Veru to Present Corporate Update at the H.C. Wainwright BioConnect Conference on January 10-13, 2022
January 03 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 cancer, today announced that the Company will
present at the H.C. Wainwright BioConnect Conference. The
presentation will be available through the Conference from January
10-13, 2022, beginning at 7:00 am Eastern Standard Time on January
10th.
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% (third-line metastatic setting)
- Planned Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a
CDK 4/6 inhibitor) in AR+ ER+ HER2- metastatic breast cancer with
AR ≥ 40% (second-line metastatic setting)
- Planned Phase 2b study of sabizabulin in AR+ ER+ HER2-
metastatic breast cancer with AR < 40% (third-line metastatic
setting)
- Planned Phase 2 study of sabizabulin + enobosarm combination
therapy in metastatic triple negative breast cancer after two
systemic chemotherapies.
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 to determine a patient’s androgen receptor expression
status. We have partnered with Roche/Ventana Diagnostics, a world
leader in oncology companion diagnostics, which will develop and,
if it is approved, commercialize the companion AR diagnostic.
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 and ongoing Phase 2 studies of
sabizabulin 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 in men with
advanced prostate cancer undergoing androgen deprivation therapy
who suffer from hot flashes
In addition, sabizabulin, which has dual antiviral and
anti-inflammatory effects, is currently enrolling in a Phase 3
study for the treatment of hospitalized COVID-19 patients at high
risk for acute respiratory distress syndrome, also known as the
cytokine storm.
Veru also has a commercial sexual health division, the proceeds
of which help fund our drug development programs. Its two main
products are:
- ENTADFI™ (finasteride and tadalafil) capsules for oral use, a
new treatment for benign prostatic hyperplasia
- 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: when commercial launch of
ENTADFI will occur; the magnitude of any potential revenues
generated by ENTADFI; whether the Company’s current or future
clinical development program results will demonstrate sufficient
efficacy and safety and potential benefits to secure FDA approval
of the Company’s drug candidates; and 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 trials possibly being unsuccessful or
insufficient to meet applicable regulatory standards or warrant
continued development; the ability to enroll sufficient numbers of
subjects in clinical trials 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 trials, 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; 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.
Investor and Media Contact:Samuel FischExecutive Director,
Investor Relationsand Corporate CommunicationsEmail:
veruinvestor@verupharma.com
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