Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 87

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 87
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 investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert, which we plan to develop for the treatment of genital human papillomavirus (HPV) infection in women as well as treatment of cervical intraepithelial neoplasia, or CIN (also known as cervical dysplasia), and other HPV-related pathologies. CIN is a precancerous condition in women strongly linked to HPV infection, the most common sexually transmitted infection in the U.S. Disease severity is classified on a scale from one to three based on how much epithelial tissue in the cervix has abnormal cells. There is no FDA-approved treatment for HPV infection and no non-surgical pharmaceutical intervention to treat CIN2 or CIN3 (collectively referred to as CIN2+). Current surgical procedures to treat cervical dysplasia are invasive and can adversely impact future pregnancies. We believe a non-surgical pharmaceutical approach could provide women with an important alternative to surgical procedures to treat cervical dysplasia. 

We are conducting activities necessary to enable submission of an IND application to the FDA for a Phase 2 clinical study of DARE-HPV as a treatment for genital persistent HPV infection with high risk strains. The IND enabling activities, IND submission, and the Phase 2 study are expected to be supported by non-dilutive funding under awards granted by the federal government in 2024. See ITEM 7. "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS–Recent Events–Non-Dilutive  Funding Awards for DARE-HPV," below.

Clinical Data

An earlier non-optimized formulation of the same two active pharmaceutical ingredients in DARE-HPV was previously evaluated in 23 non-pregnant, healthy, premenopausal, HIV un-infected Kenyan women with CIN2 or CIN3 in an open-label, proof-of-concept clinical study with all women receiving a 4:1 (133 mg lopinavir and 33 mg ritonavir) oral tablet (Lopimune) which is FDA approved for the treatment of human immunodeficiency virus (HIV), but dosed vaginally twice daily for 14 days in this study. There were no SAEs. The most common TEAEs were headache (3/23, 13%) followed by vaginal irritation (2/23, 8.7%); nausea (2/