Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health
innovation, today announced a poster presentation at the American
Society for Reproductive Medicine (ASRM) 2019 Scientific Congress
& Expo, which will take place in Philadelphia, Pennsylvania,
October 12-16, 2019.
Daré’s Chief Scientific Officer, David Friend, PhD, will present
findings from a pharmacokinetic animal study of DARE-FRT1, which is
being developed for the prevention of preterm birth and as a new
option for luteal phase support following in-vitro fertilization
(IVF). DARE-FRT1 is part of Daré’s novel intravaginal ring (IVR)
technology platform and is designed to allow for convenient
non-invasive, non-oral administration of bio-identical progesterone
during a 14-day period.
“The research being highlighted at this year's ASRM meeting
reinforces our commitment to develop new treatment options for
women at risk for preterm birth and to better support providers and
women utilizing progesterone to improve outcomes following an IVF
procedure,” said Sabrina Martucci Johnson, President and CEO of
Daré Bioscience.
Impaired fecundity (physical difficulties getting pregnant or
carrying a pregnancy to live birth) affects an estimated 6.7
million women aged 15-44 in the U.S., or approximately 11% of women
of reproductive age, and 25% of infertile couples have more than
one factor leading to infertility.1,2 According to Grand View
Research, the global IVF market size was valued at $16.68 billion
in 2018 and is estimated to expand at a compound annual growth rate
of 10.2% during the next seven years. Increases in the cases of
infertility and development of advanced technologies were cited as
growth drivers.3
“DARE-FRT1 has the potential to continuously deliver
bio-identical progesterone in a convenient way during a period of
14 days,” said Dr. Friend. “With approximately 10% of all
pregnancies in the U.S. resulting in preterm births,4 and the
increasing demand for pregnancy support following IVF procedures,
DARE-FRT1 could become an important new option for women and
healthcare providers seeking better ways to address these
significant unmet needs in women’s health.”
Poster Presentation Information
Poster Number: P-173Presentation Day: Tuesday, October 15,
2019Abstract Title: 1761: A Novel Progesterone Releasing
Intravaginal Ring for Luteal Phase Support: Pharmacokinetics and
Safety in a Sheep ModelSession Topic: IVF Outcome Predictors -
Luteal Support
1 – Chandra A, et al., Infertility and Impaired Fecundity in the
United States, 1982–2010: Data From the National Survey of Family
Growth, National Health Statistics Reports, No. 67, Aug 14, 2013,
https://www.cdc.gov/nchs/data/nhsr/nhsr067.pdf
2 – ASRM,
https://www.reproductivefacts.org/faqs/quick-facts-about-infertility/
3 – In-Vitro Fertilization (IVF) Market Size, Share & Trends
Analysis Report By Type, By Instrument (Disposable Devices, Culture
Media, Capital Equipment), By End Use, By Region, And Segment
Forecasts, 2019 – 2026, Mar 2019,
https://www.grandviewresearch.com/industry-analysis/in-vitro-fertilization-market
4 – Martin J, et al., Births: Final Data for 2017,
National Vital Statistics Reports, Vol. 67, No. 8, Nov 7, 2018,
https://www.cdc.gov/nchs/data/nvsr/nvsr67/nvsr67_08-508.pdf1
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-category
candidates in clinical development: Ovaprene®, a hormone-free,
monthly contraceptive intravaginal ring; 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 the
company'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
commitment to developing new treatment options for preventing
preterm birth and improving outcomes following IVF procedures,
DARE-FRT1’s potential to deliver bio-identical progesterone
continuously over 14 days in a convenient, non-systemic and
non-invasive way, and DARE-FRT1’s potential to prevent preterm
birth and support pregnancy maintenance following IVF procedures.
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; the risk that promising results in pre-clinical
studies may not be replicated when a product candidate is tested in
human subjects; 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.:Lee RothBurns
McClellanlroth@burnsmc.com212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake RobisonCanale
Communicationsjake@canalecomm.com619.849.5383
Source: Daré Bioscience
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