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
preclinical and clinical studies related to DARE-BV1 at the 2021
Controlled Release Society (CRS) Virtual Annual Meeting on July
27th. Daré submitted a new drug application (NDA) to the U.S. Food
and Drug Administration (FDA) for DARE-BV1 for the treatment of
bacterial vaginosis in June of 2021.
Dr. Friend’s presentation will review the
results of several preclinical and clinical studies related to
DARE-BV1 including the positive topline results from the
DARE-BVFREE Phase 3 randomized, double-blinded, placebo-controlled
clinical trial evaluating DARE-BV1 in women diagnosed with
bacterial vaginosis, a condition that can cause serious health
risks and very disruptive symptoms and is estimated to affect
approximately 21 million women in the United States. DARE-BV1 is an
investigational thermosetting bioadhesive hydrogel containing
clindamycin phosphate 2% designed as a one-time
vaginally-administered treatment for bacterial vaginosis. The
results from the DARE-BVFREE study demonstrate DARE-BV1’s potential
to provide improved clinical cure rates as compared to those of the
current branded vaginal and oral prescription products for
bacterial vaginosis in a convenient, one-time dose.
Find out more information about the 2021 CRS
Virtual Annual Meeting by visiting the CRS website:
https://www.controlledreleasesociety.org/events/2021-crs-virtual-annual-meeting.
Dr. Friend’s presentation will be available
following the conclusion of the 2021 CRS Virtual Annual Meeting
under “Presentations, Events & Webcasts" in the Investors
section of the company's website
at http://ir.darebioscience.com. Information about the results
from the DARE-BVFREE Phase 3 clinical study of DARE-BV1 currently
can be found in the company’s most recent investor presentation
under “Presentations, Events & Webcasts" 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
hormone-free, monthly intravaginal 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 regarding
DARE-BV1’s clinical cure potential for bacterial vaginosis,
DARE-BV1’s potential to provide more effective treatment for
bacterial vaginosis as compared to current branded vaginal and oral
prescription products for bacterial vaginosis and DARE-BV1’s
commercial potential. 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 data from the DARE-BVFREE clinical study and/or may
require additional clinical or nonclinical studies of DARE-BV1
prior to accepting the DARE-BV1 NDA for filing or, if filed, prior
to approving the NDA; 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.
Media contact:Lisa
Walters-Hoffert, Chief Financial Officer Daré Bioscience,
Inc.lwalters@darebioscience.com858.926.7655
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