The Directors advised that Biotron Limited has received guidance from the U.S. Food and Drug Administrations or development of its lead antiviral drug BIT225 as a potential treatment of Coronavirus Disease 2019 (COVID-19) infection in adults. The FDA's guidance was received in written response to Biotron's pre-IND briefing package and request in March 2022, which included an overview of preclinical and (HIV) clinical development, and specific questions relating to regulatory requirements for progression to filing an investigational new drug (`IND') application for the COVID-19 indication. Biotron sought guidance on the design of a proposed Phase 2 clinical trial in recently diagnosed COVID-19 infected individuals and assurance that the preclinical data package and manufacturing processes were sufficient to support this next stage of clinical development.

The FDA response gives clear indication of the Agency's interest in this novel drug target that combines direct antiviral effect and beneficial immunomodulatory activities. Recent animal studies conducted at the Scripps Institute in San Diego have demonstrated that the drug is protective of disease progression and the cytokine storm that is linked to development of severe respiratory disease. BIT225 rapidly reduced viral loads in the lungs of infected animals treated before or following SARS-CoV-2 infection.

With this guidance and acceptable trial design in hand, the Company will now determine its capital requirements for the COVID-19 clinical program and seek funding from potential partners and non-equity funding sources.