Full Press Release Details
Investor and Media Contact:
Executive Director, Investor Relations and
Corporate Communications
Email: veruinvestor@verupharma.com
Veru Reports Second Quarter Fiscal 2022 Results and Progress of Sabizabulin for COVID-19 Toward a
Request for Emergency Use Authorization
FDA States that Veru Should Submit Request for Emergency Use Authorization (EUA)
Application Based on Positive Efficacy and Safety Data from the Phase 3 Clinical Study of Sabizabulin in Hospitalized COVID-19 Patients
IDMC Unanimously Votes to Halt the Ongoing Phase 3 Trial of Sabizabulin for Hospitalized
COVID-19 Patients at High Risk of ARDS Due to Overwhelming Efficacy and Safety with 55.2% Reduction in Death
EUA Application Submission for Sabizabulin COVID-19 Treatment Expected by Calendar Q2
Phase 3 ENABLAR-2 Clinical Trial of Enobosarm and Abemaciclib
Combination Therapy in Metastatic Breast Cancer is Enrolling
Company to Host Investor Conference Call Today at
MIAMI May 12, 2022 Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on
developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced financial results for its fiscal 2022 second quarter
ended March 31, 2022.
Second Quarter Financial Summary: Fiscal 2022 vs Fiscal 2021
Year-to-Date Financial Summary: Fiscal 2022 vs
Balance Sheet Information
Following a positive Phase 3 COVID-19 clinical study where
sabizabulin treatment resulted in a clear clinical benefit by significantly reducing deaths, we met with FDA for a Pre-EUA meeting on May 10, 2022. FDA agreed that our development program had sufficient
efficacy and safety data to support a request for EUA application. No additional efficacy or safety studies will be required, said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc. The Agency has been
incredibly responsive, and we look forward to submitting a request for Emergency Use Authorization application as soon as possible. The high mortality rates observed in hospitalized moderate to severe COVID-19
patients in the placebo group underscores that this remains a high unmet medical need. We look forward to updating you as we advance sabizabulin to these high-risk patients.
Dr. Steiner added: We continue to make great progress on our clinical programs for breast and prostate cancer. We now have 2 enrolling Phase 3
metastatic breast cancer clinical trials and one Phase 3 prostate cancer clinical trial. The Phase 3 COVID-19 clinical study is completed and met its primary endpoint. In our commercial business, we continue
to see an increase in FC2 prescriptions and plan to launch ENTADFI soon. We also expect to have significant near-term revenue from sabizabulin for the treatment of hospitalized COVID-19 patients at high risk
for ARDS, if EUA is granted by U.S. FDA.
Pharmaceutical Pipeline Highlights:
COVID-19 Program; Other Viral and ARDS-Related and Inflammatory-Related Diseases
Sabizabulin for the Treatment of Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome
(ARDS) Phase 3 COVID-19 Clinical Study Study Unanimously Halted by the Independent Data Monitoring Committee (IDMC) After a Planned Interim Analysis for Overwhelming Efficacy; Company Preparing an EUA
A randomized, double-blind, placebo-controlled global Phase 3 clinical trial was conducted in hospitalized patients with moderate to
severe COVID-19 infection who were at high risk for ARDS and death. Patients were randomly assigned to receive sabizabulin 9mg or placebo once oral daily for up to 21 days in a 2:1 ratio. The primary
endpoint was all-cause mortality up to day 60, and key secondary endpoints were days in intensive care unit (ICU), days on mechanical ventilation, and days in hospital.
A total of 204 patients underwent randomization (with 134 assigned to sabizabulin-treated group and 70 assigned to placebo-treated group). Both groups were
allowed to receive standard of care. Baseline characteristics were similar in the two groups. The superiority of sabizabulin was demonstrated at the planned interim analysis conducted in the first 150 patients randomized into the study with 98
patients receiving sabizabulin and 52 patients received placebo. The IDMC unanimously voted to halt the Phase 3 because of overwhelming efficacy. Sabizabulin treatment resulted in a clinically meaningful and statistically significant 55.2% relative
reduction in deaths compared to placebo in hospitalized patients with moderate to severe COVID-19 infection who were at high risk for ARDS and death with a lower incidence of adverse events and serious adverse
events compared to placebo.
FDA agreed that the Phase 3 COVID-19 study is sufficient to support
the efficacy portion of a request for EUA submission and for an NDA submission.
FDA also agreed that the current safety data available for sabizabulin is
sufficient to support the safety portion of a request for EUA submission. FDA informed the Company that additional safety data that would be collected during the use of sabizabulin under the EUA, if granted, will be sufficient to support an NDA
submission, and furthermore, that no additional safety clinical studies are required.
The Company plans to submit a request for an EUA application in
The Company has scaled up manufacturing processes and will be able to produce commercial drug supply to address anticipated drug needs
following potential FDA authorization and subsequent authorizations in the U.S. as well as other countries and regions.
The Company has initiated
discussions with government agencies to discuss government purchases of sabizabulin in the U.S. and other countries around the world.
Enobosarm, a Novel Oral Selective Androgen Receptor Targeting Agonist, for the 3rd
Line Treatment of AR+ ER+ HER2- Metastatic Breast Cancer with AR 40% Expression - Phase 3 ARTEST Clinical Study- Enrolling.
Enobosarm is an oral, new chemical entity, selective androgen receptor targeting agonist that activates the androgen receptor (AR), a tumor suppressor, in
AR+ER+HER2- metastatic breast cancer without causing unwanted masculinizing side effects. Enobosarm has extensive nonclinical and clinical experience having been evaluated in 25 separate clinical studies in approximately 1,450 subjects dosed,
including three Phase 2 clinical studies in advanced metastatic breast cancer involving more than 250 patients. In the two Phase 2 clinical studies conducted in women with AR+ER+HER2- metastatic breast cancer, enobosarm demonstrated significant
antitumor efficacy in heavily pretreated cohorts that previously failed estrogen receptor blocking agents, chemotherapy, and/or CDK 4/6 inhibitors and enobosarm was well tolerated with a favorable safety profile.
We are enrolling the Phase 3 multicenter, international, open label, and randomized (1:1) ARTEST registration clinical trial design to evaluate enobosarm
monotherapy versus physician s choice of 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 AR expression 40% 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
registration program, a distinction that underscores the urgent need for novel, targeted therapies for this important unmet medical need.
and Abemaciclib, CDK 4/6 Inhibitor, Combination Therapy for the 2nd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer with AR 40% Expression - Phase 3 ENABLAR-2 Clinical Study-Enrolling.
We are enrolling the Phase 3 multicenter, open label, randomized (1:1), active
control clinical study, named ENABLAR-2 to evaluate the treatment of the enobosarm and abemaciclib combination versus an alternative estrogen blocking agent (fulvestrant or an aromatase inhibitor) in subjects
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 an AR 40% expression in their breast cancer tissue in approximately 186 subjects. We have a clinical trial collaboration and supply agreement with Lilly for our Phase 3
Sabizabulin, Novel Oral Cytoskeleton Disruptor Agent, for the 3rd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer with AR< 40% Expression - Phase 2b Clinical Study.
We intend to conduct a Phase 2b clinical study which will be an open label, multicenter, and randomized (1:1) study evaluating sabizabulin 32mg monotherapy
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 AR <40% expression in their breast cancer tissue who have
previously received a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6 inhibitor.
Prostate Cancer Program
Sabizabulin for the Treatment of Metastatic Castration and Androgen Receptor Targeting Agent Resistant Prostate Cancer Phase 3 VERACITY Clinical
The Company is enrolling the open label, randomized (2:1), multicenter Phase 3 VERACITY clinical study evaluating sabizabulin 32mg
versus an alternative androgen receptor targeting agent for the treatment of chemotherapy na ve 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 from 45 clinical centers.
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 Phase 2 Clinical Study - Enrolling.
VERU-100 is designed to address
the current limitations of commercially available androgen deprivation therapy. Androgen deprivation therapy is currently the mainstay of advanced prostate cancer treatment and is used as a foundation of treatment throughout the course of the
disease even as other endocrine, chemotherapy, or radiation treatments are added or stopped. Specifically, VERU-100 is a chronic, long-acting GnRH antagonist peptide administered as a small volume, three-month
depot subcutaneous injection without a loading dose. VERU-100 immediately suppresses testosterone with no testosterone surge upon initial or repeated administration, a problem that occurs with currently
approved luteinizing hormone-releasing hormone agonists used for androgen deprivation therapy. There are no GnRH antagonist depot injectable formulations commercially approved beyond a one-month injection. In June 2021, the Company initiated the
Phase 2 dose finding clinical study of VERU-100 androgen deprivation therapy for hormone sensitive advanced prostate cancer. The Phase 2 VERU-100 clinical study is
expected to enroll approximately 45 patients. A Phase 3 registration clinical study has been agreed upon with FDA and will enroll approximately 100 men.
Urev - Sexual Health Division
ENTADFI (tadalafil and finasteride) capsule, a new Treatment for Benign Prostatic
Hyperplasia (BPH) Received FDA Approval.
We plan to market ENTADFI to healthcare
providers and patients via digital tactics and distribution that will be conducted through the traditional pharmaceutical distribution channels, and potentially, a third-party telemedicine portal. We will augment our marketing and sales efforts by
seeking partners in the U.S. and ex-U.S.
FC2 Female Condom/Internal Condom
The Company markets and sells the
FC2 , an FDA-approved product for dual protection against unplanned pregnancy and the transmission of sexually transmitted infections.
Interested parties may access the call by
dialing 1-800-341-1602 from the U.S. or 1-412-902-6706 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 1-877-344-7529 for U.S. callers, or 1-412-317-0088 from outside the U.S.,
passcode 8215063, for one week.
Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related
diseases and for the management of breast and prostate cancers. Veru also has a commercial sexual health division - Urev, the proceeds of which help fund its drug development programs, comprised of 2 FDA approved products - ENTADFI (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia, for which commercialization launch plans are underway, and FC2 Female Condom (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally.