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 it is
rescheduling its 2024 Annual Meeting of Shareholders originally
scheduled to be held on March 26, 2024. As previously disclosed,
the Company is in the process of restating its historical financial
statements which are expected to be finalized and filed no later
than April 15, 2024. The Company’s estimated research and
development expenses recorded were higher than the actual expenses
that were incurred and the Company’s cash on hand is expected to
last longer than initially stated. The Annual Meeting is being
rescheduled to allow shareholders ample time to review the restated
financial statements.
The Company’s Current Report on Form 8-K filed February 15,
2024, disclosed the need for the restatement due to overestimating
certain research and development expenses associated with the
Company’s projects with third-party service providers and the
accounting for these expenses. The Company records estimated
expenses of research and development activities conducted by
third-party service providers based on factors such as estimates of
the work completed as provided to the Company by confirmations by
such third-party service providers and provisions within agreements
with such third-party service providers such as scope of work,
payment, timeline and similar provisions. The Company’s estimated
research and development expenses recorded were higher than the
actual expenses that were incurred. The net result of research and
development estimated expenses being recorded at too high of an
amount is that the Company’s cash on hand is expected to last
longer than initially stated.
Once the Company has completed and filed the restated financial
statements, the Company will notify shareholders of the new date
and time for its 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 Enobosarm
Enobosarm (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 loss
The 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, whether the Company will be successful in its
transformation into a late stage biopharmaceutical company focused
on obesity and oncology, the expected timing of the Company’s
completion and filing of restated financial statements and the net
effect of such restatement on the Company’s historical financial
statements and the timing for the determination of a new date and
time for the Annual Meeting of Shareholders. 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,
uncertainties related to work required to complete the restatement
and the timing of completion of the restatement and the other 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.
Investor and Media Contact:Samuel FischExecutive Director,
Investor Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
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