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- **Commercial Milestone**: DARE to PLAY Sildenafil Cream launched Q4 2025 via 503B, targeting $1.2B women's sexual health market.
- **Pipeline Progress**: Phase III Ovaprene contraceptive trial on track for 2026 completion; DARE-HPV intravaginal therapy IND filing underway.
- **Financial Strength**: $23M cash, $31M+ grants fund R&D; 503B launches position for near-term revenue.
- **FDA Strategy**: Dual-path approach for DARE to RECLAIM hormone therapy (503B Q1 2027 + FDA) capitalizes on FDA policy shift.

**【CEO Summary Section】**
- Launched DARE to PLAY Sildenafil Cream via 503B outsourcing facility in December 2025, targeting women's sexual health market with first FDA-backed topical Sildenafil formulation.
- Expanded commercial portfolio with DARE to RESTORE vaginal probiotics (Q1 2026 launch) and DARE to RECLAIM compounded hormone therapy (Q1 2027 launch).
- Advanced R&D pipeline with Phase III Ovaprene contraceptive trial (enrollment completion expected 2026), DARE-HPV intravaginal therapy (IND filing underway), and DARE-LARC1 long-acting contraceptive (preclinical stage).
- Leveraged $31M+ nondilutive grant funding from NIH, ARPA-H, and Gates Foundation to support clinical programs.

**【CFO Financial Commentary】**
- Ended Q3 2025 with $23M cash, up from $18.7M net proceeds from stock sales and $7.3M grants.
- G&A expenses rose 25% YoY to $2.5M due to commercial readiness and professional services.
- R&D expenses fell 56% YoY to $1.2M due to grant offsets, partially offset by new program costs.
- Maintained $3.8M working capital despite $3.7M net cash outflow.

**【Q&A Highlights】**
- FDA reversal on hormone therapy guidance validates DARE to RECLAIM's non-oral estradiol/progesterone ring strategy, with 503B launch in Q1 2027 and parallel FDA path.
- DARE to PLAY Sildenafil Cream will use Medvantx telehealth platform for prescriptions, with Google Ads and influencer partnerships planned for 2026.
- ATM limited by baby shelf rules, but $31M+ grants provide capital for clinical programs.
- Prioritizing Ovaprene (Phase III), DARE-HPV (IND), and DARE-LARC1 (preclinical) as highest-impact R&D programs.

Daré Bioscience, Inc. (DARE) Q3 2025 Earnings Call Transcript

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DARE

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