finance.yahoo.com
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 Men with Metastatic Castration Resistant Prostate Cancer--
--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 NE …..VERU Inc
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.
<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)--sm Mt(0.8em)--sm" style="color: rgb(38, 40, 42); font-family: Helvetica Neue,Helvetica,Arial,sans-serif; font-size: 15px; font-style: normal; font-variant: normal; font-weight: 400; letter-spacing: normal; margin-bottom: 1em; margin-left: 0px; margin-right: 0px; margin-top: 0px; orphans: 2; text-align: left; text-decoration: none; text-indent: 0px; text-transform: none; -webkit-text-stroke-width: 0px; white-space: normal; word-spacing: 0px;" type="text" content="“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.”" data-reactid="14">“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. Even without having an optimal dose or dose schedule yet determined, there are 4 men who are still ongoing in the trial with no progression at 9.75, 8.4, 8.4 and 5.6 months. All of these men have prostate-specific antigen (PSA) reductions. We have another 6 men that progressed at 4.2 months. The patient who has reached 9.75 months had a PSA reduction of -63% and has had 2 of his cancerous lymph nodes shrink as measured by CT scan. Another patient in the study with stable disease stopped losing weight, reported that his fatigue resolved, and had a PSA reduction.”
“Based on reports in the scientific literature, it appears that just like cabazitaxel, VERU-111 is a very active compound in metastatic castration resistant prostate cancer, and it seems to perform better than adding another androgen blocking agent in a similar patient population. VERU-111 appears to be well tolerated with a wide safety margin. Wide safety margin means that we are seeing anticancer activity at doses where we are not seeing drug toxicity. We plan to present full clinical results for this ongoing Phase 1b/2 at a future major scientific meeting."
Dr. Steiner added: “Since VERU-111 has signs of antitumor activity and an acceptable safety profile, we plan to expand and initiate in early 2020 three additional Phase 2 studies where we had demonstrated significant preclinical anticancer activity: metastatic pancreatic cancer, metastatic breast cancer and postchemotherapy (taxane) metastatic castration resistant prostate cancer. This clearly positions Veru as an oncology company with a novel oral agent that selectively targets alpha and beta subunits of tubulin.”
“We also plan to submit the Investigation New Drug (IND) application for VERU-100 – our long-acting 3-month subcutaneous depot gonadotropin-releasing hormone (GnRH) antagonist for the treatment of hormone sensitive advanced prostate cancer – in early 2020. Regarding our Phase 2 clinical trial of zuclomiphene citrate, our proprietary drug to treat hot flashes caused by androgen deprivation therapy in men with advanced prostate cancer, we expect top line clinical data by no later than next month.”
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