Veru Inc. announced that the FDA agreed in an End of Phase 2 meeting, to advance VERU-111 into a Phase 3 registration clinical study based on the clinically meaningful benefits observed with VERU-111 treatment in the recently completed double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 versus placebo in approximately 40 hospitalized COVID-19 patients at high risk for ARDS. The Phase 2 trial demonstrated clinically meaningful reductions in relevant endpoints, including respiratory failure, patient mortality, days in the ICU and days on mechanical ventilation. VERU-111 has the potential for two-pronged action against COVID-19 as an antiviral and an anti-inflammatory agent which is supported by positive Phase 2 clinical study results. The company have met with and will seek funding from The Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services (BARDA) as well as other agencies to fund the estimated amount of commercial drug to supply the needs of the US population, assuming confirmatory positive Phase 3 clinical results and FDA approval. Phase 3 Clinical Trial Design: With a similar trial design to the completed positive Phase 2 study, the Phase 3 clinical registration trial design will evaluate daily oral doses of VERU-111 versus placebo with the primary efficacy endpoint of proportion of patients alive at Day 29. It is expected that the Phase 3 clinical trial will be conducted in approximately 400 hospitalized patients who have SARS-CoV-2 virus infection and are at high risk for ARDS at a 2:1 ratio between the VERU-111 (approximately 267 patients) and placebo (approximately 133 patients) treated groups. The Company has enough clinical drug supply on hand to complete the Phase 3 clinical study. The Phase 3 clinical trial is expected to commence in April 2021 and clinical results are expected by the fourth quarter of calendar year 2021.