Full Press Release Details
Executive Director, Investor Relations and Corporate Communications
Email: veruinvestor@verupharma.com
Manager, Corporate Communications
Email: media@verupharma.com
Reports Fiscal 2022 Fourth Quarter and Full Year Financial Results
U.S. FDA reviewing EUA application for sabizabulin to treat
hospitalized COVID-19 patients at high risk for ARDS
European Medicines Agency s (EMA)
Emergency Task Force reviewing sabizabulin for emergency use in EU member states
Sabizabulin also under review for potential emergency
authorization by MHRA (UK), TGA (Australia), and Health Canada
Veru preparing for U.S. and international commercialization and
distribution of sabizabulin, and manufacturing capacity for drug supply in place
Company to host conference call and webcast today at 8:00
MIAMI, FL 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, today announced financial results for its fiscal 2022 fourth quarter and full year ended September 30, 2022 and
provided a business update.
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
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
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
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.
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 na ve 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.
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
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
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
Balance Sheet Information
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.
Veru is a biopharmaceutical company
focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology.
Infectious disease program:
The Company has completed
a positive Phase 3 COVID-19 study evaluating sabizabulin, an oral, first-in-class, new chemical entity, microtubule disruptor
that has dual anti-inflammatory and antiviral properties, 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 204 hospitalized
moderate to severe COVID-19 patients 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 clear clinical efficacy and no safety concerns were identified. Treatment with sabizabulin 9 mg once daily resulted in a clinically meaningful and statistically significant 55.2%
relative reduction in deaths compared to placebo.
The Company s late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin.
Current studies on the two drugs include:
Veru s late-stage prostate cancer portfolio comprises sabizabulin,
VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.
Current studies on these drugs include:
Commercial sexual health program, Urev, has 2 FDA approved products:
Forward-Looking Statements
The statements in this
release that are not historical facts are forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding: whether and
when the Company will receive an emergency use authorization or any approval from FDA or from any regulatory authority outside the U.S. for sabizabulin for certain COVID-19 patients; whether and when
sabizabulin will become an available treatment option for certain COVID-19 patients in the U.S. or anywhere outside the U.S.; whether any additional efficacy or safety clinical studies of sabizabulin for
certain COVID-19 patients will be required by the FDA or any other regulatory authority as a condition to any authorization or as a post-authorization requirement; whether the Company will have sufficient
supply of sabizabulin to meet demand, if an emergency use authorization or other approval is granted in the U.S. or in any other country; whether the Company will secure any advance purchase agreement with the U.S. government or any foreign
government; whether the current and future clinical development and results will demonstrate sufficient efficacy and safety and potential benefits to secure FDA approval of the Company s drug candidates and companion diagnostic; whether the