Daré Bioscience(DARE) - 2024 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - General and administrative expenses for Q3 2024 were approximately $2 million, a 24$2.7 million for Q3 2024, representing a 60% decrease compared to Q3 2023, with expectations that full-year 2024 R&D expenses will be less than those in 2023 [21] - Comprehensive loss for Q3 2024 was approximately $4.7 million, with cash and cash equivalents at approximately$11.2 million as of the end of the quarter [22] Business Line Data and Key Metrics Changes - The company continues to advance its late-stage candidates, including ongoing enrollment in the Phase III study of Ovaprene and constructive interactions with the FDA regarding Sildenafil Cream [14][35] - XACIATO, the first FDA-approved product from the company's portfolio, has seen steady month-over-month increases in total prescriptions since its launch [32] Market Data and Key Metrics Changes - The company has identified a significant market opportunity in non-hormonal contraception, with approximately 35 million women in the U.S. as potential candidates for Ovaprene [40] - The DARE-HPV program targets a significant health issue, as nearly all cervical cancer cases are caused by HPV infection, with an estimated 100,000 women treated for cervical precancer annually in the U.S. [46] Company Strategy and Development Direction - The company focuses on women's health pharmaceutical product development across various areas, including contraception and sexual health, aiming to address existing therapeutic gaps [6][7] - The company has secured over $20 million in non-dilutive funding recently, which will support the advancement of its product candidates [5][16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the increased attention on women's health and the potential for their innovative treatments to fill significant gaps in the market [10][12] - The company is well-positioned for meaningful milestones in 2025, supported by recent funding agreements and ongoing clinical trials [16][58] Other Important Information - The company has received a$10 million award from ARPA-H for the DARE-HPV program and a 10.7 million grant from the Bill & Melinda Gates Foundation to support the development of non-hormonal contraceptive products [10][11][57] Q&A Session Summary Question: Potential interim look by the end of 2Q '25 for the Ovaprene study - Management confirmed that the interim look will focus on safety and possibly some efficacy data, with ongoing discussions with the commercialization collaborator Bayer [60][62] Question: Operational progress towards Phase III for Sildefanil - Management indicated that discussions with the FDA are focused on appropriate endpoints for the Phase III program, with operational readiness being a priority [66][72] Question: Additional sites for the Ovaprene trial - Management plans to add a handful of additional sites to the study, focusing on those with a strong track record of efficient enrollment [85][88] Question: Funding requirements for the Sildefanil program - Management estimated that approximately 15 million is needed for the individual study, with flexibility in funding timing due to the study's shorter duration [100][102]