Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced the receipt by its wholly owned
subsidiary of $1.5 million in additional grant funding from the
Bill & Melinda Gates Foundation. The grant supports ongoing
development activities in 2020 for its user-controlled long acting
reversible contraceptive program, referred to as DARE-LARC1.
DARE-LARC1 has been developed with the support from the foundation
in the form of approximately $18 million in grant funding prior to
this most recent disbursement. The remaining $1 million in funding
under the grant from the foundation may be awarded before the end
of 2020 in further support of DARE-LARC1 development
activities.
The technology underlying DARE-LARC1 is designed to enable drug
storage and precise delivery of therapeutic doses over months or
years through 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 are honored to continue to receive this non-dilutive funding
support from the foundation for the ongoing development of
DARE-LARC1,” said Sabrina Martucci Johnson, President & CEO of
Daré Bioscience. “The timing of this payment coincides with
important preclinical activities planned for the second half of
this year.”
DARE-LARC1 is a preclinical stage implantable, long-acting,
reversible investigational contraceptive designed to deliver the
benefits of traditional long-acting, reversible contraceptive
products with the added flexibility of wirelessly controlling drug
release based on individual needs. The implant is intended to be
operated by the woman to deliver contraceptive medication
automatically on a pre-set schedule after initiation or on a dosing
schedule entirely controlled by the woman and, in any case, that
can be activated or deactivated wirelessly as desired.
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
eligibility to receive an additional $1 million in funding from the
foundation before the end of 2020 and to the timing of planned
preclinical activities planned for the DARE-LARC1 program.
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, including the potential impact of the
pandemic 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 raise additional capital when and as needed to advance
its product candidates and continue as a going concern; 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 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 +1
212-213-0006Burns McClellanEmail: lroth@burnsmc.com
OR
Media on behalf of Daré Bioscience, Inc.:Jake Robison +1
619-849-5383Canale CommunicationsEmail: jake@canalecomm.com
Source: Daré Bioscience, Inc.
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