Oragenics, Inc. announced that the Company has entered into an exclusive global license agreement with Inspirevax Inc. for its novel intranasal mucosal adjuvant, BDX301, for the development of NT-CoV2-1, Oragenics' lead intranasal COVID-19 vaccine candidate. Under the exclusive licensing agreement, Oragenics will pursue the development of NT-CoV2-1 with Inspirevax's novel BDX301 intranasal mucosal adjuvant. The companies will form a Joint Development Committee (JDC) comprising representatives of both companies to oversee the development efforts collaboratively.

Oragenics will make clinical, regulatory and commercial milestone payments, as well as tiered royalty payments. Additionally, the agreement provides a certain period of time for the companies to expand their collaboration to pursue the development of additional intranasal vaccine candidates using Inspirevax's adjuvants. In December 2022, Oragenics reported results indicating no toxicity signals or adverse events from its Good Laboratory Practices toxicology study in rabbits evaluating the safety and immunogenicity of NT-CoV2-1 plus BDX301, including a full histopathology evaluation.

Oragenics believes these findings confirm a safety and immunogenicity profile that supports its plan to advance the program further toward clinical study. NT-CoV2-1 vaccine candidate demonstrated a robust antigen-specific IgG and IgA titers in preclinical models and a reduction in viral load is made possible by two complementary technologies, the spike protein licensed from the National Institutes of Health and Inspirevax's intranasal mucosal adjuvant, BDX301. This enables several potential benefits compared with injectable vaccines, including targeting mucosal immunity, reducing transmission, and offering a needle-free alternative for patients.