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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 announced that CEO Sabrina Martucci Johnson will participate in a virtual fireside chat at the H.C. Wainwright Global Investment Conference from May 23-26, 2022. The conference will be held both in-person at the Fountainebleau Miami Beach Hotel and virtually. The chat will be available on-demand starting May 24, 2022, at 7:00 a.m. Eastern Time, with an archived version accessible until June 7, 2022. Daré focuses on innovative women's health products, notably XACIATO, a treatment for bacterial vaginosis.
Daré Bioscience (NASDAQ: DARE) reported financial results for Q1 2022, with cash and cash equivalents of $39.3 million as of March 31, 2022. The company announced the initiation of the DARE-HRT1 Phase 1/2 clinical study in April 2022 and an exclusive global license agreement with Organon for XACIATO™, expected to close in Q2 2022. This agreement includes a $10 million cash payment to Daré and the U.S. commercial launch is anticipated in Q4 2022. However, the company's comprehensive loss increased to $8.4 million compared to $7.3 million in Q1 2021.
Daré Bioscience, Inc. (NASDAQ: DARE) has received a $249,000 grant from NICHD to support research aimed at understanding U.S. women's preferences for long-acting injectable (LAI) contraceptives. The study will survey around 1,000 women aged 18-44 to gather insights on user preferences and characteristics of LAI products. Daré is developing 6- and 12-month contraceptive formulations (ADARE-204 and ADARE-214) in collaboration with Adare Pharma Solutions, aiming to enhance user compliance and effectiveness over current options.
Daré Bioscience, Inc. (NASDAQ: DARE) has scheduled a conference call for May 12, 2022, at 4:30 p.m. ET to discuss its financial results for Q1 2022 and provide a company update. Investors can access the call by dialing (844) 831-3031 in the U.S. or (443) 637-1284 internationally. Daré is focused on women's health innovation with products like XACIATO for bacterial vaginosis and clinical candidates like Ovaprene for contraception. The company emphasizes transparency in communication regarding financials and product developments through various channels.
Daré Bioscience (NASDAQ: DARE) announced that Sabrina Martucci Johnson, its President and CEO, will participate in a panel discussion titled "Femtech: Emerging Technology in Women’s Health" at the Innovations in Women’s Health Business Conference on April 21, 2022, from 4:00-5:00 p.m. ET in Boston, Massachusetts. The panel will explore the integration of technology in addressing unique women’s health needs and feature key innovators in the FemTech sector. Daré focuses on advancing therapeutic products dedicated to women's health, including contraception and sexual health.
Daré Bioscience, Inc. (NASDAQ: DARE) has initiated a Phase 1/2 clinical study for DARE-HRT1, an intravaginal ring delivering bio-identical hormones aimed at treating menopause symptoms. This novel therapy potentially marks the first FDA-approved monthly delivery of combined estradiol and progesterone. The study will span three months and evaluate pharmacokinetics, safety, and symptom relief in 20 post-menopausal women. Previous Phase 1 results have shown promising pharmacokinetic profiles, supporting ease of use and consistent dosing. If successful, DARE-HRT1 could address significant menopausal health needs.
Daré Bioscience, Inc. (NASDAQ: DARE) has entered into a global license agreement with Organon to commercialize XACIATO™ (clindamycin phosphate vaginal gel, 2%), which includes a $10 million upfront payment. The anticipated U.S. launch of XACIATO is set for 4Q-2022. The company reported a comprehensive loss of $38.8 million for the year ended December 31, 2021, with $51.7 million in cash reserves. Daré is also progressing on Ovaprene’s pivotal Phase 3 study and expects topline data from DARE-VVA1 in 2H-2022.
Organon (NYSE: OGN) and Daré Bioscience (NASDAQ: DARE) have entered an agreement for Organon to license global rights to XACIATO, an FDA-approved treatment for bacterial vaginosis (BV) affecting an estimated 21 million U.S. women. The deal includes a $10 million upfront payment to Daré, potential milestone payments of up to $182.5 million, and tiered royalties on net sales. XACIATO is expected to be commercially available in the U.S. in Q4 2022, pending regulatory review. This collaboration aligns with Organon's strategy to enhance women's healthcare options.
Daré Bioscience (NASDAQ: DARE) will host a conference call on March 31, 2022, at 4:30 PM ET to discuss its 2021 financial results and company updates. Investors can join via phone or live webcast, with access details provided. The call is part of the company's commitment to transparency in communicating financial and product-related information. Daré specializes in women's health and has an FDA-approved product, XACIATO, along with various innovative candidates in development, including Ovaprene and Sildenafil Cream.
Daré Bioscience (NASDAQ: DARE) announces participation of President and CEO Sabrina Martucci Johnson at the 2022 Virtual Growth Conference hosted by Maxim Group LLC and M-Vest from March 28-30, 2022. Johnson will join the panel titled “Advances in Women's Health: From Clinical to Commercial” on March 28 at 3:00 p.m. ET and deliver a company presentation available on-demand from March 28 at 9:00 a.m. ET. Archived webcasts will be accessible from April 4-8, 2022, and registration links for the conference and presentations are provided in the PR.
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