Novavax Reports Third Quarter 2016 Financial Results

  • Announces Corporate Restructuring and Cost Savings
  • Highlights Strategic Focus and Development Activities for 2017

GAITHERSBURG, Md., Nov. 09, 2016 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) today announced its financial results for the third quarter and nine months ended September 30, 2016, in conjunction with its Investor and Analyst Day update.

The Company presented a restructuring plan designed to meet the following key objectives:
  • Prioritize development activities to achieve clinical data events within 2017;
  • Reduce cash burn, extend financial horizon and minimize near-term dilution; and
  • Maintain operational core competencies to execute development plans.

The restructuring includes an immediate reduction in workforce of approximately 30%. The Company expects to incur one-time restructuring costs of approximately $3 million to $4 million, including severance expenses, in the fourth quarter of 2016. In addition, management has initiated expense reduction measures relating to pre-commercialization activities, capital equipment investments, project specific and general research and development, and general and administrative expenses. As a result of the restructuring, Novavax estimates a reduction in cash burn of $70 million to $100 million in 2017 relative to 2016.

The restructuring plan was engineered to decrease cash burn and support the Company's development priorities through the balance of 2016 and in 2017, specifically:
  • Continued execution of the Phase 3 Prepare™ clinical trial to prevent RSV in infants via maternal immunization at multiple international sites. Prepare is a randomized, observer-blinded, placebo-controlled trial. The primary objective is to determine the efficacy of maternal immunization with our RSV F Vaccine against symptomatic RSV lower respiratory tract infection with hypoxemia in infants through a minimum of the first 90 days of life. Prepare is supported by a grant of up to $89 million from the Bill & Melinda Gates Foundation (BMGF);  
  • Initiation of a randomized, observer-blinded, multi-arm, dose-ranging Phase 2 clinical trial, in one and two dose formulations, both with and without adjuvants, of its RSV F Vaccine in older adults (60 years of age and older). The trial will evaluate safety and immunogenicity of these formulations in older adults as measured by serum microneutralization titers against RSV/A and RSV/B, palivizumab competing antibodies ("PCA") and anti-F IgG; and 
  • Initiation of a Phase 1 clinical trial of its Zika virus envelope dimer nanoparticle vaccine candidate (ZIKV EnvD Vaccine) in 2017.

Summary

"We have identified a clear path forward that we expect will provide us with important clinical data throughout 2017 and protect liquidity," said Stanley C. Erck, President and CEO. "We have the balance sheet to execute this plan. We have resized our organization consistent with this plan and look forward to reporting data from these programs in 2017. We continue to have great confidence in our platform technology, our RSV F Vaccine and the significant commercial opportunity for an RSV vaccine for infants via maternal immunization."

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