Veru to Present at the H.C. Wainwright Global Investment Conference on May 24th 2022
May 17 2022 - 8:30AM
Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on
developing novel medicines for COVID-19 and other viral and
ARDS-related diseases and for the management of breast and prostate
cancers, today announced that the Company will present at the H.C.
Wainwright Global Investment Conference. The presentation will be
available through the Conference on Tuesday, May 24th at 11:30 AM –
12:00 PM (Eastern Daylight 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 a biopharmaceutical
company focused on developing novel medicines for COVID-19 and
other viral and ARDS-related diseases and for the management of
breast and prostate cancers.
A double-blind, randomized, placebo-controlled Phase 3 COVID-19
clinical trial was conducted in approximately 210 hospitalized
COVID-19 patients with moderate to severe COVID (WHO 4
-supplemental oxygen) at high risk for ARDS and death. The primary
endpoint was the proportion of deaths by Day 60. Based on a planned
interim analysis of the first 150 patients randomized, the
Independent Data Monitoring Committee unanimously halted the study
for overwhelming efficacy and safety. Treatment with sabizabulin
9mg once daily, an oral, first-in-class, new chemical entity,
cytoskeleton disruptor that has dual anti-inflammatory and
antiviral properties, resulted in a clinically meaningful and
statistically significant 55.2% relative reduction in deaths. After
a pre-EUA meeting with FDA, the Company is in the process of
submitting a request for FDA emergency use authorization. FDA
granted Fast Track designation to the Company’s COVID-19 program in
January 2022.
The Company’s late-stage breast cancer development portfolio
comprises enobosarm, a selective androgen receptor targeting
agonist, and sabizabulin.
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.
- Enrolling 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 Eli Lilly and Company have entered into a clinical
study collaboration and supply agreement for the ENABLAR-2 study.
Lilly is providing clinical supply of Verzenio® (abemaciclib).
- Planned Phase 2b study of sabizabulin in AR+ ER+ HER2-
metastatic breast cancer with AR < 40% expression (third-line
metastatic setting).
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.
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, for which
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 and when the Company
will submit an EUA application, or receive an emergency use
authorization or any approval from FDA or from any regulatory
authority outside the U.S. for sabizabulin for certain COVID-19
patients; whether and when sabizabulin will become an available
treatment option for certain COVID-19 patients in the U.S. or
anywhere outside the U.S.; whether the Company will have sufficient
supply of sabizabulin to meet demand, if an emergency use
authorization or other approval is granted; whether the Company
will secure any advance purchase agreement with the U.S. government
or any foreign government; whether the 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 of 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; 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 U.S. 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; and whether and when ENTADFI will be
commercialized successfully. 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 or
other regulatory authorities and any determinations made by the FDA
or any other regulatory authority, including the risk that the
Company may not be able to obtain an EUA from the FDA or similar
authorizations from other regulatory authorities on a timely basis
or at all; any agreements or positions taken by the FDA in a
pre-EUA meeting does not bind the FDA or prevent it from later
taking a different position, asking for more data or delaying or
denying the application; 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 lacks experience in scaling up or
commercializing a drug product and may not be able to successfully
commercialize sabizabulin as a COVID-19 treatment; the Company may
be unable to manufacture sabizabulin as a COVID-19 treatment in
sufficient quantities or at sufficient yields; 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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