--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 2022--
-- 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 8 AM ET--
MIAMI, May 12, 2022 (GLOBE NEWSWIRE) -- 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
- Total net revenues decreased 2% to $13.0 million from $13.3 million
- US FC2 prescription net revenues climbed 12% to $11.6 million from $10.3 million
- Gross profit rose 2% to $11.2 million from $10.9 million
- Gross margin increased to 86% of net revenues from 82% of net revenues, a record high compared to any prior quarter
- Operating loss was $11.8 million versus $1.5 million
- Net loss was $14.2 million, or $0.18 per share, compared $2.8 million, or $0.04 per share
Year-to-Date Financial Summary: Fiscal 2022 vs Fiscal 2021
- Total net revenues decreased 3% to $27.2 million from $28.0 million
- US FC2 prescription net revenues climbed 19% to $23.2 million from $19.4 million
- Gross profit rose 6% to $23.0 million from $21.7 million
- Gross margin increased to 85% of net revenues from 78% of net revenues
- Operating loss was $16.7 million compared with operating income of $17.7 million, which included an $18.4 million gain on the December 2020 sale of the PREBOOST® business
- Net loss was $20.6 million or $0.26 per diluted share compared with net income, which included the gain on the sale of the PREBOOST business, of $14.4 million or $0.18 per diluted share
Balance Sheet Information
- Cash and cash equivalents were $112.0 million as of March 31, 2022 versus $122.4 million at September 30, 2021
- Net accounts receivable of $8.1 million as of March 31, 2022 versus $8.8 million as of September 30, 2021
“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 Submission.
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 calendar 2Q 2022.
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.
Breast Cancer Program
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.
Enobosarm 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 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 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 ENABLAR-2 trial.
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