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 clinical results
from the Phase 2 clinical study of enobosarm, a selective androgen
receptor targeting agonist, in heavily pretreated women with
AR+ER+HER2- advanced breast cancer including further efficacy data
and an analysis of patients who have failed both estrogen blocking
agents and CDK 4/6 inhibitors, has been accepted for a poster
presentation at the European Society for Medical Oncology (ESMO)
Breast Cancer Virtual Congress 2021 to be held May 05-08, 2021.
Enobosarm is an oral, first-in-class, selective androgen receptor
targeting agonist that activates the androgen receptor, a tumor
suppressor, in AR+ER+HER2- metastatic breast cancer. The planned
Phase 3 ARTEST study will evaluate enobosarm monotherapy versus an
active control (exemestane or SERM) for the treatment of metastatic
AR+ER+HER2- breast cancer patients whose disease has progressed
after treatment with a nonsteroidal aromatase inhibitor
(anastrozole or letrozole), fulvestrant, and a CDK 4/6 inhibitor
and the study is anticipated to commence in Q2 2021.
Presentation details:
Abstract Title: Efficacy of enobosarm, a
selective androgen receptor (AR) targeting agent, in patients with
metastatic AR+ER+ breast cancer resistant to estrogen receptor
targeted agents and CDK 4/6 inhibitor in a Phase 2 clinical
study Presenter: Carlo Palmieri, BSc, MB BS,
PhD, FRC, Professor of Translational Oncology & Medical
Oncologist, University of LiverpoolAbstract
Number: 568
Additional information on the meeting can be found on the ESMO
website
https://www.esmo.org/meetings/esmo-breast-2021-virtual
“With the recent validation of the androgen receptor as a tumor
suppressor and a therapeutic target in AR+ER+HER2- breast cancer as
well as the positive proof of concept efficacy and safety results
in the Phase 2 clinical study, we remain very excited about
advancing the clinical development of enobosarm into a Phase 3
ARTEST registration trial and its potential role in the targeted
treatment refractory AR+ER+HER2- advanced breast cancer,” said Dr.
Mitchell Steiner, Chairman, President and CEO of Veru Inc.
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: VERU-111, an oral,
first-in-class, targeted cytoskeleton disruptor, is expected to
commence in Q2 2021 a Phase 3 VERACITY clinical trial in
approximately 245 men for the treatment of metastatic castration
and androgen receptor targeting agent resistant prostate cancer.
VERU-100, a novel, proprietary GnRH antagonist peptide long acting
3-month subcutaneous injection formulation for androgen deprivation
therapy, will start the planned Phase 2 clinical study in Q2 2021
and the Phase 3 clinical study in Q4 2021 to treat hormone
sensitive advanced 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
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. The second
indication for VERU-111 is for the treatment of taxane resistant
metastatic triple negative breast cancer; the planned Phase 2b in
200 subjects is expected to begin Q3 2021. Based on positive Phase
2 results on the reduction of mortality, VERU-111 is being
evaluated in a Phase 3 trial 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 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.
"Safe Harbor" statement under the Private Securities
Litigation Reform Act of 1995: 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 enobosarm to
treat certain breast cancer patients and whether future clinical
development will demonstrate sufficient efficacy and safety to
secure FDA approval of the Company's drug candidates and statements
regarding the expected timing, design and efficacy of the other
drug candidates in the Company's development pipeline. Any
forward-looking statements in this release are based upon the
Company's current plans and strategies and reflect the Company's
current assessment of the risks and uncertainties related to its
business and are made as of the date of this release. The Company
assumes no obligation to update any forward-looking statements
contained in this release because of new information or future
events, developments or circumstances. Such forward-looking
statements are subject to known and unknown risks, uncertainties
and assumptions. If any such risks or uncertainties materialize or
if any of the assumptions prove incorrect, our actual results could
differ materially from those expressed or implied by such
statements. Factors that may cause actual results to differ
materially from those contemplated by such forward-looking
statements include, but are not limited to, the following: risks
related to the development of the Company's product portfolio,
including clinical trials, regulatory approvals and the time and
cost to bring any of our product candidates to market; potential
delays in the timing of and results from clinical trials and
studies, including potential delays in the recruitment of patients
and their ability to effectively participate in such trials and
studies due to COVID-19, and the risk that such results will not
support marketing approval and commercialization; potential delays
in the timing of any submission to the FDA and regulatory approval
of products under development and the risk that disruptions at the
FDA caused by the COVID-19 pandemic may delay the review of
submissions or approvals for new drugs; the risk of a delay or
failure in reaching agreement with the FDA on the design of a
clinical trial or in obtaining authorization to commence a clinical
trial; preclinical or clinical results or early data from clinical
trials may not be replicated or continue to occur in additional
trials or may not otherwise support further development in the
specified product candidate or at all; our pursuit of a COVID-19
treatment candidate is at an early stage and we may be unable to
develop a drug that successfully treats the virus in a timely
manner, if at all; risks related to our commitment of financial
resources and personnel to the development of a COVID-19 treatment
which may cause delays in or otherwise negatively impact our other
development programs, despite uncertainties about the longevity and
extent of COVID-19 as a global health concern and the possibility
that as vaccines become widely distributed the need for new
COVID-19 treatment candidates may be reduced or eliminated;
government entities may take actions that directly or indirectly
have the effect of limiting opportunities for VERU-111 as a
COVID-19 treatment, including favoring other treatment alternatives
or imposing price controls on COVID-19 treatments; the risk that
the Company's existing products and any future products, if
approved, may not be commercially successful; risks related to the
impact of the COVID-19 pandemic on our business, the nature and
extent of which is highly uncertain and unpredictable; risks
relating to the ability of the Company to obtain sufficient
financing on acceptable terms when needed to fund development and
operations, including our ability to secure timely grant or other
funding to develop VERU-111 as a potential COVID-19 treatment;
product demand and market acceptance; competition in the Company's
markets and therapeutic areas and the risk of new or existing
competitors with greater resources and capabilities and new
competitive product approvals and/or introductions; the risk that
the Company will be affected by regulatory developments, including
a reclassification of products; price erosion, both from competing
products and increased government pricing pressures; manufacturing
and quality control problems; compliance and regulatory matters,
including costs and delays resulting from extensive governmental
regulation, and effects of healthcare insurance and regulation,
including reductions in reimbursement and coverage or
reclassification of products; some of the Company's product
candidates are in development and the Company may fail to
successfully commercialize such products, if approved; risks
related to intellectual property, including the uncertainty of
obtaining patents, the effectiveness of the patents or other
intellectual property protections and ability to enforce them
against third parties, the uncertainty regarding patent coverages,
the possibility of infringing a third party’s patents or other
intellectual property rights, and licensing risks; government
contracting risks, including the appropriations process and funding
priorities, potential bureaucratic delays in awarding contracts,
process errors, politics or other pressures, and the risk that
government tenders and contracts may be subject to cancellation,
delay, restructuring or substantial delayed payments; the risk 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; a
governmental tender award indicates acceptance of the bidder's
price rather than an order or guarantee of the purchase of any
minimum number of units, and as a result government ministries or
other public sector customers may order and purchase fewer units
than the full maximum tender amount or award; penalties and/or
debarment for failure to satisfy tender awards; 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; risks related to
concentration of accounts receivable with our largest customers and
the collection of those receivables; the economic and business
environment and the impact of government pressures; risks involved
in doing business on an international level, including currency
risks, regulatory requirements, political risks, export
restrictions and other trade barriers; 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; risks related
to the 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 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.
Contact:Sam Fisch 800-972-0538Director of
Investor Relations
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