Daré Bioscience, Inc. (NASDAQ: DARE), a
leader in women’s health innovation, and Avomeen, an
accredited, independent contract research, development, and
manufacturing organization specializing in chemical analysis and
product development, today announced that the companies have signed
an agreement under which Avomeen will provide contract product
development laboratory services with a team specifically assembled
to support the advancement of Daré’s innovative pipeline of
investigational products designed to address persistent unmet needs
in women’s health. The unique partnership model is intended
to enable Daré to leverage Avomeen’s scientific expertise,
including advanced instrumentation and development techniques, and
accelerate development of key programs in a capital-efficient
manner.
Daré and Avomeen are currently collaborating on
development-stage programs, including Ovaprene®, an investigational
hormone-free, monthly contraceptive, and intend to expand their
partnership to include more programs in Daré’s women’s health
pipeline. Central to the collaboration is Avomeen’s ability to
develop customized protocols, test methods, and formulations with
processes tailored to unique product requirements and
specifications. This capability aligns with Daré’s portfolio of
potential first-in-category products, which often require a
customized approach to method development.
“One of the clear goals of this partnership is
to leverage Avomeen’s ingenuity and expertise in biopharmaceutical
development to support our clinical program initiatives in women’s
health,” said Sabrina Martucci Johnson, President and CEO of Daré
Bioscience. “Avomeen has a proven track record and impressive
regulatory accreditations combined with cutting-edge technological
capabilities that we believe will enable us to accelerate
development activities across our portfolio. Further, we
believe that the partnership agreement will result in greater
efficiencies and savings in our research and development
expenditures.”
Under the terms of the agreement, Avomeen will
be Daré’s preferred provider of product development laboratory
services for an initial three-year period, provided that Avomeen
has the expertise, resources and availability to perform the
services that Daré requires. In exchange for receiving that
exclusive service provider status, Avomeen will assemble operating
and oversight teams committed to the partnership and provide a
preferred discounted pricing structure and, if volume reaches
designated levels, will also provide scientific personnel dedicated
exclusively to supporting Daré’s development programs covered by
the agreement.
“Avomeen is excited about this partnership and
is well positioned to augment the existing clinical technical and
regulatory competencies at Daré,” said Mark Harvill, CEO of
Avomeen. “We have been able to apply our novel scientific and
technical solutions to Daré’s diverse portfolio, in large part due
to the collaborative approach that Daré implements with its
development partners like Avomeen.”
About Daré BioscienceDaré
Bioscience is a clinical-stage biopharmaceutical company committed
to the advancement of innovative products for women’s health. The
company’s mission is to identify, develop and bring to market a
diverse portfolio of differentiated therapies that expand treatment
options, improve outcomes and facilitate convenience for women,
primarily in the areas of contraception, vaginal health, sexual
health, and fertility.
Daré’s clinical-stage product portfolio includes potential
first-in-category candidates in clinical development: Ovaprene®, a
hormone-free, monthly contraceptive intravaginal ring
whose U.S. commercial rights are under a license
agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream
formulation of sildenafil to treat female sexual arousal disorder
utilizing the active ingredient in Viagra®; DARE-BV1, a unique
hydrogel formulation of clindamycin phosphate 2% to treat bacterial
vaginosis via a single application; and DARE-HRT1, a combination
bio-identical estradiol and progesterone intravaginal ring for
hormone replacement therapy following menopause. To learn more
about Daré’s full portfolio of women’s health product candidates,
and mission to deliver differentiated therapies for women, please
visit www.darebioscience.com.
Daré may announce material information about its
finances, product candidates, clinical trials and other matters
using its investor relations website
(http://ir.darebioscience.com), SEC filings, press releases, public
conference calls and webcasts. Daré will use these channels to
distribute material information about the company, and may also use
social media to communicate important information about the
company, its finances, product candidates, clinical trials and
other matters. The information Daré posts on its investor relations
website or through social media channels may be deemed to be
material information. Daré encourages investors, the media, and
others interested in the company to review the information Daré
posts on its investor relations website
(https://darebioscience.gcs-web.com/) and to follow these Twitter
accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the
list of social media channels the company may use to communicate
information will be posted on the investor relations page of Daré’s
website mentioned above.
About AvomeenAvomeen is an
accredited, independent contract research organization (CRO) and
contract development and manufacturing organization (CDMO),
bringing chemists and scientists together to tackle scientific
product-development challenges in the biopharmaceutical industry
and across other industries and applications. The company’s
unique approach is singularly focused on applying its expertise and
working closely with clients to help transform their biggest goals
into real solutions. Throughout each step of product development,
Avomeen’s scientists and experts work within a rigorous quality
system to ensure products comply with regulatory requirements and
consumer expectations.
Avomeen’s facility is FDA-Registered and
DEA-Licensed (schedules 1-5), and its laboratories are also
GLP/GMP-compliant, ISO 17025 accredited, and QP authorized for
clinical trial material in the EU. Avomeen offers complete,
comprehensive scientific solutions that support the entire product
development lifecycle, with a focus on growing strategic
partnerships. For a complete overview of service offerings and
areas of expertise, please visit www.avomeen.com.
Forward-Looking Statements
Daré cautions you that all statements, other
than statements of historical facts, contained in this press
release, are forward-looking statements. Forward-looking
statements, in some cases, can be identified by terms such as
“believe,” “may,” “will,” “estimate,” “continue,” “anticipate,”
“design,” “intend,” “expect,” “could,” “plan,” “potential,”
“predict,” “seek,” “should,” “would,” “contemplate,” “project,”
“target,” “tend to,” or the negative version of these words and
similar expressions. Such statements include, but are not limited
to, statements relating to the anticipated benefits to Daré of its
agreement with Avomeen. Forward-looking statements involve known
and unknown risks, uncertainties and other factors that may cause
Daré’s actual results, performance or achievements to be materially
different from future results, performance or achievements
expressed or implied by the forward-looking statements in this
press release, including, without limitation, risk and
uncertainties related to: Daré’s ability to raise additional
capital when and as needed to advance its product candidates and
continue as a going concern; the effects of the COVID-19 pandemic
on Daré’s operations, financial results and condition, and ability
to achieve current plans and objectives, including the potential
impact of the pandemic on Daré’s ability to timely enroll, conduct
and report results of its clinical trials and on the ability of
third parties on which Daré relies to assist in the conduct of its
business, including its clinical trials, to fulfill their
contractual obligations to Daré; Daré’s ability to develop, obtain
regulatory approval for, and commercialize its product candidates;
the failure or delay in starting, conducting and completing
clinical trials or obtaining FDA or foreign regulatory approval for
Daré’s product candidates in a timely manner; Daré’s ability to
conduct and design successful clinical trials, to enroll a
sufficient number of patients, to meet established clinical
endpoints, to avoid undesirable side effects and other safety
concerns, and to demonstrate sufficient safety and efficacy of its
product candidates; the risk that positive findings in early
clinical and/or nonclinical studies of a product candidate may not
be predictive of success in subsequent clinical and/or nonclinical
studies of that candidate; Daré’s ability to retain its licensed
rights to develop and commercialize a product candidate; Daré’s
ability to satisfy the monetary obligations and other requirements
in connection with its exclusive, in-license agreements covering
the critical patents and related intellectual property related to
its product candidates; developments by Daré’s competitors that
make its product candidates less competitive or obsolete; Daré’s
dependence on third parties to conduct clinical trials and
manufacture clinical trial material; Daré’s ability to adequately
protect or enforce its, or its licensor’s, intellectual property
rights; the lack of patent protection for the active ingredients in
certain of Daré’s product candidates which could expose its
products to competition from other formulations using the same
active ingredients; the risk of failure associated with product
candidates in preclinical stages of development that may lead
investors to assign them little to no value and make these assets
difficult to fund; and disputes or other developments concerning
Daré’s intellectual property rights. Daré’s forward-looking
statements are based upon its current expectations and involve
assumptions that may never materialize or may prove to be
incorrect. All forward-looking statements are expressly qualified
in their entirety by these cautionary statements. For a detailed
description of Daré’s risks and uncertainties, you are encouraged
to review its documents filed with the SEC including Daré’s recent
filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not
to place undue reliance on forward-looking statements, which speak
only as of the date on which they were made. Daré undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were made,
except as required by law.
Contact:
Investors on behalf of Daré Bioscience, Inc.: Lee Roth Burns
McClellanlroth@burnsmc.com212-213-0006
Source: Daré Bioscience, Inc.
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