Daré Bioscience, Inc. (NASDAQ: DARE), a leader in
innovation for the health and wellbeing of women, announced that it
was notified by the Nasdaq Office of General Counsel that the
Company regained compliance with the minimum bid price requirement
in Nasdaq Listing Rule 5550(a)(2) as a result of the closing bid
price of the Company’s common stock being $1.00 per share or
greater for 10 consecutive trading sessions and that the matter is
closed.
“We are thrilled to announce that we have regained compliance
with the Nasdaq minimum bid price rule,” said Sabrina Martucci
Johnson, President and CEO of Daré Bioscience. “This strengthens
our position in the market and enhances our ability to drive our
vision forward. We look forward to the opportunity to accelerate
our development efforts on key programs in our portfolio and to
ultimately provide great therapeutic options for women.”
“We continue to enroll participants in our pivotal Phase 3 study
of Ovaprene®, our potentially first-in-category hormone-free
monthly intravaginal contraceptive candidate, at sites across the
U.S.,” Johnson continued. “We are also continuing activities to
support progressing toward a Phase 3 trial of Sildenafil Cream,
3.6% in female sexual arousal disorder, for which there are
currently no FDA-approved treatments. We continue to execute on our
mission to accelerate development of and bring to market innovative
treatments that women want and need by advancing our late-stage
candidates – all of which represent a first-in-category opportunity
– as we seek to deliver value for all Daré stakeholders.”
About Daré BioscienceDaré Bioscience is a
biopharmaceutical company committed to advancing 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 prioritize women's health and well-being, expand
treatment options, and improve outcomes, primarily in the areas of
contraception, vaginal health, reproductive health, menopause,
sexual health and fertility.
The first FDA-approved product to emerge from Daré’s portfolio
of women’s health product candidates is XACIATO™ (clindamycin
phosphate) vaginal gel 2%, a lincosamide antibacterial indicated
for the treatment of bacterial vaginosis in female patients 12
years of age and older, which is under a global license agreement
with Organon. Organon commenced U.S. marketing of XACIATO
in the fourth quarter of 2023. Daré’s portfolio also includes
potential first-in-category candidates in clinical development:
Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive
whose U.S. commercial rights are under a license
agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream
formulation of sildenafil, the active ingredient in Viagra®, to
treat female sexual arousal disorder (FSAD); and DARE-HRT1, a
combination bio-identical estradiol and progesterone intravaginal
ring for menopausal hormone therapy. To learn more about XACIATO,
Daré’s full portfolio of women’s health product candidates, and
Daré’s mission to deliver differentiated therapies for women,
please visit www.darebioscience.com.
Daré Bioscience leadership has been named on the Medicine
Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In
2023, Daré's CEO was honored as one of Fierce Pharma’s Most
Influential People in Biopharma for Daré’s contributions to
innovation and advocacy in the women’s health space. Daré
Bioscience placed #1 in the Small Company category of the
San Diego Business Journal’s 2023 Best Places to Work Awards.
Daré may announce material information about its finances,
product and product candidates, clinical trials and other matters
using the Investors section of its 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 and 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 in the Investors section of its website and
to follow these X (formerly Twitter) accounts: @SabrinaDareCEO
and @DareBioscience. Any updates to the list of social media
channels the company may use to communicate information will be
posted in the Investors section of Daré’s website.
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,” “objective,” or the negative version of these
words and similar expressions. In this press release,
forward-looking statements include, but are not limited to,
statements relating to plans and expectations with respect to
Daré’s product candidates, including clinical development plans,
targeted indications, the potential for FDA approval of Ovaprene
based on a single pivotal clinical study, and the expectation that
a product candidate could be a first-in-category product. As used
in this press release, the description of a product candidate as
“first-in-category” is a forward-looking statement relating to the
potential of the candidate to represent a new category of product
if it were to receive marketing approval for the indication for
which Daré is developing it. 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, risks and
uncertainties related to: Daré’s ability to raise additional
capital when and as needed to advance its product candidates,
execute its business strategy and continue as a going concern;
Daré’s ability to develop, obtain FDA or foreign regulatory
approval for, and commercialize its product candidates and to do so
on communicated timelines; failure or delay in starting, conducting
and completing clinical trials of a product candidate; Daré’s
ability to design and conduct 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; Daré’s dependence on third parties to conduct
clinical trials and manufacture and supply clinical trial material
and commercial product; 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; the risk that the FDA, other regulatory
authorities, members of the scientific or medical communities or
investors may not accept or agree with Daré’s interpretation of or
conclusions regarding data from clinical studies of its product
candidates; the risk that development of a product candidate
requires more clinical or nonclinical studies than Daré
anticipates; the loss of, or inability to attract, key personnel;
the effects of macroeconomic conditions, geopolitical events,
public health emergencies, and major disruptions in government
operations on Daré’s operations, financial results and condition,
and ability to achieve current plans and objectives; the risk that
developments by competitors make Daré’s product or product
candidates less competitive or obsolete; difficulties establishing
and sustaining relationships with development and/or commercial
collaborators; failure of Daré’s product or product candidates, if
approved, to gain market acceptance or obtain adequate coverage or
reimbursement from third-party payers; Daré’s ability to retain its
licensed rights to develop and commercialize a product or 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 and product candidates; 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; product liability claims;
governmental investigations or actions relating to Daré’s product
or product candidates or the business activities of Daré, its
commercial collaborators or other third parties on which Daré
relies; the impact of pharmaceutical industry regulation and health
care legislation in the United States and internationally; global
trends toward health care cost containment; cybersecurity incidents
or similar events that compromise Daré’s technology systems or
those of third parties on which it relies and/or significantly
disrupt Daré’s business; 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:
Media and Investors on behalf of Daré Bioscience,
Inc:
Camilla White / Simona KormanikovaDentons Global
AdvisorsDareBioscience@dentonsglobaladvisors.com /
1.212.466.6450
Source: Daré Bioscience, Inc.
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From Sep 2024 to Oct 2024
Dare Bioscience (NASDAQ:DARE)
Historical Stock Chart
From Oct 2023 to Oct 2024