Dare Bioscience Inc - DARE STOCK NEWS

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.