Veru to Report Fiscal 2021 Second-Quarter Financial Results, Host Conference Call on May 12th
Veru Inc. (NASDAQ: VERU) announced it will report its fiscal 2021 second quarter financial results on May 12, 2021, before market opening. The company specializes in oncology, focusing on prostate and breast cancer treatments. Critical products under development include sabizabulin, with a Phase 3 study targeting metastatic prostate cancer expected to begin in Q2 2021, and enobosarm for breast cancer, also anticipated to launch Phase 3 trials in Q2 2021. A conference call will be held at 8 a.m. ET on the same day to discuss performance and answer questions.
- Anticipated Phase 3 clinical studies for sabizabulin and enobosarm are set to start in Q2 2021, indicating continued progression in drug development.
- Veru's pipeline includes innovative cancer treatments aimed at significant unmet medical needs, potentially enhancing its market position.
- Forward-looking statements express uncertainty regarding trial outcomes, FDA approval, and market acceptance, reflecting potential risks involved.
- The impact of COVID-19 and related measures pose risks to clinical trials and operational effectiveness, which could affect future performance.
MIAMI, April 28, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, today announced that it will report financial results for its fiscal 2021 second quarter on Wednesday, May 12, 2021 before the market opens. Veru’s management will host a conference call that same day at 8 a.m. ET to review the Company’s performance and to answer questions. The call will also be accessible via webcast.
Event Details
Interested parties may access the call by dialing 800-341-1602 from the U.S. or 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 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10154431, for one week.
About Veru Inc.
Veru Inc. is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer and breast cancer. Veru’s prostate cancer pipeline includes: sabizabulin (VERU-111), an oral, first-in-class, targeted androgen receptor transport disruptor, whose Phase 3 VERACITY clinical study in approximately 245 men for the treatment of metastatic castration and androgen receptor targeting agent resistant prostate cancer is expected to commence in calendar Q2 2021; and VERU-100, a novel, proprietary GnRH antagonist peptide long acting 3-month subcutaneous injection formulation for androgen deprivation therapy to treat hormone sensitive advanced prostate cancer, with a planned Phase 2 clinical study initiation in Q2 2021 and a planned Phase 3 clinical study initiation in Q4 2021. Veru’s breast cancer pipeline includes: enobosarm, an oral, first-in-class, new chemical entity, selective androgen receptor agonist that targets and activates the androgen receptor, a tumor suppressor, to treat AR+ER+HER2- metastatic breast cancer without unwanted masculinizing side effects; a Phase 3 ARTEST clinical study to evaluate enobosarm in approximately 210 subjects with AR+ER+HER2- advanced breast cancer who have failed a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK 4/6 inhibitor is anticipated to commence Q2 2021. Sabizabulin is also being evaluated for the treatment of taxane resistant metastatic triple negative breast cancer in a planned Phase 2b clinical study in approximately 200 subjects expected to begin Q3 2021. Based on positive Phase 2 results on the reduction of mortality, sabizabulin is also being evaluated in a Phase 3 clinical study in 300 subjects for the treatment of hospitalized patients with COVID-19 who are at high risk for acute respiratory distress syndrome.
The Company’s Sexual Health Business commercial product is the FC2 Female Condom® (internal condom) (“FC2”), an FDA-approved product for dual protection against unintended pregnancy and the transmission of sexually transmitted infections. The Company’s Female Health Company Division markets and sells FC2 commercially and in the public health sector both in the U.S. and globally. In the U.S., FC2 is available by prescription through multiple third-party telemedicine and internet pharmacy providers and retail pharmacies. In the global public health sector, the Company markets FC2 to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world. The second product if approved and expected for the Sexual Health Business is TADFIN™ (tadalafil 5mg and finasteride 5mg) capsule for the administration of tadalafil 5mg and finasteride 5mg combination formulation dosed daily for benign prostatic hyperplasia (BPH). An NDA was submitted in February 2021. To learn more about Veru products, please visit www.verupharma.com.
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 the potential of sabizabulin to combat COVID-19 and prevent deaths in patients with moderate to severe COVID-19 disease who are at risk for ARDS, whether future clinical development and results will demonstrate sufficient efficacy and safety and potential benefits to secure FDA approval of the Company's drug candidates, the anticipated design and scope for clinical trials and FDA acceptance of such design and scope, whether sabizabulin, enobosarm, VERU-100 and TADFIN will serve any unmet need, what dosage, if any, might be approved for use in the US or elsewhere, and whether the enrollment timelines for the clinical trials will be met, and also statements about the potential, timing and efficacy of the rest of the Company’s development pipeline, including the ability of the Company to successfully launch TADFIN. These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: the development of the Company's product portfolio and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development; the timing of any submission to the FDA and any determinations made by the FDA or any other regulatory authority; the possibility that as vaccines become widely distributed the need for new COVID-19 treatment candidates may be reduced or eliminated; government entities possibly taking take actions that directly or indirectly have the effect of limiting opportunities for sabizabulin as a COVID-19 treatment, including favoring other treatment alternatives or imposing price controls on COVID-19 treatments; the Company's existing products and any future products, if approved, possibly not being commercially successful; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain and other third-party providers, commercial efforts, and business development operations; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to successfully commercialize any of its products, if approved; the Company’s ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; the Company's reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company's production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, COVID-19 (including the impact of COVID-19 on suppliers of key raw materials), product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims; the Company's ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company's ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company's press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the fiscal year ended September 30, 2020 and subsequent quarterly reports on Form 10-Q. These documents are available on the "SEC Filings" section of our website at www.verupharma.com/investors. The Company disclaims any intent or obligation to update these forward-looking statements.
| Contact: | ||
| Sam Fisch | 800-972-0538 | |
| Director of Investor Relations | ||
FAQ
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