Business
Veru Reports Fiscal 2019 Full-Year Net Revenues Doubled, Gross Profit Up 147%
--Update on Ongoing Phase 1b/2 VERU-111, Oral Selective Antitubulin, Clinical Trial Demonstrates Antitumor Activity and No Dose Related Toxicity Reached in
About this update from Veru Inc.
[{"type":"text","content":"--Update on Ongoing Phase 1b/2 VERU-111, Oral Selective Antitubulin, Clinical Trial Demonstrates Antitumor Activity and No Dose Related Toxicity Reached in Men with Metastatic Castration Resistant Prostate Cancer--\n --VERU-111 Has Promising Signs of Progression Free Survival-- --Advancing VERU-111 into Three Phase 2 Clinical Studies in Additional Cancer Types-- --Company to Host Investor Conference Call Today at 8 a.m. ET to Discuss Financial Results and Clinical Study Data-- MIAMI, Dec. 12, 2019 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), The Prostate Cancer Company, an oncology and urology biopharmaceutical company developing novel medicines for the management of prostate cancer, today announced that its fiscal 2019 full-year net revenues doubled to $31.8 million and gross profit increased 147% to $21.7 million. “For both the fiscal 2019 fourth quarter and full year, we continue to generate impressive increases to net revenues and gross profit compared with the prior year,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “The robust ramp up of prescription as well as global public sector sales of FC2® and increased consumer demand for our PREBOOST®/Roman® Swipes product drove the significantly improved financial performance.” “I would like to highlight on the clinical development front, VERU-111 -- our proprietary, oral, next generation, first-in-class, selective antitubulin – as it continues to show antitumor activity and no dose related toxicity in men with metastatic castration resistant prostate cancer. VERU-111 appears to be well tolerated with no evidence of neutropenia, neurotoxicity, or allergic (hypersensitivity) reactions that typically occur with IV taxane chemotherapy. To date, our Phase 1b/2 clinical study has enrolled and dosed 33 patients from 4.5 mg per day up to 81 mg per day. The study will continue to enroll patients using increasing doses of VERU-111 until maximum tolerated dose is observed.\" “Although this study was designed for determination of safety, we do see evidence of significant antitumor activity. Historical controls from the literature report that the time to imaging based tumor progression in men like those enrolled in our study averages about 2-3 months. In our Phase 1b/2, we have 20 men in the study that had the potential to be treated for 4.5 months. ...