Company: DARE
Filing Date: 2025-07-14
Form Type: 8-K
Source: 0001641172-25-018894
Chunk: 1

Company: Dare Bioscience, Inc.
Filing Date: 2025-07-14
Form: 8-K
Item: Item 8.01
Chunk 1
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Item
8.01 Other Events.

On
July 11, 2025, the study’s data safety monitoring board conducted a planned interim analysis focused on reviewing safety data from
the study, and recommended the study continue without modification.

No
new safety or tolerability concerns were identified. At the time of the interim analysis, approximately 9% of the women treated in the
study had experienced a pregnancy. Approximately 17% of participants discontinued the study due to vaginal odor, the most commonly reported
product-related adverse event. No serious safety concerns were identified, and overall tolerability was favorable. Participants who had
completed the study reported they would be very likely or likely to use Ovaprene if it became available.

The
study is a multicenter, single-arm, open-label study enrolling women aged 18 - 40 across five sites. As of the interim analysis,
approximately 115 participants were ongoing or had completed the study. The target enrollment is approximately 250 participants completing
approximately 12 months of use. The primary objective of the study is to assess the typical use pregnancy rate over 13 menstrual cycles,
or the estimated Pearl Index for Ovaprene. Secondary objectives are to assess Ovaprene’s 13-cycle use cumulative pregnancy rate,
safety, acceptability, product fit/ease of use, and assessments of vaginal health.

Item
9.01 Financial Statements and Exhibits