Business
Veru Reports Fiscal 2023 Third Quarter Financial Results
Company receives further regulatory clarity from FDA on Phase 3 ENABLAR-2 study. Potential for enobosarm +/- abemaciclib accelerated approval pathway in
About this update from Veru Inc.
[{"type":"text","content":"Company receives further regulatory clarity from FDA on Phase 3 ENABLAR-2 study. Potential for enobosarm +/- abemaciclib accelerated approval pathway in metastatic breast cancer, if successful based on new FDA Guidance Company plans to expand sabizabulin Phase 3 confirmatory study to include all types of viral induced lung infections (influenza, RSV and COVID-19) in hospitalized patients requiring supplemental oxygen who are at risk for ARDS Company reported positive separate preclinical data for sabizabulin against both influenza and against poxvirus; FDA preIND meeting for sabizabulin against poxvirus set for August 2023 Company-owned telehealth digital platform making good progress; FC2 prescriptions growing ENTADFI® product sold for $20 million, plus up to an additional potential $80 million from sales milestones Company’s cash burn during this quarter was $7.3 million - a $16.1 million reduction compared to the prior quarter Company to host conference call and webcast today at 8:00 a.m. ET MIAMI, FL, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for metastatic breast cancer and for viral induced acute respiratory distress syndrome (ARDS), today announced financial results for its fiscal 2023 third quarter and provided a business update. “This quarter was marked by important Company efforts to seek additional regulatory clarity from FDA regarding our two lead development programs, enobosarm and sabizabulin and to secure funding sources,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “We recently received further FDA regulatory clarity on the first stage of the Phase 3 ENABLAR-2 clinical trial design in order to add enobosarm alone as well as enobosarm in combination with abemaciclib as a 2nd line treatment for metastatic breast cancer with objective tumor response rates (ORR) as the primary endpoint. If ORR improvement is significant, we plan to pursue the accelerated approval pathway. As for sabizabulin, although there is a new summer and expected fall/winter COVID-19 surge, we believe that sabizabulin, as a broad antiviral and anti-inflammatory agent, may address viral lung infections and ARDS caused by other common viruses as well. Accordingly, we plan to discuss with FDA expanding t...