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Novavax Reports First Quarter 2020 Financial Results
CEPI increases investment up to $388 million for NVX‑CoV2373 vaccine development & manufacturingNVX‑CoV2373 Phase I trial initiating in May with preliminary
About this update from Novavax, Inc.
[{"type":"text","content":"CEPI increases investment up to $388 million for NVX‑CoV2373 vaccine development & manufacturingNVX‑CoV2373 Phase I trial initiating in May with preliminary results in JulyNanoFlu recently achieved all primary endpoints in pivotal Phase 3 clinical trialCompany to host conference call today at 4:30 p.m. ET GAITHERSBURG, Md., May 11, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the first quarter ended March 31, 2020. “Our accomplishments to-date in 2020, including significant progress in our influenza and COVID‑19 vaccine programs, are the most impressive in the company’s history,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We shared successful pivotal Phase 3 results for NanoFlu that demonstrated both efficacy and safety in a pivotal trial, a significant milestone towards bringing this innovative product to an influenza market in need of new options. We also reacted quickly to the coronavirus pandemic by developing and quickly advancing NVX‑CoV2373, our COVID‑19 vaccine candidate, which shows strong potential to have a positive impact on this global health crisis. Looking ahead, with a strengthened balance sheet and CEPI’s substantial funding, we will focus on scaling up manufacturing and delivering clinical data for NVX‑CoV2373, while simultaneously completing the necessary actions needed to prepare our BLA filing for NanoFlu.” First Quarter 2020 and Subsequent Operational Highlights NanoFlu™ Program Novavax announced in March that NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix‑M™ adjuvant, achieved all primary objectives in its pivotal Phase 3 clinical trial in older adults. As required by the FDA’s accelerated approval pathway, the trial’s primary objectives were to demonstrate non-inferior immunogenicity of NanoFlu compared to a licensed vaccine (Fluzone® Quadrivalent), using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR), as well as the overall safety of NanoFlu. These endpoints were met for all four strains included in NanoFlu. Immunogenicity was measured by hemagglutination inhibition (HAI) assays using egg-derived reagents. ...