Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced that it received the final
approximately $0.9 million in funding under the current grant from
the Bill & Melinda Gates Foundation. The grant payment will
support ongoing development activities for Daré’s investigational
user-controlled, long-acting reversible contraceptive (UC-LARC),
DARE-LARC1. Development of DARE-LARC1 has been supported by
approximately $19.5 million in grant funding from the foundation
prior to this most recent disbursement.
The technology underpinning DARE-LARC1 is
designed to store and precisely deliver therapeutic doses over
months or years in a single implant and was originally developed at
the Massachusetts Institute of Technology (MIT) by renowned
researchers Robert Langer, Ph.D. and Michael J. Cima, Ph.D.
“We believe the non-dilutive funding support
from the foundation for the development of DARE-LARC1 is a clear
validation of the unmet need in the long-acting, reversible
contraceptive, or LARC, category,” said Sabrina Martucci Johnson,
President & CEO of Daré Bioscience. “LARCs are one of the most
successful innovations in contraception, due to their exceedingly
high effectiveness rates and duration of protection ranging from 3
to 10 years. The current FDA-approved LARCs require physician
insertion and subsequent removal procedures for return to
fertility, which can be a deterrent for women who know they will
likely want to pause their contraception at some point during a
typical 3 to 10 year implant duration. Our DARE-LARC1 program seeks
to improve upon this product profile by providing a user-controlled
LARC with a comparably high level of contraceptive effectiveness
that will not require a woman to undergo procedures to remove and
re-insert the device when she wants to return to fertility and,
subsequently, when she wants resume contraception.”
DARE-LARC1 is a preclinical stage implantable
contraceptive product that is designed to deliver the benefits of
traditional long-acting, reversible contraceptive products with the
added flexibility of wirelessly controlling the duration of drug
release based on individual user needs. The implant is intended to
be operated by the user to deliver medication on a pre-determined
schedule that can be activated or deactivated wirelessly, as
required to provide contraceptive protection or enable her to
return to fertility. This grant payment will support
critical ongoing preclinical activities necessary to advance the
program to the next stage of development.
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 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 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 DARE-LARC1’s potential to satisfy an
unmet need in the contraceptive market, DARE-LARC1’s ability to
operate as designed and to demonstrate a rate of contraceptive
effectiveness comparable to currently marketed LARCs and the
potential for DARE-LARC1 to advance into clinical development.
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 study volunteers,
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; 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 Burns McClellanEmail: lroth@burnsmc.com+1 212-213-0006
Source: Daré Bioscience, Inc.
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