Shares of Novavax Inc. (NVAX) jumped 30 percent in Monday’s regular trading and gained nearly 40 percent in after-hours, following significant progress in the Company’s influenza and COVID-19 vaccine programs and increased funding from the Coalition for Epidemic Preparedness Innovations.
We had alerted readers to this stock on January 21, 2020, when it was trading around $9. (Report titled “Novavax (NVAX) Gains Over 46% in 5 Days, To Report Phase 3 NanoFlu Data In Q1”).
In March, Novavax announced that its pivotal phase III clinical trial of NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate with Matrix-M adjuvant, in older adults achieved all primary and key secondary endpoints. The Company is planning to seek licensure for the NanoFlu vaccine under the FDA’s accelerated approval pathway.
Novavax, which began efforts to develop a novel vaccine to protect against COVID-19 in January of this year, identified NVX-CoV2373 as an ideal vaccine candidate last month. NVX-CoV2373 is a stable, prefusion protein made using the Company’s proprietary nanoparticle technology. The incorporation of the proprietary Matrix-M adjuvant with the coronavirus vaccine candidate NVX-CoV2373 is expected to enhance immune responses and stimulate high levels of neutralizing antibodies.
The NVX-CoV2373 clinical development program is a phase I/II trial, in which the phase I portion of the trial is designed to enroll about 130 healthy adults. The phase I portion of the NVX-CoV2373 vaccine trial began this month in Australia.
Novavax has an agreement with Emergent BioSolutions (EBS) for the contract development and manufacturing of NanoFlu and NVX-CoV237 vaccine candidates.
To advance the clinical development of NVX-CoV2373, the Coalition for Epidemic Preparedness Innovations (CEPI), on Monday, announced additional funding of up to $384 million. The CEPI had provided initial funding of $4 million to accelerate the vaccine development in March of this year.
The preliminary immunogenicity and safety results from the phase I portion of the NVX-CoV2373 vaccine trial are expected in July.
The phase II portion of the NVX-CoV2373 vaccine trial will be conducted in multiple countries, following successful phase I results.
The Company expects to manufacture up to 100 million vaccine doses by the end of 2020.
Large-scale manufacturing capacity in multiple countries with a goal of potentially producing over one billion doses is planned during 2021.
A phase IIb clinical trial of Serum Institute of India’s malaria vaccine candidate is being conducted in Burkina Faso, in West Africa. Novavax’s Matrix-M vaccine adjuvant is a key component of the malaria vaccine candidate. Top-line data from the trial are expected in the second quarter of 2020.
Under a license agreement inked with Serum Institute of India (SII) in March, Novavax has the rights to sell and distribute the SII-manufactured vaccine in high-income countries, primarily in the travelers and military vaccine markets.
As of March 31, 2020, Novavax had $244.7 million in cash, cash equivalents, marketable securities, and restricted cash.
NVAX closed Monday’s trading at $24.50, up 30.8%. In after-hours, the stock gained another 37.96% and was at $33.80.
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