Novavax gets another boost with $1.6B contract from Operation Warp Speed

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While Novavax has yet to bring a vaccine to market, the company remains on a meteoric trajectory most recently marked by a $1.6 billion contract with BARDA and the DoD for its COVID-19 vaccine. The deal is Operation Warp Speed’s second publicly disclosed and largest commitment to a vaccine developer.

Shares of Novavax gained $25.12 (32%) to $104.56 on Tuesday, pushing its market cap above $6 billion. Its share price is 18x greater than its close of $5.74 on Jan. 17, the last day of trading before the company disclosed it was working on a COVID-19 vaccine.

Novavax will receive $1.6 billion from Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense (DoD) to fund manufacturing and a Phase III trial of NVX-CoV2373 that is slated to start this fall. The U.S. also secured 100 million doses of the vaccine, which could come as early as late 2020. Operation Warp Speed has an option for additional procurement.

Warp Speed made its first vaccine investment in May, awarding up to $1.2 billion to support the development and manufacturing of AZD1222, the vaccine developed by the University of Oxford and licensed by AstraZeneca plc (LSE:AZN; NYSE:AZN) (see “Operation Warp Speed Takes First Step”).

Other finalists in Warp Speed’s program are Moderna Inc. (NASDAQ:MRNA); Pfizer Inc. (NYSE:PFE) and partner BioNTech SE (NASDAQ:BNTX); Johnson & Johnson (NYSE:JNJ); and Merck & Co. Inc. (NYSE:MRK).

The Novavax investment comes as the U.K. is reportedly closing in on securing access to a second COVID-19 vaccine from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Sanofi (Euronext:SAN; NASDAQ:SNY) (see “U.K. May Be Near 60M Dose Deal”).

Also on Tuesday, Warp Speed committed $450 million to an antibody therapeutic from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) (see "Operation Warp Speed Secures Thousands of Antibody Doses").

Vaccine roller coaster

Founded in 1987, Novavax has yet to bring a product to market, and vaccines developed with its recombinant nanoparticle technology have seen mixed success over the past five years.

Novavax’s ResVax RSV vaccine has failed in two Phase III trials -- one to prevent respiratory syncytial virus infection in infants via maternal immunization, and one in elderly adults. Following the latter readout, which occurred in 2016, the company reduced headcount by 30% (see “Novavax Down after Phase III Miss”).

The biotech’s NanoFlu vaccine has had a better track record. In March, Novavax reported Phase III data showing the flu vaccine was non-inferior to Fluzone Quadrivalent from Sanofi on both of its primary immunogenicity endpoints (see “Novavax’s Flu Data Showcase Vaccine Platform’s Potential”).

At BIO’s annual meeting in June, Novavax reported non-human primate data showing NVX-CoV2373 elicited SARS-CoV-2 neutralizing titers in the 10,000 range, the highest levels disclosed thus far in monkey studies (see “Comparing Neutralizing Titers”).

NVX-CoV2373 is currently in a Phase I/II trial in Australia, with data expected this month.

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