Veru Announces Acceptance of Two Abstracts for Presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual M...
May 24 2021 - 8:30AM
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 two abstracts were
accepted for presentation at the 2021 American Society of Clinical
Oncology Annual Meeting which will be held virtually from June 4-8,
2021.
Poster Discussion Session – Breast Cancer
(Metastatic)Abstract #1020: Efficacy
of enobosarm, a selective androgen receptor (AR) targeting agent,
correlates with degree of AR positivity in advanced AR+/estrogen
receptor (ER)+ breast cancer in an international Phase 2 clinical
studyPresenter: Carlo Palmieri, BSc, MB BS, PhD,
FRCP, Professor of Translational Oncology & Medical Oncologist,
University of Liverpool
Poster Presentation - Genitourinary Cancer—Prostate,
Testicular, and PenileAbstract
#5056: Sabizabulin (VERU-111), an oral cytoskeleton
disruptor, to treat men with metastatic castration resistant
prostate cancer (mCRPC) who failed an androgen receptor targeting
agentPresenter: Dr. Mark C. Markowski, Assistant
Professor of Oncology, Sidney Kimmel Comprehensive Cancer Center,
Johns Hopkins University School of Medicine
Additional information on the meeting can be found on the ASCO
website https://conferences.asco.org/
“These exciting clinical results have allowed us to advance two
novel agents, enobosarm and sabizabulin into Phase 3 registration
trials. The Phase 3 ARTEST clinical trial of enobosarm monotherapy
in the 3rd line metastatic setting in subjects with AR+ER+
metastatic breast cancer is expected to begin enrolling in June
2021 and the Phase 3 VERACITY trial for sabizabulin in men with
metastatic castration resistant prostate cancer who have failed at
least one androgen receptor targeting agent is expected to initiate
in early June 2021,” said Dr. Mitchell Steiner, Chairman, President
and CEO of Veru Inc. “We are a step closer to potentially bringing
these important drugs to large and growing unmet medical need
indications in treatment of refractory breast and prostate
cancers.”
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, an oral,
first-in-class, new chemical entity that targets the cytoskeleton
disruptor which in prostate cancer also disrupts androgen receptor
transport. A Phase 3 VERACITY clinical trial evaluating the
efficacy and safety of sabizabulin in approximately 245 men for the
treatment of metastatic castration and androgen receptor targeting
agent resistant prostate cancer is expected to commence in early
June. VERU-100, a novel, proprietary gonadotropin releasing hormone
antagonist peptide long acting 3-month subcutaneous injection
formulation for androgen deprivation therapy, is expected to start
the planned Phase 2 clinical study later this month, and the Phase
3 clinical study is planned to initiate in calendar Q4 2021 to
treat hormone sensitive metastatic prostate cancer. 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; Phase 3 ARTEST clinical trial to evaluate enobosarm
in a 3rd line metastatic setting in approximately 210 subjects with
AR+ER+HER2- advanced breast cancer who have failed nonsteroidal
aromatase inhibitor, fulvestrant, and a CDK 4/6 inhibitor is
anticipated to commence Q2 2021. In a separate clinical development
program, a Phase 2 study to evaluate the efficacy and safety of
enobosarm in combination with CDK 4/6 inhibitor (abemaciclib)
compared to estrogen receptor blocking agent (Active Control) for
the treatment of AR+ER+HER2- metastatic breast cancer in a 2nd line
metastatic setting in approximately 106 patients who have failed an
estrogen receptor blocking agent plus a CDK 4/6 inhibitor
(palbociclib) is expected to commence in calendar Q3 2021.
Sabizabulin is also being evaluated in a three arm Phase 2b
clinical study in calendar Q3 2021 to evaluate oral daily dosing of
sabizabulin monotherapy, TRODELVY® monotherapy, and sabizabulin +
TRODELVY combination therapy in approximately 156 women with
metastatic triple negative breast cancer that have become resistant
to at least two systemic chemotherapies including a taxane. Based
on positive Phase 2 results on the reduction of mortality,
sabizabulin is also being evaluated in a Phase 3 trial in
approximately 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 potential product,
if approved, 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 filed by
FDA in April 2021 with a PDUFA date in December 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 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, whether and when a companion diagnostic test for AR will be
developed and used successfully for enobosarm in breast cancer, 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
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 |
|
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