On
August 29, 2022, Daré announced that, based on the results of an interim analysis to evaluate the relative magnitude of the treatment
effect, Daré expects to complete enrollment in the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in the
fourth quarter of 2022, allowing for a topline data announcement target of the second quarter of 2023. The interim analysis was conducted
by an independent third-party statistical resource and Daré and its collaborator, Strategic Science & Technologies, LLC, continue
to remain blinded to results of the study by treatment group.
The
Phase 2b RESPOND clinical study is a multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of Sildenafil
Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD). The primary efficacy endpoint of the study is a composite
endpoint that includes patient-reported improvement in genital sensations of arousal and reduction in distress associated with FSAD.
The exploratory study is designed to evaluate Sildenafil Cream, 3.6% compared to placebo cream over 12 weeks of dosing following both
a non-drug and placebo run-in period. While the study was originally expected to randomize a minimum of 400 subjects into the double-blind
dosing period from 40 to 50 sites in the U.S. to achieve 150 subjects per arm completing the 12-week double-blind dosing period, based
on the analysis of unblinded data by the independent third-party statistical resource to evaluate the relative magnitude of the treatment
effect, it was determined to complete enrollment in the fourth quarter of 2022 with a revised projected 150 subjects expected to complete
the 12-week double-blind dosing period (approximately 75 subjects per arm). The reduction in the number of subjects should not be viewed
as indicative of the magnitude of the treatment effect. The relative magnitude of the treatment effect seen in the interim analysis should
not be viewed as predictive that topline data will show Sildenafil Cream, 3.6% achieved the efficacy endpoints of the Phase 2b study.
Forward-Looking
Statements
Daré
cautions you that all statements, other than statements of historical facts, contained in this report, 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 report, forward-looking statements include, but are not limited to, statements relating to the timing
of the completion of enrollment in the Phase 2b RESPOND clinical study and of the topline data announcement. 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 report, including, without limitation, risk and uncertainties related to: 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 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; 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; the loss of, or inability to attract, key personnel;
the effects of the COVID-19 pandemic, macroeconomic conditions and geopolitical events 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 to fulfill their contractual obligations to Daré; the risk that developments by competitors
make Daré’s product or product candidates less competitive or obsolete; failure to timely establish or maintain third-party
partnerships or collaborations to develop and/or commercialize Daré’s product and Daré’s product candidates, if
approved; 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, product candidates or business activities; cyberattacks, security breaches 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 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.