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, today announced that the
Company has now filed both an amendment to its Annual Report on
Form 10-K/A for the year ended September 30, 2023 (“Form 10-K/A”)
as well as its Quarterly Report on Form 10-Q for the three months
ended December 31, 2023. With the filings completed, the Annual
Meeting of Shareholders will now be held on Tuesday, June 18, 2024.
The Company intends to file an amendment to its definitive proxy
statement for the Annual Meeting with the Securities and Exchange
Commission to reflect, among other things, the rescheduled meeting
date for the Annual Meeting and the new record date for the Annual
Meeting. The Company will mail a new notice of the Annual Meeting
and proxy card to all shareholders entitled to vote as of the new
record date for the Annual Meeting.
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 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.
About EnobosarmEnobosarm (aka ostarine,
MK-2866, GTx-024, and VERU-024), a novel daily oral selective
androgen receptor modulator (SARM), has been previously studied in
5 clinical studies involving 968 older normal men and
postmenopausal women as well as older patients who have muscle
wasting because of advanced cancer. Advanced cancer simulates a
“starvation state” where there is significant unintentional loss of
both muscle and fat mass like that seen with GLP-1 RA treatment.
The totality of the clinical data from these five clinical trials
demonstrates that enobosarm treatment leads to preservation of
muscle mass with improvements in physical function as well as
significant reductions in fat mass. Enobosarm has a large safety
database, which includes 27 clinical trials involving 1581 men and
women dosed with duration of treatment in some patients for up to 3
years. In this large safety database, enobosarm was generally well
tolerated with no increase in gastrointestinal side effects. This
is important as there are already significant and frequent
gastrointestinal side effects with a GLP-1 RA treatment alone.
The efficacy and safety clinical data that were generated from
five enobosarm clinical trials in both elderly patients and in
patients with a cancer induced starvation-like state provide strong
clinical rationale for enobosarm. The expectation is that enobosarm
in combination with a GLP-1 RA would potentially augment the fat
reduction with higher quality total weight loss while preserving
muscle and physical function.
Planned Phase 2b enobosarm clinical trial design for
potentially high quality weight lossThe Phase 2b,
multicenter, double-blind, placebo-controlled, randomized,
dose-finding clinical trial is designed to evaluate the safety and
efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment
to preserve muscle and augment fat loss in 90 sarcopenic obese or
overweight elderly (>60 years of age) patients receiving a GLP-1
RA who are at-risk for developing muscle atrophy and muscle
weakness. The primary endpoint is lean body mass (muscle), and the
key secondary endpoints are total body fat mass and physical
function at 16 weeks. The IND has received FDA clearance, and the
clinical study is expected to begin in April 2024 with the topline
clinical results from the trial expected calendar year-end
2024.
After completing the efficacy dose-finding portion of the Phase
2b clinical trial, participants will then continue into a Phase 2b
extension clinical trial where all patients will stop receiving a
GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or
enobosarm 6mg for an additional 12 weeks. The Phase 2b extension
clinical trial will evaluate whether enobosarm can maintain muscle
and prevent the fat and weight rebound that occurs after stopping a
GLP-1 RA drug. The topline results of the separate Phase 2b
extension clinical study is expected in calendar Q2 2025.
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 planned phase 2b trial of enobosarm discussed
above will commence or produce topline data or patients will
progress into the extension study, the planned design, 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, 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 risks that are detailed in the Company’s
periodic reports filed with the SEC, including the Company's Form
10-K for the year ended September 30, 2023, as amended by the Form
10-K/A.
Investor and Media Contact:
Samuel FischExecutive Director, Investor
Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
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