Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical
company focused on developing innovative medicines for potentially
higher quality weight loss, oncology, and viral induced acute
respiratory distress syndrome (ARDS), today announced financial
highlights for its fiscal 2024 first quarter and provided a
business update.
“FDA’s clearance of the Investigational New Drug application
(IND) for the planned enobosarm clinical trial to further increase
fat loss and weight loss while preventing the significant muscle
loss that occurs with weight-loss drugs, is a significant milestone
for Veru,” said Mitchell Steiner, M.D., Chairman, President, and
CEO of Veru Inc. “There's a critical unmet medical need for orally
administered therapeutics today that produce higher quality weight
loss for patients by preserving muscle and augmenting fat loss with
minimal to no additional side effects. Based on the promising
results of past enobosarm clinical muscle studies, we think that
enobosarm could effectively meet this critical unmet medical need.
We plan to commence the Phase 2b clinical study in April 2024 and
expect top line data by the end of the calendar year.”
Dr. Steiner added: "Supported by the solid institutional
investment of our recent financing, including many highly regarded
biotech institutional investors who were excited about the
potential of enobosarm for the avoidance of muscle loss - weight
loss indication, we believe our current funds are sufficient to
complete and report topline results for the Phase 2b enobosarm
study for potentially higher quality weight loss as well as the
Phase 2b open label extension study.”
Metabolic Disease Program Update:
The Company’s metabolic disease drug pipeline is focused
on the clinical development of enobosarm, a novel oral selective
androgen receptor modulator, to preserve muscle while augmenting
fat loss in patients receiving a GLP-1 RA for weight
loss.
Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a
novel oral daily 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 or wasting of both muscle and fat mass similar
to what is observed with GLP-1 RA treatment. The totality of the
clinical data from these five clinical trials demonstrates that
enobosarm treatment leads to dose-dependent increases in muscle
mass with improvements in physical function as well as significant
dose-dependent reductions in fat mass. The patient data that were
generated from these 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 and total weight loss while
avoiding muscle loss.
In addition, 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.
Initially, enobosarm will be developed in a Phase 2b clinical
study to address the large subpopulation of sarcopenic obese or
overweight elderly patients receiving a GLP-1 RA who are at-risk
for developing muscle atrophy and muscle weakness leading to
physical function mobility disability and frailty.
Phase 2b multicenter, double-blind, placebo-controlled,
randomized, dose-finding clinical trial to evaluate enobosarm as a
treatment to augment fat loss and to prevent muscle loss in
receiving GLP-1 drug for weight loss.
We submitted an Investigational New Drug (IND) application for
enobosarm in January 2024. In February 2024, the Company received
FDA clearance to initiate the Phase 2b, multicenter, double-blind,
placebo-controlled, randomized, dose-finding clinical trial
designed to evaluate the safety and efficacy of enobosarm 3mg,
enobosarm 6mg, or placebo as a treatment to augment fat loss and to
prevent muscle loss in 90 sarcopenic obese or overweight elderly
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 endpoint is total body fat mass at
16 weeks. The clinical study is expected to begin in April 2024
with the topline clinical results from the trial expected in the
end of the fourth calendar quarter of 2024.
After completing the efficacy dose-finding portion of the Phase
2b clinical trial, it is expected that participants will then
continue into an open label extension trial where all patients will
receive 6 mg of enobosarm monotherapy for 12 weeks to determine the
ability of enobosarm to rescue, or reverse muscle loss and prevent
fat and weight rebound after stopping a GLP-1 RA. The results of
the separate Phase 2b open label extension clinical study are
expected in calendar Q2 2025.
Other Program Updates:
The Company’s oncology drug pipeline is focused on the
clinical development of enobosarm, an oral selective androgen
receptor agonist, for the 2nd
line treatment of metastatic breast cancer.
Enobosarm is a new kind of endocrine therapy for advanced breast
cancer. Enobosarm is an oral, new chemical entity, selective
androgen receptor agonist that activates the androgen receptor (AR)
in AR+ ER+ HER2- metastatic breast cancer, which
suppresses tumor growth without the unwanted masculinizing side
effects and increases in hematocrit seen with androgens. Enobosarm
was being developed in a Phase 3 clinical trial for 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. As we have
prioritized our clinical programs to focus on enobosarm for
obesity, the continued clinical development of enobosarm for the
treatment of metastatic breast cancer is subject to the
availability of sufficient funding.
The Company’s infectious disease pipeline is focused on
the clinical development of sabizabulin, an oral, microtubule
disruptor for hospitalized adult COVID-19 patients at high risk for
ARDS.
The Company is developing sabizabulin 9mg, a novel oral
microtubule disruptor, which has both host targeted antiviral and
broad anti-inflammatory properties, as a two-pronged approach to
the treatment of hospitalized patients with viral lung infection at
high risk for ARDS and death. The Company has completed positive
Phase 2 and positive Phase 3 COVID-19 clinical studies that have
demonstrated that sabizabulin treatment resulted in a mortality
benefit in hospitalized moderate to severe patients with COVID-19
viral lung infection at high risk for ARDS and death. The Company
met with the FDA and reached agreement on the design of the Phase 3
confirmatory COVID-19 clinical trial to evaluate sabizabulin
treatment of hospitalized moderate to severe COVID-19 patients who
are at high risk for ARDS and the path forward to submit a new EUA
application and/or NDA. Although we received agreement from the FDA
on the design of a Phase 3 clinical trial broadly evaluating
sabizabulin in any viral-induced ARDS, we will continue to seek
external funding through government grants, pharmaceutical
partnerships, and similar sources to fund the clinical development
program. Without such external funding, we do not plan to advance
the Phase 3 development of sabizabulin as a treatment for
viral-induced ARDS.
FC2 Female Condom®
(internal condom)
The Company sells FC2 in both the U.S. commercial sector and in
the public health sector both in the U.S. and globally. FC2 is the
only FDA approved female (internal) condom in the US. FC2 is a
well-established business that has sold over 750 million female
condoms worldwide. Since 2017, FC2 has generated over $213 million
of net revenue.
Telehealth is an important commercial strategy in the U.S. for
access to birth control products especially FC2 as a nonhormonal
and latex free option to prevent pregnancy and transmission of
sexually transmitted infections. In order to maximize its reach and
to have more direct control of the promotion, distribution, and
sales of FC2, the Company made the decision last year to launch its
own independent, FC2-dedicated telehealth digital portal. The
Company continues to invest in and grow its direct to patient
telehealth portal as well as adding new telehealth and internet
fulfillment pharmacy partners to provide coverage in all 50 states
in the U.S.
In the global public health sector, the Company markets FC2 to
entities, including ministries of health, government health
agencies, U.N. agencies, nonprofit organizations and commercial
partners, that work to support and improve the lives, health and
well-being of women around the world. We are currently supplying a
large multi-year South African tender for female condoms, which is
expected to continue until 2025 and have seen sales grow in the
current year as the current tender launched. We also expect a
formal Brazil tender process to commence this year.
First Quarter Financial Summary: Fiscal 2024 vs Fiscal
2023
- Net revenues decreased to $2.1 million from $2.5 million
- Gross profit increased to $1.2 million from $0.7 million
Balance Sheet Information
- Cash and cash equivalents were $40.6 million as of December 31,
2023 versus $9.6 million as of September 30, 2023
Event DetailsThe audio webcast will be
accessible under the Investors page of the Company’s website at
www.verupharma.com. To join the conference call via telephone,
please dial 1-800-341-1602 (domestic) or 1-412-902-6706
(international) and ask to join the Veru Inc. call. An archived
version of the audio webcast will be available for replay on the
Company’s website for approximately three months. A telephonic
replay will be available on February 8, 2024 at approximately 12:00
p.m. ET by dialing 1-877-344-7529 (domestic) or 1-412-317-0088
(international), passcode 8260066, for one week.
About Sarcopenic Obesity
According to the CDC, 41.5% of older adults have obesity in the
United States and could benefit from a weight loss medication. Up
to 34.4% of these obese patients over the age of 60 have sarcopenic
obesity. This large subpopulation of sarcopenic obese patients is
especially at risk for taking GLP-1 drugs for weight loss as they
already have critically low amount of muscle due to age-related
muscle loss. Further loss of muscle mass when taking a GLP-1 RA
medication may lead to muscle weakness leading to poor balance,
decreased gait speed, mobility disability, loss of independence,
falls, bone fractures and increased mortality which is a condition
like age-related frailty. Because of the magnitude and speed of
muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA
drugs may accelerate the development of frailty in older obese or
overweight elderly patients.
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.
Metabolic pipeline: Enobosarm (aka ostarine, MK-2866, GTx-024,
and VERU-024), an oral daily novel selective androgen receptor
modulator (SARM), is being developed as a treatment in combination
with weight loss drugs to augment fat loss and avoid muscle loss in
overweight or obese patients for chronic weight management.
Initially, enobosarm will be developed in a Phase 2b clinical study
to address the large subpopulation of sarcopenic obese or
overweight elderly patients receiving a GLP-1 RA who are at-risk
for developing muscle atrophy and muscle weakness leading to
physical function mobility disability and frailty.
Oncology pipeline: Phase 3 clinical development of enobosarm for
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.
Infectious disease pipeline: 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 Veru’s
expectations regarding whether and when the planned phase 2b trial
of enobosarm discussed above will commence by April 2024, the
planned design, timing, endpoints, patient population and patient
size of such Phase 2b trial and whether such trial will
successfully meet any of its endpoints; whether enobosarm will be
shown to preserve muscle and physical function while augmenting fat
loss in the specified patient populations; whether the Phase 2b
data will be available by the end of 2024; whether the data will
warrant continued study and whether and when the clinical trial
participants will continue into an open-label extension study and
when those results will be available; whether enobosarm will meet
any unmet need for obesity patients; the planned timing, design,
endpoints, patient population and expected funding of the Company’s
breast cancer and infectious disease pipeline; and whether the
Company will be successful in its transformation into a late stage
biopharmaceutical company focused on obesity and oncology; and
whether the Company has sufficient cash to complete the planned
enobosarm Phase 2b trial in specified obesity patients. 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,
uncertainties related to market conditions and the satisfaction of
customary closing conditions related to the proposed public
offering and the Company’s expectations regarding the completion,
timing and size of the proposed public offering and the use of
proceeds therefrom. This list is not exhaustive and other risks 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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