
Core Insights - DARE-HPV is a potential first-in-category treatment for HPV-related cervical disease, which could significantly alter the treatment landscape for clinical HPV management [1][3] - The National Institute of Allergy and Infectious Diseases (NIAID) may provide up to 12 million [1][4] Company Overview - Daré Bioscience, Inc. is focused on advancing innovative products for women's health, with a mission to develop a diverse portfolio of therapies that improve outcomes in areas such as contraception, sexual health, and infectious diseases [9] - The company has previously received a $10 million milestone-based funding award to support IND and Phase 2 clinical study activities for DARE-HPV [3][4] Product Details - DARE-HPV is an investigational treatment that combines lopinavir and ritonavir in a soft gel vaginal insert, aiming to be the first FDA-approved pharmaceutical intervention for high-grade cervical lesions and HPV infections [7] - Currently, there are no FDA-approved non-surgical pharmaceutical treatments for high-grade cervical lesions, highlighting the potential market opportunity for DARE-HPV if approved [7][8] Market Context - HPV is the most common sexually transmitted infection in the U.S., with nearly all cervical cancers caused by HPV infection, leading to significant health concerns for women [6][8] - An estimated 100,000 women are treated for cervical precancer annually in the U.S., with over 4,000 deaths from cervical cancer each year, indicating a critical need for effective treatments [2][8]