Vaginal health conditions, such as bacterial vaginosis, remain prevalent and serious problems that can negatively impact a woman's quality of life and create economic burden for women, employers, and the broader healthcare system. Scientific evidence suggests that there may be benefits to following an effective primary bacterial infection treatment with administration of live bacterial cultures to rebalance the vaginal microbiota disrupted by the infection. It is believed that addressing the vaginal dysbiosis by reconstituting the vaginal microbiota could reduce recurrence and reduce susceptibility to other infections and conditions, including sexually transmitted infections and preterm labor and birth. A barrier to development of live biotherapeutic products for vaginal administration in low and middle income countries is the identification of a delivery vehicle capable of maintaining the viability of the live microbes during product storage, shipment and distribution.
'One of Dare's top priorities is to accelerate the development of differentiated products that can not only improve outcomes but increase access and convenience for women,' said
On
About
Dare's first FDA-approved product, XACIATO (clindamycin phosphate) vaginal gel, 2% is 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. XACIATO is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. Dare's portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly intravaginal contraceptive whose
Dare 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),
Forward-Looking Statements
Dare 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 the potential development of a reconstitutable vaginal thermosetting gel formulation for delivery of live biotherapeutics, the potential capabilities and benefits of such a gel formulation and any therapeutic product in which it may be used, and the expected timing of the first commercial sale of XACIATO. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Dare's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements in this press release, including, without limitation: Dare'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; Dare'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;Dare's dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; Dare'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 Dare's operations, financial results and condition, and ability to achieve current plans and objectives, including the potential impact of the pandemic on Dare's ability to timely enroll, conduct and report results of its clinical trials and on the ability of third parties on which Dare relies to assist in the conduct of its business to fulfill their contractual obligations to Dare; 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 Dare's product or product candidates less competitive or obsolete;difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Dare's product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Dare's ability to retain its licensed rights to develop and commercialize a product or product candidate; Dare'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; Dare'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 Dare'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 Dare's product or product candidates or the business activities of Dare, its commercial collaborators or other third parties on which Dare relies; the impact of pharmaceutical industry regulation and health care legislation in
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