On February 24, 2022 Vaxart, Inc. (NASDAQ: VXRT) reported its business update today for the fourth quarter and full year 2021, reporting forward momentum for the Company, including its oral norovirus and COVID-19 vaccine candidates (Press release, Aviragen Therapeutics, FEB 24, 2022, View Source [SID1234608950]).

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Vaxart said it expected further material progress across its programs in 2022.

"Vaxart made significant progress in 2021 that has us well-positioned to achieve several important milestones in 2022," said Andrei Floroiu, Vaxart’s Chief Executive Officer. "Our potentially transformative oral vaccine programs continued to advance in clinical development. Patient dosing is underway in our U.S. Phase II COVID-19 trial and we have started a Phase II monovalent norovirus GI.1 challenge study."

"We have improved our manufacturing capacity, added to our research and manufacturing ranks, and hired top leadership talent," Floroiu said. "We anticipate building on 2021’s momentum, and are excited about the continued progress we expect to make in 2022, including launching the international clinical studies of our COVID-19 vaccine."

"In 2021, we generated exciting preclinical and clinical data," said Dr. Sean Tucker, Vaxart’s founder and Chief Scientific Officer. "A hamster challenge study showed that our oral COVID-19 vaccine candidate has the potential ability to reduce transmission of SARS-CoV-2, and a Phase I study showed that our vaccine candidate produced broad cross-reactive T cell and IgA responses against both SARS-CoV-2 and other coronaviruses. Therefore, we believe that our COVID-19 vaccine candidate may be reactive against SARS-CoV-2 variants. In 2022, we are planning to conduct additional trials that may highlight the advantages of triggering mucosal immunity as well as of other aspects of our platform."

Recent Business Highlights

Preclinical and Clinical

COVID-19 Vaccine Developments

During the fourth quarter of 2021, Vaxart began Phase II clinical trials of its oral tablet COVID-19 vaccine in the U.S. Vaxart dosed its first subject in late October 2021.

The U.S. portion of the trial is a randomized open-label dose and age escalation lead-in segment in naïve and previously vaccinated subjects. Vaxart expects data from this portion of the trial to be available during the first half of 2022.

In October 2021, a Duke University-led study showed Vaxart’s COVID-19 vaccine candidate reduced the airborne transmission of SARS-CoV-2 virus in an animal model and suggested the vaccine candidate would trigger superior mucosal protection.

The study’s findings, published by bioRxiv, are consistent with those from Vaxart’s Phase II human flu challenge study published in 2020, which showed Vaxart’s oral tablet flu vaccine was better at reducing shedding than the injectable flu vaccine competitor.

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 clinical 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 also announced it would test the cross-reactivity of its oral tablet COVID-19 vaccine candidate against the Omicron SARS-CoV-2 variant in two different studies now expected to begin in March 2022.

In the first study, Vaxart will test the activity of its Phase II COVID-19 oral vaccine candidate against Omicron by analyzing mucosal and serum samples from subjects to whom the vaccine was administered in Vaxart’s current COVID-19 vaccine Phase II trials.

In the second study, Vaxart will conduct an animal Omicron challenge study to assess how its current Phase II COVID-19 vaccine candidate performs in comparison to an Omicron-specific vaccine candidate, which Vaxart is currently developing.

Results from Phase I clinical testing and earlier preclinical testing support Vaxart’s belief that its vaccine candidates may be reactive against Omicron.

Vaxart completed enrollment in its Phase IB placebo-controlled, dose-ranging, repeat dose trial investigating 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.

The Company expects initial data from this study to be available in the first quarter of 2022 and more complete data to be available by the second quarter of 2022.

Vaxart is conducting an additional GI.1 norovirus vaccine study to evaluate the optimal timing for boost administration under VXA-NVV-105. This study has completed enrollment.

The Company expects initial data from this study to be available in the first quarter of 2022 and more complete data to be available in the first half 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. The study will yield data on efficacy, safety and immune correlates of protection, with data to be reported in the first quarter of 2023.

Manufacturing Updates

During the fourth quarter of 2021, Vaxart purchased its second clinical manufacturing facility and will be producing vaccines at two plants in parallel. Vaxart expects its manufacturing facilities to produce oral tablet vaccines required for Vaxart’s planned clinical trials in 2022.

Corporate Developments

A new Stanford study published in Cell Host and Microbe found that protection against influenza infection may be achieved through mechanisms other than the development of serum antibodies. The Phase II study demonstrated that VXA-A1.1, an investigational oral tablet flu vaccine under development by Vaxart, had cellular correlates of protection against influenza infection.

Vaxart grew its full-time employee headcount from 28 to 110 during 2021, expanding its research, manufacturing and quality groups as well as its management team to better advance its pipeline of vaccine programs.

In February 2022, Vaxart appointed industry veteran Edward B. Berg as the Company’s first in-house General Counsel. Mr. Berg has practiced law for more than 30 years and has represented Fortune 500 and mid-cap companies in biotechnology, pharmaceuticals and life sciences.

2022 Planned Milestones

Vaxart anticipates the progress and momentum of 2021 will continue into 2022:

Initial data from Vaxart’s Phase II COVID-19 vaccine trials is expected to be available in the first half of 2022.

The Company’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 two norovirus trials that Vaxart began in 2021 are expected in the first half of 2022.

Financial Results for the Three Months Ended December 31, 2021

Vaxart ended the year with cash, cash equivalents and available-for-sale debt securities of $182.7 million, compared to $204.0 million as of September 30, 2021. The decrease was primarily due to $15.8 million of cash used in operations and $4.8 million spent on a business acquisition.

The Company reported a net loss of $20.8 million for the fourth quarter of 2021, compared to $13.9 million for the fourth quarter of 2020. Net loss per share for the fourth quarter of 2021 was $0.17, compared to a net loss of $0.13 per share in the fourth quarter of 2020. The increase in net loss per share was primarily due to a significant increase in research and development expenses.

Revenue for the fourth quarter of 2021 was $74,000, compared to $356,000 in the fourth quarter of 2020. The decrease was due to lower royalty revenue from sales of Inavir in Japan.

Research and development expenses were $15.5 million for the fourth quarter of 2021, compared to $8.6 million for the fourth quarter of 2020. 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 $5.8 million for the fourth quarter of 2021, compared to $5.1 million for the fourth quarter of 2020. The increase was mainly due to an increase in headcount and related costs.

Financial Results for the Full Year Ended December 31, 2021

Vaxart reported a net loss of $70.5 million for full year 2021, compared to $32.2 million for full year 2020. Net loss per share for 2021 was $0.58, compared to $0.36 for 2020.

Revenue in 2021 was $892,000, compared to $4.0 million in 2020. The decrease was principally due to lower royalty revenue from sales of Inavir in Japan.

Research and development expenses were $48.7 million for 2021 compared to $19.9 million for 2020. 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 $21.9 million for 2021 compared to $15.2 million for 2020. The increase was mainly due to increases in personnel costs, D&O insurance and legal and professional fees.