On August 14, 2018 Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company, reported its financial results for the fiscal 2018 third quarter ended June 30, 2018 (Press release, Veru, AUG 14, 2018, View Source [SID1234529157]).

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!

"We have made strong progress in this quarter advancing our pipeline of proprietary prostate cancer product candidates and suite of urology specialty pharmaceuticals," commented Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer. "We look forward to enrolling the first patient in the Phase 2 trial of zuclomiphene (aka cis-clomiphene) to treat hot flashes caused by prostate cancer hormone therapy during the fiscal fourth quarter of 2018. Within this calendar year, we expect to conduct the bioequivalence studies for new formulation product candidates tamsulosin DRS granules and XR capsules, as well as tadalafil-finasteride combination tablets. Our product candidates address unmet medical needs in prostate cancer, prostate cancer supportive care, and urology which are multibillion dollar markets."

"With regard to our financial results: net revenues, which are primarily derived from product sales of FC2 Female Condoms, increased 28% in the third quarter of fiscal 2018 over the comparable prior year period and more than doubled from the preceding quarter. We are expecting the South African government to announce soon the results of the tender award for 40 million female condoms per year — a total of 120 million units over the full three-year tender time period — and we are confident that we will receive a substantial portion of the award."

Summary of Accomplishments During FY Q3

In June 2018, the Company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for a Phase 2 clinical study of zuclomiphene for the treatment of hot flashes in men with advanced prostate cancer who are receiving hormone therapy, which has been accepted. Also in June, the U.S. Patent and Trademark Office issued Patent No. 9,913,815, which provides protection until 2035 for the use of zuclomiphene in men with prostate cancer as a method of treating and preventing side effects caused by androgen deprivation therapy (ADT), including hot flashes, loss of bone mineral density and bone fractures.

In May 2018, preclinical results for VERU-111, a novel oral alpha and beta tubulin inhibitor with potential for development in the treatment of prostate and other cancer types, were featured in a moderated poster session at the 2018 American Urological Association Annual Meeting. In June 2018, preclinical results showing the efficacy of VERU-111 in four different cancer models (novel androgen blocking agent resistant human prostate cancer, a paclitaxel sensitive and resistant triple negative breast cancer, as well as ovarian cancer and pancreatic cancer) were presented as part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Fiscal Third Quarter Results: 2018 vs. 2017

For the third quarter of fiscal 2018, net revenues increased to $5.5 million from $4.3 million for the third quarter of fiscal 2017. Gross profit rose to $3.1 million, or 56% of net revenues, from $2.3 million, or 53% of net revenues, for the third quarter of fiscal 2017. Operating expenses were $8.0 million compared with $3.6 million. Net loss was $7.9 million, or $0.15 per share, compared with $0.8 million, or $0.03 per share, for the third quarter of fiscal 2017.

Significant quarter-to-quarter variations in the Company’s results have historically resulted from the timing and shipment of large orders rather than from any fundamental changes in the business or the underlying demand for female condoms.

Conference Call Event Details

Veru Inc. will host a conference call on Tuesday, Aug. 14, 2018, at 8 a.m. Eastern Time 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.

In addition, investors may access a replay of the conference call the same day beginning at approximately noon ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10122133. The replay will be available for one week, after which the recording will be available via the Company’s website at View Source