Daré Bioscience, Inc. Discusses Key Goals with Wall Street Analyzer
August 03 2017 - 8:30AM
Daré Bioscience, Inc. (NASDAQ:DARE) discussed with Wall Street
Analyzer key goals over the next twenty-four months, including the
Ovaprene® clinical development program, the memorandum of
understanding with CONRAD to enter into an agreement in connection
with a postcoital test (PCT) clinical trial of Ovaprene®, and the
opportunities to license product candidates in women’s reproductive
health.
The interview is available for two days via the following
link:http://wallstreetanalyzer.com/2017/08/02/dare-bioscience-inc-nasdaq-dare-ceo-interview/
Ovaprene® is a clinical stage, non-hormonal vaginal
contraceptive ring intended to provide protection over multiple
weeks of use, require no intervention at the time of intercourse,
and fill a void in today’s contraception method mix. There are 40
million women in the US alone using contraception today, and half
of them prefer a short acting (meaning daily, weekly or monthly),
quickly reversible method.
In a pilot PCT clinical trial conducted in 21 women and
published in the Journal of Reproductive Medicine in 2009,
Ovaprene® demonstrated the following:
- Ability to immobilize sperm and prevent their progression into
the cervical mucus
- Acceptability of the device to both partners
- No serious adverse events were reported
While the original pilot PCT clinical trial was not designed to
be utilized as part of a regulatory submission, its data provide
preliminary proof-of-concept contraceptive efficacy. PCT clinical
trials have been used to assess the preliminary efficacy of other
contraception methods that work by preventing or blocking the
progression of sperm into the cervical mucus.
Daré intends to commence a PCT clinical trial of
Ovaprene® with CONRAD, and has begun the series of study
initiation activities that include manufacturing as well as other
clinical trial related activities, to prepare for enrolling the
first subjects in the PCT clinical trial in early 2018. Based on
current projections, Daré believes it is adequately funded to
advance Ovaprene® through the completion of the PCT clinical trial
within the next two years. A successful PCT clinical trial outcome
would represent a meaningful milestone and should allow Daré to
proceed directly to a pivotal contraceptive efficacy trial in the
United States.
Daré’s business model is built around licensing the rights to
promising product candidates (many with clinical proof-of-concept
data), advancing their clinical development, and if successful,
implementing a comprehensive global commercialization strategy in
combination with established pharmaceutical partners and regional
distributors. Daré is committed to developing a portfolio that
expands options, improves outcomes, and enhances safety for women
across a broad spectrum of categories relating to women’s
reproductive health. In addition to contraception, women’s
reproductive health encompasses categories including vaginal
health, fertility, pain, among others, and in parallel to advancing
the Ovaprene® development program Daré is actively evaluating other
portfolio opportunities that are also clinical stage products that
address unmet needs in women’s health.
About Daré Bioscience
Daré Bioscience is a healthcare company committed to the
development and commercialization of innovative products in women’s
reproductive health. Daré believes there is an unmet need in the
United States, in other developed countries, and in developing
countries, for innovative product candidates that expand options,
improve outcomes and are easy to use. Product development in
women’s reproductive health is fragmented creating a potential
opportunity for Daré. Daré’s goal is to fill the gap by taking
products from innovation through development and believes its
management team is well-suited to ensure Daré’s current and
potential future product candidates and products advance and one
day become commercially available. Daré’s founders, including its
executive management team, bring experience in global women’s
healthcare as well as success in prior ventures in funding,
achieving regulatory approvals, partnering, and launching a number
of products, including devices, therapeutics and diagnostics.
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Forward Looking Statements
This press release contains “forward-looking statements”
regarding matters that are not historical facts, including
statements relating to Daré’s expectations regarding the timing and
availability of results from its clinical trials, the timing of
commencement of manufacturing its products, the safety and
effectiveness of its products, Daré’s projected capital needs and
its ability to raise additional funds as needed, and the continued
ability of Daré to develop and market Ovaprene® under its license
with ADVA-Tec. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Words such
as “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “feel,” “hypothesize,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “would,” and
similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including: whether cash resources will be sufficient to
fund the operations of Daré it will undertake; the uncertainties
inherent in the initiation and completion of clinical trials;
availability and timing of data from ongoing and future clinical
trials and the results of such trials; whether preliminary results
from a clinical trial will be predictive of the final results of
that trial or whether results of early clinical trials will be
indicative of the results of later clinical trials; whether the
company will maintain its NASDAQ listing, expectations for
regulatory approvals; claims of infringement and other risks
relating to Daré’s owned and licensed intellectual property rights;
and other factors discussed in the "Risk Factors" section of Daré’s
Quarterly Report on Form 10-Q filed with the SEC on May 12, 2017,
and in other filings that Daré made with the SEC, including the
definitive proxy statement relating to the transaction with Daré
Bioscience Operations, Inc. filed with the SEC on June 19, 2017. In
addition, any forward-looking statements included in this press
release represent our views only as of the date of this release and
should not be relied upon as representing our views as of any
subsequent date. Daré specifically disclaims any obligation to
update any forward-looking statements included in this press
release.
For more information on Daré, please visit www.darebioscience.com
Phone: 858-926-7655
innovations@darebioscience.com
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