On February 12, 2020 Veru Inc. (NASDAQ: VERU), The Prostate Cancer Company, an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, reported that net revenues increased 66% and gross profit rose 57% for its fiscal 2020 first quarter ended December 31, 2019 (Press release, Veru, FEB 12, 2020, View Source [SID1234554217]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

First-Quarter Financial Highlights: Fiscal 2020 vs Fiscal 2019

Net revenues increased 66% to $10.6 million from $6.4 million;

Gross profit increased 57% to $7.3 million from $4.6 million;

FC2 US prescription net revenues increased 148% to $6.1 million from $2.4 million;

Operating loss was $1.8 million; and

Net loss was $3.3 million, or $0.05 per share.

"Our robust fiscal 2020 first quarter net revenues and gross profit were driven primarily by the 148% growth in prescription sales of FC2," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "Both our top line and gross profit for the period exceeded last year’s first quarter, as well as the preceding quarter. Increased public sector sales of FC2 and growing demand for our PREBOOST/Roman Swipes product were also key contributors to our positive momentum. We continue to generate significant cash to invest in the clinical development of our prostate and oncology drug pipeline. We are off to a great start for fiscal 2020.

"On the clinical development front, we are on target to complete before the end of our current quarter, the Phase 1b portion and to initiate the Phase 2 portion of the clinical trial for VERU-111, our proprietary prostate cancer product. VERU-111, an oral, next generation, first-in-class, selective antitubulin, has demonstrated preliminary antitumor activity in men with metastatic castration resistant prostate cancer and appears to be well tolerated with no evidence of treatment induced 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 39 patients from 4.5 mg per day up to 81

mg per day. The study protocol called for continuing to enroll patients until a maximum tolerated dose was reached, or some safety side effect that indicates that higher doses may not be well tolerated, was observed. There have been reported side effects consistent with VERU-111’s and other antitubulins’ cytotoxic effects, such as mostly mild to moderate diarrhea, nausea, and vomiting, which appear to be dose dependent.

"Although this study was designed for determination of safety, we do see evidence of preliminary 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 3.7 months. In our Phase 1b/2 trial, 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 11.75, 10.4, 10.4 and 7.6 months. All these men have prostate-specific antigen (PSA) reductions. We have another 6 men that progressed at 4.2 months. The patient who has reached 11.75 months had a PSA reduction of -63% and has had cancerous lymph nodes shrink as measured by CT scan and confirmed by a second CT scan. We also have another patient who at the time of enrollment had progressing prostate cancer bone metastases, show improvements of these bone metastases based on a bone scan following treatment with VERU-111. There is also evidence that these anticancer effects appear to have a dose response—meaning higher doses at 3-week cycles have more activity.

"Last month, we announced positive top line data from our Phase 2 clinical study of Zuclomiphene citrate, a nonsteroidal oral estrogen receptor agonist, for the treatment of androgen deprivation hormone therapy (ADT) induced hot flashes in men who have advanced prostate cancer. The interim results at Day 42 indicate that Zuclomiphene has clinically meaningful activity against moderate to severe hot flashes and appears to be well tolerated with no reports of estrogen related side effects like breast tenderness or enlargement or venothromboembolic events. We plan to meet with the FDA to review the development plan and based on that discussion, we anticipate initiation of the pivotal Phase 3 clinical trial to evaluate Zuclomiphene for the treatment of ADT-induced moderate to severe hot flashes in men with prostate cancer by early summer.

"Our plan is also to submit by the end of next quarter an Investigational New Drug (IND) application for VERU-100, our long-acting 3-month, small volume, subcutaneous depot gonadotropin-releasing hormone (GnRH) antagonist for the treatment of hormone sensitive advanced prostate cancer.

"TADFIN (Tadalafil and Finasteride Combination Capsule), which is being developed for benign prostatic hyperplasia (BPH) and would be the first combination of a PDE5 inhibitor and 5 alpha reductase inhibitor, is collecting 12-month stability data on manufacturing batches. The Company will submit an NDA for TADFIN which is expected in the second half of 2020. Our plan is to launch this product in the U.S. via telemedicine.

"Finally, two of our scientific abstracts have been accepted for presentation at the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) 2020 Genitourinary Cancers Symposium and are to be presented this weekend. The first presentation will provide proof of concept preclinical data on VERU-100 as a long acting GnRH antagonist subcutaneous depot. The second presentation is a survey of the impact of hot flashes on a contemporary cohort of men with advanced prostate cancer on ADT. This is the patient population that Zuclomiphene is being developed for to address this unmet medical need."

Event Details

Veru Inc. will host a conference call today at 8 a.m. ET to review the Company’s performance. Interested investors may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call. The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register,

download and install any necessary software. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10138979, for one week.