Dare Bioscience, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for DARE-VVA1, a novel intravaginal proprietary formulation of tamoxifen being developed as a non-hormonal treatment option for moderate to severe dyspareunia, a symptom of VVA associated with menopause. With the IND clearance from the FDA, Dare can begin planning for an anticipated Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1. VVA is an inflammation and thinning of the vaginal epithelium due to chronic hypo-estrogenism, which is the reduction in levels of circulating estrogen.

Localized tamoxifen therapy such as DARE-VVA1 thus has the potential to counter the physiologic changes underlying VVA without introducing estrogen back into the system. Dare's first FDA-approved product, XACIATO?? (clindamycin phosphate) vaginal gel 2% is a lincosamide antibiotic 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.

Dare may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website, SEC filings, press releases, public conference calls and webcasts. DARE 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 candidate, clinical trials and other matters. In this press release, forward-looking statements include, but are not limited to, statements relating to DARE-VVA1's potential as a safe and effective therapy, and the first non-hormonal vaginal option, for moderate to severe dyspAREunia, a symptom of V VA, DARE-VVA1' potential to be a treatment option for the HR+ breast cancer population, the potential for the IND clearance of DARE-VVA 1 to support Dare's strategic discussions, Dare's Phase 2 clinical development plans for DARE-VVA 1, and the potential market opportunity for DARE-VVA2, if approved.

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 candidates; 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; the risk that positive findings in early 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 Dare's interpretation of or conclusions regarding data from clinical studies of its product candidates; the risks that development of a product candidate requires more clinical or nonclinical studies than Dare 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 Dare's operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors makeDare's product or product candidates less competitive or obsolete; difficulties and sustaining relationships with development and/or commercial collaborators; failure or sustaining relationships with development and/or commercial collaborators; failure or delay in the development and/or commercial collaborators.