On December 5, 2022 Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, reported financial results for its fiscal 2022 fourth quarter and full year ended September 30, 2022 and provided a business update (Press release, Veru, DEC 5, 2022, View Source [SID1234624805]).
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"This has been a transformational year for Veru. We reported positive Phase 3 results demonstrating that sabizabulin treatment resulted in a statistically and clinically significant reduction in death in hospitalized moderate to severe COVID-19 patients at high risk for ARDS and death, which was published in the NEJM Evidence," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. "As sabizabulin is being reviewed in the U.S. and internationally for potential emergency use authorization, we are preparing for commercialization and will be ready to deliver this treatment to patients, if authorized."
Dr. Steiner added, "While FC2 revenue decreased this past year due to business challenges experienced by our largest telemedicine customers, we are working diligently to regenerate FC2 product sales, and our recently launched telemedicine platform has shown steady market uptake to date."
Infectious Disease Program Highlights
Sabizabulin: A Novel Oral, First-in-Class, Microtubule Disruptor for the Treatment of Hospitalized Moderate to Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)
In November 2022, the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee met with the Company to review its request for Emergency Use Authorization (EUA) of sabizabulin. The Advisory Committee voted 8-5 that the known and potential benefits of sabizabulin when used for the treatment of adult patients hospitalized with COVID-19 at high risk of ARDS do not outweigh the known and potential risks of sabizabulin. The FDA considers the Advisory Committee’s input as part of their review, but the FDA makes the final decision on issuing an EUA.
In October 2022, the Company presented data from the Phase 3 trial of sabizabulin in a late-breaker oral presentation at IDWeek (Infectious Disease Week) 2022.
In August 2022, Australia’s Therapeutic Goods Administration (TGA) granted the Company an expedited provisional registration regulatory pathway for sabizabulin treatment in hospitalized COVID-19 patients at high risk for ARDS.
In August 2022, the Company presented the Phase 3 trial results of sabizabulin at the 11th International Conference on Emerging Infectious Diseases (ICEID).
In July 2022, European Medicines Agency’s (EMA) Emergency Task Force (ETF) initiated the review of sabizabulin for emergency use in the EU member states.
In July 2022, United Kingdom’s (UK’s) Medicines and Healthcare Products Regulatory Agency (MHRA) supported an expedited review of the marketing authorization application for sabizabulin treatment in hospitalized COVID-19 patients at high risk for ARDS.
On July 6, 2022, The New England Journal of Medicine Evidence published results from the Phase 3 trial evaluating the efficacy and safety of oral sabizabulin in hospitalized COVID-19 patients.
Breast Cancer Program Highlights
Enobosarm, a Novel Oral Selective Androgen Receptor Targeting Agonist, for the 3rd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer with sufficient AR Expression
We are enrolling patients in the Phase 3 multicenter, international, open label, randomized (1:1) ARTEST registrational trial to evaluate enobosarm versus 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 sufficient AR expression 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 registrational program.
Enobosarm and Abemaciclib, CDK 4/6 Inhibitor, Combination Therapy for the 2nd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer with sufficient AR Expression
We are enrolling patients in the Phase 3 multicenter, open label, randomized (1:1), active control ENABLAR-2 trial to evaluate 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 sufficient AR expression in their breast cancer tissue in approximately 186 subjects. We have a collaboration and supply agreement with Eli Lilly for this trial.
Sabizabulin for the 3rd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer with sufficient AR Expression
We intend to conduct a Phase 2b open label, multicenter, randomized (1:1) trial evaluating sabizabulin 32mg 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 sufficient AR expression in their breast cancer tissue who have previously received a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6 inhibitor.
Prostate Cancer Program Highlights
Sabizabulin for the Treatment of Metastatic Castration and Androgen Receptor Targeting Agent Resistant Prostate Cancer
We are enrolling patients in the Phase 3 VERACITY open label, randomized (2:1), multicenter trial 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.
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
We are enrolling patients in the Phase 2 clinical dose finding trial of VERU-100 for androgen deprivation therapy of advanced prostate cancer. The trial design for a future Phase 3 registrational trial of approximately 100 patients has been agreed upon by the FDA.
Urev – Sexual Health Program Highlights
ENTADFI (tadalafil and finasteride) capsule, a new Treatment for Benign Prostatic Hyperplasia (BPH)
The Company recently initiated the U.S. commercial launch and availability of ENTADFI– an FDA-approved oral, once daily product for benign prostatic hyperplasia (BPH) that is approved for men with an enlarged prostate that are experiencing the signs and symptoms of BPH for up to 26 weeks.
FC2 Female Condom/Internal Condom
The Company markets and sells the FC2 Female Condom, an FDA-approved product for dual protection against unplanned pregnancy and the transmission of sexually transmitted infections.
Full Year Financial Summary: Fiscal 2022 vs Fiscal 2021
Total net revenues decreased to $39.4 million from $61.3 million
Gross profit decreased to $30.6 million from $47.9 million
Gross margin remained consistent at 78% of net revenues
Research and development expenses increased to $70.6 million from $32.7 million
Operating loss was $83.2 million compared with operating income of $13.0 million, which included an $18.4 million gain on the December 2020 sale of the PREBOOST business
Net loss was $83.8 million, or $1.05 per diluted share, compared with net income, which included the gain on sale of the PREBOOST business, of $7.4 million, or $0.09 per diluted share
Balance Sheet Information
Cash and cash equivalents were $80.2 million as of September 30, 2022 versus $122.4 million as of September 30, 2021
Net accounts receivable were $3.6 million as of September 30, 2022 versus $8.8 million as of September 30, 2021
Event Details
The audio webcast will be accessible under "Investor Kit" in the Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available on December 5, 2022 at approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 passcode 4646397 (international) for one week.