On May 9, 2022 Vaxart, Inc. (NASDAQ: VXRT) reported its business update for the first quarter of 2022, reporting continued progress on its oral vaccine candidates (Press release, Aviragen Therapeutics, MAY 9, 2022, View Source [SID1234614017]).

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"We continue to make progress on our pipeline of potentially game changing oral tablet vaccine programs, with norovirus studies that will report results in the second quarter as well as our Phase II study for our COVID-19 program that will report results from the first part of the planned two-part study in the third quarter," said Andrei Floroiu, Vaxart’s Chief Executive Officer. "Vaxart’s oral vaccine technology may address many public health challenges, including rapidly emerging COVID-19 variants because the cross-reactive nature of mucosal IgA response increases the likelihood of variant coverage."

Recent Business Highlights

Preclinical and Clinical

COVID-19 Vaccine Developments

In February 2022, Vaxart’s COVID-19 non-human primate study was published by bioRxiv. The study demonstrates that Vaxart’s S-only COVID-19 vaccine candidate, now being studied by Vaxart in Phase II trials, generated antibodies to the original COVID-19 virus strain and to the Beta, Delta, Alpha and Gamma variants of SARS-CoV-2 in the serum and nasal mucosa of non-human primates (NHPs).
Vaxart’s S-only candidate is believed to be the first vaccine candidate to demonstrate neutralizing antibody responses in mucosal sites, which is where primary infection occurs.
The candidate also induced a 1000-fold increase in nasal IgA responses to the variants, which may reduce community transmission.
In April 2022, an article was published in Vaccines that highlights the potential of Vaxart’s oral tablet vaccine platform to transform vaccine strategies for respiratory viral pathogens.
The article discusses one of the chief advantages of oral vaccines, which is to induce an immune response in the mucosa, the first line of defense against invading respiratory pathogens.
The article also outlines how Vaxart’s oral tablet vaccine candidates are very well suited to transform global vaccination strategies by potentially removing cold-chain requirements and the necessity of administration by healthcare professionals, enabling rapid deployment of new vaccines to address novel pathogens.
Vaxart now expects data from the dose selection portion of its two part dose-ranging and preliminary efficacy Phase II clinical trials of its oral tablet COVID-19 vaccine candidate to be available in the third quarter of 2022. This is an open-label dose and age escalation lead-in segment in naïve and previously vaccinated subjects.
Norovirus Vaccine Developments

Vaxart has dosed all subjects in its Phase IB placebo-controlled, dose-ranging, repeat dose trial of its oral norovirus vaccine candidate in elderly subjects aged 55 to 80 years. This study is designed to evaluate the safety and immunogenicity of Vaxart’s GI.1 vaccine candidate and results will be available in the second quarter of 2022.
Vaxart launched a Phase II GI.1 norovirus challenge study in January 2022 to evaluate the safety and clinical efficacy of its oral vaccine candidate. This double blind, placebo-controlled study uses a safe, well-characterized challenge with norovirus GI.1 of volunteers vaccinated with our monovalent norovirus vaccine candidate. The study will yield data on efficacy, safety, and immune correlates of protection, with data expected to be reported in the first quarter of 2023.
2022 Planned Clinical Milestones

Data from the first part of Vaxart’s two-part Phase II trial of its COVID-19 vaccine candidate is expected to be available in the third quarter of 2022.
Vaxart’s international Phase IB and Phase II COVID-19 trials, including a placebo-controlled efficacy trial in India, are anticipated to begin this year.
Results from Vaxart’s Phase IB trial of its norovirus vaccine candidate in elderly subjects are expected in the second quarter of 2022.
Financial Results for the Three Months Ended March 31, 2022

Vaxart ended the first quarter with cash, cash equivalents and available-for-sale debt securities of $157.0 million, compared to $182.7 million as of December 31, 2021. The decrease was primarily due to $25.1 million of cash used in operations.
The Company reported a net loss of $25.1 million for the first quarter of 2022, compared to $16.0 million for the first quarter of 2021. Net loss per share for the first quarter of 2022 was $0.20, compared to a net loss of $0.14 per share in the first quarter of 2021. The increase in net loss was primarily due to a significant increase in research and development expenses.
Revenue for the first quarter of 2022 was $85,000, compared to $506,000 in the first quarter of 2021. The decrease was due to lower royalty revenue from sales of Inavir in Japan.
Research and development expenses were $18.2 million for the first quarter of 2022, compared to $10.1 million for the first quarter of 2021. The increase was mainly due to increases in headcount and related costs and in manufacturing and clinical trial expenses related to our COVID-19 and norovirus vaccine candidates.
General and administrative expenses were $6.7 million for the first quarter of 2022, compared to $5.9 million the first quarter of 2021. The increase was mainly due to an increase in headcount and related costs.