Positive Interim Phase 3 Results Highlight Potential of Ovaprene®, Novel Hormone-Free Contraceptive

Core Insights - Daré Bioscience announced positive interim results from its Phase 3 clinical trial for Ovaprene, a hormone-free intravaginal contraceptive, highlighting its potential as a first-in-category product [1][3][5] Clinical Trial Results - The independent Data Safety Monitoring Board recommended the continuation of the trial without modifications after a planned interim analysis [2] - Approximately 9% of participants experienced pregnancy, aligning with pre-pivotal study expectations, indicating Ovaprene's effectiveness [3] - No new safety concerns were reported, with 17% of participants discontinuing due to vaginal odor, the most common adverse event [4] Market Potential - The CEO emphasized the significant unmet need for effective, hormone-free contraceptives in the U.S., suggesting Ovaprene could transform the contraceptive landscape [5] - The ongoing trial aims to enroll about 250 participants, assessing the typical use pregnancy rate over 13 menstrual cycles [6] Commercialization and Financials - Bayer holds the option to obtain exclusive U.S. commercialization rights for Ovaprene upon completion of the pivotal trial, contingent on a $20 million payment [7] - Daré could receive up to $310 million in milestone payments and tiered royalties on net sales, subject to third-party agreements [7] Company Overview - Daré Bioscience focuses on innovative solutions in women's health, aiming to address unmet needs in areas such as contraception and sexual health [8] - The company has previously launched XACIATO™, a vaginal gel for bacterial vaginosis, and is developing other first-in-category candidates [9]