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Sunday, January 16, 2022

Odds are Stacked Against Novavax, Inc. (NASDAQ:NVAX)

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ResVax Failure Ramifications

Novavax, Inc. (NASDAQ:NVAX) is at a crucial moment as its ResVax influenza vaccine failed. NVAX missed on the primary endpoint for the drug and the stock fell hard going from $2.13 to now just above $0.60. The reason here is obvious, but there may still be some ways NVAX could salvage ResVax.

“Although we are disappointed to announce that the Prepare trial did not meet the prespecified criterion for the primary endpoint, ResVax did, however, demonstrate statistically significant efficacy against hospitalization associated with RSV lower respiratory tract infection at 44% with the lower band of confidence of nearly 20%,” said, President and CEO Stan Erck. This announcement leaves NVAX with really three options to choose from: the vaccine’s ability to hit on key secondary endpoints may be enough to convince regulators to approve the vaccine outright. Next, regulators might approve the vaccine based on these promising hints of efficacy in severe RSV cases, but with the understanding that Novavax would conduct a post-licensure trial. Lastly, regulators may require the company to undertake yet another late-stage trial prior to granting approval.

Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that drives improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Its two priority programs are ResVax™, its RSV vaccine for infants via maternal immunization, and NanoFlu™, its quadrivalent influenza nanoparticle vaccine. Novavax’ proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic nanoparticles addressing urgent global health needs.

According to NVAX, ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant. It is being developed to protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants through the first months of life. In February 2019, Novavax announced top-line data from Prepare™, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom have received the vaccine, and their infants. Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).

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Digesting the Big Blow

All of these discussions take time to set up, but we are pressing to have them as soon as reasonably possible, hopefully in the second quarter or early third quarter of this year. We will provide an update on our progress at the appropriate time. In parallel, we continue to assess the best partner for our ResVax program and perhaps multiple partners, with capabilities in different geographies,” Erck added in the call.

This news was obviously a crushing blow to the stock and its beleaguered shareholders. Primary concern is cash to keep the company up and running. CFO John Trizzino noted that Novavax raised around $41 million in cash in the first quarter of 2019 by selling additional shares. He said that the company took this step even though its stock price has been beaten down because management “concluded that it was more important to add to our balance sheet as we negotiate with potential partners and regulators.”

Novavax, Inc. (NASDAQ:NVAX) has a market cap of $226.34M and a current float of 378.41M. We expect the company to make some drastic moves to shore up cash flow, but this stock is no longer for the feint of heart. For continuing coverage on shares of Novavax stock, as well as our other breakout picks, sign up for our free newsletter today and get our next hot stock pick!

Disclosure: we hold no position in $NVAX, either long or short, and we have not been compensated for this article.

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