Daré Bioscience Reports Third Quarter 2025 Financial Results and Provides Corporate Update

Core Insights - Daré Bioscience is set to launch DARE to PLAY™ Sildenafil Cream by the end of 2025, which is expected to generate near-term revenue through the 503B compounding pathway [1][3][7] - The company reported positive interim results from the Ovaprene® Phase 3 study, supporting continued enrollment and indicating potential for a hormone-free contraceptive option [1][3][7] - Daré is advancing multiple grant-funded programs aimed at women's health, including treatments for HPV and long-acting non-hormonal contraception, with four products expected to be commercially available within the next two years [1][2][8] Financial Highlights - For Q3 2025, Daré reported total revenue of $2.26 million, a significant decrease from $41.69 million in Q3 2024, primarily due to reduced royalty revenue [9][24] - Operating expenses for Q3 2025 were approximately $3.67 million, down from $4.72 million in the same quarter of the previous year, with a notable decrease in R&D expenses by 56% [13][24] - The net loss for Q3 2025 was $3.56 million, compared to a net loss of $4.70 million in Q3 2024, indicating improved financial performance year-over-year [24] Product Pipeline and Development - DARE to RESTORE™ Vaginal Probiotics are targeted for launch in Q1 2026, followed by DARE to RECLAIM™ Monthly Hormone Therapy expected in early 2027, establishing entry into the $4.5 billion compounded hormone therapy market [3][12] - The company is actively pursuing FDA approval for its products while leveraging the 503B pathway for quicker market access [3][12][21] - Ongoing discussions with the FDA regarding endpoint assessments for the Sildenafil Cream Phase 3 studies are in progress, indicating a proactive approach to regulatory compliance [3][21] Grant-Funded Initiatives - The DARE-HPV program is currently funded by an ARPA-H award and NIH grant, focusing on a novel intravaginal therapy for persistent high-risk HPV infections [2][4] - DARE-LARC1 is in preclinical development, fully funded by a foundation grant, aimed at providing long-acting contraceptive solutions [2][4] - DARE-NHC is a preclinical research initiative supported by grant funding to develop a non-hormonal contraceptive product suitable for women in low- and middle-income countries [4]