Daré Bioscience(US:DARE)2021-03-31 02:57Financial Data and Key Metrics Changes - For the year ended December 31, 2020, the company's general and administrative expenses were approximately $6.5 million, licensed expenses were approximately $83,000, and research and development (R&D) expenses were approximately $20.8 million, leading to a comprehensive loss of approximately $27.4 million [49][50]. - Net cash proceeds from financing activities were approximately $25.1 million, with total cash received during 2020 amounting to approximately $29.5 million, resulting in an ending cash balance of approximately $4.7 million [51][52]. Business Line Data and Key Metrics Changes - The DARE-BV1 program demonstrated a clinical cure rate of 70% in the modified intent to treat population and 77% in the per protocol population, outperforming current branded prescription products for bacterial vaginosis [16][17]. - The Sildenafil cream program commenced its Phase 2b clinical study, with topline data readout targeted for the end of 2021, aiming to address a significant unmet need in female sexual arousal disorder [24][26]. Market Data and Key Metrics Changes - The market for female sexual arousal disorder (FSAD) is estimated to be significant, with approximately 10 million women in the U.S. experiencing distress from symptoms, yet no FDA-approved products currently exist [23]. - The company has established a commercial partnership with Bayer for the Ovaprene product, which includes potential milestone payments and royalties, indicating strong market interest and collaboration [7][27]. Company Strategy and Development Direction - The company focuses on advancing women's health innovation through a portfolio of clinical stage programs in vaginal health, sexual health, contraception, and menopause, aiming to create first-in-category products [6][10]. - The strategic commercialization agreement for DARE-BV1 is expected to be executed before the end of the year, with various partnership structures being considered to maximize shareholder value [41][66]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for DARE-BV1 to become a first-line treatment for bacterial vaginosis, with plans for NDA submission in the second quarter of 2021 [19][39]. - The ongoing COVID-19 pandemic has influenced timelines and operational strategies, but the company remains committed to advancing its clinical programs and partnerships [60][72]. Other Important Information - The company has received grant funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Bill and Melinda Gates Foundation, which supports its R&D activities [56][58]. - The company plans to file a new Form S3 shelf registration statement with the SEC to explore various financing options, enhancing its capital flexibility [54]. Q&A Session Summary Question: What is the expected approval timeline for DARE-BV1 if priority review is not granted? - Management indicated that without priority review, the PDUFA date would likely be towards the end of the first quarter [63]. Question: Will the company prioritize upfront cash in partnerships? - Management emphasized the importance of finding the best partnership structure that maximizes value for shareholders and access to women, rather than solely focusing on upfront cash [65]. Question: What is driving the timing of the IDE for Ovaprene? - The IDE process has been recalibrated due to the COVID-19 pandemic and the need for additional non-clinical work, with a focus on ensuring data availability in 2022 [70][72]. Question: What are the next steps for the Sildenafil cream program following the Phase 2b study? - Following a successful Phase 2b study, the next step would be an end-of-Phase 2 meeting with the FDA to align on the Phase 3 study design [89]. Question: When does the company plan to partner its hormone replacement therapy products? - Management stated that discussions with potential partners are ongoing, and decisions will depend on the specific program and investment appetite [92].