Vaxart (VXRT) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Platform innovation and advantages

• Oral pill vaccine platform generates both systemic and mucosal immunity, offering advantages over injectables such as ease of administration, thermostability, and elimination of injection site reactions and medical waste.

• The platform uses an Ad5 vector with antigen and molecular adjuvant to stimulate immune response in the gut, aiming for broad protection, especially for pathogens entering through mucosal surfaces.

• Second-generation (Gen 2) constructs are more stable, easier to produce, more immunogenic, and improve cost efficiency and vaccine response.

• Oral pill vaccines induce both systemic IgG and mucosal IgA responses, offering broader cross-reactivity and variant coverage compared to injectable vaccines.

• Manufacturing operations are fully based in the United States.

Clinical pipeline and milestones

• COVID-19 oral vaccine is in phase IIb with 5,400 subjects; topline safety data from a 400-person cohort is expected soon, and efficacy data from the main cohort is anticipated by year-end or in Q4 2026.

• Norovirus vaccine program has shown significant improvements in immunogenicity with Gen 2 constructs and is preparing for a phase IIb study, with phase III potentially involving 10,000–25,000 subjects pending FDA feedback and partnership.

• Influenza vaccine demonstrated statistically significant efficacy in previous studies and promising preclinical results, with Gen 2 constructs expected to enhance performance and strong survival benefit in animal models for H5N1.

• HPV therapeutic vaccine is in preclinical development, showing tumor reduction in animal models.

• BARDA-funded COVID-19 study provides head-to-head efficacy and safety data versus FDA-approved mRNA vaccines.

Strategic partnerships and business development

• Partnership with Dynavax (now part of Sanofi) brought $30 million upfront, potential $50 million milestone at end of phase II, and up to $670 million in milestone-based payments and tiered royalties, contingent on successful Phase 2b results and program advancement.

• Due diligence by Dynavax included validation of science, clinical design, manufacturing, and IP, leading to the partnership and subsequent acquisition by Sanofi.

• Ongoing discussions for norovirus partnerships are influenced by competitor progress, particularly Moderna, and strategic decisions are being evaluated regarding further investment or partnership.

• Cash runway extended into Q2 2027, supported by Dynavax partnership and milestone payments.