Business
Novavax Reports Third Quarter 2020 Financial and Operational Results
Advanced clinical development of NVX‑CoV2373 with initiation of first Phase 3 trial to evaluate efficacy, safety and immunogenicityU.K. Phase 3 interim data
About this update from Novavax, Inc.
[{"type":"text","content":"Advanced clinical development of NVX‑CoV2373 with initiation of first Phase 3 trial to evaluate efficacy, safety and immunogenicityU.K. Phase 3 interim data expected as soon as early first quarter 2021Secured additional large-scale manufacturing for NVX-CoV2373 with expected global capacity over two billion doses by mid-2021Formed leadership team to advance NanoFlu through global licensureCompany to host conference call today at 4:30 p.m. ET GAITHERSBURG, Md., Nov. 09, 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 third quarter ended September 30, 2020. “Novavax continued to deliver remarkable progress this quarter, with our most notable achievement being the initiation of a 15,000-person pivotal Phase 3 trial in the U.K. of NVX-CoV2373, our COVID-19 vaccine candidate,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “With multiple clinical trials ongoing worldwide, we expect initial efficacy data potentially by early first quarter 2021. In the U.S., we made significant progress in large-scale manufacturing and expect to launch a pivotal Phase 3 trial by the end of November. We also announced a newly formed team to lead the NanoFlu program to licensure in the U.S. and look forward to providing updates as the team finalizes its strategy.” Third Quarter 2020 and Recent Highlights COVID-19 Program Secured funding for late-stage clinical development of NVX‑CoV2373 U.S. Government funding through Operation Warp Speed (OWS) up to $1.6 billionCoalition for Epidemic Preparedness Innovations (CEPI) funding increased up to a total of $399 millionCumulative $2 billion funding to date through OWS, CEPI and Department of Defense (DoD) Advanced ongoing clinical trials for NVX‑CoV2373 Phase 3 clinical trial in the United Kingdom (U.K.) initiated Trial expanded to 15,000 participants with full enrollment expected by the end of NovemberEnrollment approximately 9,000 participants, over 60% as of todayEvent-driven interim data expected as soon as early first quarter 2021 Pivotal Phase 3 clinical trial in the U.S. expected to begin by end of November U.S. Food and Drug Administration granted Fast Track designationConducted with support from t...