October 21, 2020
BIOINVEST NEWS
Special Update: Vaxart (VXRT) – Starts Phase I Dosing & Delivers Positive Hamster Challenge Data, Stock Remains Under Short Selling Pressure – BUY
VXRT has delivered two very good pieces of news – the Company has enrolled its first patient in the COVID vaccine study and also released uniformly positive hamster challenge data. Despite this good fundamental news, the stock has been under pressure from short sellers since then based on an SEC filing of a self offering filed on the same day as the clinical/pre-clinical updates. Unfortunately, lawyers penned the S-1 offering and opened up the NYTimes allegations back in July requested information regarding VXRT being chosen by Operation Warp Speed (OWS) to participate in a non-human primate (NHP) challenge study back in June. This is completely old news and the Company’s actions and response was clean, “The Vaxart non-human primate challenge study was organized and funded by Operation Warp Speed, as stated in the June 26, 2020 Company press release. The statements made in that press release are accurate and any allegation to the contrary is baseless.” We strongly believe that Vaxart will not be using the shelf any time soon (they have over $130 million in cash/no debt), or if ever, as government and public funding will be readily available and plentiful once the Phase I trials come in. Despite the frustrating stock, we recommending adding to VXRT on this non-fundamental weakness. BUY
Phase I Officially Underway
Last week, VXRT announced that the first subject has been dosed in its Phase 1 study of VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate. The Phase 1, open-label, dose-ranging trial (NCT04563702) is designed to examine the safety and immunogenicity of two doses of VXA-CoV2-1 in up to 48 healthy adult volunteers aged 18 to 54 years old. Enrollment is expected to be completed by early November 2020, with participants receiving the low or high dose of the VXA-CoV2-1 oral tablet at days 1 and 29. Safety, reactogenicity and immunogenicity assessments will be performed at set times during the active phase. The first clinical data from this trial will be available in the next few weeks, by early November.
Hamster Challenge As Good Or Better Than Big Boys
VXRT also announced last week, topline results from its Hamster Challenge Study. The available results show that all hamsters that received two oral doses of COVID-19 vaccine candidate showed no systemic weight loss, a key indicator of protection against COVID-19 in this animal model. “Our oral vaccine showed that 100% of hamsters receiving two oral doses of vaccine in the study were protected against systemic weight loss (p<0.001), as well as lung weight gain, which is a key indicator of lung damage due to infection,” said Sean Tucker, Ph.D., chief scientific officer, and founder of Vaxart. “Given that the hamster is a great model for assessing severe infection, this study helps to validate our vaccine’s potential to provide potent protection against COVID-19. These results increase our confidence as we move our vaccine candidate into human clinical trials.” Specifically, hamsters provide a very sensitive model for assessing COVID-19 infection since they can be infected via the intranasal route, and, if infected, they demonstrate pronounced clinical symptoms such as weight loss. JNJ has presented similar hamster challenge data with its own COVID vaccine under development.
More News Very Soon
VXRT is positioned for two more near-term events – the first human data (most likely biomarker data) in the next few weeks and the NHP data from OWS could come in the same time frame. It is hard to watch short sellers take advantage of old news from the shelf offering as it did not necessarily have to be filed and was most likely strongly encouraged by bankers. Nevertheless, the upcoming data from both human’s and the NHP data from OWS will put the SEC investigation in the rear view mirror.
In our view, a room temperature stable oral tablet vaccine has the potential to ease many of the problems associated with distribution and administration of cold chain dependent injectable vaccines. In fact, an AP story this week pointed that almost 3 billion of the world’s 7.8 billion live beyond the cold chain temperature-controlled in unavailable. VXRT is the only oral vaccine in human development, and in our view, is a leader in the second wave of COIVID-19 vaccines.