Veru Reports Positive Phase 2 Clinical Results of VERU-111 in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

              – Potential for two-pronged action against COVID-19 as an antiviral and anti-inflammatory agent supported by Phase 2 clinical study results –

– Primary efficacy endpoint in hospitalized patients shows VERU-111 treatment had statistically significant 81% relative reduction in death or respiratory failure at Day 29 –

– Statistically significant 82% relative reduction in patient mortality versus placebo–

– Statistically significant reduction in days in ICU; there was also a decrease in days on mechanical ventilation–

– Oral daily dosing well tolerated with no treatment-related adverse events –

– Granted expedited meeting with FDA to discuss Phase 3 trial design and meeting with BARDA to discuss potential funding; Phase 3 clinical study expected to begin in April 2021 with clinical results expected in calendar Q4 2021 –

– Company to host an investor conference call at 9:00 am ET today to discuss results and next steps –

MIAMI, Feb. 08, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, today announced positive efficacy and safety results from a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 versus placebo in approximately 40 hospitalized patients at high risk for Acute Respiratory Distress Syndrome (ARDS) from SARS-CoV-2.

“We are very pleased with the results of our Phase 2 trial, which demonstrated clinically meaningful reductions in relevant endpoints, including respiratory failure, days in the ICU and on mechanical ventilation and patient mortality. We believe VERU-111 has significant potential in treating COVID-19, both as a broad-spectrum antiviral and an anti-inflammatory agent, helping to prevent the effects that lead to ARDS and death,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “Due to the urgency of the global pandemic and need for more effective treatment options for patients, we are duty-bound to pursue this indication, even though it has not been the primary focus of Veru. We have the resources to conduct a Phase 3 trial without impacting our cancer drugs’ clinical development. We look forward to our upcoming discussion with FDA concerning the regulatory and clinical development steps to move VERU-111 for COVID-19 forward.”