On Jul. 13, 2020, Innovation Pharma announced that, in parallel to previously reported manufacturing efforts, the Company had drafted a study protocol toward initiating a planned Phase 2 trial of Brilacidin for COVID-19. This proposed study has two active treatment arms evaluating different IV dosing regimens in hospitalized patients with COVID-19. The exigencies of the pandemic coupled with Brilacidin’s multiple therapeutic properties – its anti-viral SARS-CoV-2 activity, its anti-inflammatory potential to abate the COVID-19 associated cytokine storm, as well as its proven anti-bacterial properties – have the Company working vigilantly to advance Brilacidin into human trials against COVID-19 during fourth-quarter 2020.

As previously released, manufacturing steps are now underway to prepare Brilacidin for COVID-19 clinical trial use, including the sourcing of materials and making of sterile IV drug product. In parallel to these manufacturing efforts, the Company has drafted a study protocol toward initiating a planned Phase 2 trial of Brilacidin for COVID-19. This proposed study has two active treatment arms evaluating different IV dosing regimens in hospitalized patients with COVID-19. The ongoing in vitro testing at independent laboratories of Brilacidin against SARS-CoV-2, in which Brilacidin has shown consistently robust results in human and animal cell lines, is helping to inform trial design.

Given the continuing coronavirus pandemic, and especially in light of surging cases in the United States, the Company is looking to start a clinical trial with Brilacidin for COVID-19 treatment in Q4 2020. This forecast assumes manufacturing is completed, per the manufacturer’s timeline, and a successful Investigational New Drug (IND) application with the Food and Drug Administration.