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Shares of Vaxart (VXRT) are under pressure on Monday after the company reported worse-than-expected first quarter losses and said that its Phase II trial of VXA-CoV2-1 is now expected to start mid-year 2021 instead of in the second quarter.

Vaxart is expected to provide new data comparing the T-Cell responses induced by its VXA-CoV2-1 vaccine with those of other vaccines and present new mucosal antibody data and review the recent Phase 1 clinical results that suggest VXA-CoV2-1 is potentially protective against new and future COVID-19 strains due to the vaccine’s more conserved target.

Results

Vaxart reported first quarter losses per share of 14 cents and revenue of $506,000, both below the expected 10 cents and $620,000, respectively. Vaxart ended the quarter with cash, cash equivalents, and available-for-sale debt securities of $177.3 million, compared to $126.9 million as of Dec. 31, 2020.

Trial Delay

Alongside quarterly results, Vaxart said that its Phase II trial of VXA-CoV2-1, the company's vaccine encoding both the S and the N proteins, is now expected to start mid-year 2021 instead of in the second quarter. The delay is due to manufacturing issues at the Baltimore contract manufacturing facility, the same facility where other COVID-19 vaccine manufacturers have also reported issues, the company said.

New Data

Vaxart is expected to provide new data comparing the T-cell responses induced by its VXA-CoV2-1 vaccine with those of other vaccines.

"The recent results of a poll we commissioned suggested that as many as 19 million more Americans would decide to get vaccinated against COVID-19 if the vaccine was administered as a pill instead of a needle injection — a number we expect to be much higher worldwide, particularly given the distribution advantages of a room-temperature stable tablet. That alone could potentially make a significant global impact,” said Andrei Floroiu, Chief Executive Officer of Vaxart.

Preliminary Data from Phase 1 Trial 

Back in February, Vaxart announced preliminary data from its Phase 1 study of VXA-CoV2-1 showing that its oral COVID-19 tablet vaccine candidate was generally well-tolerated and immunogenic as measured by multiple markers of immune response to SARS-CoV-2 antigens.

According to the company, its scientists "recognized early the risk of variants of SARS-CoV-2 emerging and they designed a vaccine with the potential to be protective not only against the prevalent strain, but also against emerging mutations of the Spike protein, by including both the S and N proteins. Virtually all other COVID-19 vaccines include just the S protein."

Price Action

In early trading, shares of Vaxart had dropped 15% to $9.16. As of time of publication, shares are trading at around $8.02.