Shots:

• The US FDA agreed to advance VERU-111 into a P-III study which will evaluate VERU-111 vs PBO in ~400 hospitalized patients in a ratio (2:1) with COVID-19 and are at high risk for ARDS. The study is anticipated to begin in Apr’2021 with clinical results expected in Q4’21
• The P-II trial has demonstrated clinically meaningful reductions in relevant endpoints- including respiratory failure- patient mortality- days in the ICU and mechanical ventilation and was well tolerated with a good safety profile
• The company will seek funding from BARDA to fund the estimated amount of commercial drug to supply the needs of the US population

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