Daré Bioscience Reports Second Quarter 2021 Financial Results and Provides a Company Update

About this update from Dare Bioscience, Inc.

[{"type":"text","content":"Conference Call and Webcast Today at 4:30 p.m. Eastern Time\nSAN DIEGO, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the quarter ended June 30, 2021 and provided a company update. “This has been, and continues to be, an incredibly productive year for Daré,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Consistent with our guidance, we submitted our New Drug Application for DARE-BV1, a potential new first-line treatment for bacterial vaginosis, to the FDA in June. Our NDA was accepted for filing and received Priority Review with a PDUFA target date of December 7, 2021. This year we also commenced the Phase 2b RESPOND study of Sildenafil Cream, 3.6%, a potential first-in-category product in development to treat female sexual arousal disorder, a physiological condition for which there are no FDA approved products. In June, we announced positive topline results from our Phase 1 study of DARE-HRT1, a novel intravaginal ring designed to deliver bio-identical hormones which is being developed to treat vasomotor symptoms and the genitourinary syndrome commonly associated with menopause. And finally, we reported two new sources of non-dilutive funding for two of our programs – first, a grant intended to support the continued development of DARE-LARC1 over more than five years through the non-clinical proof of principle work, and second, a collaboration with the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development providing financial and operational support for the conduct of a pivotal Phase 3 clinical trial of Ovaprene®, an investigational hormone-free monthly contraceptive whose U.S. commercial rights are under a license agreement with Bayer.” Portfolio Accomplishments and Management Expectations for 2021-2022 DARE-BV1: Daré innovation: Novel, investigational thermosetting bioadhesive hydrogel formulated with clindamycin phosphate 2% as a first-line, single-administration treatment for bacterial vaginosis.4Q 2020: Successfully completed DARE-BVFREE Phase 3 clinical study.June 2021: Submitted New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).2021 Prescription Drug User Fee Act (PDUFA) goal date: NDA accepted and received Priority R...

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