Novovax, Inc. NVAX has been actively engaged in development of a coronavirus vaccine.
Investors will be keen to know about the progress of its coronavirus vaccine candidate when the company reports second-quarter 2020 results.
The company is developing its coronavirus vaccine candidate, NVX-CoV2373, in a phase I/II study, which has been made using the company’s proprietary nanoparticle technology. Notably, NVX-CoV2373 includes Novavax’s proprietary Matrix-M adjuvant to improve immune responses and stimulate high levels of neutralizing antibodies.
Novavax’s shares have skyrocketed 3407.5% so far this year compared with the industry’s increase of 5%.
In May, the company initiated the phase I portion of the phase I/II study on NVX-CoV2373. Preliminary immunogenicity and safety data from the study is expected soon. Please note that NVX-CoV2373 showed high immunogenicity in pre-clinical studies after a single immunization.
We expect the company to provide the timeline to start the phase II portion of the study on its second-quarter earnings call, which should start following the preliminary data readout. Novavax had earlier said that it expects to start a phase III study to evaluate NVX-CoV2373 in the fourth quarter of 2020. An update is expected on the upcoming call.
Meanwhile, the company received a funding commitment of $388 million from the Coalition for Epidemic Preparedness, $1.6 billion from the U.S. federal government and a contract worth $60 million by the United States, Department of Defense to support clinical development of NVX-CoV2373.
Novavax is also increasing its manufacturing capacities to support its clinical studies and a potential launch through collaborations and acquisitions. The company has an agreement with Emergent BioSolutions EBS to manufacture and supply GMP vaccine product for use in its clinical studies. It also acquired Praha Vaccines in Czech Republic to strengthen its manufacturing capacity in May. The company anticipates to deliver 100 million doses of NVX-CoV2373 beginning as early as late 2020 and more than 1 billion doses in 2021.
Some of these deals are likely to have increased operating expenses during the second quarter. However, we note that the company has significant funding available, which must have helped it to foot the bill.
Please note that there are several other pharma/biotech companies that are developing vaccines against COVID-19. Leading among them are Moderna’s MRNA mRNA-1273, Pfizer and BioNTech’s BNT162b2, and AstraZeneca AZN and Oxford University’s AZD1222.
Apart from the coronavirus vaccine candidate, Novavax is also developing four other vaccine candidates in clinical stage studies. The company’s seasonal influenza vaccine candidate, NanoFlu, and respiratory syncytial virus vaccine candidate, ResVax, are the most advanced candidates in its pipeline. The company has completed phase III studies on both vaccine candidates. We expect investors to ask questions related to regulatory filings for these candidates on the second-quarter earnings call. (Read more: What’s in Store for Novavax This Earnings Season?)
Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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