Veru to Report Fiscal 2023 Third Quarter Financial Results on August 10, 2023
August 03 2023 - 8:30AM
Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical
company focused on developing novel medicines for breast cancer and
for viral acute respiratory distress syndrome (ARDS), today
announced it will host a conference call and audio webcast on
Thursday, August 10, 2023, at 8:00 a.m. ET to discuss its fiscal
2023 third quarter financial results and to provide a business
update.
The audio webcast will be accessible under “Investor Kit” in the
Investors page of the Company’s website at www.verupharma.com. To
join the conference call via telephone, please dial 1-800-341-1602
(domestic) or 1-412-902-6706 (international) and ask to join the
Veru Inc. call. An archived version of the audio webcast will be
available for replay on the Company’s website for approximately
three months. A telephonic replay will be available on August 10,
2023 at approximately 12:00 p.m. ET by dialing 1-877-344-7529
(domestic) or 1-412-317-0088 (international), passcode 1699199, for
one week.
About Veru Inc.Veru is a late clinical stage
biopharmaceutical company focused on developing novel medicines for
breast cancer and for viral ARDS.
Oncology program: advanced breast cancerThe
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 will supply Verzenio®
(abemaciclib).
- Planned Phase 3 study of enobosarm in nonmeasurable bone only
metastatic breast cancer.
Infectious disease program focuses on
viruses that pose serious worldwide global threat
- 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 Phase 3 confirmatory COVID-19 clinical trial to evaluate
sabizabulin in hospitalized moderate to severe COVID-19 patients at
high risk for ARDS. The Company plans to initiate this Phase 3
clinical study in 2H 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.
- Influenza: The Company is planning a Phase 3
clinical trial to evaluate sabizabulin in hospitalized influenza
patients at high risk for ARDS.
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.
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.. 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 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, including FC2
and ENTADFI and, if authorized, sabizabulin, 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; 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 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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