Novavax (NASDAQ: NVAX), a late-stage biotechnology company based in Maryland, announced a series of positive developments on May 11th that caused its stock price to double in after-hours trading. The primary reason for the investor enthusiasm was news that the company received an increased investment of $384 million for the development and manufacturing of its NVX-CoV2373 vaccine targeting the novel coronavirus. The trial, which is expected to involve approximately 130 healthy adults, is expected to start later this month followed by preliminary results in July of this year.

The funding will be provided by the Coalition for Epidemic Preparedness Innovation (CEPI). In March 2020, CEPI invested $4 million in the vaccine’s development so the new funding brings its total investment to $388 million. The Novavax coronavirus vaccine candidate is described as a stable, prefusion protein made with the company’s nanoparticle technology and is designed to enhance the immune system’s response and stimulate high levels of neutralizing antibodies.

Novavax SEC Filings

First Quarter Loss Narrows

The small cap company also reported 2020 first quarter financial performance that surpassed consensus analyst expectations. It reported a net loss of $25.9 million compared to a net loss of $43.2 million in the first quarter of 2019. Revenue decreased 15% to $3.4 million primarily due to the conclusion of the company’s Prepare trial of infant pneumonia vaccine ResVax last year.

Novavax exited the period with a significantly higher cash balance of $244.7 million. It raised $186 million in capital through at-the-market (ATM) offerings during the quarter as well as an additional $74 million so far in the second quarter for a year-to-date total of $260 million.

The funding Novavax receives from CEPI will strengthen an already improving balance sheet and put it in a better position to develop the NVX-CoV2372 vaccine and to potentially have a profound impact on the current global health crisis. The company plans to use the money to scale the delivery of clinical data and potential manufacturing of the vaccine.

Nanoflu Program Sees Positive Phase 3 Results

Novavax continued to wow investors by announcing positive data from the pivotal Phase 3 clinical trial of NanoFlu, its seasonal influenza vaccine candidate. The vaccine in combination with its proprietary Matrix-M adjuvant achieved all primary endpoints associated with efficacy and safety in older adult patients. The results represent a major milestone towards bringing the product to an influenza market that was already in need of novel treatments prior to the outbreak of the coronavirus. The data from the trial will support the company’s U.S. biologics license application (BLA) using the U.S. Food and Drug Administration’s (FDA) accelerated approval pathway.

CEO Stanley Erck commented, “Our accomplishments to-date in 2020, including significant progress in our influenza and COVID-19 vaccine programs, are the most impressive in the company’s history.”

Looking ahead

Nanovax continues to make progress in its quest to provide next-generation vaccines for a variety of serious infectious diseases including the novel coronavirus. Today’s three-pronged press release highlights what has already been a banner year for the company underscored by the rapid development of its COVID-19 vaccine candidate.

The company scored big with investors as the shares soared above $35 in the after-market. Investors and the world as a whole will be awaiting the preliminary results of its coronavirus vaccine candidate which are expected sometime in July.

Novavax SEC Filings

 

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