Veru to Present at the H.C. Wainwright 25th Annual Global Investment Conference on September 11th, 2023
30 Agosto 2023 - 7:30AM
Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical
company focused on developing novel medicines for metastatic breast
cancer and for viral induced acute respiratory distress syndrome
(ARDS), today announced that Mitchell Steiner, M.D., Chairman,
President and Chief Executive Officer of Veru, will present at the
H.C. Wainwright 25th Annual Global Investment Conference to be held
at the Lotte New York Palace Hotel in New York City on Monday,
September 11th, 2023 at 9:00 a.m. ET.
A live webcast will be accessible through the Investors section
of the Company’s website at www.verupharma.com. Following the
event, an archived webcast will be available on the Veru
website.
About Veru Inc.Veru is a late clinical stage
biopharmaceutical company focused on developing novel medicines for
metastatic breast cancer and for viral ARDS.
Oncology program: metastatic breast cancer
The Company’s late-stage breast cancer development portfolio
comprises enobosarm, a selective androgen receptor targeting
agonist.
- Enrolling Phase 3 clinical ENABLAR-2 study – enobosarm +/-
abemaciclib combination versus estrogen blocking agent (active
control) as a 2nd line treatment in AR+ ER+ HER2-
metastatic breast cancer. The Company and Eli Lilly and Company
have entered into a clinical study collaboration and supply
agreement for the ENABLAR-2 study. Lilly supplies Verzenio®
(abemaciclib).
Infectious disease program: viral ARDS
- COVID-19: Sabizabulin is an
oral, first-in-class, new chemical entity, microtubule disruptor
that has dual anti-inflammatory and host mediated antiviral
properties. Veru has conducted a positive double-blind, randomized,
placebo-controlled Phase 3 COVID-19 clinical trial in 204
hospitalized moderate to severe COVID-19 patients at high risk for
ARDS and death. The primary endpoint was the proportion of deaths
by Day 60. Treatment with sabizabulin resulted in a clinically
meaningful and statistically significant 51.6% relative reduction
in deaths (p=0.0046) and was well tolerated. FDA granted Fast Track
designation to the Company’s COVID-19 program in January
2022. In April 2023, the Company reached agreement with FDA on
design of the Phase 3 confirmatory COVID-19 clinical trial to
evaluate sabizabulin in hospitalized moderate to severe COVID-19
patients at high risk for ARDS. Although the Company has reached
agreement with FDA for the design of Phase 3 confirmatory COVID-19
clinical trial, the Company now plans to meet with FDA to reach
agreement on the design of a proposed expanded Phase 3 confirmatory
study evaluating sabizabulin 9mg for the treatment of hospitalized
adult patients who have and type of viral lung infection and on
oxygen support who are at high risk for ARDS and death. The FDA has
granted a meeting with Veru for September 2023.
- Smallpox and Ebola viruses: The Company is
planning a pre-IND meeting with FDA to discuss the development of
sabizabulin for smallpox virus and Ebola virus under the Animal
Rule FDA regulatory approval pathway. A pre-IND meeting has been
granted for smallpox virus in August 2023.
Sexual health program – Urev
Veru has a commercial sexual health division called Urev that is
comprised of 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. The Company has launched its own independent,
FC2-dedicated direct to patient telehealth and pharmacy services
portal. The Company is focused on executing new contracts with
additional telehealth partners and has internet fulfillment
pharmacy partners that provide coverage in all 50 states in the
U.S. 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 planned design, enrollment, timing, commencement,
interim and full data readout timing, scope, regulatory pathways,
and results of the Company’s current and planned clinical trials,
including the confirmatory Phase 3 study of sabizabulin for certain
COVID-19 patients, the Phase 3 study of enobosarm in combination
with abemaciclib for the 2nd line treatment of AR+ ER+ HER2
metastatic breast cancer, the Phase 3 study of enobosarm in
bone-only non-measurable hormone receptor and HER2- metastatic
breast cancer, the Phase 3 study of sabizabulin in hospitalized
influenza patients at high risk of ARDS, and studies of sabizabulin
in smallpox virus and Ebola virus, and whether any of such studies
will meet any of its primary or secondary endpoint; whether and
when any of the planned interim analyses in the planned Phase 3
confirmatory study of sabizabulin for certain COVID patients will
occur and what the results of any such interim analyses will be;
whether the results of such interim analyses or the completed
confirmatory Phase 3 study or any other interim data will be
sufficient to support a new EUA application or an NDA; whether and
when the Company will expand the study of sabizabulin into other
ARDS indications; whether and when the Company will receive the
future installment payments of the ENTADFI purchase price or sales
milestone payments; and the outlook for growth in the Company's FC2
business through telehealth customers, our direct to patient
telehealth portal and the global public health sector. 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 as well
as other operations of the Company; the timing of any submission to
the FDA or any other regulatory authority and any determinations
made by the FDA or any other regulatory authority; the possibility
that as vaccines, anti-virals and other treatments become widely
distributed the need for new COVID-19 or other ARDS 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 or other
ARDS treatment, including favoring other treatment alternatives or
imposing price controls on COVID-19 or other ARDS treatments; the
Company’s existing products, including FC2 and, if authorized,
sabizabulin, and any future products, if approved, possibly not
being commercially successful; 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; 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, development costs, and
market awareness and acceptance of any telehealth platform we
develop; risks relating to our ability to increase sales of FC2
after significant declines in recent periods due to telehealth
industry consolidation and the bankruptcy of a large telehealth
customer; 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, product testing, transportation delays or regulatory
actions; costs and other effects of litigation, including product
liability claims and securities litigation; 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, 2022 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.
Investor and Media Contact:Samuel FischExecutive Director,
Investor Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
Veru (NASDAQ:VERU)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
Veru (NASDAQ:VERU)
Gráfica de Acción Histórica
De May 2023 a May 2024