Veru Reports Fiscal 2022 Fourth Quarter and Full Year Financial Results
U.S. FDA reviewing EUA application for sabizabulin to treat hospitalized COVID-19 patients at high risk for ARDS
European Medicines Agency’s (EMA) Emergency Task Force reviewing sabizabulin for emergency use in EU member states
Sabizabulin also under review for potential emergency authorization by MHRA (UK), TGA (Australia), and Health Canada
Veru preparing for U.S. and international commercialization and distribution of sabizabulin, and manufacturing capacity for drug supply in place
Company to host conference call and webcast today at 8:00 a.m. ET
MIAMI, FL, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced financial results for its fiscal 2022 fourth quarter and full year ended September 30, 2022 and provided a business update.
“This has been a transformational year for Veru. We reported positive Phase 3 results demonstrating that sabizabulin treatment resulted in a statistically and clinically significant reduction in death in hospitalized moderate to severe COVID-19 patients at high risk for ARDS and death, which was published in the NEJM Evidence®,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “As sabizabulin is being reviewed in the U.S. and internationally for potential emergency use authorization, we are preparing for commercialization and will be ready to deliver this treatment to patients, if authorized.”
Dr. Steiner added, “While FC2 revenue decreased this past year due to business challenges experienced by our largest telemedicine customers, we are working diligently to regenerate FC2 product sales, and our recently launched telemedicine platform has shown steady market uptake to date.”
Infectious Disease Program Highlights
In October 2022, the Company presented data from the Phase 3 trial of sabizabulin in a late-breaker oral presentation at IDWeek (Infectious Disease Week) 2022.
In August 2022, Australia’s Therapeutic Goods Administration (TGA) granted the Company an expedited provisional registration regulatory pathway for sabizabulin treatment in hospitalized COVID-19 patients at high risk for ARDS.
In August 2022, the Company presented the Phase 3 trial results of sabizabulin at the 11th International Conference on Emerging Infectious Diseases (ICEID).
In July 2022, European Medicines Agency’s (EMA) Emergency Task Force (ETF) initiated the review of sabizabulin for emergency use in the EU member states.
In July 2022, United Kingdom’s (UK’s) Medicines and Healthcare Products Regulatory Agency (MHRA) supported an expedited review of the marketing authorization application for sabizabulin treatment in hospitalized COVID-19 patients at high risk for ARDS.
On July 6, 2022, The New England Journal of Medicine Evidence® published results from the Phase 3 trial evaluating the efficacy and safety of oral sabizabulin in hospitalized COVID-19 patients.
Breast Cancer Program Highlights
We are enrolling patients in the Phase 3 multicenter, international, open label, randomized (1:1) ARTEST registrational trial to evaluate enobosarm versus either exemestane ± everolimus or a selective estrogen receptor modulator (SERM) as the active comparator for the treatment of AR+ER+HER2- metastatic breast cancer in approximately 210 patients with sufficient AR expression in their breast cancer tissue who had previously received a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6 inhibitor. In January 2022, the FDA granted Fast Track designation to the ARTEST Phase 3 registrational program.
Enobosarm and Abemaciclib, CDK 4/6 Inhibitor, Combination Therapy for the 2nd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer with sufficient AR Expression
We are enrolling patients in the Phase 3 multicenter, open label, randomized (1:1), active control ENABLAR-2 trial to evaluate enobosarm and abemaciclib combination versus an alternative estrogen blocking agent (fulvestrant or an aromatase inhibitor) in subjects with AR+ER+HER2- metastatic breast cancer who have failed first line palbociclib (a CDK 4/6 inhibitor) plus an estrogen blocking agent (non-steroidal aromatase inhibitor or fulvestrant) and who have sufficient AR expression in their breast cancer tissue in approximately 186 subjects. We have a collaboration and supply agreement with Eli Lilly for this trial.
Sabizabulin for the 3rd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer with sufficient AR Expression
We intend to conduct a Phase 2b open label, multicenter, randomized (1:1) trial evaluating sabizabulin 32mg versus active comparator (exemestane ± everolimus or a SERM, physician’s choice) for the treatment of AR+ER+HER2- metastatic breast cancer in approximately 200 patients with sufficient AR expression in their breast cancer tissue who have previously received a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6 inhibitor.
Prostate Cancer Program Highlights
We are enrolling patients in the Phase 3 VERACITY open label, randomized (2:1), multicenter trial evaluating sabizabulin 32mg versus an alternative androgen receptor targeting agent for the treatment of chemotherapy naïve men with metastatic castration resistant prostate cancer who have tumor progression after previously receiving at least one androgen receptor targeting agent. The primary endpoint is radiographic progression free survival in approximately 245 patients.
VERU-100, a Novel Proprietary Long-Acting Gonadotropin-Releasing Hormone (GnRH) Antagonist Peptide 3-Month Subcutaneous Depot Formulation, for Androgen Deprivation Therapy of Advanced Prostate Cancer
We are enrolling patients in the Phase 2 clinical dose finding trial of VERU-100 for androgen deprivation therapy of advanced prostate cancer. The trial design for a future Phase 3 registrational trial of approximately 100 patients has been agreed upon by the FDA.
Urev - Sexual Health Program Highlights
The Company recently initiated the U.S. commercial launch and availability of ENTADFI™– an FDA-approved oral, once daily product for benign prostatic hyperplasia (BPH) that is approved for men with an enlarged prostate that are experiencing the signs and symptoms of BPH for up to 26 weeks.
FC2 Female Condom/Internal Condom®
The Company markets and sells the FC2 Female Condom®, an FDA-approved product for dual protection against unplanned pregnancy and the transmission of sexually transmitted infections.
Full Year Financial Summary: Fiscal 2022 vs Fiscal 2021
Balance Sheet Information
About Veru Inc.
Infectious disease program:
The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin, an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and antiviral properties, in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.
A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in 204 hospitalized moderate to severe COVID-19 patients at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously halted the study for clear clinical efficacy and no safety concerns were identified. Treatment with sabizabulin 9 mg once daily resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths compared to placebo.
The Company’s late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin.
Current studies on the two drugs include:
Veru’s late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.
Current studies on these drugs include:
Commercial sexual health program, Urev, has 2 FDA approved products:
Verzenio® is a registered trademark of Eli Lilly and Company
NEJM Evidence® is a registered trademark of the Massachusetts Medical Society
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