Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today announced that David Friend, PhD, the
company’s Chief Scientific Officer, will present data from the
company’s Phase 1 pharmacokinetic and safety study of DARE-HRT1 at
the European Menopause and Andropause Society’s (EMAS) 13th
European Congress on Menopause and Andropause being held virtually
September 8 - 10, 2021.
Dr. Friend will review the results of the Phase
1 clinical trial of DARE-HRT1, a novel segmented intravaginal ring
(IVR) designed to deliver bio-identical 17β-estradiol and
bio-identical progesterone continuously over a 28-day period as
part of a hormone therapy (HT) regimen to treat the vasomotor
symptoms (VMS) and genitourinary syndrome associated with
menopause. The topline data from the study support DARE-HRT1’s
potential to be the first FDA-approved product to offer vaginal
delivery of combination bio-identical estradiol and bio-identical
progesterone hormone therapy in a convenient monthly format to
treat both VMS as well as vaginal symptoms of menopause.
Find out more information about the 13th
European Congress on Menopause and Andropause by visiting the EMAS
website: https://2021.emas-online.org.
Dr. Friend’s presentation, entitled “Results of
a Phase 1 pharmacokinetic and safety study of DARE-HRT1, a 28-day
intravaginal ring for codelivery of bio-identical estradiol and
progesterone,” will be available following the conclusion of the
13th European Congress on Menopause and Andropause under
“Presentations, Events & Webcasts" in the Investors section of
the company's website at http://ir.darebioscience.com. Daré
announced topline results of the Phase 1 study of DARE-HRT1 in June
2021, and a copy of that announcement is available under “Press
Releases” in the Investors section of the company's website
at http://ir.darebioscience.com.
About Daré Bioscience
Daré 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 product portfolio includes potential
first-in-category candidates in clinical development: Ovaprene®, a
novel, hormone-free monthly contraceptive
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 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 the Investors section of its 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 in the Investors section of its website 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.
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. In this press release, forward-looking
statements include, but are not limited to, statements relating to
DARE-HRT1’s potential as a safe and effective hormone therapy for
symptoms of menopause and to be the first monthly therapy for VMS
and vaginal symptoms of menopause. 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: the risk that the FDA, other regulatory
authorities or members of the scientific or medical communities may
not accept or agree with Daré’s interpretation of or conclusions
regarding the study data; 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
design and conduct 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; the risk that developments by
competitors make Daré’s product candidates less competitive or
obsolete; failure of Daré’s product candidates, if approved, to
gain market acceptance or obtain adequate coverage from third-party
payers; 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;
Daré’s failure to timely establish or leverage third-party
partnerships or collaborations to commercialize its product
candidates, if approved; 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; cyber
attacks, security breaches or similar events that compromise Daré’s
technology systems or those of third parties on which it relies
and/or significantly disrupt Daré’s business; 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.
Contacts:
Investors on behalf of Daré Bioscience,
Inc.:Lisa Walters-Hoffert, Chief Financial OfficerDaré Bioscience,
Inc.lwalters@darebioscience.com 858.926.7655
OR
Media on behalf of Daré Bioscience, Inc.:Jake RobisonCanale
Communicationsjake.robison@canalecomm.com 619.849.5383
Source: Daré Bioscience, Inc.
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