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Overview of Dare Bioscience Inc
Dare Bioscience Inc (DARE) is a clinical-stage biopharmaceutical company committed to advancing innovative therapies for women’s health. The company is driven by a focused mission to identify, develop, and ultimately bring to market a diverse portfolio of products designed to expand treatment options and improve outcomes in key areas of women’s reproductive and sexual health. With a strong commitment to innovation, Dare Bioscience is uniquely positioned at the intersection of rigorous scientific research and patient-centric solutions that address unmet needs in contraception, vaginal health, fertility, and sexual dysfunction disorders.
Core Business and Product Portfolio
Dare Bioscience operates primarily within a single operating segment dedicated to women’s health. The company develops therapies that target multiple facets of reproductive and sexual wellness. Its portfolio includes several promising product candidates:
- XACIATO™: The first FDA-approved product from its portfolio, this clindamycin phosphate vaginal gel is indicated for the treatment of bacterial vaginosis in women aged 12 and older and operates under a global licensing agreement.
- Ovaprene®: A novel, hormone-free monthly intravaginal contraceptive candidate developed under partnership agreements, offering an innovative approach in non-hormonal contraception.
- Sildenafil Cream, 3.6%: An investigational topical cream formulation designed to treat female sexual arousal disorder (FSAD) by locally enhancing genital blood flow while mitigating systemic side effects. Its development is supported by robust clinical data and exploratory analyses demonstrating improved arousal sensations and reduced sexual distress.
- DARE-HRT1: A combination bio-identical estradiol and progesterone intravaginal ring intended for menopausal hormone therapy, further highlighting the company’s commitment to addressing diverse aspects of women’s health.
- DARE-HPV: An innovative investigational treatment for HPV-related cervical disease. This candidate aims to be the first FDA-approved pharmaceutical intervention that addresses both late-stage cervical lesions and early-stage HPV infections, potentially transforming clinical management of cervical precancer conditions.
- Casea S and DARE-LARC1: Reflecting the company’s efforts in contraceptive innovation, these candidates focus on long-acting, reversible contraceptives with design features such as biodegradability, precision dosing, extended duration, and wireless control, thus providing women with more convenient and minimally invasive options to manage their reproductive health.
Clinical Development, Innovation, and Strategic Partnerships
The clinical development programs at Dare Bioscience are underscored by a thorough evaluation of safety and efficacy through various phases of clinical trials. Its development strategy involves robust collaboration with regulatory authorities, extensive clinical research, and strategic partnerships. The company has secured funding and grant awards from prominent organizations, including substantial non-dilutive strategic financing, grants from private foundations, and awards from federal agencies. These funding sources are instrumental in de-risking clinical programs and supporting the advancement of product candidates such as Ovaprene, Sildenafil Cream, and DARE-HPV.
Collaborative partnerships with industry leaders and specialty pharmaceutical companies further enhance the company’s capabilities. For instance, licensing agreements and co-development partnerships enable Dare Bioscience to leverage external expertise, share the costs of clinical development, and expedite the advancement of first-in-category therapeutic solutions. The company’s approach involves meticulous trial design, including the use of patient-reported outcome measures (PROs) in conditions like FSAD, ensuring that the clinical benefits are clearly demonstrated and validated.
Market Position and Significance in Women’s Health
Within the highly competitive biopharmaceutical landscape, Dare Bioscience distinguishes itself through a dedicated focus on women’s health. The company’s innovative product candidates are designed to address conditions where there is a significant unmet medical need. By targeting areas such as non-hormonal contraception, vaginal health, fertility enhancement, and sexual dysfunction, Dare Bioscience holds a differentiated position relative to traditional pharmaceutical companies. Its scientific rigor, evidenced by the publication of clinical trial data in renowned peer-reviewed journals, establishes the company as a trusted source of advanced therapeutic solutions.
This focused approach not only broadens treatment options for patients but also aligns with the evolving demand for personalized medicine and targeted therapies within the female demographic. The company’s commitment to addressing commonly overlooked issues in women’s health helps to create a niche market with sustainable long-term growth potential.
Research, Technology, and Development Excellence
The technical foundation of Dare Bioscience’s novel therapies is built on cutting-edge research in pharmacology and drug delivery systems. The use of innovative technology, such as proprietary cream formulations and advanced intravaginal delivery systems, positions the company to overcome common limitations associated with systemic drug therapies. For example, the topical application of Sildenafil Cream minimizes systemic side effects often seen with oral formulations, while targeted delivery ensures higher local concentrations and optimal therapeutic efficacy.
Moreover, the drug delivery platforms being explored by the company have potential applications beyond women’s health, potentially addressing therapeutic needs in areas such as metabolic disorders and chronic conditions that require precise dosing. This versatility underscores the company’s research and development expertise, providing a robust platform for future product innovations.
Commitment to Scientific Rigor and Regulatory Compliance
Dare Bioscience’s path to regulatory approval is characterized by its disciplined approach to clinical trial design, patient safety, and statistical analysis. The company engages in continuous dialogue with the U.S. Food and Drug Administration (FDA) and other regulatory bodies throughout its clinical development process. This collaborative relationship ensures that the company’s clinical programs adhere to high standards of safety and efficacy, as evidenced by multiple milestone achievements and positive discussions regarding trial endpoints.
The company’s publications in key medical journals serve as external validations of its research methodology and clinical findings. By providing transparent and detailed data on patient outcomes, Dare Bioscience reinforces its commitment to rigorous scientific inquiry and maintains high levels of trust with the medical community, investors, and patients alike.
Operational Excellence and Future Research Directions
Operationally, Dare Bioscience excels in integrating research, clinical operations, and strategic capital management. The company utilizes non-dilutive financing mechanisms and maintains strategic funding partnerships to support its expansive clinical pipeline without compromising operational independence. This prudent fiscal strategy allows it to focus on breakthrough research and efficient clinical trial execution.
While the company remains committed to addressing current unmet needs in women’s health, its research infrastructure and technological platforms also lay the groundwork for exploring additional therapeutic areas in the future. The possibility of leveraging its advanced drug delivery systems in conditions beyond reproductive health highlights the innovative potential and scalable business model inherent in its approach.
Conclusion
In summary, Dare Bioscience Inc represents a sophisticated blend of targeted research, innovative product development, and strategic operational management focused on improving women’s health outcomes. Through its diversified portfolio ranging from non-hormonal contraceptives to novel therapies for conditions such as FSAD and HPV-related cervical diseases, the company addresses significant gaps in current clinical practice. Its methodical approach to regulatory interactions, rigorous clinical testing, and strategic partnerships collectively position it as a pivotal player in the evolving biopharmaceutical landscape for women’s health.
This comprehensive focus, backed by industry-recognized research, enhances the company's authority and credibility, providing a valuable resource for investors and healthcare professionals seeking to understand the impact of innovative solutions in women’s reproductive and sexual health care.
Daré Bioscience (NASDAQ: DARE) has announced its expanded business strategy featuring a dual-path approach for its proprietary Sildenafil Cream formulation, with plans to make it available via prescription in Q4 2025. The company's President and CEO, Sabrina Martucci Johnson, will present these developments at the Jones Healthcare and Technology Innovation Conference on April 9th, 2025.
The strategy includes utilizing Section 503B compounding to expedite market access for select Daré proprietary formulations. The company is also exploring bringing consumer health products to market without prescription requirements. Additional strategic partnerships and timing updates are expected this quarter.
The presentation will be accessible via webcast at 1:00 p.m. PT, with a replay available until April 23, 2025, through the company's investor relations website.
Daré Bioscience (NASDAQ: DARE) reported its full year 2024 financial results and announced plans to make its proprietary Sildenafil Cream available via prescription through 503B compounding in Q4 2025, expecting to generate revenue and cash flow. The company ended 2024 with $15.7 million in cash and a working capital deficit of $3.2 million.
Financial highlights show reduced expenses, with G&A costs down 24% to $9.2 million and R&D expenses decreased 34% to $14.2 million compared to the previous year. Key pipeline developments include the ongoing Ovaprene® Phase 3 contraceptive study, with approximately 125 women expected to complete six months of use by Q2 2025, supported by a $10.7 million non-dilutive grant.
The company is pursuing a dual-path approach for select proprietary formulations, including both FDA approval and 503B framework distribution. Daré plans to invest less than $1 million to support the Sildenafil Cream 503B initiative and expects to provide strategic partnership updates in Q2 2025.
Daré Bioscience (NASDAQ: DARE), a women's health innovation company, has scheduled its full year 2024 financial results conference call and webcast for March 31, 2025, at 4:30 p.m. Eastern Time. The presentation will include both financial performance review and company updates.
Participants can join via phone at (646) 307-1963 (U.S.) or (800) 715-9871 (toll-free) using conference ID 9767621. A live webcast will be available through the Investors section of Daré's website. The webcast recording will remain accessible for replay until April 14, 2025.
Daré Bioscience (NASDAQ: DARE) and Theramex have entered into a co-development and licensing agreement for Casea S, a potential first-in-category biodegradable contraceptive implant. The product is designed to release contraceptive medication over 18-24 months before dissolving, eliminating the need for surgical removal.
A fully-funded Phase 1 trial is currently ongoing, conducted by FHI 360, investigating pharmacokinetics, removability, safety, and tolerability. Daré has received a royalty-free, exclusive license to the US patents for Casea S. There are currently no development costs for either company due to foundation grant funding.
If Phase 1 results are positive, Daré will be responsible for conducting the Phase II study in the US. Future Phase II and III study funding will be shared between both companies, with terms to be determined based on market opportunity in their respective regions.
Daré Bioscience (NASDAQ: DARE) has received a Notice of Award from the National Institute of Allergy and Infectious Diseases (NIAID) to support the development of DARE-HPV, a potential first-in-category treatment for HPV-related cervical disease. The award includes $1 million for 2025 and a recommended additional $1 million for a subsequent year, subject to conditions.
This funding supplements a previously announced $10 million milestone-based award from October 2024, bringing the total potential non-dilutive funding for DARE-HPV to $12 million. DARE-HPV aims to be the first FDA-approved pharmaceutical intervention for both late-stage cervical lesions and earlier stage HPV-related cervical infections, offering an alternative to current surgical treatments that can increase risks of preterm birth and sexual dysfunction.
Daré Bioscience (NASDAQ: DARE) announced its participation in the Women's Health Series at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. CEO Sabrina Martucci Johnson will speak on the ARPA-H | Investing in Women's Health panel on Tuesday, January 14th at 2:15 p.m. PT.
The conference features three panels dedicated to women's health, highlighting the growing focus on innovation in this sector. This follows Daré's recent collaboration with ARPA-H in ringing the Nasdaq closing bell on January 2nd.
The company is developing potentially disruptive therapeutic candidates in areas including contraception, sexual health, menopause, infectious disease, fertility, and pelvic pain. Johnson will also speak at a Grant Engine event on January 15th about non-dilutive funding, highlighting two recent $10 million awards: a foundation grant for non-hormonal contraceptive development and an ARPA-H Sprint award for HPV treatment to prevent cervical cancer.
Daré Bioscience (NASDAQ: DARE) has announced plans for a Phase 3 study of its Sildenafil Cream, 3.6%, aimed at treating Female Sexual Arousal Disorder (FSAD). FSAD, akin to erectile dysfunction in men, currently has no FDA-approved treatments. Approximately 10 million women in the U.S. experience FSAD symptoms and seek solutions. The Phase 3 study, developed in collaboration with Strategic Science & Technologies, , will assess the safety and efficacy of Sildenafil Cream for premenopausal women. Daré plans to submit the study protocol and statistical analysis plan to the FDA in Q1 2025, with the study commencing by mid-2025. A second Phase 3 study will be needed for the New Drug Application (NDA) submission. If approved, Sildenafil Cream could become the first FDA-approved treatment for FSAD, creating a new market category in female sexual dysfunction.
Daré Bioscience has announced the publication of additional data from the Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% for treating female sexual arousal disorder (FSAD). Published in Sexual Medicine, the study reveals that age and hormonal contraceptive use did not impact the cream's efficacy. The analysis also explored other subgroups and found no significant impact of hormonal contraceptives on primary or secondary efficacy endpoints.
Sabrina Martucci Johnson, CEO of Daré Bioscience, highlighted the potential benefits for a broad population of premenopausal women with FSAD. Dr. Annie Thurman, Medical Director, emphasized that the data showed hormonal contraceptive users could also benefit from the treatment. The study aims to identify the patient population experiencing the most meaningful improvement and refine target populations for future studies.
Previous safety and efficacy data from the Phase 2b RESPOND study have been published in The Journal of Sexual Medicine and Obstetrics & Gynecology.
Daré Bioscience received a $2.5 million grant installment for developing DARE-LARC1, a novel contraceptive technology. This payment is part of a larger $49 million grant agreement, of which $31.8 million has been received to date. DARE-LARC1 represents a potential new category of long-acting, reversible contraceptive featuring precision dosing, extended device duration, and wireless control.
The technology, originally developed at MIT, achieved technological proof of concept earlier this year. The platform uses levonorgestrel and is designed to store and deliver therapeutic doses over extended periods through a single device. Key features include precision dosing, extended duration capability, built-in battery lasting up to 20 years, wireless communication, and smartphone integration.
The company is exploring strategic partnerships for applications beyond reproductive health, including diabetes, obesity, and other conditions requiring precise, prolonged treatment.
Daré Bioscience (DARE) reported Q3 2024 financial results with cash and equivalents of $11.2 million. Research and development expenses decreased 60% to $2.7 million compared to Q3 2023, while general and administrative expenses declined to $2.0 million from $2.7 million. The company received significant funding, including a $10.7 million foundation grant, a $10 million ARPA-H award, and established a $15 million equity line. Key developments include ongoing recruitment for Ovaprene's Phase 3 study, progress toward Sildenafil Cream's Phase 3 trial, and advancement of other pipeline candidates including DARE-HPV, DARE-VVA1, and DARE-PTB1.
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