Dare Bioscience, Inc. - DARE STOCK NEWS

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.

Daré Bioscience has entered into a $15 million common stock purchase agreement with Lincoln Park Capital Fund, (LPC). This 24-month agreement allows Daré to sell up to $15 million of its stock to LPC at its discretion, subject to SEC approval and other conditions. Daré will control the timing and amount of sales, with LPC purchasing at prevailing market prices. The agreement provides Daré with access to capital to fund portfolio advancement, particularly the Phase 3 program for Sildenafil Cream, 3.6%, a potential first-in-category treatment for female sexual arousal disorder. The agreement includes no warrants, short selling restrictions, or limitations on use of proceeds. Daré can terminate the agreement at any time without penalty.

Daré Bioscience (NASDAQ: DARE) announced the publication of safety data from its Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in The Journal of Sexual Medicine. The study, involving 1,357 sexual experiences, showed that the topical cream was safe and well-tolerated by women with female sexual arousal disorder (FSAD) and their partners. Notably, the cream did not produce common side effects associated with oral sildenafil, such as headache and flushing. This is likely due to the hundred-fold lower systemic exposure compared to oral dosing. The study was designed to identify the most responsive patient population and appropriate patient-reported outcome measures for future Phase 3 trials. Daré is currently in discussions with the FDA regarding the development program for Sildenafil Cream as an FSAD treatment.

Daré Bioscience (NASDAQ: DARE) announced the publication of additional data from its Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in The Journal of Sexual Medicine. The study, focusing on female sexual arousal disorder (FSAD), revealed that 1-month and 24-hour recall patient reported outcome (PRO) instruments yielded similar responses. This finding supports the use of either method for assessing treatment efficacy in future clinical studies, with longer recall intervals being less burdensome for participants and potentially improving data collection compliance.

The company previously announced a positive end-of-Phase 2 meeting with the FDA, supporting the advancement of Sildenafil Cream for FSAD treatment. Daré continues to interact with the FDA on the development program. Efficacy data from the Phase 2b RESPOND study were also published in Obstetrics & Gynecology.