On May 4, 2023, Veru Inc. announced that in an April 27, 2023 meeting, the company and FDA reached agreement on the design of the Phase 3 confirmatory COVID-19 clinical trial to evaluate sabizabulin treatment in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome (ARDS) and the path forward to submit a new Emergency Use Authorization (EUA) application and/or New Drug Application (NDA). Based on the FDA's positive feedback on the confirmatory Phase 3 clinical study design and program, the Company anticipates initiating the clinical study in the second half of 2023. Highlights from the April 27th FDA meeting: FDA agreed to a confirmatory Phase 3, randomized (1:1), multicenter, global, efficacy and safety study of sabizabulin 9mg oral daily dose plus standard of care treatment versus placebo plus standard of care treatment in 408 hospitalized adult patients with moderate to severe SARS-CoV-2 infection who are at high risk for ARDS: Indication (patient population) for sabizabulin has been expanded to include all hospitalized moderate to severe COVID-19 patients: WHO-4 (passive, low flow oxygen), WHO-5 (forced, high flow oxygen), or WHO-6 (mechanical ventilation) without a requirement to have a comorbidity.

Endpoints: Primary efficacy endpoint is all-cause mortality at Day 60; Secondary endpoints include Days in the hospital, Days in the ICU, Days on mechanical ventilation, and proportion of patients alive without respiratory failure; and Exploratory endpoint is the presence of long COVID-19 symptoms at Day 180. In order to get a potentially efficacious drug to patients in an efficient time frame, two interim efficacy analyses are planned: the first planned interim analysis is expected to occur when 50% of patients (204) have completed the Day 60 primary efficacy endpoint as recommended by FDA, and the second planned interim analysis is expected to occur when 71% of patients (290) have completed the Day 60 primary efficacy endpoint. If either planned interim efficacy analysis meets statistical significance criteria, the trial could be stopped.

Should the pre-specified primary efficacy endpoint analysis demonstrate a statistically significant effect on all-cause mortality favoring sabizabulin – the Company may consider a new request for an EUA and/or a submission of an NDA, as the Company would have two adequate and well controlled trials demonstrating efficacy. As the program has FDA Fast Track designation, a rolling NDA submission is a possibility for sabizabulin. The Phase 3 confirmatory COVID-19 clinical trial is expected to begin enrolling in the second half of 2023, and the first planned interim efficacy analysis is anticipated to be conducted in 2024.