On August 11, 2022 Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and Acute Respiratory Distress Syndrome (ARDS)-related diseases and for the management of breast and prostate cancers, reported financial results for its fiscal 2022 third quarter ended June 30, 2022, and sabizabulin for COVID progress towards regulatory decisions in key territories (Press release, Veru, AUG 11, 2022, View Source [SID1234618094]).
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Third Quarter Financial Summary: Fiscal 2022 vs Fiscal 2021
Total net revenues decreased 46% to $9.6 million from $17.7 million
US FC2 prescription net revenues decreased 50% to $6.7 million from $13.5 million
Gross profit decreased 49% to $7.1 million from $13.9 million
Gross margin decreased to 74% of net revenues from 79% of net revenues
Research and development expenses increased to $18.1 million from $11.2 million
Operating loss was $21.8 million versus $2.9 million
Net loss was $22.2 million, or $0.28 per share, compared to $2.7 million, or $0.03 per share
Year-to-Date Financial Summary: Fiscal 2022 vs Fiscal 2021
Total net revenues decreased 19% to $36.8 million from $45.6 million
US FC2 prescription net revenues decreased 9% to $29.9 million from $32.9 million
Gross profit decreased 16% to $30.1 million from $35.6 million
Gross margin increased to 82% of net revenues from 78% of net revenues
Research and development expenses increased to $43.8 million from $24.4 million
Operating loss was $38.6 million compared with operating income of $14.8 million, which included an $18.4 million gain on the December 2020 sale of the PREBOOST business
Net loss was $42.8 million, or $0.53 per diluted share, compared with net income, which included the gain on sale of the PREBOOST business, of $11.7 million, or $0.14 per diluted share
Balance Sheet Information
Cash and cash equivalents were $100.6 million as of June 30, 2022 versus $122.4 million as of September 30, 2021
Net accounts receivable were $8.3 million as of June 30, 2022 versus $8.8 million as of September 30, 2021
"COVID-19 new cases and hospitalizations are on the rise again with both summer and fall-winter surges expected. Unfortunately, the death rate in hospitalized patients with moderate to severe COVID-19 who are at risk for ARDS remains unacceptably high with current standard of care," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. "By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19."
Dr. Steiner added: "I am proud of how expeditiously the Veru team moved to get the Emergency Use Authorization (EUA) application submitted to FDA in June. I was also very pleased to see the UK’s Medicines and Healthcare Products Regulatory Agency’s decision to expedite review of a marketing authorization application for sabizabulin as well as the European Medicines Agency’s Emergency Task Force’s decision to initiate data review, for the first time ever under their article 18, for potential emergency use of sabizabulin in European Union member countries. Veru has scaled up manufacturing of sabizabulin 9mg capsules to meet the needs of patients in the U.S. and ex-US, if authorizations are received, and we are building our U.S. and ex-U.S. infectious disease commercial franchises."
Finally, Dr. Steiner noted: "We expect to have significant near-term revenue from sabizabulin for the treatment of hospitalized COVID-19 patients at high risk for ARDS, if the EUA is granted by the U.S. FDA. The decrease in the third quarter FC2 net revenues in the U.S. prescription channel is primarily due to lower volume from telemedicine customers because of some business challenges experienced by our customers which resulted in a slow-down in orders during the current quarter. We expect their historical ordering patterns to resume in future quarters, although there is uncertainty as to timing of the resumption, and we also anticipate new revenues from the launch of ENTADFI which is now commercially available."
Pharmaceutical Pipeline Highlights:
Infectious Disease Franchise:
The Company has Completed a Positive Phase 3 COVID-19 Study 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 approximately 210 hospitalized COVID-19 patients with moderate to severe COVID (≥ WHO 4-supplemental oxygen) 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 overwhelming efficacy and safety. Treatment with sabizabulin 9mg once daily, an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths.
On June 6, 2022, the Company submitted a request for emergency use authorization to FDA. On July 6, 2022, the Company announced the publication of the Phase 3 COVID-19 trial results evaluating the efficacy and safety of oral sabizabulin in The New England Journal of Medicine Evidence. On July 25, 2022, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) informed the Company that the sabizabulin marketing authorization application will receive expedited review. On July 27, 2022, the European Medicines Agency’s Emergency Task Force initiated the review of sabizabulin treatment for hospitalized COVID-19 patients for emergency use in European Union countries.
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 potential 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 <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 Study—Enrolling.
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 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 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) – commercially launched
Today the Company initiated the U.S. commercial launch and availability of ENTADFI– a new oral treatment for benign prostatic hyperplasia. ENTADFI has been shown to be faster and more effective to treat urinary tract symptoms caused by BPH with less potential for adverse sexual side effects compared to finasteride monotherapy. ENTADFI dosing is one capsule orally once a day, and the FDA approved indication is to initiate treatment of the signs and symptoms of BPH in men with an enlarged prostate for up to 26 weeks. ENTADFI will be featured on GoodRx, a leading consumer-focused digital healthcare platform, to drive awareness among consumers and providers.
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.
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 1902173, for one week.