Vaxart Inc (NASDAQ: VXRT) stock rose 9.37% on September 21^st, 2020 (Source: Google finance) after the U.S. Food and Drug Administration (FDA) finished its review of the Company’s Investigational New Drug (IND) application for its Phase 1 clinical trial evaluating its oral COVID-19 vaccine candidate. The IND clearance and the initiation of the Phase 1 clinical trial has moved the company a step closer to proving the superiority of the convenient oral COVID-19 solution in the clinic. The company had planned to start enrollment for the Phase 1 this month. The Phase 1, open-label, dose-ranging study will be conducted in healthy adults ages 18 to 55 years old. The study’s primary objective is to examine the safety and reactogenicity of two-doses of the vaccine. The secondary objectives include immunogenicity, duration of immune response and occurrence of symptomatic COVID-19. Vaxart is conducting a SARS-CoV-2 challenge study in hamsters to offer efficacy data and insights into the optimal dose regimen of the vaccine candidate.  The results from this study, which began in early August, are expected mid-October.

Meanwhile, Vaxart is awaiting results from a non-human primate (NHP) challenge study that is testing its vaccine in a harmonized protocol as part of Operation Warp Speed. This preclinical program is being conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and other entities working with Operation Warp Speed. Both hamsters and monkeys are susceptible to SARS-CoV-2 infection and these models may be capable of providing a deeper understanding of the immune responses and correlates of protection elicited by the oral vaccine candidate.

On the other hand, in June, VXRT had signed a Memorandum of Understanding with Attwill Medical Solutions Sterilflow, LP (“AMS”) affirming the parties’ intent to establish AMS as a resource for lyophilization development and large-scale manufacturing including tableting and enteric coating for the oral COVID-19 vaccine. The company had also informed that its oral COVID-19 vaccine was selected to participate in a non-human primate challenge study, organized and funded by Operation Warp Speed.

Moreover, the company had reported a net loss of $9.0 million for the second quarter of 2020 compared to $5.6 million for the second quarter of 2019. The increase was driven by an increase in operating expenses. The company had ended the quarter with cash and cash equivalents of $44.4 million compared to $29.9 million at March 31, 2020.