Financial Data and Key Metrics Changes - The company ended the quarter with approximately $5 million in cash and cash equivalents and a working capital deficit of approximately $12.6 million [17] - General and administrative expenses were $2.4 million compared to $2.5 million in 2024, primarily due to decreases in personnel costs and stock-based compensation [18] - Research and development expenses were $1.4 million, a 71% decrease versus Q2 2024, mainly due to reductions in R&D expenses recognized from non-dilutive funding awards [18] Business Line Data and Key Metrics Changes - The company is on track to support the commercial availability of DARE2PLAY Sildenafil Cream through a 503B outsourcing facility in Q4 2025, representing a significant milestone in women's sexual health [5][6] - Ovaprene, a hormone-free contraceptive candidate, continues to progress with the Phase three trial, receiving a recommendation to continue from the Independent Data and Safety Monitoring Board [10] - DARE HRT1, an intravaginal ring for hormone therapy, is pursuing both FDA approval and a 503B compounding opportunity, targeting availability in late 2026 [12][13] Market Data and Key Metrics Changes - The company is addressing a significant unmet need in the contraceptive landscape with Ovaprene, which could transform the market for hormone-free birth control [11] - The compounded hormone therapy market is estimated at $4.5 billion, where DARE HRT1 is expected to generate meaningful revenue [12] Company Strategy and Development Direction - The company is executing a dual path strategy, focusing on commercializing proprietary formulations while pursuing FDA approval for innovative women's health solutions [2][5] - The strategy includes leveraging non-dilutive capital and a disciplined investment approach to unlock value efficiently [6] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant interest and unmet need in supporting women with arousal concerns, as evidenced by the feedback from the direct-to-patient awareness campaign [7] - The company remains optimistic about the potential of DARE2PLAY Sildenafil Cream as a near-term revenue driver and is excited about the ongoing clinical programs addressing women's health needs [9][15] Other Important Information - The company received approximately $17.6 million in net proceeds from sales of common stock and a $6 million grant payment after the quarter end, strengthening its balance sheet [17] - The company is preparing to launch two non-prescription vaginal probiotics designed to support vaginal microbiome health, complementing its prescription offerings [13] Summary of Q&A Session - Due to technical difficulties, there was no Q&A session held during the call [18]

Financial Data and Key Metrics Changes - General and administrative expenses decreased by 14% to approximately $2,300,000 compared to Q1 2024, primarily due to reduced stock-based compensation and headcount [12] - Research and development expenses decreased by 31% to approximately $2,300,000 compared to Q1 2024 [12] - Comprehensive loss for the quarter was approximately $4,400,000, with cash and cash equivalents at approximately $10,300,000 and a working capital deficit of approximately $9,400,000 [12][13] Business Line Data and Key Metrics Changes - The company plans to commercialize three additional solutions for women, including two vaginal probiotics in 2025 and a proprietary monthly hormone therapy in 2026, targeting a $4,500,000,000 compounded hormone therapy market [4][17] - The company expects to start recording revenue in the fourth quarter of 2025 [5][65] Market Data and Key Metrics Changes - Women's health is identified as an underfunded and fragmented sector, presenting significant opportunities for returns [6][65] - The company is leveraging a dual path strategy to commercialize products via 503B compounding while seeking FDA approval [7][19] Company Strategy and Development Direction - The company is focused solely on women's health, developing therapeutic products for various conditions affecting women [8] - The strategy includes rapid commercialization of multiple products through various channels, including telehealth and online platforms [19][21] - The company aims to establish strategic partnerships to enhance access to its products [20] Management's Comments on Operating Environment and Future Outlook - The management acknowledges distractions in the healthcare and biotech sectors but believes the company is well-positioned to deliver value to stakeholders [5] - The management emphasizes the urgency for faster access to evidence-based treatments for women [14][15] - The company is committed to ensuring that women do not have to wait for needed medical treatment solutions while pursuing FDA approval [21] Other Important Information - The company is actively evaluating the dual path approach for other proprietary formulations to expedite market access [21] - The company received a grant from the Gates Foundation to identify evidence-based formulations for vaginal probiotics [10][18] Q&A Session Summary Question: Will there be unique partnerships for each product or multiple partnerships for an individual product? - The company intends to have multiple partnerships for individual products to ensure wide access [29] Question: Is there sufficient manufacturing capacity for Sildenafil Cream by year-end? - The company is working with a 503B collaborator to ensure the manufacturer is prepared for GMP production [31][32] Question: What additional information has the FDA requested for Sildenafil? - The FDA requested information regarding patient-reported outcomes psychometrics, which is crucial for the Phase III study [42] Question: Will there be an opportunity to increase the sample size for Ovaprene? - The upcoming Data Safety Monitoring Board meeting will focus on safety, with no opportunity for sample size changes [45] Question: Are all four products pursuing a dual path? - Sildenafil and hormone therapy are dual path products, while vaginal probiotics are consumer health brands without FDA approval plans [50] Question: Will the grant cover costs to add additional sites for Ovaprene? - The grant is designed to cover costs for adding subjects to the study, with flexibility to add more sites if needed [55] Question: Should R&D expenses be expected to continue at a lower level? - Current R&D expenses reflect the ongoing Ovaprene study, and trends are expected to continue until new studies are initiated [57] Question: Will there be additional costs for the hormone therapy product? - Additional costs will be associated with production activities and tech transfer for the hormone therapy product [59]