Daré Bioscience, Inc. (NASDAQ: DARE), a
leader in women’s health innovation, today announced that it
received a Notice of Award of a grant from the Eunice Kennedy
Shriver National Institute of Child Health and Human Development
(NICHD), a division of the National Institutes of Health (NIH). The
award will support the clinical development of its novel
intravaginal ring (IVR), DARE-FRT1. DARE-FRT1 is designed to
deliver bio-identical progesterone continuously over a 14-day
period and is being developed as a more convenient treatment option
for the prevention of preterm birth and broader luteal phase
support as part of an in vitro fertilization regimen.
Daré’s IVR technology is designed to allow for
sustained drug delivery over time periods ranging from weeks to
months. Unlike other vaginal rings, Daré’s IVRs feature a solid
ethylene vinyl acetate (EVA) polymer matrix to contain and release
a single or multiple active drugs without the need for a membrane
or reservoir. DARE-FRT1 represents one of the potential unique
applications of Daré’s IVR technology in that it is designed to
deliver non-oral bio-identical progesterone over multiple weeks
without the need for daily administration, which has the potential
to offer a better patient experience when compared to other
delivery methods and may improve key aspects of treatment in terms
of convenience and compliance.
“The World Health Organization (WHO) estimates
that every year 15 million babies are born preterm, before 37
completed weeks of gestation, that this number is rising, and that
complications from preterm birth are the leading cause of death
among children under five years of age, equating to approximately
one million deaths in 2015¹,” said Sabrina Martucci Johnson,
President and CEO of Daré Bioscience. “We continue to strive to
deliver against our mission of addressing persistent unmet needs in
women’s health, and based on the latest data from the WHO, it’s
clear that preterm birth is an area of continued and growing unmet
need. We are grateful to the NICHD for its commitment to advancing
new innovation in this important therapeutic area and look forward
to advancing the development of DARE-FRT1 with the NICHD’s
support.”
In July, Daré announced the initiation of a
Phase 1 clinical trial of DARE-HRT1, a development-stage program
utilizing the same IVR technology as DARE-FRT1 to deliver non-oral,
bio-identical progesterone and estradiol for the treatment of
menopausal symptoms.
“We believe the DARE-HRT1 Phase 1 study will
provide important scientific information for both DARE-HRT1 and
DARE-FRT1, given that they both utilize the same IVR technology and
bio-identical progesterone as an active ingredient,”
said David Friend, PhD, Chief Scientific Officer of Daré
Bioscience. “Specifically, in the Phase 1 study of DARE-HRT1, we
anticipate collecting useful pharmacokinetics characteristics of
the bio-identical progesterone alone, which can be expected to
directly apply to DARE-FRT1, and inform the work that the NICHD
award will support.”
Daré worked with Grant Engine on the development
of its grant proposal to the NICHD. Grant Engine is regularly
identified as a leading company to assist with federally funded
grant opportunities, including through the Small Business
Innovation Research (SBIR) program for the NIH, the Department of
Defense, the Defense Advanced Research Projects Agency and others.
Daré plans to continue to pursue non-dilutive funding opportunities
to support the further development of its product candidates.
NIH funding is awarded in phases and Daré may be
eligible to receive up to a total of approximately $2.3 million in
grant funding for its DARE-FRT1 program based on the grant
application it submitted to support the DARE-FRT1 Phase 1 human
clinical study. The NICHD award granted to date of approximately
$300,000 is for what is referred to as the “Phase I” segment of the
project outlined in Daré’s grant application, which is to occur
during the period of August 2020 through July 2021. Additional
potential funding of up to approximately $2 million for the “Phase
II” segment of the project outlined in the grant application is
contingent upon satisfying specified requirements, including,
assessment of the results of the Phase I segment, determination
that the Phase I goals were achieved, and availability of
funds.
The content of this press release is solely the
responsibility of Daré Bioscience, Inc. 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 &
Human Development of the National Institutes of Health under Award
Number R44HD101169.
¹ World Health Organization, Preterm birth
key facts [accessed 2020 Aug 18],
https://www.who.int/news-room/fact-sheets/detail/preterm-birth
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 EngineGrant 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 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 clinical-stage 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 StatementsDaré
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, the potential for DARE-FRT1 to
provide a safe, effective and convenient treatment option for the
prevention of preterm birth or broader luteal phase support as part
of an in vitro fertilization regimen, the potential utility of
Daré’s IVR technology to address persistent unmet needs in women’s
health, the potential utility of the Phase 1 clinical study of
DARE-HRT1 in the development of DARE-FRT1, Daré’s plans to continue
to pursue non-dilutive funding opportunities to support the further
development of its product candidates, and the potential for Daré
to receive up to approximately $2.3 million in total grant funding
from the NICHD based on the grant application it submitted for
DARE-FRT1. 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 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 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
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; 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.
Contact:
Investors on behalf of Daré Bioscience, Inc.:
Lee Roth Burns McClellanlroth@burnsmc.com212-213-0006
Source: Daré Bioscience, Inc.
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