Veru to Present at the Oppenheimer 32nd Annual Healthcare Conference on March 15-17, 2022
March 01 2022 - 8:30AM
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company
with a focus on developing novel medicines for the management of
breast and prostate cancers, today announced that the Company will
present at the Oppenheimer 32nd Annual Healthcare Conference. The
presentation will be available through the Conference on March 15,
2022, at 11:20 am Eastern Time.
A webcast of the presentation will be available at
https://verupharma.com/investors. 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. The webcast will be archived and accessible on the web
site for at least 30 days.
About Veru Inc.Veru is an oncology
biopharmaceutical company with a principal focus on developing
novel medicines for the management of breast and prostate
cancers.
The Company’s late-stage breast cancer development portfolio
comprises enobosarm, a selective androgen receptor targeting
agonist, and sabizabulin, a cytoskeleton disruptor.
Current studies on the two drugs include:
- Enrolling Phase 3 ARTEST study of enobosarm in androgen
receptor positive, estrogen receptor positive, and human epidermal
growth factor receptor two negative (AR+ ER+ HER2-) metastatic
breast cancer with AR ≥ 40% expression (third-line metastatic
setting), and which has been granted Fast Track designation by the
FDA.
- Planned Q1 2022 Phase 3 ENABLAR-2 study of enobosarm +
abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2-
metastatic breast cancer with AR ≥ 40% expression (second-line
metastatic setting). The Company and Lilly have entered into a
clinical study collaboration and supply agreement for the ENABLAR-2
study. Lilly will supply Verzenio® (abemaciclib).
- Planned Q1 2022 Phase 2b study of sabizabulin in AR+ ER+ HER2-
metastatic breast cancer with AR < 40% expression (third-line
metastatic setting).
The Company has determined that patients who have ≥ 40% androgen
receptor nuclei staining by immunohistochemistry in their breast
cancer tissue, a measure of AR expression, are most likely to
respond to enobosarm. Consequently, Veru is developing a companion
diagnostic test to determine a patient’s androgen receptor
expression status and has partnered with Roche/Ventana Diagnostics,
a world leader in oncology companion diagnostic tests, which will
develop and, if it is approved, commercialize the AR companion
diagnostic test.
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:
- Enrolling Phase 3 VERACITY study in metastatic castration and
androgen receptor targeting agent resistant prostate cancer prior
to IV chemotherapy.
- Enrolling Phase 2 dose-finding study of VERU-100 in advanced
hormone sensitive prostate cancer.
- Planned Phase 2b study of zuclomiphene citrate to treat hot
flashes in men with advanced prostate cancer undergoing androgen
deprivation therapy.
In addition, sabizabulin, which has dual antiviral and
anti-inflammatory effects, is currently enrolling in a Phase 3
COVID-19 study for the treatment of hospitalized COVID-19 patients
at high risk for acute respiratory distress syndrome, and which has
been granted Fast Track designation by the FDA.
Veru also has a commercial sexual health division - Urev, the
proceeds of which help fund its drug development programs,
comprised of 2 FDA approved products:
- ENTADFI™ (finasteride and tadalafil) capsules for oral use, a
new treatment for benign prostatic hyperplasia, commercialization
launch plans are underway.
- FC2 Female Condom® (internal condom), for the dual protection
against unplanned pregnancy and the transmission of sexually
transmitted infections which is sold in the U.S. and globally.
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 whether 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 drug candidates will be approved for the targeted line of
therapy, the anticipated design and scope for clinical studies and
FDA acceptance of such design and scope, whether any regulatory
pathways, including the accelerated Fast Track designations, to
seek FDA approval for sabizabulin, enobosarm or any of the
Company’s drug candidates are or continue to be available; whether
the expected commencement and timing of the Company’s clinical
studies, including the Phase 3 ENABLAR-2 study, the sabizabulin
monotherapy Phase 2b clinical study for 3rd line treatment of
metastatic breast cancer, the Phase 2 registration clinical study
for VERU-100, and the development of the companion diagnostic will
be met, including the Phase 3 VERU-100 clinical study and the
sabizabulin clinical study for the treatment of hospitalized
Covid-19 patients at high risk of ARDS; when clinical results from
the ongoing clinical studies will be available, whether
sabizabulin, enobosarm, VERU-100, zuclomiphene, and ENTADFI will
serve any unmet need or, what dosage, if any, might be approved for
use in the US or elsewhere, and also statements about the
potential, timing and efficacy of the rest of the Company’s
development pipeline, and the timing of the Company’s submissions
to FDA and FDA’s review of all such submissions; whether any of the
selective clinical properties previously observed in clinical
studies of sabizabulin, enobosarm, VERU-100 or other drug
candidates will be replicated in the current and planned clinical
development program for such drug candidates and whether any such
properties will be recognized by the FDA in any potential approvals
and labeling; whether the companion diagnostic for enobosarm will
be developed successfully or be approved by the FDA for use. 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 studies
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical studies 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 studies, 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; risks relating to the Company's development
of its own dedicated direct to patient telemedicine and
telepharmacy services platform, including the Company's lack of
experience in developing such a platform, potential regulatory
complexity, and development costs; 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, 2021 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.
Verzenio® is a registered trademark of Eli Lilly and Company
Investor and Media Contact:Samuel FischExecutive Director,
Investor Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
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