Veru Reminds Shareholders to Vote in Advance of Tomorrow’s Deadline for 2024 Annual Meeting of Shareholders
18 6월 2024 - 5:45AM
Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical
company focused on developing innovative medicines for preserving
muscle for high quality weight loss, oncology, and viral induced
acute respiratory distress syndrome, would like to remind
shareholders to vote in connection with the Company’s upcoming
annual meeting of shareholders, to be held on Tuesday, June 18,
2024, at 9:00 AM ET. Shareholders are advised to vote their shares
in advance of the proxy voting deadline of tomorrow, Tuesday, June
18, 2024, at 9:00 AM ET.
Shareholders are encouraged to read the materials relating to
the Annual Shareholder Meeting, available on the Company’s website
https://verupharma.com/. In the interest of time, shareholders may
vote online or by telephone in accordance with the voting
instructions found on their Form of Proxy or their Voting
Instruction Form.
About Veru Inc.Veru is a late clinical stage
biopharmaceutical company focused on developing novel medicines for
the treatment of metabolic diseases, oncology, and ARDS. The
Company’s drug development program includes two late-stage novel
small molecules, enobosarm and sabizabulin.
Enobosarm, a selective androgen receptor modulator (SARM), is
being developed for two indications: (i) Phase 2b clinical study of
enobosarm as a treatment to augment fat loss and to prevent muscle
loss in sarcopenic obese or overweight elderly patients receiving a
GLP-1 RA who are at-risk for developing muscle atrophy and muscle
weakness and (ii) subject to the availability of sufficient
funding, Phase 3 ENABLAR-2 clinical trial of enobosarm and
abemaciclib for the treatment of androgen receptor positive (AR+),
estrogen receptor positive (ER+) and human epidermal growth factor
receptor 2 negative (HER2-) metastatic breast cancer in the 2nd
line setting.
Sabizabulin, a microtubule disruptor, is being developed as a
Phase 3 clinical trial for the treatment of hospitalized patients
with viral-induced ARDS. The Company does not intend to undertake
further development of sabizabulin for the treatment of
viral-induced ARDS until we obtain funding from government grants,
pharmaceutical company partnerships, or other similar third-party
external sources.
The Company also has an FDA-approved commercial product, the FC2
Female Condom® (Internal Condom), for the dual protection against
unplanned pregnancy and sexually transmitted infections.
Forward-Looking StatementsThis press release
contains "forward-looking statements" as that term is defined in
the Private Securities Litigation Reform Act of 1995, including,
without limitation, express or implied statements related to
whether and when the phase 2b trial of enobosarm discussed above
will produce topline data or patients will progress into the
extension study, the planned design, number of sites, timing,
endpoints, patient population and patient size of such trial and
whether such trial will successfully meet any of its endpoints,
whether enobosarm will enhance weight loss or preserve muscle in,
or meet any unmet need for, obesity patients and whether it will
enhance weight loss, whether the Company’s scientific advisors will
make valuable contributions to the Company’s enobosarm program and
whether the Company will be successful in its transformation into a
late stage biopharmaceutical company focused on obesity and
oncology. The words "anticipate," "believe," "could," "expect,"
"intend," "may," "opportunity," "plan," "predict," "potential,"
"estimate," "should," "will," "would" and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Any
forward-looking statements in this press release are based upon
current plans and strategies of the Company and reflect the
Company's current assessment of the risks and uncertainties related
to its business and are made as of the date of this press release.
The Company assumes no obligation to update any forward- looking
statements contained in this press release because of new
information or future events, developments or circumstances. Such
forward-looking statements are subject to known and unknown risks,
uncertainties and assumptions, and if any such risks or
uncertainties materialize or if any of the assumptions prove
incorrect, our actual results could differ materially from those
expressed or implied by such statements. Factors that may cause
actual results to differ materially from those contemplated by such
forward-looking statements include, but are not limited 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 Company’s existing product, FC2, 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 telehealth
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 year ended September 30, 2023, as amended by the Form
10-K/A, 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.
* Wegovy® is a registered trademark of Novo Nordisk A/S
Investor and Media Contact:Samuel FischExecutive Director,
Investor Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
Veru (NASDAQ:VERU)
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Veru (NASDAQ:VERU)
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