Daré Bioscience Regains Full Control of Ovaprene as Bayer Exits; Phase 3 Contraceptive Program Set to Accelerate with Grant Support

San Diego, December 1, 2025 – A significant shift is underway in the development of Ovaprene, the hormone-free intravaginal contraceptive that could reshape women’s birth control options. Daré Bioscience Inc. (NASDAQ: DARE) announced that it is reclaiming complete ownership and commercialization rights to Ovaprene from Bayer HealthCare LLC, following Bayer’s strategic decision to terminate their licensing partnership. The transition becomes official in February 2026.

This move marks a turning point for the San Diego-based biotech firm. Rather than being managed by a large pharmaceutical partner, Ovaprene’s future now rests entirely in Daré’s hands at a critical juncture—with Phase 3 clinical trials progressing and positive interim results already in hand.

Why This Matters for Ovaprene’s Market Potential

The consolidation of rights represents a reshuffling of control over what could become a first-in-category product. If approved by the FDA, Ovaprene would become the first hormone-free monthly intravaginal contraceptive option available to women—a distinction that hasn’t been achieved in decades within this category.

The biotech company sees this as an advantage rather than a setback. “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.”

By owning all commercialization rights, Daré gains the ability to shape the product’s go-to-market strategy without compromise. The company can now explore diverse partnership structures, retention of economics, and novel distribution pathways that might not have been available under Bayer’s stewardship.

Clinical Progress Validates the Approach

The interim data released in July 2025 provides compelling support for Ovaprene’s clinical profile. Results from the ongoing open-label Phase 3 trial (ClinicalTrials.gov ID: NCT06127199) demonstrated:

• Consistent safety and tolerability with no serious adverse events identified
• Favorable overall tolerability throughout the trial period
• Pregnancy rates aligned with expectations based on pre-pivotal postcoital test results
• Strong potential as a non-hormonal alternative to existing contraceptive options

These findings remain unchanged and continue to support the asset’s viability. The ongoing trial is expected to complete enrollment in 2026.

A particularly notable advantage: Ovaprene operates through a dual mechanism combining physical and chemical action. The device features a proprietary knitted polymer barrier that blocks sperm entry into the cervical canal, while a silicone-reinforced ring releases ferrous gluconate—a non-hormonal agent—to impede sperm motility. It’s inserted at the end of one menstrual cycle and removed at the start of the next, requiring no fitting and minimal user intervention.

Funding Without Compromise

The Gates Foundation’s backing provides crucial support for Daré’s continued development efforts. The previously announced grant funding ensures that trial operations can continue without timeline disruptions or operational changes. This non-dilutive capital structure is essential for biotech firms seeking to maintain control during late-stage development.

The combination of external funding support and Daré’s now-complete ownership creates a favorable environment for accelerated progress. The company is freed from navigating another entity’s strategic priorities while retaining financial resources to drive the program forward.

Strategic Flexibility and Market Opportunities

With global rights consolidated, Daré is positioned to evaluate multiple commercialization pathways. The company believes Ovaprene will attract broad interest from pharmaceutical organizations, consumer health companies, and other strategic partners.

“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 stated.

This expanded optionality represents a key strategic advantage. Daré can now:

• Structure partnerships that reflect the asset’s true value
• Explore direct-to-consumer models if appropriate
• Consider geographic licensing arrangements
• Retain higher economic upside than a traditional licensing-out arrangement would provide

Timeline and Regulatory Strategy

The roadmap ahead is clearly defined:

• 2026: Phase 3 enrollment expected to complete
• Grant-supported operations: Trial continues with full funding
• FDA pathway: Premarket approval (PMA) strategy with the Center for Devices and Radiological Health (CDRH) as lead review division
• Global expansion: Increasing international recognition of non-hormonal contraception demand

This regulatory approach treats Ovaprene as a medical device rather than a pharmaceutical, which may offer a distinct advantage in the approval timeline and pathway complexity.

The Broader Women’s Health Context

Daré Bioscience positions itself as addressing a critical gap in women’s reproductive health. The company’s mission extends across contraception, menopause management, pelvic pain, fertility support, vaginal health, and infectious disease prevention.

The landscape for women’s health innovation is shifting. Growing public awareness of menopause, sexual wellness, and vaginal health has elevated these topics in medical and consumer conversations. Yet access to evidence-based solutions remains constrained.

Ovaprene, if approved, would represent a meaningful expansion of options for women seeking non-hormonal contraception. Current monthly intravaginal products all contain hormones; this would be the first hormone-free alternative in that category.

What’s Next

The return of Ovaprene to Daré’s portfolio removes a layer of complexity from its development path. The company is now free to pursue the commercial strategy that best serves its long-term interests and positions the asset for maximum value realization.

With positive interim clinical data, grant funding support, and ownership consolidation now in place, Ovaprene’s trajectory through Phase 3 completion and regulatory approval appears more streamlined. Daré’s expanded strategic options—whether through partnerships, alternative commercialization models, or full independent launch—provide multiple pathways to bring this first-in-category contraceptive to market.

The biotech company’s leadership team believes the timing and combination of factors position Ovaprene as one of the sector’s most promising assets in the women’s health pipeline. The next critical milestone arrives in 2026 with Phase 3 enrollment completion, followed by the regulatory and commercial inflection points that will determine this product’s ultimate market impact.