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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) announced that CEO Sabrina Martucci Johnson will present at the 2020 BIO Investor Forum, held digitally from October 13-15, 2020. Registered attendees can access the presentation on demand during the event. Following the forum, a recording will be available in the Investor Relations section of the company's website until October 29, 2020. Daré is focused on innovative women's health products, including Ovaprene®, Sildenafil Cream, DARE-BV1, and DARE-HRT1, enhancing treatment options across various areas including contraception and sexual health.
Daré Bioscience (NASDAQ: DARE) announced the receipt of approximately $0.9 million in funding from the Bill & Melinda Gates Foundation, completing a total of $19.5 million in grant support for its user-controlled long-acting reversible contraceptive (UC-LARC), DARE-LARC1. This funding will aid in advancing the preclinical development of DARE-LARC1, designed to deliver therapeutic doses without requiring medical procedures. The technology, developed by MIT researchers, aims to address the limitations of current LARCs, offering a more flexible contraceptive solution.
Daré Bioscience, focused on women’s health, announced CEO Sabrina Martucci Johnson's participation in two virtual conferences on September 14 and 15, 2020. She will join the Women’s Health Innovation Summit's expert panel for women-centric clinical research and a CEO leadership panel, with both discussions available on-demand. Additionally, Johnson will present a company update at the H.C. Wainwright 22nd Annual Global Investment Conference on September 15, 2020, at 4:00 PM EDT. Live webcasts and an archive will be accessible through the company's website.
Daré Bioscience (NASDAQ: DARE) has formed a strategic partnership with Avomeen to enhance the development of its women’s health product pipeline. This agreement will allow Avomeen to provide tailored product development laboratory services for the next three years, prioritizing projects like Ovaprene®, a hormone-free contraceptive. The collaboration aims to leverage Avomeen’s scientific expertise to improve efficiency and reduce research costs. Both companies believe this partnership will facilitate faster market introductions for innovative products targeting unmet needs in women's health.
Daré Bioscience (NASDAQ: DARE) announced that Sabrina Martucci Johnson, President and CEO, will join a panel at Maxim Group's M-Vest Virtual Conference on August 13, 2020, at 10:00 a.m. ET. The discussion, moderated by Jason McCarthy, PhD, focuses on innovations in women's health. Daré is dedicated to advancing women's health through innovative product development, with a clinical-stage portfolio that includes Ovaprene®, Sildenafil Cream, DARE-BV1, and DARE-HRT1. For event registration and details, visit https://bit.ly/2DlgeRW.
Daré Bioscience (NASDAQ: DARE) has initiated a Phase 1 clinical trial for DARE-HRT1, aimed at delivering bio-identical hormones over 28 days to treat menopausal symptoms and prevent bone loss. This IVR product could be the first FDA-approved option following NAMS guidelines. The study will assess pharmacokinetics and safety in post-menopausal women. Conducted in Australia, the trial also allows for potential cash credits from the R&D tax incentive. The technology promises to enhance convenience and effectiveness in hormone therapy.
Daré Bioscience (NASDAQ: DARE) has published a literature review in Biology of Reproduction, highlighting positive results from a postcoital test (PCT) study of their hormone-free contraceptive, Ovaprene. The review concludes that PCT is a strong predictor of contraceptive effectiveness. Furthermore, if Ovaprene's clinical trial success aligns with previous studies, it may achieve contraceptive effectiveness rates of 86-91% comparable to traditional methods. Daré has an exclusive licensing agreement with Bayer for U.S. commercialization, which could yield up to $310 million in milestone payments and royalties.
Daré Bioscience (NASDAQ: DARE) announced it received an additional $1.5 million grant from the Bill & Melinda Gates Foundation, enhancing its development of the DARE-LARC1 contraceptive program. This funding is part of a previous $18 million commitment from the foundation, with an expectation of another $1 million by year-end. DARE-LARC1 aims to deliver precise drug doses from an implant, allowing user-controlled release. The company is focused on advancing innovative women's health products, including several clinical candidates.
Daré Bioscience (NASDAQ: DARE) announced its participation in the BIO Digital International Convention from June 8-12, 2020. CEO Sabrina Martucci Johnson will join a panel titled Redefining BioPharma in a Female-Forward World and deliver a company presentation. Both sessions will be available on-demand for registered attendees. Daré focuses on innovative women's health solutions including contraceptives and treatments for sexual health and bacterial vaginosis. The company aims to enhance treatment options and improve health outcomes for women.
Daré Bioscience (NASDAQ: DARE) has partnered with Health Decisions to enhance its clinical development for women's health products. This exclusive agreement assigns Health Decisions to provide CRO services in the U.S. for three years, focusing on Daré's reproductive health assets, including its pivotal Ovaprene® study and the DARE-BV1 Phase 3 study in bacterial vaginosis. The collaboration aims to leverage Health Decisions’ expertise and reduce clinical development costs. The partnership could expedite the advancement of innovative treatments in contraception, fertility, and gynecological disorders.
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