As of December 31, 2020, VBI Vaccines had $119.1 million in cash, cash-equivalents, and short-term investments.

What upcoming milestones does VBI Vaccines have for 2021?

In 2021, VBI plans to advance clinical studies for its therapeutic vaccine candidates targeting chronic HBV and recurrent glioblastoma.

What new vaccine candidates has VBI Vaccines added to its pipeline?

VBI Vaccines added two new candidates: VBI-2901, a multivalent pan-coronavirus vaccine, and VBI-2902, a monovalent COVID-19 vaccine.

What partnerships have VBI Vaccines established recently?

VBI partnered with Syneos Health for commercialization in the U.S., Europe, and Canada, pending regulatory approvals.