Daré Bioscience Announces Publication in Contraception of Positive Efficacy and Safety Findings from a Pre-Pivotal Postcoital Test Study of Ovaprene

an Investigational Hormone-Free Monthly Intravaginal Contraceptive

Published data shows that Ovaprene was safe and effective in a postcoital test study of 33 women

Pivotal Phase 3 contraceptive efficacy clinical study of Ovaprene currently enrolling

Ovaprene has the potential to be the first FDA-approved hormone-free monthly intravaginal contraceptive for women

SAN DIEGO, April 11, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the publication of data from the postcoital test clinical study of Ovaprene in two original research articles in the journal Contraception.

Publication Details:

Mauck, et al. “Successful postcoital testing of Ovaprene: An investigational non- hormonal monthly vaginal contraceptive.” Contraception. Vol. 132, April 2024, 110373. https://doi.org/10.1016/j.contraception.2024.110373

Mauck, et al. “Safety Testing of Ovaprene: an Investigational Non-Hormonal Monthly Vaginal Contraceptive.” Contraception. Advance online publication, 110440. https://doi.org/10.1016/j.contraception.2024.110440

“We are very pleased to have the postcoital test study results for our investigational, hormone-free intravaginal contraceptive Ovaprene published in a leading reproductive health journal,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Our published results show Ovaprene was safe and prevented essentially all sperm from entering the cervical canal across all women and cycles evaluated without disrupting the vaginal microbiome. PCT studies have been used as surrogate markers for contraceptive effectiveness and, based on comparable PCT studies, Ovaprene is expected to deliver efficacy approaching hormonal methods. The published results were seminal in enabling us to commence the pivotal Phase 3 clinical study of Ovaprene, which is now enrolling across the United States as we continue to advance this innovative candidate for women who want or need a hormone-free contraceptive.”

The pivotal study is a single arm, open-label contraceptive efficacy study of Ovaprene which aims to enroll sufficient participants across approximately 20 study sites in the U.S. to have approximately 250 participants complete approximately 12 months (13 menstrual cycles) of use. Daré plans to provide updates on anticipated timing for study completion as enrollment progresses. If successful, Daré expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries.