On Apr. 11, 2022, Veru announced positive efficacy and safety results from a planned interim analysis of the double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial evaluating oral sabizabulin 9 mg versus placebo in 150 hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome. The Independent Data Safety Monitoring Committee unanimously recommended that the Phase 3 study be halted early due to efficacy, and they further remarked that no safety concerns were identified.

The Phase 3 COVID-19 study is a double-blind, randomized, placebo-controlled Phase 3 clinical trial evaluating oral, once-a-day dosing of sabizabulin 9 mg versus placebo in approximately 210 hospitalized moderate to severe COVID-19 patients (≥WHO 4) who were at high risk for ARDS and death. Patients were randomized in a 2:1 ratio to the sabizabulin treatment group versus placebo. Patients in both treatment groups were allowed to receive standard of care including remdesivir, dexam

The prespecified primary endpoint was death at or before day 60. Sabizabulin treatment resulted in a clinically and statistically meaningful 55% relative reduction in deaths (p=0.0029) in the intent to treat population. Placebo group (n=52) had a 45% mortality rate compared to the sabizabulin-treated group (n=98) which had a 20% mortality rate. The secondary efficacy endpoints are still being analyzed at the time of this release.

Sabizabulin treatment was well tolerated in this patient population with no clinically relevant safety observations in the sabizabulin treated group compared to placebo. The Company plans to meet with FDA to discuss next steps including the submission of an emergency use authorization application. As previously disclosed, the FDA granted Fast Track designation to the sabizabulin COVID-19 clinical program in January 2022, which the Company hopes will help streamline the emergency use authorization process.

The Company has scaled up manufacturing processes to produce commercial drug supply to address anticipated drug needs following potential FDA authorization. The Company has been in discussions with BARDA and other US government agencies in an effort to secure an advance purchasing agreement of drug product for the U.S.