 Conference Call Today at 4:30 p.m. Eastern TimeSAN DIEGO, Aug. 12, 2020 GLOBE NEWSWIRE -- Daré Bioscience, Inc. NASDAQ: DARE, a leader in womens health innovation, today reported financial results for the second quarter ended June 30, 2020 and provided a company update. During the second quarter, we continued to execute on key strategic and operational objectives, despite the challenges presented by the COVID-19 pandemic, said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. Importantly, we initiated the DARE-BVFREE pivotal study for DARE-BV1 in June. Given the anticipated short duration of the study, we expect to report topline data from the study by year-end 2020. Positive results from this single pivotal study will enable us to submit a new drug application for DARE-BV1 with the FDA in early 2021, two years from licensing the technology.Daré licensed the rights to DARE-BV1 and the underlying hydrogel technology at the end of 2018. The company applied for and obtained a qualified infectious disease product QIDP designation from the U.S. Food and Drug Administration FDA for DARE-BV1 in 2019, making DARE-BV1 eligible for a 5-year marketing exclusivity extension for the treatment of bacterial vaginosis in women upon approval. Daré also received Fast Track designation for DARE-BV1 for the treatment of bacterial vaginosis, which is granted by the FDA for drugs that are intended for the treatment of serious or life-threatening diseases or conditions and demonstrate the potential to address an unmet medical need. The designation offers the opportunity for more frequent interactions with the FDA to discuss the drugs development plan and ensure collection of appropriate data needed to support FDA approval. The Fast Track program is intended to facilitate development and expedite review of a Fast Track drug so that an approved product can reach the market expeditiously.The DARE-BVFREE study represents the first of a series of important upcoming milestones for our clinical-stage product candidates that are integral to our value creation strategy, said William Rastetter, PhD, Chairman of Darés Board of Directors. In addition to anticipating the topline data readout for our Phase 3 study of DARE-BV1 in 2020, in 2021, we expect to report topline data from our planned Phase 2b study of Sildenafil Cream 3.6 in female sexual arousal disorder, as well as topline data from our ongoing Phase 1 study of DARE-HRT1 for the vasomotor symptoms of menopause; and in 2022, we expect to report topline data for our planned pivotal contraceptive study of Ovaprene.Recent Business Highlights Ovaprene Publication of a peer-reviewed article supporting the use of the postcoital test study as a predictor of contraceptive effectiveness in Biology of Reproduction. DARE-BV1 Initiation of DARE-BVFREE pivotal Phase 3 clinical trial of DARE-BV1 in patients with bacterial vaginosis. DARE-HRT1 Initiation of Phase 1 clinical trial of DARE-HRT1, a novel intravaginal ring designed to deliver non-oral, bio-identical hormone therapy for the treatment of menopausal symptoms. DARE-LARC1 Receipt of 1.6 million in additional grant funding from the Bill Melinda Gates Foundation for the continued development of a user-controlled, long-acting reversible contraceptive. The remaining approximately 900,000 in funding under the current grant supplement from the foundation may be awarded before the end of 2020 in further support of DARE-LARC1 development activities. Second Quarter 2020 Financial Results General and administrative expenses were approximately 1.6 million for the second quarter of 2020, as compared to approximately 1.3 million for the second quarter of 2019, with the increase primarily due to increased personnel costs and an increase in rent and facilities expenses. Research and development expenses were approximately 5.6 million for the second quarter of 2020, as compared to approximately 2.5 million for the second quarter of 2019. The increase was due primarily to expenses related to development activities for DARE-BV1, Ovaprene and DARE-LARC1, and increased personnel costs, with such expenses partially offset by grant funding related to both Ovaprene and DARE-LARC1, and reduced costs related to development activities for Sidenafil Cream, 3.6 and DARE-HRT1. License expenses, which reflect payments due under Darés various product license agreements, were approximately 21,000 for the second quarter of 2020, as compared to 162,500 for the second quarter of 2019. Comprehensive loss for the second quarter of 2020 was approximately 7.1 million, as compared to approximately 4.7 million for the same period in the prior year substantially due to a greater loss from operations in the second quarter of 2020. Net cash provided by financing activities for the six months ended June 30, 2020 was approximately 11.3 million and consisted of net proceeds from sales of common stock in at-the-market offerings and under the companys equity line, proceeds from exercises of warrants and options and loan proceeds. Cash and cash equivalents were approximately 5.3 million at June 30, 2020, compared to approximately 4.8 million at December 31, 2019.Recent Developments Additional cash of approximately 3.4 million net of fees raised after June 30, 2020 from sales of common stock in at-the-market offerings and under the companys equity line. As of August 11, 2020, approximately 31.6 million shares of Daré common stock are outstanding.Upcoming Milestones DARE-BV1 topline data expected by year-end 2020; New drug application NDA submission anticipated early 2021 DARE-HRT1 topline data expected first half 2021 Sildenafil Cream, 3.6 - topline data expected by year-end 2021 Ovaprene topline data expected by year-end 2022COVID-19 Update: Daré continues to monitor the pandemic, its associated restrictions and their potential effects on the companys business, financial condition and results of operations, including the potential impacts on the companys planned clinical trials and its ability to raise additional capital when needed. Due to rapidly evolving circumstances, Daré is unable to predict with any reasonable accuracy the full financial and business impact of the pandemic on its business, financial condition or results of operations at this time.Conference CallDaré will host a conference call and live webcast today at 4:30 p.m. Eastern Time to review the companys financial results for the quarter ended June 30, 2020 and to provide a company update.To access the conference call via phone, dial 844 831-3031 U.S. or 443 637-1284 international. The conference ID number for the call 4097126. The live webcast can be accessed under Events Presentations in the Investor Relations section of the companys website at Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. To access the replay, please call 855 859-2056 U.S. or 404 537-3406 international. The conference ID number for the replay is 4097126. The call and webcast replay will be available until August 19, 2020.About Daré BioscienceDaré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for womens health. The companys mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health, and fertility.Darés clinical-stage product portfolio includes potential first-in-category candidates in clinical development: Ovaprene, a hormone-free, monthly contraceptive intravaginal ring whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; DARE-BV1, a unique hydrogel formulation of clindamycin phosphate 2 to treat bacterial vaginosis via a single application; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone replacement therapy following menopause. To learn more about Darés full portfolio of womens health product candidates, and mission to deliver differentiated therapies for women, please visit may announce material information about its finances, product candidates, clinical trials and other matters using its investor relations website SEC filings, press releases, public conference calls and webcasts. Daré 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 candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts on its investor relations website and to follow these Twitter accounts: SabrinaDareCEO and DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted on the investor relations page of Darés website mentioned above.Forward-Looking StatementsDaré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. 