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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 CEO Sabrina Martucci Johnson's participation in two upcoming conferences focused on women’s health. The Informa Connect Women’s Healthcare Access & Innovation Digital Conference will take place on September 21, 2022, featuring a presentation on non-hormonal female contraception. The Longwood Healthcare Leaders Fall Webconference is scheduled for September 22, 2022, and will include a panel on innovative partnerships. Daré aims to advance products that enhance women's health.
Daré Bioscience (NASDAQ: DARE) announced that its President and CEO, Sabrina Martucci Johnson, will participate in a fireside chat at the H.C. Wainwright 24th Annual Global Investment Conference. The event is scheduled from September 12-14, 2022 at the Lotte New York Palace Hotel, with virtual attendance options available.
The chat will start on September 12 at 11:30 AM ET, and can be accessed on-demand through their website until September 26, 2022. Daré is focused on advancing women's health innovations.
Daré Bioscience (NASDAQ: DARE) announced key updates regarding their Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6%, targeting female sexual arousal disorder (FSAD). Enrollment is expected to complete by 4Q-2022, with topline data anticipated in 2Q-2023. This study aims to evaluate the efficacy and safety of the cream compared to a placebo in premenopausal patients. If successful, it could become the first FDA-approved treatment for FSAD, filling a significant market gap as currently no such options exist for women.
Daré Bioscience has announced a licensing agreement with Hennepin Life Sciences, acquiring exclusive global rights to develop and commercialize glycerol monolaurate (GML) for various vaginal infections. GML, a natural antimicrobial, has shown efficacy against significant strains of Candida and Gardnerella vaginalis without promoting antibiotic resistance. The deal includes milestone payments and royalties based on sales, with patents extending to 2040. This initiative advances Daré's mission to enhance women's health options, building on its recent agreement for the XACIATO treatment.
Daré Bioscience (NASDAQ: DARE) reported its financial results for Q2 2022, highlighting a $32.1 million cash position and a $10 million revenue recognition from a licensing agreement with Organon for XACIATO, an FDA-approved treatment for bacterial vaginosis. The company expects to launch XACIATO in the U.S. in Q4 2022. Ongoing clinical studies for DARE-VVA1 and DARE-HRT1 are also on track for topline data in the fourth quarter. General and administrative expenses increased to $2.8 million, while research and development expenses decreased slightly to $6.8 million.
Daré Bioscience (NASDAQ: DARE) will host a conference call and live webcast on August 9, 2022, at 4:30 p.m. ET, to discuss its financial results for Q2 2022 and company updates. Investors can access the call by dialing (800) 715-9871 (U.S.) or (646) 307-1963 (international), using conference ID 3817141. The call will also be available on the company’s website and will replay until August 23, 2022. Daré focuses on innovative women's health products, including its FDA-approved XACIATO™ and various candidates in development.
Daré Bioscience, Inc. (NASDAQ: DARE) announced that its President and CEO, Sabrina Martucci Johnson, will participate in a virtual panel titled "A Tipping Point in Women’s Health" on July 13, 2022, at 11:00 a.m. ET. The panel, hosted by Maxim Group LLC on M-Vest, will discuss the implications of recent SCOTUS outcomes on contraception. Other panelists include CEOs from Agile Therapeutics and Femasys. An archived webcast will be available from July 15-28, 2022. Daré Bioscience focuses on innovative women’s health products, including FDA-approved XACIATO™ for bacterial vaginosis.
Daré Bioscience (NASDAQ: DARE) has finalized an exclusive licensing agreement with Organon for XACIATO, a treatment for bacterial vaginosis, which affects approximately 21 million American women. Daré will receive a $10 million upfront payment, with opportunities for milestone payments totaling up to $182.5 million and tiered royalties based on net sales. XACIATO is expected to be commercially available in the U.S. in Q4 2022. This collaboration aims to enhance the treatment options available to women suffering from this condition.
Daré Bioscience announced the partial adjournment of its 2022 Annual Meeting, focusing on Proposal 5, which seeks to increase authorized shares to 240 million. While all director nominees and Proposals 2, 3, 4, and 6 were approved, Proposal 5 did not receive enough votes. The meeting will reconvene on July 14, 2022, to further solicit votes. Currently, only 49.2% of outstanding shares voted in favor. Two proxy advisory firms have recommended voting for Proposal 5. The company stresses that flexibility in capital structure is crucial for future growth.
SAN DIEGO, June 6, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience (NASDAQ: DARE) announced President and CEO, Sabrina Martucci Johnson, will participate in a panel and present at the 2022 BIO International Convention in San Diego from June 13-16, 2022. The panel titled "Primed for Growth: Innovating to Address the Business Opportunity in Building a Women’s Health Market" is scheduled for June 13, 2022, at 2:15 PM PT. The women’s health market is projected to reach $24.5 billion by 2027, growing at a 12.5% CAGR.
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