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Daré Bioscience, Inc. (NASDAQ: DARE) is a clinical-stage biopharmaceutical company focused on the advancement of innovative products for women's reproductive health. The company's mission is to identify, develop, and bring to market a diverse portfolio of novel therapies that expand treatment options, improve outcomes, and facilitate convenience for women. Initially, the company's focus is on contraception, vaginal health, and fertility.
Daré's portfolio includes several product candidates in advanced clinical development. Their lead product, Ovaprene, is a non-hormonal monthly contraceptive ring currently undergoing clinical studies. The company's first FDA-approved product, XACIATO (clindamycin phosphate vaginal gel 2%), is a prescription gel for treating bacterial vaginosis in females aged 12 and older. Another prominent product candidate is Sildenafil Cream, 3.6%, a novel formulation intended to treat female sexual arousal disorder (FSAD).
Daré Bioscience has also engaged in significant partnerships to further its mission. For instance, the U.S. commercial rights for Ovaprene are licensed to Bayer, while XACIATO is under a global license agreement with Organon. This collaborative approach has enabled Daré to harness the clinical and market expertise of its partners while retaining control over development and regulatory approval processes.
Recently, Daré has aligned with the FDA on key elements of the Phase 3 program for Sildenafil Cream, setting the stage for a pivotal study to support a New Drug Application (NDA) filing. The company has also received grants, such as the $750,000 from the Bill & Melinda Gates Foundation, to support the development of bacteria-based biotherapeutic products. In addition, Daré is progressing with the clinical development of its hormonal therapy candidate, DARE-HRT1, a bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy.
Daré continues to build on its achievements from 2023, advancing its portfolio of novel investigational therapies, particularly those demonstrating proof of concept. The company actively engages in strategic processes to explore partnering opportunities for additional indications, such as GLP-1s for obesity and metabolic disorders.
Moreover, Daré received a $1 million payment as the latest installment under a grant agreement to advance its investigational contraceptive, DARE-LARC1. This product aims to address specific individual family planning goals with features like precision dosing and wireless control.
For the latest news and updates, investors and interested parties can visit Daré's investor relations website and follow their social media channels. The company remains committed to distributing material information through these channels and encourages stakeholders to stay informed about their developments and milestones.
Daré Bioscience (NASDAQ: DARE) will present at the 2021 BIO Digital virtual event from June 10-11 and 14-18, 2021. CEO Sabrina Martucci Johnson will discuss the company's portfolio of innovative investigational products beginning June 10 at 9 a.m. ET. The presentation will be accessible to registered attendees on-demand. Following the event, a recording will be available on Daré's investor relations website until July 2, 2021. Daré is focused on advancing women's health through unique products, including Ovaprene® and Sildenafil Cream, among others.
Daré Bioscience (NASDAQ: DARE) announced its financial results for Q1 2021, reporting a comprehensive loss of approximately $7.3 million, up from $4.3 million in Q1 2020. The company has $7.7 million in cash and cash equivalents. Daré plans to submit a New Drug Application for DARE-BV1, a treatment for bacterial vaginosis, in Q2 2021. Additionally, the Phase 2b study for Sildenafil Cream, aimed at treating female sexual arousal disorder, has commenced. The company also targets several key milestones for 2021-2022 across its product portfolio.
Daré Bioscience, Inc. (NASDAQ: DARE) will host a conference call and live webcast on May 13, 2021, at 4:30 p.m. ET to discuss its financial results for Q1 2021 and provide updates on the company. Interested participants can join via phone or through a webcast on the company’s investor relations website. Daré is focused on innovating women's health products, including candidates for contraception, sexual arousal disorder, bacterial vaginosis, and hormone therapy for menopause.
Daré Bioscience, Inc. (NASDAQ:DARE) announced that results from its postcoital test (PCT) clinical study of Ovaprene, a hormone-free monthly intravaginal contraceptive, will be presented at the 2021 ACOG Annual Meeting from April 30 to May 2, 2021. The topline results indicate Ovaprene effectively prevented motile sperm from entering the cervical canal. Medical Director, Christine Mauck, expressed confidence in advancing to a pivotal effectiveness study pending FDA approval. The virtual presentation will be accessible on the ACOG website starting April 30, 2021.
Daré Bioscience, Inc. (NASDAQ:DARE) announced positive topline results from its Phase 3 DARE-BVFREE study of DARE-BV1, a vaginal gel for treating bacterial vaginosis, set to be presented at the ACOG Annual Meeting from April 30 to May 2, 2021. The study involved 307 women, showing a clinical cure rate of 70% for the DARE-BV1 group compared to 36% for the placebo at Day 21-30. Notably, DARE-BV1 outperformed existing treatments in terms of efficacy and was well-tolerated with no adverse event-related discontinuations.
Daré Bioscience (NASDAQ: DARE) announced the appointment of Dr. Sophia N. Ononye-Onyia to its Board of Directors. Dr. Ononye-Onyia brings extensive experience in women's health commercialization, having held senior roles in global biopharmaceutical companies. Her leadership is expected to guide Daré's product candidates, including DARE-BV1, towards successful market entry. Dr. Ononye-Onyia is the founder of The Sophia Consulting Firm and has a strong background in medicinal chemistry and public health. This strategic appointment aims to enhance shareholder value.
Daré Bioscience (NASDAQ: DARE) reported its financial results for the year ending December 31, 2020. The company achieved a commercial partnership with Bayer for Ovaprene, potentially bringing in up to $310 million in milestone payments. The completion of its first Phase 3 study for DARE-BV1 showed a 76% clinical cure rate for bacterial vaginosis. Financially, the company reported a comprehensive loss of $27.4 million, with significant increases in R&D expenses. Cash equivalents were $4.7 million, with $29.5 million in net cash received during FY2020. Future objectives include NDA submissions and ongoing clinical trials.
Daré Bioscience Initiates Phase 2b RESPOND Study
On March 24, 2021, Daré Bioscience (NASDAQ:DARE) announced the start of the Phase 2b RESPOND clinical study for Sildenafil Cream, 3.6%, targeting female sexual arousal disorder (FSAD). This topical formulation of sildenafil aims to directly enhance blood flow to the genital area, potentially becoming the first FDA-approved treatment for FSAD. The study will involve approximately 400 to 590 subjects and aims for topline data by year-end 2021. FSAD affects around 10 million U.S. women, highlighting a significant market opportunity.
Daré Bioscience (NASDAQ: DARE) announced a conference call on March 30, 2021, at 4:30 p.m. ET to discuss its year-end financial results for 2020 and provide company updates. Interested participants can access the call via phone or live webcast on the company's investor relations website. Daré focuses on women's health, developing innovative products including Ovaprene®, Sildenafil Cream, DARE-BV1, and DARE-HRT1, aimed at enhancing treatment options in contraception and women’s health.
Daré Bioscience (NASDAQ: DARE) announced the completion of patient recruitment for its Phase 1 clinical trial of DARE-HRT1, an intravaginal ring designed to deliver bio-identical hormones for menopause treatment. The trial aims to assess pharmacokinetics and safety in approximately 30 post-menopausal women. Topline data is expected in Q2 2021. This study could position DARE-HRT1 as a first-in-category product, offering a novel option for hormone therapy. The company plans to utilize existing safety data for regulatory approval through the FDA’s 505(b)(2) pathway.
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