Veru to Report Fiscal 2021 Second-Quarter Financial Results, Host Conference Call on May 12th
28 April 2021 - 10:30PM
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 DetailsInterested 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 StatementsThe 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: |
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Sam Fisch |
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800-972-0538 |
Director of Investor Relations |
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