Novavax, Inc.
NVAX 4.93% shares are higher Friday following a coronavirus vaccine supply deal the company announced with the Australian government.
Deal Sealed: Novavax, based in Gaithersburg, Maryland, said late Thursday the Australian government has executed a purchase agreement to buy 51 million doses of NVX-CoV2373, the company's coronavirus vaccine candidate, with an option to buy an additional 10 million doses. This follows an agreement in principle the parties announced in November.
Upon the vaccine candidate hitting efficacy and safety goals in ongoing pivotal trials, the company will work with the Australian drug regulator to obtain product approvals. The company expects to deliver the initial doses by mid-2021.
Is this timeline a practically achievable target, given the delays the company experienced in the start of the late-stage trial? Here's a look at where Novavax' vaccine program stands.
The Wait Extends: NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, created using the company's recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein. It's adjuvanted with Novavax's patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies.
The company's vaccine program is federally funded, with CEPI, the Department of Defense and the Operation Warp Speed program extending financial support to the tune of $1.6 billion to bring the program to fruition.
In early August 2020, Novavax reported positive interim readout from the Phase 1 portion of the Phase 1/2 trial evaluating the investigational vaccine. Both dose levels of NVX-CoV2373 — 5 mcg and 25 mcg — generated peak geometric mean titer greater than 1:3,300, and the vaccine-induced neutralization in 100% of participants. Following the data readout, Novavax initiated the Phase 2 portion of the trial in late August.
Interim readout from the study was scheduled to be released in the fourth quarter of 2020. In late November, the company said preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 was reviewed by the FDA, and additional data are expected to be unblinded in the first quarter of 2021 and targeted for publication.
NVX-CoV2373 is also currently being evaluated in two pivotal Phase 3 trials; A trial in the U.K that completed enrollment in November; and the PREVENT-19 trial in the U.S. and Mexico that began in December. The U.S. and Mexico leg of the trial was delayed multiple times before going online in late December.
A Phase 2b trial is underway in South Africa.
From Thursday's update, it looks like a readout from the event-driven, late-stage trials should be coming over the next couple of months — a seemingly ambitious timeline. In the interim, Novavax announced multiple production and supply agreements.
"We believe this part of Novavax' COVID-19 program, as well as its collaborations with key strategic regional players in Asia, bolsters our view that the company is very competitive versus much larger COVID-19 vaccine players, and has a comprehensive global vaccine distribution plan that remains underappreciated," HC Wainwright analyst Vernon Bernardino said in a December note.
The yet-to-be-proven vaccine program led to a huge run-up in Novavax stock in 2020, as it ended as one of the best performing biopharma of the year. In 2020, the stock appreciated over 2,700%, and has added another 15% in the new year.
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