Daré Bioscience, Inc. (NASDAQ: DARE), a
leader in women’s health innovation, today announced it received a
Notice of Award of $730,722 in a grant supporting the
Ovaprene® postcoital test (PCT) clinical study research from
the Eunice Kennedy Shriver National Institute of Child Health
& Human Development, a division of the National Institutes
of Health (NIH). Having previously received two tranches under
the grant, this final tranche brings the total funds under the
grant to nearly $2 million. The NIH issued this final notice of
award for the PCT project after reviewing data from the completed
PCT clinical study and commercialization plans for Ovaprene, an
investigational hormone-free, monthly contraceptive.
“This additional non-dilutive funding from the NIH supports our
efforts to develop Ovaprene, which has the potential to be the
first hormone-free, monthly contraceptive option for women,”
said Sabrina Martucci Johnson, President & CEO of Daré
Bioscience. “This third grant award notice, which comes shortly
after our recently-announced exclusive licensing agreement with
Bayer, reflects our strategy to continue to support advancement of
our programs by accessing capital via a broad range of sources and
structures, including ways that don’t require a return to the
equity markets. This award notice is timely, as we plan to file an
Investigational Device Exemption application with the FDA to
support the ongoing development of Ovaprene later this year.”
Ovaprene is a clinical-stage, hormone-free vaginal contraceptive
intended to provide pregnancy prevention for multiple
weeks. Requiring no intervention at the time of intercourse,
if approved, Ovaprene could fill a void in today’s contraception
alternatives.
The award will fund the balance of the costs associated with the
completed Ovaprene PCT clinical study, a multi-center, open-label,
non-significant risk device pre-pivotal trial. In November 2019,
Daré announced positive topline results from the PCT study, where,
in all women and across all cycles evaluated, it prevented
virtually all sperm from entering the cervical canal, a surrogate
marker for contraceptive effectiveness.1 The topline results
from the PCT clinical study support continued clinical development
of Ovaprene and its potential to be the first hormone-free, monthly
contraceptive option for women. This notice of award follows
the January 2020 announcement of an exclusive licensing agreement
between Daré and Bayer, in which Bayer may commercialize Ovaprene
in the United States once approved by the Food and Drug
Administration (FDA).
Daré worked with Grant Engine on the development of its grant
proposal. Grant Engine provides grant writing expertise and has
successfully assisted its clients in securing grants under
the Small Business Innovation Research program for the
NIH, the U.S. Department of Defense, the Defense Advanced
Research Projects Agency and other government agencies. Daré
plans to continue to pursue non-dilutive funding opportunities to
support the further development of its product candidates.
The content of this press release is solely the responsibility
of Daré and does not necessarily represent the official views of
the National Institutes of Health. This press release
discusses research supported by the Eunice Kennedy Shriver National
Institute of Child Health & Human Development of
the National Institutes of Health under Award Number
R44HD095724.
1 https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-announces-positive-findings-postcoital-test
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 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.
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 Daré’s expectation for receipt of
funding from the NIH under the Notice of Award, Daré’s plans for
obtaining additional funding, Ovaprene’s potential to be the first
hormone-free, monthly contraceptive product, and the development
timeline for Ovaprene, including the timing of filing an
Investigational Device Exemption application with the FDA in
2020. 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 effects of the COVID-19 pandemic on Daré’s operations,
financial results and condition, and ability to achieve current
plans and objectives; Daré’s ability to continue as a going
concern; Daré’s ability to raise additional capital when and as
needed, to advance its product candidates; 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 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; the risks that the license agreement with Bayer
may not become effective and, if it becomes effective, that future
payments to Daré under the agreement may be significantly less than
the anticipated or potential amounts; 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.
Contacts:
Investors on behalf of Daré Bioscience, Inc.:
Lee Roth +1 212-213-0006 Burns McClellan
Email: lroth@burnsmc.com
OR
Media on behalf of Daré Bioscience, Inc.: Jake Robison +1
619-849-5383 Canale Communications
Email: jake@canalecomm.com
Source: Daré Bioscience, Inc.
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