On
December 12, 2022, Daré issued a press release announcing development of a new product candidate, DARE-PDM1, an investigational,
proprietary hydrogel formulated with diclofenac, a nonsteroidal anti-inflammatory drug, for vaginal administration as a treatment for
primary dysmenorrhea. A Phase 1 clinical study of DARE-PDM1 is targeted for 2023.
In
the press release, Daré also reviewed that other anticipated 2023 portfolio milestones include: (1) the first commercial sale
of XACIATO™ (clindamycin phosphate) vaginal gel, 2%, expected in the first half of 2023 in the United States; (2) announcement
of topline data from the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6%, targeted for the second quarter of 2023;
and (3) initiation of participant recruitment for the pivotal Phase 3 clinical study of Ovaprene®, targeted for mid-2023.
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. Forward-looking statements include, but are not limited to, statements relating to plans and expectations with
respect to Daré’s product candidates, including anticipated timing for commencement and conduct of clinical trials and clinical
trial data readouts, potential regulatory approval pathways, potential for FDA approval based on a single pivotal clinical study, and
potential to be first-line and/or first-in-category products, expectations regarding the commercial launch of XACIATO in the U.S., expectations
regarding commercial collaborations and potential payments under commercial collaboration agreements, expectations regarding market potential
for women’s health products outside of oncology, expectations regarding potential for investment in women’s health product
candidates to be efficient and disproportionately impactful in terms of translating dollars invested in research and development to sales
revenue, and expectations regarding Daré’s business model. 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 those
expressed or implied by the forward-looking statements, including, without limitation: 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; 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 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 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;
cyber attacks, 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 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.