We recently zoomed with the  management team at Vaxart (VXRT) to catch up and get a feel for the upcoming Phase II COVID-19 oral vaccine development, notes John McCamant, biotech sector expert and editor of The Medical Technology Stock Letter.

The dose ranging portion of the Phase II trial is expected to begin shortly and may test three or more different cohorts; an S+N, an S, and an unidentified third cohort.

The initial portion will enroll 12 patients per dose in all the different cohorts being tested, which will be revealed in the Phase II press release expected shortly.

The dose-ranging part of Phase will be open-label and VXRT could announce data within a few months after dosing as they will be able to track the trial results real time as they reveal themselves using the open-label design.

The Phase II trial will almost certainly enroll patients who need a booster shot after receiving the mRNA vaccine from either Moderna or Pfizer. The first portion of Phase II is expected to occur in the U.S. with the second portion expanding to overseas with SE Asia and Africa being likely candidate locations.

The second half of 2021 holds significant promise for VXRT as the Phase II data has the potential to transform the company from an interesting “story stock” to a major player in COVID-19 vaccine development space. 

The booster data could be huge if the vaccine can protect against the Delta variant. In our view, the recent noravirus data where VXRT demonstrated the ability to boost the immune response in patients who had previously received the VXRT vaccine candidate bodes well for the upcoming booster data in COVID-19. 

Importantly, the company has also made progress on the manufacturing front with an announcement expected by year end on the progress. VXRT has the potential to be both a major player and part of the long-term vaccine solution. The stock is a buy under $15 with a target price of $30 per share.

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