Veru Announces Notification from Nasdaq Related to Delayed Quarterly Report on Form 10-Q
February 27 2024 - 7:15PM
Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical
company focused on developing innovative medicines for preserving
muscle for higher quality weight loss, oncology, and viral induced
acute respiratory distress syndrome (ARDS), today announced that it
received a delinquency notification letter (“Notice”) from the
Listing Qualifications staff of the Nasdaq Stock Market LLC
(“Nasdaq”) on February 21, 2024 due to the Company’s non-compliance
with Nasdaq Listing Rule 5250(c)(1) as a result of the Company’s
failure to timely file its Quarterly Report on Form 10-Q for the
fiscal quarter ended December 31, 2023 (the “Form 10-Q”). Nasdaq
Listing Rule 5250(c)(1) requires listed companies to timely file
all required periodic financial reports with the Securities and
Exchange Commission (the “SEC”).
The Notice states that the Company has 60 calendar days to
submit to Nasdaq a plan to regain compliance with the Nasdaq
Listing Rules. If Nasdaq accepts the Company’s plan, then Nasdaq
may grant the Company up to 180 calendar days from the prescribed
due date for filing the Form 10-Q or until August 19, 2024, to
regain compliance. If Nasdaq does not accept the Company’s plan,
then the Company will have the opportunity to appeal that decision
to a Nasdaq Hearings Panel.
As previously disclosed, the Company’s estimated research and
development expenses recorded were higher than the actual expenses
that were incurred, leading to the Company’s failure to file the
Form 10-Q on a timely basis. The net result of these 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. The Company continues to work
diligently to complete the Form 10-Q and plans to file the Form
10-Q as promptly as possible to regain compliance with the Listing
Rule.
This announcement is made in compliance with Nasdaq Listing Rule
5810(b).
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.
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,
expectations for the rest of the Company’s development pipeline,
the timing of the Company’s delinquent Form 10-Q filing and other
future filings, whether Nasdaq will accept the Company’s plan to
regain compliance with Nasdaq listing standards and the timing of
regaining compliance with Nasdaq listing standards, the potential
magnitude of the actual expenses to be recorded and the length of
time that the Company’s cash is expected to last. 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 Veru Inc. (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 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
Veru (NASDAQ:VERU)
Historical Stock Chart
From Apr 2024 to May 2024
Veru (NASDAQ:VERU)
Historical Stock Chart
From May 2023 to May 2024