Vaxart VXRT

Vaxart, Inc. is a clinical-stage biotechnology company focused on the development of oral recombinant vaccines using its proprietary Vector-Adjuvant-Antigen Standardized Technology (VAAST) platform. The company develops vaccine candidates targeting infectious diseases such as norovirus, SARS-CoV-2, influenza, and human papillomavirus (HPV). Its oral tablet vaccine platform is designed to generate systemic, mucosal, and T cell immune responses by delivering antigens and adjuvants directly to the small intestine via a non-replicating adenovirus type 5 vector. This approach aims to improve vaccine accessibility, patient compliance, and distribution efficiency compared to traditional injectable vaccines.

Vaxart generates revenue primarily through government contracts, grants, and partnership agreements that fund its research and development activities. The company has received funding from entities such as the Biomedical Advanced Research and Development Authority (BARDA) and the Bill & Melinda Gates Foundation to support clinical trials for its norovirus and COVID-19 vaccine candidates. Additionally, Vaxart earns royalties from the net sales of two antiviral products, Relenza and Inavir, which were acquired through its merger with Aviragen Therapeutics. These royalties are paid by GlaxoSmithKline and Daiichi Sankyo, respectively, based on sales in Japan.

The company operates through the following segments:

• Norovirus Program: This segment focuses on the development of oral tablet vaccine candidates to prevent norovirus infection, a leading cause of acute gastroenteritis worldwide. Vaxart is developing a bivalent vaccine targeting norovirus GI.1 and GII.4 strains, which are responsible for the majority of human norovirus infections. The program includes clinical trials such as the Phase 2 GI.1 norovirus challenge study and the Phase 1 Study VXA-109 evaluating second-generation vaccine constructs. The company has also conducted studies in breastfeeding mothers to assess passive immunity transfer to infants.
• COVID-19 Program: This segment involves the development of oral tablet vaccine candidates targeting SARS-CoV-2, including strains such as Wuhan, XBB, and KP.2. Vaxart has advanced its KP.2-targeted candidate into a Phase 2b clinical study in collaboration with BARDA and Advanced Technology International (ATI). The study aims to compare the efficacy of Vaxart’s oral vaccine against an approved mRNA comparator in previously immunized adults. The company has received funding under the 2024 ATI-RRPV Contract to support trial execution, manufacturing, and comparator vaccine acquisition.
• Influenza Program: This segment is dedicated to creating oral tablet vaccines for seasonal and pandemic influenza, including H1N1, H3N2, and influenza B lineages. Vaxart has completed Phase 1 and Phase 2 challenge trials for its H1N1 vaccine candidate, supported by a BARDA contract. The program also includes preclinical work on avian influenza strains such as H5N1 clade 2.3.4.4b. The company is evaluating both single-tablet and multi-tablet formulations to enhance flexibility in strain matching and distribution.
• HPV Therapeutic Vaccine Program: This segment targets the development of a bivalent therapeutic vaccine against HPV-16 and HPV-18, the strains responsible for approximately 70% of cervical cancer cases. Vaxart is designing the vaccine to target the E6 and E7 oncoproteins of HPV to induce T cell responses and reduce cervical dysplasia. Preclinical studies have demonstrated immunogenicity and tumor growth suppression in mouse models. The company plans to initiate clinical trials in subjects with HPV-related cervical dysplasia upon regulatory clearance.

Vaxart operates in a highly competitive biotechnology and vaccine industry, facing competition from large pharmaceutical companies such as Pfizer-BioNTech, Moderna, Merck, GSK, Sanofi, and AstraZeneca, which dominate markets for influenza, COVID-19, and HPV vaccines. The company differentiates itself through its oral tablet delivery platform, which aims to elicit mucosal immunity—a feature not commonly emphasized in injectable vaccines. Its proprietary VAAST technology, use of the well-characterized Ad5 vector, and focus on T cell and IgA responses provide potential advantages in durability, safety, and ease of administration. Additionally, Vaxart’s intellectual property portfolio, including patents on its platform and vaccine formulations, supports its competitive positioning.

Vaxart serves patients and healthcare systems seeking vaccines for norovirus, influenza, COVID-19, and HPV-related conditions. Its norovirus vaccine candidates are intended for use in adults, children aged eight and older, breastfeeding mothers, and infants through passive immunity transfer. The influenza vaccine targets healthy adults and at-risk populations such as the elderly and young children. The COVID-19 vaccine candidate is being developed for previously immunized adults seeking booster protection. The HPV therapeutic vaccine aims to assist individuals with cervical dysplasia or cancer caused by high-risk HPV strains. While specific customer names are not disclosed, the company engages with government agencies like BARDA and nonprofit organizations such as the Bill & Melinda Gates Foundation as funding and collaboration partners.