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Veru Reports Record Fiscal 2021 Full-Year
FY21 Net Revenues Increase 44% to $61 Million and Gross Profit Increases 56% to $48 Million, Achieving New
Phase 3 Sabizabulin COVID-19 Clinical Study for Treatment
of Hospitalized Moderate to Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome Being Conducted in US, Mexico, South America, and Europe; Clinical Results Expected 1H 2022
Expansive Breast Cancer Program Continues Its Rapid Advance; Four Late-Stage Clinical Studies Enrolling or Planned in
Metastatic Breast Cancer
Phase 3 VERACITY Clinical Study of Oral, Targeted, Cytoskeleton Disruptor Sabizabulin
for Metastatic Castration Resistant Prostate Cancer Enrolling
Phase 2 Dose Finding Clinical Study of VERU-100 Long-Acting GnRH Antagonist Peptide, SubQ, 3-Month, Depot Injection for Advanced Hormone Sensitive Prostate Cancer Enrolling
ENTADFI, a New Treatment for Benign Prostatic Hyperplasia, PDUFA Date is On Track for this Month
Company to Host Investor Conference Call Today at 8 AM ET
MIAMI December 2, 2021 Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing
novel medicines for the management of breast and prostate cancer, today announced that fiscal 2021 full-year net revenues increased 44% to $61 million and gross profit increased 56% to $48 million, achieving new historical highs.
Fourth-Quarter Financial Highlights: Fiscal 2021 vs Fiscal 2020
Full-Year Financial Highlights: Fiscal 2021 vs Fiscal 2020
Balance Sheet Information
Once again we ve reported new historical highs for full fiscal year net revenues and gross profit
based on the robust growth of our US FC2 prescription business, said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc. On a sobering note, US and global COVID-19
hospitalizations and deaths are on the rise again. The identification of the omicron variant and the possibility that the current vaccines and antibody drugs may not be as effective against this variant means that drugs to treat severe COVID-19 are desperately needed. The mechanism of drug action of sabizabulin is that it disrupts microtubule intracellular transport of the coronavirus, a process that will still be required by new variants or
strains of COVID-19, including omicron, to cause infection. While there have been recent developments evaluating molnupiravir and PAXLOVID (PF-07321332; ritonavir) for the treatment of unhospitalized patients with mild to moderate COVID-19 at a relatively lower risk of dying, sabizabulin is being developed for
hospitalized patients with a high risk of death. In our positive Phase 2 clinical study in hospitalized COVID-19 patients at risk for acute respiratory distress syndrome, sabizabulin treatment resulted in an
82% relative reduction in death compared to placebo. If our Phase 2 clinical results are replicated to any significant degree in our global Phase 3 clinical study, we believe sabizabulin would fill a significant current unmet medical need for
hospitalized patients. In our global Phase 3 clinical study of sabizabulin we are enrolling 300 hospitalized patients with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress
Syndrome. We expect to have clinical results in the first half of calendar 2022.
These strong financial results have also enabled us to continue to
advance our deep late clinical stage drug pipeline portfolio. We are heavily committed to developing our drug candidate assets in breast and prostate cancer. In our breast cancer program, we are addressing 3rd line treatment of ER+ metastatic breast cancer through two separate studies with patient populations depending on the AR expression in the breast cancer tissue. Targeting patients whose AR
expression in breast cancer is 40% AR, we are enrolling the Phase 3 ARTEST clinical study to evaluate enobosarm monotherapy. Targeting patients whose AR breast cancer expression is <40%, we plan to
conduct a Phase 2b clinical study of sabizabulin monotherapy. We are also moving enobosarm earlier in the treatment sequence to the 2nd line treatment of AR+ER+ metastatic breast cancer by
targeting patients with AR breast cancer expression 40% in the Phase 3 ENABLAR-2 study. The Phase 3 ENABLAR-2 study will
evaluate the efficacy and safety of enobosarm and CDK 4/6 inhibitor combination. Finally, for AR+ metastatic triple negative breast cancer, we plan to conduct a single arm Phase 2 clinical study evaluating the combination of enobosarm and
sabizabulin treatment in patients who have progressed after receiving at least 2 systemic chemotherapies. Because of the importance of determining the patient s AR status and based on the recommendation of FDA, we will develop a companion
diagnostic AR test. We are pleased to be partnering with Roche/Ventana Diagnostics, a global oncology diagnostics company, who will develop and, if approved, commercialize a companion diagnostic AR test.
In our prostate cancer program, we are enrolling our Phase 3 VERACITY clinical study of sabizabulin for
metastatic castration and androgen receptor targeting agent resistant prostate cancer, but prior to IV chemotherapy. We are also enrolling our Phase 2 dose-finding clinical study of VERU-100, a novel
long-acting GnRH antagonist 3-month depot injection formulation for androgen deprivation therapy for hormone sensitive advanced prostate cancer. Once completed, we will start the Phase 3 registration study.
Finally, our Sexual Health division, led by robust FC2 sales, and if approved this month, the addition of ENTADFI sales expected in the first half of
calendar year 2022, we will continue to have substantial resources to invest in our premium oncology drug pipeline line which is dedicated to addressing significant unmet medical needs for two of the most prevalent cancers, prostate and breast
cancer. I am pleased and excited with Veru s transformation into a premium oncology biopharmaceutical company seeking large market opportunities. The Company remains duty-bound during this persistent global pandemic to pursue this COVID-19 indication even though it is not the primary focus of the Company.
Pharmaceutical Pipeline
Breast Cancer Program
Enobosarm, a Novel Oral Selective Androgen Receptor Targeted Agonist, for the 3rd Line Treatment of
Androgen Receptor Positive (AR+), Estrogen Receptor Positive (ER+) and Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer with AR 40% - Phase 3 ARTEST
Clinical Study- Enrolling.
Enobosarm is the first new class of targeted endocrine therapy in advanced breast cancer in decades. Enobosarm is an oral,
new chemical entity, selective androgen receptor agonist that targets the androgen receptor, a tumor suppressor, in AR+ER+HER2- metastatic breast cancer without the unwanted masculinizing side effects. Enobosarm has extensive nonclinical and
clinical experience having been evaluated in 25 separate clinical studies in over 2,000 patients including three Phase 2 clinical studies in advanced 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 failed estrogen receptor targeting agents, chemotherapy, and/or CDK 4/6 inhibitors and 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 the efficacy and safety of enobosarm monotherapy versus physician s
choice of either exemestane everolimus or a SERM as the active comparator for the treatment of AR+ ER+ HER2- metastatic breast cancer in approximately 210 patients with AR nuclei staining 40% in
their breast cancer tissue who had tumor progression on a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6 inhibitor.
Oral Cytoskeleton Disruptor Agent, Monotherapy for the 3rd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer with AR< 40% - Phase 2b Clinical Study.
We intend to conduct a Phase 2b clinical study of sabizabulin for the treatment of AR+ ER+ HER2- metastatic breast cancer in patients with an AR nuclei
staining <40%. The Phase 2b clinical study will be an open label, multicenter, and randomized (1:1) study evaluating the efficacy and safety of sabizabulin 32mg monotherapy versus active comparator (exemestane everolimus or a SERM,
physician s choice) for the treatment of ER+ HER2- metastatic breast cancer in approximately 200 patients with AR nuclei staining <40% in their breast cancer tissue who had tumor progression on a nonsteroidal aromatase inhibitor,
fulvestrant, and a CDK4/6 inhibitor. The Phase 2b study is expected to commence in calendar Q1 2022.
Enobosarm and Abemaciclib, CDK 4/6 Inhibitor, Combination Therapy for the 2nd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer with AR 40% - Phase 3 ENABLAR-2 Clinical
CDK 4/6 inhibitor and estrogen blocking agent combination has become first line therapy for patients with ER+HER2- advanced breast cancer.
Unfortunately, almost all patients will develop resistance to CDK 4/6 inhibitors, and will eventually, have breast cancer progression. Based on positive Phase 2 clinical data and the preclinical data supporting the use of enobosarm in combination
with a CDK 4/6 inhibitor in patients that are CDK 4/6 inhibitor and estrogen blocking agent resistant, we plan to conduct a Phase 3 multicenter, open label, randomized (1:1), active control clinical study, named
ENABLAR-2 to evaluate the efficacy and safety of enobosarm plus abemaciclib combination therapy 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 have an AR nuclei staining 40% in their breast cancer tissue. We plan to enroll approximately 186 subjects in this Phase 3 clinical study which is expected to commence during the first quarter of calendar year 2022.
Sabizabulin and Enobosarm Combination Therapy for AR+ Metastatic Triple Negative Breast Cancer Patients who have Progressed After Receiving at Least Two
Systemic Chemotherapies Phase 2 Clinical Study.
Sabizabulin is an oral,
first-in-class, new chemical entity that targets and inhibits microtubules to disrupt the cytoskeleton. Sabizabulin is not a substrate for
P-glycoprotein drug resistance protein. Over expression of P-glycoprotein is a common mechanism that results in taxane and chemotherapy resistance in metastatic triple
negative breast cancer. Preclinical studies in human triple negative breast cancer grown in animal models demonstrate that sabizabulin significantly inhibits cancer proliferation, migration, metastases, and invasion of triple negative breast cancer
tumors that have become resistant to paclitaxel (taxane). Furthermore, an enobosarm + pembrolizumab combination Phase 2 study in 18 heavily pretreated women with AR+ metastatic triple negative breast cancer demonstrated that enobosarm was well
tolerated and resulted in promising preliminary efficacy of 25% clinical benefit rate (CR+PR+SD) at 16 weeks and objective tumor responses (1 CR and 1 PR). Thus, the combination of two oral agents, sabizabulin + enobosarm, may provide a new
treatment option for women who have AR+ metastatic triple negative breast cancer. We intend to conduct a single arm, sabizabulin plus enobosarm combination therapy Phase 2 clinical study in approximately 111 women in calendar Q1 2022.
Companion Diagnostic AR Test
We have identified that
patients who have greater than 40% androgen receptor nuclei staining in their breast cancer tissue are most likely to respond to enobosarm. Based on the recommendation of FDA to have a companion diagnostic test to determine the patient s AR
status, we are partnering with Roche/Ventana Diagnostics, a global oncology diagnostics company, who will develop and, if approved, commercialize a companion diagnostic AR test. The companion diagnostic test will be developed in parallel with the
Phase 3 ARTEST clinical study.
Prostate Cancer Program
Sabizabulin, a Novel Oral Androgen Receptor Transport Disruptor, for the Treatment of Metastatic Castration and Androgen Receptor Targeting Agent Resistant
Prostate Cancer Phase 3 VERACITY Clinical Study - Enrolling.
Sabizabulin is a novel oral new chemical entity that targets microtubules in the
cytoskeleton to disrupt androgen receptor transport. In June, the Company initiated 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 failed at least one androgen receptor targeting agent. The primary endpoint is radiographic progression free survival. The Phase 3 VERACITY
clinical study is expected to enroll approximately 245 patients from 45 clinical centers.
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 formulation 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, 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 35 patients. A Phase 3 registration clinical study has been agreed upon with FDA and will enroll approximately 100 men. The Phase 3 clinical study is anticipated to begin in 1H calendar 2022.
Sabizabulin for the Treatment of Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome
(ARDS) Phase 3 Clinical Study- Enrolling.
Sabizabulin has both broad anti-viral and anti-inflammatory activities which may serve a two-pronged approach to the treatment of COVID-19 virus infection and the subsequent debilitating inflammatory effects that lead to ARDS and death. In May, we initiated the
Phase 3 clinical study which is a double-blind, multicenter, multinational, randomized (2:1), placebo-controlled study evaluating daily oral doses of 9mg sabizabulin for up to 21 days versus placebo in 300 hospitalized
COVID-19 patients (200 subjects will be treated with sabizabulin and 100 subjects will receive standard of care) who are at high risk for ARDS. The primary efficacy endpoint will be proportion of patients that
die on study up to Day 60. Secondary endpoints will include the proportion of patients without respiratory failure, days in ICU, WHO Ordinal Scale for Clinical Improvement change from baseline, days on mechanical ventilations, days in the hospital,