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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.
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.
Daré Bioscience, a leading innovator in women’s health, has announced its participation in several upcoming conferences. Notably, Sabrina Martucci Johnson, CEO, will present at the Cowen 42nd Annual Health Care Conference on March 8, 2022, at 1:30 p.m. ET. Additionally, she will engage in a panel discussion at the Therapeutic Area Partnerships Conference on March 8 and participate in the 34th Annual Roth Conference on March 14. The company focuses on advancing therapies in women's health, with products like XACIATO for bacterial vaginosis.
Daré Bioscience, a leader in women’s health innovation, announced its President and CEO, Sabrina Martucci Johnson, will present at two major conferences: the 2022 BIO CEO & Investor Conference (February 14-17, 2022) and the SVB Leerink Virtual 11th Annual Global Healthcare Conference (February 14-18, 2022). Johnson's in-person presentation at the BIO CEO Conference is scheduled for February 14 at 2:15 p.m. EST, while her SVB Leerink presentation will be on February 17 at 1:00 p.m. EST. Archived webcasts will be available post-event on Daré's website.
Daré Bioscience (NASDAQ: DARE) announced that President and CEO Sabrina Martucci Johnson will present at the H.C. Wainwright BIOCONNECT 2022 Conference, taking place virtually from January 10-13, 2022. Her presentation will be available on-demand starting January 10 at 7:00 a.m. ET, and accessible under the Investors section of the company’s website. A recorded version will be available until January 27, 2022. Daré focuses on innovative women’s health products, including their FDA-approved product XACIATO and various clinical candidates.
On December 7, 2021, Daré Bioscience announced FDA approval for XACIATO (clindamycin phosphate vaginal gel, 2%), marking a significant milestone as it becomes the company's first FDA-approved product targeting bacterial vaginosis in women aged 12 and older. With over 21 million women affected, XACIATO aims to address the high recurrence rate of bacterial vaginosis and improve treatment outcomes. The company is pursuing strategic partnerships for commercialization, with expectations for a U.S. launch in 2022.
Daré Bioscience (NASDAQ: DARE) reported significant progress in Q3 2021, with the FDA accepting the NDA for DARE-BV1, targeting a PDUFA action date of December 7, 2021. The company entered a CRADA for Ovaprene's pivotal Phase 3 study and initiated a Phase 1/2 study for DARE-VVA1. Financially, Daré had cash equivalents of $45.6 million and a comprehensive loss of $12.7 million. R&D expenses rose to $10.4 million, driven by clinical trials. The company anticipates robust market introduction for DARE-BV1 in H1 2022, pending FDA approval.
Daré Bioscience (NASDAQ: DARE) announced that CEO Sabrina Martucci Johnson will present at the Stifel 2021 Virtual Healthcare Conference on November 16, 2021, at 3:20 p.m. ET. A live webcast of the presentation will be available, with an archived version accessible until November 30, 2021. Daré focuses on innovative products for women's health, with a portfolio including potential first-in-category therapies like Ovaprene® and Sildenafil Cream, 3.6%. The company aims to enhance treatment options in contraception, fertility, and sexual health.
Daré Bioscience (NASDAQ: DARE) will host a conference call on November 10, 2021, at 4:30 p.m. ET to discuss its financial results for Q3 2021 and provide an update on the company. Interested parties can join via phone or through a live webcast available on their website. Daré is focused on women's health, with products in development including Ovaprene, Sildenafil Cream, DARE-BV1, and DARE-HRT1, aimed at contraception, sexual health, and hormone therapy.
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