Dare Bioscience Inc Stock Price, News & Analysis

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.

Daré Bioscience (NASDAQ: DARE) has secured a grant of up to $10.7 million from the Bill & Melinda Gates Foundation. The funding will support two key initiatives: the development of a novel non-hormonal intravaginal contraceptive product candidate and the expansion of clinical sites for the ongoing Ovaprene® pivotal study. The company will receive an initial payment of $5.4 million in 2024, with additional payments contingent upon achieving specific development milestones during the 24-month grant period. The new contraceptive product aims to serve women in low- and middle-income countries.

Daré Bioscience (NASDAQ: DARE), a women's health innovation company, has announced it will host a conference call and webcast on November 14, 2024, at 4:30 p.m. Eastern Time to discuss its third quarter 2024 financial results and provide a company update. The financial results will be released after market close on the same day. Participants can join via phone at (646) 307-1963 (U.S.) or (800) 715-9871 (international) using conference ID 6400145. A webcast will be available on the company's investor relations website and archived until November 28, 2024.

Daré Bioscience has been selected to receive a $10 million award from ARPA-H's Sprint for Women's Health program for the development of DARE-HPV, a potential first-in-category treatment for HPV-related cervical disease. The funding will be distributed over two years through the launchpad track for later-stage health solutions. DARE-HPV aims to provide an alternative to current surgical treatments, which can increase risks of preterm birth and sexual dysfunction. The treatment could potentially address both late-stage cervical lesions and earlier stage HPV-related cervical infections, potentially transforming clinical HPV management with an at-home strategy.