On February 9, 2022 Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of breast and prostate cancer, reported financial results for its fiscal 2022 first quarter ended December 31, 2021 (Press release, Veru, FEB 9, 2022, View Source [SID1234607908]).
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First Quarter Financial Summary: Fiscal 2022 vs Fiscal 2021
Total net revenues decreased 3% to $14.1 million from $14.6 million
FC2 net revenues increased 3% to $14.1 million from $13.8 million
US FC2 prescription net revenues climbed 27% to $11.6 million from $9.1 million
Gross profit rose 9% to $11.8 million from $10.8 million
Gross margin increased to 84% of net revenues from 74% of net revenues, a record high compared to any prior quarter
Operating loss was $5.0 million compared with operating income of $19.2 million, which included an $18.4 million gain on the December 2020 sale of the PREBOOST business
Net loss was $6.4 million or $0.08 per diluted share compared with net income, which included the gain on the sale of the PREBOOST business, of $17.2 million or $0.23 per diluted share
Balance Sheet Information
Cash and cash equivalents were $116.1 million as of December 31, 2021 versus $122.4 million at September 30, 2021
Net accounts receivable of $8.1 million as of December 31, 2021 versus $8.8 million as of September 30, 2021
"The 27% increase in year-over-year US FC2 prescription net revenues as well as achieving an all-time high in gross margin percentage underscore the continued robust US demand for our best-in-class FC2 product," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc. "In addition to securing additional telemedicine and internet pharmacy partners, we are actively constructing our own direct to patient telemedicine and internet pharmacy services platform to further increase the US prescription business. This quarter also marked FDA’s approval of Veru’s ENTADFITM, (finasteride and tadalafil) capsule, a new treatment for BPH with low potential for sexual side effects, including impotence. ENTADFI will also be marketed and distributed by our own direct to patient telemedicine and internet pharmacy services platform. Veru has also partnered with GoodRx, a US based digital resource for healthcare, to reach their almost 20 million monthly visitors. GoodRx will drive awareness and be integrated with our direct to patient telemedicine platform. ENTADFI’s approval is a significant execution milestone for Veru and an important step in expanding revenues from our Sexual Health Division called Urev. Urev is comprised of the ENTADFI and FC2 FDA approved products."
"These strong financial results enable us to continue to fund and advance our late clinical stage oncology drug development pipeline. During the quarter we began enrolling patients in our Phase 3 ARTEST clinical trial evaluating enobosarm monotherapy in a third-line setting for AR+ER+HER2- metastatic breast cancer patients whose AR expression in breast cancer is ≥ 40%. We were very pleased that FDA granted Fast Track designation to the enobosarm ARTEST Phase 3 registration program, a distinction that underscores the urgent need for new, novel, targeted therapies for this important patient population suffering from this aggressive disease. FDA Fast Track designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs. We also recently announced a clinical trial collaboration and supply agreement with Eli Lilly and Company for our Phase 3 ENABLAR-2 trial to evaluate enobosarm in combination with Verzenio (abemaciclib), Lilly’s CDK4/6 inhibitor, as a second line therapy in the treatment of AR+ER+HER2- metastatic breast cancer."
"Also, we received good news that FDA had granted Fast Track designation to our Phase 3 COVID-19 registration program for the investigation of sabizabulin, a novel, proprietary, oral cytoskeleton disruptor with both anti-inflammatory and anti-viral properties, to combat COVID-19 infection and the cytokine storm that is responsible for acute respiratory distress syndrome and death. We expect to have Phase 3 clinical results in the first half of calendar 2022."
"This marks the receipt of two fast track designations from FDA on two of the Company’s major drug development programs, all within the span of just a few weeks. We look forward to ongoing, productive regulatory interactions with the FDA on both drug development programs, which are further enabled with this designation."
Pharmaceutical Pipeline Highlights:
COVID-19 Program
Sabizabulin for the Treatment of Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS) Phase 3 COVID-19 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 2021, we initiated the Phase 3 COVID-19 clinical study which is a double-blind, multicenter, multinational, randomized (2:1), placebo-controlled study evaluating daily oral 9mg dose of sabizabulin for up to 21 days versus placebo in 300 hospitalized COVID-19 patients
who are at high risk for ARDS. The primary efficacy endpoint will be the 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 ventilation, days in the hospital, and viral load. The study is being conducted in the US, Brazil, Argentina, Mexico, Colombia and Bulgaria. In January 2022, FDA granted Fast Track designation to our Phase 3 COVID-19 registration program. We expect to have Phase 3 clinical results in the first half of calendar 2022.
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 AR+ ER+ HER2- 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 failed estrogen receptor blocking 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 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.
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. 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% Expression – Phase 3 ENABLAR-2 Clinical Study.
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 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. We plan to enroll approximately 186 subjects which is expected to commence during the first quarter of calendar year 2022. We recently announced a clinical trial collaboration and supply agreement with Lilly for our Phase 3 ENABLAR-2 trial.
Sabizabulin and Enobosarm Combination Therapy for AR+ Metastatic Triple Negative Breast Cancer Patients who have Progressed After Receiving at Least Two Systemic Chemotherapies –Planned Phase 2 Study.
We intend to conduct a single arm, sabizabulin plus enobosarm combination therapy Phase 2 clinical study in approximately 111 women. However, due to prioritizing several other late stage Phase 3 studies, the Company has made the strategic decision to suspend further work on this metastatic triple negative breast cancer Phase 2 trial at this time.
Prostate Cancer Program
Sabizabulin for the Treatment of Metastatic Castration and Androgen Receptor Targeting Agent Resistant Prostate Cancer – Phase 3 VERACITY Clinical Study—Enrolling.
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 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. The Phase 3 VERACITY clinical study is expected to enroll 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 35 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 in December 2021.
We plan to market and distribute ENTADFI by our own "direct to patient" telemedicine and internet pharmacy services platform. We have also partnered with GoodRx, America’s digital resource for healthcare, to reach their almost 20 million monthly visitors, which include both consumers and healthcare providers to increase awareness and to drive patients to our telemedicine platform. Commercialization launch plans are underway.
Event Details
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 3664461, for one week.