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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) announced participation in the Xpectives.Health Summit in Boston, MA, from October 12-14, 2021. Sabrina Martucci Johnson, the company’s President and CEO, will join an expert panel to discuss the pharmaceutical industry's commitment to advancing women’s health innovation. The panel, titled Industry and Investors Commitment to Women’s Health, is scheduled for October 14, 2021, from 2:00 to 2:45 pm ET. Daré focuses on developing products that address unmet needs in areas such as contraception, vaginal health, and fertility.
Daré Bioscience announced a Notice of Award from the NICHD granting $309,614 to support the development of DARE-LARC1, a user-controlled long-acting reversible contraceptive (LARC). This funding adds to a previously announced grant of up to $48.95 million. DARE-LARC1 is designed for self-administration, offering flexibility for women to pause or resume contraception without medical intervention. The project aims to meet the unmet needs in women's health while ensuring a comparable contraceptive effectiveness to existing LARCs.
Daré Bioscience has initiated a Phase 1/2 clinical study of DARE-VVA1, an investigational intravaginal tamoxifen product aimed at treating moderate to severe vulvar and vaginal atrophy (VVA) in postmenopausal women, particularly those with hormone receptor-positive breast cancer. The study will assess the safety, pharmacokinetics, and pharmacodynamics of four different doses of DARE-VVA1 over a treatment period of 56 days. This offers a potential non-hormonal alternative to estrogen-based therapies, addressing unmet needs in women's health.
Daré Bioscience (NASDAQ: DARE) will feature its President and CEO, Sabrina Martucci Johnson, at the Virtual Global Healthcare Conference from September 27 to 30, 2021. Johnson's presentation is scheduled for September 30 at 12:40 p.m. ET. Investors can access a live webcast at this link, with an archived version available until October 15, 2021, on the company's investor website. Daré is known for its commitment to advancing innovative women’s health products, including Ovaprene® and Sildenafil Cream, 3.6%.
Daré Bioscience, Inc. (NASDAQ: DARE) announced that its President and CEO, Sabrina Martucci Johnson, will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The presentation will be available on-demand starting September 13 at 7:00 a.m. ET. An archived version will be accessible until September 29, 2021. Daré specializes in women’s health and is developing innovative therapies, including Ovaprene®, Sildenafil Cream, DARE-BV1, and DARE-HRT1. More information can be found on their website.
Daré Bioscience (NASDAQ: DARE) announces its participation in the Women’s Health Innovation Summit in Boston on September 14-15, 2021. The panel will focus on optimizing study enrollment during the COVID-19 pandemic, specifically discussing the DARE-BVFREE Phase 3 study of DARE-BV1, an investigational treatment for bacterial vaginosis. The study, initiated in 2020, successfully enrolled 307 women and met its primary endpoint, showing clinical cure rates of 70-81%, significantly higher than current FDA-approved treatments. A new drug application for DARE-BV1 has been submitted to the FDA, with a review date set for December 7, 2021.
Daré Bioscience announces a presentation by Dr. David Friend at the EMAS 13th European Congress on Menopause, from September 8-10, 2021. He will present data from the Phase 1 clinical trial of DARE-HRT1, a novel intravaginal ring delivering bio-identical estradiol and progesterone over 28 days. The results support DARE-HRT1’s potential to be the first FDA-approved hormone therapy for menopause symptoms, potentially transforming treatment options. For more information, visit Daré's Investor Relations.
Daré Bioscience (NASDAQ: DARE) reported strong advancements in women’s health innovation with its Q2 2021 financial results, marking a productive year. The company submitted a New Drug Application for DARE-BV1 and secured Priority Review by the FDA, targeting a PDUFA date of December 7, 2021. Clinical studies are underway for Sildenafil Cream and DARE-HRT1. Financially, cash equivalents increased to $9.1 million, with net cash from financing activities nearing $24.6 million. However, the company reported a comprehensive loss of $9.2 million for Q2 2021, up from $7.1 million YoY.
Daré Bioscience (NASDAQ: DARE) announced that the FDA has accepted its New Drug Application (NDA) for DARE-BV1, a treatment for bacterial vaginosis, granting it Priority Review with a PDUFA date set for December 7, 2021.
The NDA is backed by data from the DARE-BVFREE Phase 3 trial, showing clinical cure rates of 70-81% after a single dose of DARE-BV1. If approved, the company plans a robust market launch in 2022, supported by strategic discussions and commercialization arrangements.
Daré Bioscience (NASDAQ: DARE) announced a conference call on August 12, 2021, at 4:30 PM ET to review its financial results for Q2 2021 and provide an update on company developments. Investors can access the call by dialing (844) 831-3031 for the U.S. or (443) 637-1284 internationally, with conference ID 5286254. The company focuses on women's health, offering innovative solutions like the hormone-free contraceptive Ovaprene and Sildenafil Cream for sexual arousal disorders. To learn more, visit darebioscience.com.
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