Full Press Release Details
Bioscience Regains Compliance with Nasdaq Minimum Bid Price Rule
DIEGO, July 19, 2024 (GLOBE NEWSWIRE) - Dare 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.
are thrilled to announce that we have regained compliance with the Nasdaq minimum bid price rule," said Sabrina Martucci Johnson,
President and CEO of Dar 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."
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 Dar stakeholders."
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.
first FDA-approved product to emerge from Dar '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. Dar '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, Dar 's full portfolio of women's health product candidates, and Dar 's mission to deliver
differentiated therapies for women, please visit www.darebioscience.com.
Bioscience leadership has been named on the Medicine Maker's Power List and Endpoints News' Women in Biopharma 2022. In 2023,
Dar 's CEO was honored as one of Fierce Pharma's Most Influential People in Biopharma for Dar 's contributions
to innovation and advocacy in the women's health space. Dar Bioscience placed #1 in the Small Company category of the San
Diego Business Journal's 2023 Best Places to Work Awards.
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. Dar
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 Dar posts
on its investor relations website or through social media channels may be deemed to be material information. Dar encourages investors,
the media, and others interested in the company to review the information Dar 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 Dar 's website.
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 Dar '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 Dar is developing it. Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause Dar '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: Dar '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; Dar '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; Dar '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; Dar '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 Dar '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 Dar 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 Dar 's operations, financial results
and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Dar 's
product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or
commercial collaborators; failure of Dar 's product or product candidates, if approved, to gain market acceptance or obtain
adequate coverage or reimbursement from third-party payers; Dar 's ability to retain its licensed rights to develop and
commercialize a product or product candidate; Dar '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; Dar '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 Dar '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 Dar 's product or product candidates or the business activities of Dar , its
commercial collaborators or other third parties on which Dar 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 Dar 's technology systems or those of third parties on which it relies and/or significantly
disrupt Dar 's business; and disputes or other developments concerning Dar 's intellectual property rights.
Dar '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 Dar 's risks and uncertainties, you are encouraged to review its documents filed with the
SEC including Dar '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. Dar 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
and Investors on behalf of Dar Bioscience, Inc:
White / Simona Kormanikova
Dar Bioscience, Inc.