Daré Bioscience is making strides in women's health with advancements across its portfolio, bolstered by new funding and progress in clinical trials. The company's focus remains on developing differentiated therapies in contraception, sexual health, and other areas of unmet need.
Ovaprene Phase 3 Trial Expansion
The pivotal Phase 3 trial for Ovaprene, a hormone-free monthly intravaginal contraceptive, is ongoing across the United States. A recently announced foundation grant of approximately $10.7 million will enable Daré to increase the number of clinical sites, aiming to accelerate the development timeline. Enrollment began in December 2023, and the company anticipates approximately half of the target 250 participants to complete six months of product use by the end of Q2 2025. Ovaprene represents a significant commercial opportunity as the first monthly, hormone-free contraceptive.
Sildenafil Cream 3.6% for FSAD Advances Toward Phase 3
Sildenafil Cream 3.6%, a topical formulation of sildenafil for female sexual arousal disorder (FSAD), is moving closer to a Phase 3 trial. Following an end-of-Phase 2 meeting with the FDA in December 2023, discussions are focused on aligning on primary and secondary patient-reported outcome endpoints. Exploratory post-hoc analyses of Phase 2b data showed statistically significant and meaningful patient improvement with Sildenafil Cream. Two successful Phase 3 studies will be required to support an NDA submission, with each study estimated to cost approximately $15 million. Currently, there are no FDA-approved treatments for FSAD, highlighting the potential impact of this therapy.
DARE-HPV to Enter Phase 2 with ARPA-H Support
DARE-HPV, a proprietary formulation of lopinavir and ritonavir for HPV-related cervical diseases, is advancing towards a Phase 2 clinical study. The study, a randomized, placebo-controlled, double-blind trial, will assess DARE-HPV's efficacy in clearing high-risk HPV infection in women. Funding for this trial will be supported by a $10 million award from ARPA-H's Sprint for Women's Health. Given that nearly all cervical cancer cases worldwide are caused by HPV infection, DARE-HPV addresses a critical need.
Further Pipeline Developments
Daré Bioscience is also progressing DARE-VVA1, a tamoxifen formulation for dyspareunia, and DARE-PTB1, a progesterone intravaginal ring for preterm birth prevention. Activities are underway in preparation for a Phase 2 clinical study of DARE-VVA1, based on Daré's FDA-cleared IND, and a Phase 1 clinical study of DARE-PTB1, supported by a $2 million grant from NICHD.
Financial Position
As of September 30, 2024, Daré Bioscience reported cash and cash equivalents of $11.2 million. Research and development expenses for the third quarter of 2024 were $2.7 million, compared to $6.7 million in the same period of 2023. The company's strategic financing activities, including a $10.7 million grant agreement, the $10 million ARPA-H award, a $15 million equity line, and $22 million in royalty financing, position Daré for meaningful milestones in 2025, according to Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
