Novavax Posts Mixed Q3 Results, Announces Restructuring And Update On RSV Program

Novavax, Inc. NVAX reported its Q3 results after Wednesday's close. The company saw a net loss of $(0.24) per share, beating the Street’s consensus by $0.02. Revenue of $3.23 million, however, missed expectations for $4.02 million in sales.

On top of the results, management announced a corporate restructuring and cost savings plan aimed at:

• Prioritizing “development activities to achieve clinical data events within 2017."
• Reducing cash burn, extending its financial horizon and minimizing near-term dilution
• Maintaining “operational core competencies to execute development plans.”

This plan also implies an immediate 30 percent cut in Novavax’s workforce, will cost $3 million to $4 million, and is expected to result in savings of $70 million to $100 million in 2017.

Back in September, the company issued data from the Resolve Phase 3 trial for its vaccine for a potentially deadly respiratory virus, which didn't meet the efficacy endpoints set. At that time the company told Benzinga, "We are continuing to investigate potential root causes that could have impacted the outcome of this trial. We also continue to believe that there is a path forward for our RSV vaccine and that there is an important unmet need for an RSV vaccine in older adults."

In Wednesday’s press release, Novavax shared an update on its RSV program.

“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,” said President and CEO Stanley C. Erck.

Between this moment and the end of 2017, the company plans to continue to execute the “Phase 3 Prepare™ clinical trial to prevent RSV in infants via maternal immunization at multiple international sites… 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),” the release explained.

In addition, the company will initiate “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.”