Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s
health innovation, today announced that it received a second Notice
of Award of $982,851, part of a grant providing up to $1.9 million
in the aggregate for Ovaprene® research from the Eunice Kennedy
Shriver National Institute of Child Health and Human Development
(NICHD), a division of the National Institutes of Health (NIH). The
first award under the grant was $224,665. This second award, an
additional $982,851, followed the NIH’s review of an interim data
analysis and other results of the first phase of work. The award
will be applied to important clinical development efforts
supporting Ovaprene, a potential first-in-class hormone-free
contraceptive solution. The remaining portion of the award under
the grant, $730,722, is contingent upon, among other matters,
assessment that the results of the ongoing Ovaprene study satisfy
specified requirements set out in the award notice, and the
availability of funds.
“We are honored to continue to receive this
non-dilutive funding to support the ongoing Ovaprene study,” said
Sabrina Martucci Johnson, President & CEO of Daré Bioscience.
“The second notice is well timed as we are actively enrolling
couples in our pre-pivotal, postcoital test (PCT) clinical study
and gathering data regarding Ovaprene’s general safety,
acceptability, and effectiveness in preventing progressively motile
sperm from reaching the cervical mucus. The completion of the PCT
clinical study will represent a significant milestone for Daré, and
we currently expect to report topline data during the second half
of 2019. If positive, we intend to submit an investigational device
exemption (IDE) application to the U.S. Food & Drug
Administration (FDA) in order to commence a pivotal contraceptive
study of Ovaprene during 2020.”
Ovaprene is a clinical stage, non-hormonal
contraceptive ring intended to provide contraceptive protection for
multiple weeks. It requires no intervention at the time of
intercourse and fills a void in today’s contraception alternatives.
It represents a new approach to contraception and if approved, will
offer women a convenient non-hormonal and non-invasive
contraception method.
Daré worked with Grant Engine, a leading company
in the Small Business Innovation Research program for the NIH, U.S.
Department of Defense, Defense Advanced Research Projects Agency
and other federal government funding opportunities, on the
development of the grant proposal. 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 a project that will be supported by Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD) of the National Institutes of Health under
Award Number R44HD095724.
About the Eunice Kennedy
Shriver National Institute of Child Health and Human
Development (NICHD)
NICHD conducts and supports research in the
United States and throughout the world on fetal, infant and
child development; maternal, child and family health; reproductive
biology and population issues; and medical rehabilitation. For more
information, visit http://www.nichd.nih.gov.
About Grant Engine
Grant Engine principals are company builders
first and last. Grant Engine helps leading companies build
value through its proprietary process. The key principals
have an excellent track record of building companies through
non-dilutive funding as well as equity. For more
information, visit grantengine.com.
About Funding under the
Grant
NIH funding is often distributed in phases.
Phase I funding of the Ovaprene grant was $224,665 and covered
research and development activities from May 2, 2018 through
October 31, 2018. Phase II funding of up to $982,851 will
cover approved activities from March 11, 2019 through February 29,
2020. The award of the last phase of funding of up to $730,722 is
contingent upon Daré satisfying specified requirements set out in
the Phase II notice of award, including a determination that the
Phase II goals were achieved, as well as an assessment of the
project’s commercialization and availability of funds.
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-class candidates in clinical development: Ovaprene®, a
non-hormonal, monthly contraceptive intravaginal ring; Sildenafil
Cream, 3.6%, a novel cream formulation of sildanefil 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 uses these channels to
communicate with its investors and the public about the company and
other company-related matters. The information Daré posts on its
investor relations website 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: www.darebioscience.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 potential to receive reimbursement
for expenses incurred under the Phase II of the NIH grant; the
potential to receive notification of award of the Phase III funding
of the NIH grant; the completion of the PCT clinical study;
expectations regarding the timing of reporting on data from the PCT
clinical study; the intent to submit an IDE application to the FDA
to commence a pivotal contraceptive study of Ovaprene and the
timing thereof. 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;
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; 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.
Contacts:
Investors on behalf of Daré Bioscience, Inc.:Alex GrayBurns
McClellanagray@burnsmc.com212-213-0006
OR
Media on behalf of Daré Bioscience, Inc.:Amanda GuisbondCanale
Communicationsamanda@canalecomm.com781-405-8775
Source: Daré Bioscience
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