Veru Receives FDA Agreement to Advance VERU-111 into Phase 3 Study in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS) - Seite 2

We 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.

About the Phase 2 COVID-19 Clinical Trial:

Veru conducted a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 18mg versus placebo in approximately 40 hospitalized COVID-19 patients who were at high risk for ARDS. The trial was conducted in five sites across the United States. Patients hospitalized with documented evidence of COVID-19 infection and at high risk for ARDS were enrolled. Subjects received an 18mg dose of VERU-111 or placebo, as well as standard of care for 21 days or until released from hospital. The primary efficacy endpoint was the proportion of patients alive without respiratory failure at Day 29.

Clinical Efficacy and Safety Results:

For the primary endpoint in a modified intent-to-treat (MITT) population, VERU-111 treatment compared to placebo had a statistically significant and clinically meaningful reduction in the proportion of patients who are treatment failures (dead or alive with respiratory failure) with a 30% treatment failure rate in the placebo group (n=20) compared to 5.6% in the VERU-111 treated group (n=18) at Day 29. This represents an 81% relative reduction in the VERU-111 treatment failures and showed statistical significance with p=0.05.