Financial Data and Key Metrics Changes - The company ended Q3 2025 with approximately $23 million in cash and cash equivalents and working capital of approximately $3.8 million [21] - During Q3, the company received approximately $18.7 million in net proceeds from sales of common stock and a total of $7.3 million in grant payments, strengthening its balance sheet [21] - General and administrative (G&A) expenses were $2.5 million compared to $2 million in Q3 2024, primarily due to increases in professional services and commercial readiness expenses [22] - Research and development (R&D) expenses were $1.2 million compared to $2.7 million in Q3 2024, a 56% decrease, attributed to non-dilutive funding and reduced manufacturing costs [22] Business Line Data and Key Metrics Changes - The company is on track to support the commercial availability of Dare to Play Sildenafil Cream through a 503(b) outsourcing facility before the end of 2025, marking a significant milestone in women's sexual health [5][11] - The Dare to Restore product line, which includes proprietary vaginal probiotic products, is expected to be available in the U.S. in Q1 2026 [15] - The company is also pursuing a combination estradiol and progesterone intravaginal ring branded as Dare to Reclaim, targeting early 2027 for availability [16] Market Data and Key Metrics Changes - The company is addressing significant unmet needs in women's health, including contraception, HPV infection, and preterm birth, through its clinical pipeline [5][17] - The estimated market for compounded hormone therapy is $4.5 billion, with Dare to Reclaim positioned as a unique solution in this space [16] Company Strategy and Development Direction - The company employs a dual-path strategy, commercializing proprietary formulations while pursuing FDA approval and advancing select solutions as branded consumer health products [2][5] - The focus is on bridging the gap between promising science and real-world solutions for women, leveraging non-dilutive capital and disciplined investment strategies [6][17] - The company aims to create a self-reinforcing ecosystem for growth through its commercial initiatives, enhancing brand awareness and provider engagement [16][39] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recent FDA guidance on hormone replacement therapy, which aligns with the company's development of Dare to Reclaim [24][28] - The company is excited about the potential of Dare to Play Sildenafil Cream as a near-term revenue driver and anticipates initial revenue recognition in Q4 2025 [39][40] - The management believes that the women's health market is ripe for value creation due to its historical underfunding and underserved status [40] Other Important Information - The company is actively recruiting for its pivotal phase III study of Oviprene, a contraceptive product, with completion anticipated in 2026 [17][18] - The company has received significant grant funding to support various programs, including DARE HPV and DARE LARK 1, demonstrating its ability to leverage strategic collaborations [20] Q&A Session Summary Question: Can you comment on FDA's recent reversal and guidance on hormone replacement therapy in menopause? - Management expressed excitement about the FDA's change and highlighted the development of Dare to Reclaim, a hormone therapy vaginal ring that combines estradiol and progesterone [24][25] Question: Will Dare to Reclaim be available through a compounder or is there a path for FDA approval? - Management confirmed that both paths are being pursued, similar to the strategy for Dare to Play Sildenafil Cream [29] Question: How is the company prioritizing R&D programs for FDA approval? - The focus is on advancing Dare to Play, Dare to Reclaim, and grant-funded programs like Oviprene and DARE HPV, prioritizing those with clear regulatory pathways [30][32] Question: What partnerships are being considered to increase awareness for Dare to Play? - Management mentioned plans for clinician awareness initiatives and online advertising, as well as partnerships with telehealth resources to facilitate prescription fulfillment [33][36] Question: Is there additional capacity left on the ATM? - Management indicated that the company is subject to baby shelf limitations, which restrict the amount available under the ATM [38]