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Overview of Daré Bioscience Inc.
Daré Bioscience Inc. (NASDAQ: DARE) is a clinical-stage biopharmaceutical company dedicated to advancing innovative solutions in women’s health. With a mission to address significant unmet needs, Daré focuses on developing and bringing to market a diverse portfolio of differentiated therapies that prioritize women’s health and well-being. The company’s core areas of focus include contraception, sexual health, fertility, menopause, pelvic pain, and infectious diseases.
Business Model and Revenue Streams
Daré Bioscience operates through a strategic blend of partnerships, licensing agreements, and non-dilutive funding sources. The company collaborates with industry leaders like Bayer and Organon to commercialize its innovative products, leveraging these partnerships to expand market reach. Additionally, Daré secures grants and funding from organizations such as the Bill & Melinda Gates Foundation and ARPA-H to support the development of its pipeline products. This approach minimizes financial risk while advancing its mission to deliver groundbreaking therapies.
Product Portfolio
Daré’s product pipeline is centered around first-in-category candidates that address critical gaps in women’s health care:
- Ovaprene®: A hormone-free, monthly intravaginal contraceptive currently in advanced clinical trials. Licensed to Bayer for U.S. commercialization, Ovaprene represents a novel, non-hormonal option for contraception.
- Sildenafil Cream, 3.6%: An investigational topical cream for female sexual arousal disorder (FSAD), a condition analogous to erectile dysfunction in men. This product aims to be the first FDA-approved treatment for FSAD.
- XACIATO™: An FDA-approved vaginal gel for the treatment of bacterial vaginosis in females aged 12 and older, marketed in collaboration with Organon.
- DARE-HRT1: A combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy, designed to address menopausal symptoms effectively.
- DARE-HPV: An investigational treatment for HPV-related cervical diseases, with the potential to be the first FDA-approved pharmaceutical intervention for both early and late-stage cervical lesions.
- DARE-LARC1: A long-acting, reversible contraceptive implant featuring wireless control and precision dosing, designed to provide extended contraceptive efficacy.
Market Position and Competitive Landscape
Daré Bioscience differentiates itself through its focus on women’s health, a historically underserved market segment. By addressing unmet needs with innovative, first-in-category products, the company positions itself as a key player in the biopharmaceutical industry. Strategic collaborations with global leaders like Bayer and Organon enhance its market reach and credibility. Despite challenges such as regulatory hurdles and competition from established pharmaceutical companies, Daré’s targeted approach and robust pipeline underscore its potential for significant impact in women’s health care.
Regulatory and Clinical Development
Daré’s product candidates undergo rigorous clinical trials to ensure safety and efficacy. For instance, Sildenafil Cream has completed a Phase 2b study demonstrating promising results for FSAD, and the company is preparing for Phase 3 trials. Similarly, Ovaprene is progressing through pivotal clinical studies, with FDA feedback shaping its development pathway. These efforts exemplify Daré’s commitment to meeting stringent regulatory standards while advancing innovative therapies.
Strategic Partnerships and Funding
Daré’s collaborations with organizations like Bayer, Organon, and Theramex play a pivotal role in its business strategy. These partnerships not only facilitate commercialization but also validate the company’s innovative approach. Additionally, non-dilutive funding from entities such as the Gates Foundation and ARPA-H supports the development of groundbreaking products, reducing financial risk and enabling sustained innovation.
Conclusion
Daré Bioscience Inc. is at the forefront of innovation in women’s health, addressing critical unmet needs with a robust pipeline of first-in-category products. Through strategic partnerships, rigorous clinical development, and a focus on underserved markets, the company is poised to make a significant impact in the biopharmaceutical industry.
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.
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.
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