Daré Bioscience(US:DARE)2020-05-15 02:49Financial Data and Key Metrics Changes - For the quarter ended March 31, 2020, the company's general and administrative expenses were approximately $1.9 million, licensed expenses were $12,500, and research and development expenses were approximately $2.4 million [49][50] - The comprehensive loss for the quarter was approximately $4.3 million, with net cash provided by financing activities amounting to approximately $6.9 million [51][52] - The company ended the first quarter with approximately $5 million in cash and cash equivalents, indicating a need for additional capital to advance its programs [52][56] Business Line Data and Key Metrics Changes - The company is focused on three main programs: DARE-BV1 for bacterial vaginosis, Sildenafil Cream for female sexual arousal disorder, and Ovaprene as a hormone-free contraceptive [9][31][32] - DARE-BV1 has shown a clinical cure rate of 86% in a proof-of-concept study, significantly higher than currently marketed products [17][18] - The Sildenafil Cream program is expected to report topline results from a Phase 2b study in 2021, with the potential to be the first FDA-approved treatment for female sexual arousal disorder [9][29] Market Data and Key Metrics Changes - The market for female sexual arousal disorder is estimated to be as large or larger than the erectile dysfunction market, with 33% of women aged 21 to 60 experiencing symptoms [28] - The prevalence of bacterial vaginosis is estimated to impact over 20 million women in the U.S. alone, highlighting a significant market opportunity for DARE-BV1 [9][16] Company Strategy and Development Direction - The company aims to accelerate the availability of new prescription products in women's health by advancing product candidates that have the potential to be first-in-category [7] - The partnership with Bayer for Ovaprene is seen as a validation of the product's market potential and a strategic move to enhance the company's profile in women's health [35][40] - The collaboration with Health Decisions is expected to provide efficiencies in clinical program timelines and cost structures, enhancing the company's ability to advance its portfolio [42][60] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the potential disruptions caused by the COVID-19 pandemic but remains optimistic about meeting clinical and regulatory milestones [11][12] - The company is closely monitoring the evolving circumstances related to COVID-19 and its impact on business operations and financial conditions [56][57] - Management expressed confidence in maintaining timelines for clinical trials, particularly for the bacterial vaginosis program, due to the nature of the condition requiring in-person consultations [68][70] Other Important Information - The company has raised additional cash through various means, including a recent purchase agreement with Lincoln Park Capital Fund for the potential sale of up to $15 million in shares [54][55] - The company plans to file an investigational device exemption application for Ovaprene this year, with the expectation of initiating a pivotal clinical study in 2021 [36][37] Q&A Session Summary Question: Can you provide some color on how much faster the partnership with Health Decisions allows you to move your clinical program? - Management highlighted that the partnership provides efficiencies in time and cost, allowing for real-time engagement and quicker initiation of activities [60][63] Question: How many sites does the partnership involve and what types of trials are their expertise? - The partnership involves a large number of sites focused on women's health, particularly in contraception and vaginal health, leveraging Health Decisions' extensive experience [65] Question: How has the company maintained timelines amidst COVID-19 disruptions? - Management noted that the nature of bacterial vaginosis requires in-person consultations, allowing the study to proceed as planned, supported by the partnership with Health Decisions [68][70] Question: Do you expect R&D expenses to remain about $2.5 million a quarter for the rest of this year? - Management indicated that R&D expenses will vary and are not expected to be linear, depending on the progression of various programs [79][80] Question: How many patients will be enrolled in the Ovaprene trial? - The expected enrollment for the Ovaprene trial is around 250 subjects, as it is regulated under the device division of the FDA [81] Question: What will be the placebo control for the Ovaprene trial? - There will be no placebo arm in the contraceptive studies; all participants will receive the study drug, and pregnancy rates will be monitored [84]