Veru to Participate in Fireside Chat at the 2023 Cantor Fitzgerald Global Healthcare Conference on September 28th, 2023
20 September 2023 - 2:30PM
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 participate in
a fireside chat at the 2023 Cantor Fitzgerald Global Healthcare
Conference to be held at the InterContinental New York, Barclay
Hotel in New York City on September 28th, 2023 at 10:55 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 Ebola virus under the Animal Rule FDA regulatory
approval pathway. Veru had pre-IND meeting with FDA in August for
smallpox virus. FDA agreed that the Animal Rule pathway is
acceptable for evaluating the efficacy of smallpox virus. The
Company will work with FDA to develop a plan for the nonclinical
studies that could support a smallpox indication.
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 alone or 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 the ENABLAR-2 study will
show results consistent with or greater than the ARTEST results
reported above; 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, antivirals
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
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