Daré Bioscience Regains Full Rights To Ovaprene As Bayer Terminates License Agreement

Daré Bioscience, Inc. (NASDAQ:DARE), a purpose-driven health biotech company solely focused on closing the gap in women's health between promising science and real-world solutions, today announced that all rights to Ovaprene®, the company's first-in-category, investigational, hormone-free monthly intravaginal contraceptive, will be returned to Daré by Bayer HealthCare LLC as a result of Bayer electing to terminate the license agreement between the parties as part of a strategic prioritization. In accordance with the license agreement, the termination will be effective in February 2026. With the Phase 3 program advancing with non-dilutive grant support, the return of rights will provide Daré with full control of a late-stage asset that is differentiated in a large market with significant unmet need.

Late-Stage, First-in-Category Asset

The consolidation of commercialization rights will strengthen Daré's strategic position as Ovaprene advances through its pivotal Phase 3 clinical study. Ovaprene has the potential to become the first FDA-approved hormone-free, monthly intravaginal contraceptive option available to women, representing a meaningful innovation in a category that has seen limited advancement in decades.

"We view the consolidation of commercial rights under Daré at this stage of Ovaprene's development as value-enhancing for our company," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "The Phase 3 study is progressing, supported by non-dilutive funding, and the positive interim data announced in July 2025 underscore the asset's potential. We will have maximum strategic flexibility to capture the value of this opportunity."

Positive Interim Results Reinforce Clinical and Commercial Potential

In July 2025, Daré announced positive interim data from the ongoing open-label Phase 3 trial of Ovaprene (ClinicalTrials.gov ID: NCT06127199) demonstrating encouraging results including consistent safety and tolerability; no serious safety concerns were identified, and overall tolerability was favorable. The rate of pregnancy in women treated in the study at the time of the interim analysis was consistent with the company's expectations based on the results of the pre-pivotal postcoital test clinical study of Ovaprene. These interim findings support Ovaprene's potential as a meaningful hormone-free alternative. These fundamentals remain unchanged, and the study is progressing toward anticipated completion of enrollment in 2026.

The ongoing trial is supported by previously announced external grant funding, including the award from the Gates Foundation announced in 2024, and continues without any change to timelines or operations.

Expanded Strategic Optionality

With global commercialization rights consolidated at Daré, the company is now positioned to evaluate partnership structures that best reflect the value of a late-stage, non-hormonal contraceptive with differentiation and relevance. The company believes that Ovaprene will attract broad strategic interest across pharmaceutical and consumer health organizations.

"We believe this development gives us the ability to pursue the most attractive commercial and access pathways for Ovaprene, including partnerships, non-traditional commercialization models, and opportunities to retain greater long-term economics," Johnson added. "This increased optionality, combined with the clinical profile demonstrated to date, positions Ovaprene as one of the most exciting assets in the women's health pipeline."

Clear Path Forward

• Phase 3 study enrollment expected to be completed in 2026
• Continuation of grant funded trial operations
• Premarket approval (PMA) strategy with the FDA's Center for Devices and Radiological Health (CDRH) as lead review division
• Increasing global interest in non-hormonal contraception
• Company will explore partnership and strategic transaction opportunities