Novavax has announced an underwritten public offering to sell up to $125 million of its common stock. In addition, the Maryland biotech has given underwriters a 30-day option to buy an additional $18.75 million of its common stock at the public offering price.
The proceeds from the fundraising may go into the continued global launch of Nuvaxovid, Novavax’s protein subunit COVID-19 vaccine developed in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI). The funds will also be used for the repayment or repurchase of part of the $325 million of the company’s 3.75% convertible senior unsecured notes which is due February 2023.
Nuvaxovid contains a version of the spike protein found on SARS-CoV-2, the virus that causes COVID-19. In a Phase 3 trial called Prevent-19, Nuvaxovid showed an overall efficacy of 90.4% and was 100% successful in preventing moderate or severe disease. However, the results were presented before the arrival of the now-dominant Omicron variant, which has been shown to reduce the effectiveness of many early vaccines such as Moderna’s and Pfizer’s shots.
Novavax has since developed an Omicron-specific vaccine (NVX-CoV2515) and ambivalent Omicron/original strain-based vaccine, and is also evaluating a COVID-19-influenza combination (CIC) vaccine candidate in Phase 1/2.
While the approval of Nuvaxovid in many parts of the world (including the US and the EU) was relatively speedy for a new drug, the production of the vaccine has seen many delays.
In October 2020, Novavax had to delay the Prevent-19 trial due to production problems, which were subsequently compounded by a lack of the large, sterile bags used to grow vaccine cells.
The company also delayed seeking FDA approval for Nuvaxovid, citing its inability to prove to regulators its manufacturing consistency across facilities.
And in June 2022, the FDA delayed its decision to authorize Novavax’s shot after the company made changes to its manufacturing process.
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