Daré Bioscience (DARE) Q1 2026 earnings summary

Executive summary

• Focused on women's health with a comprehensive pipeline in contraception, menopause, sexual health, fertility, vaginal health, and HPV, advancing both clinical and preclinical candidates.

• Dual-path strategy: commercializing proprietary formulations via 503B compounding and pursuing FDA approval, with initial launches for DARE to PLAY, Flora Sync LF5, and DARE to RECLAIM in 2026–2027.

• Transitioning to a revenue-generating company, with first direct product revenue expected in June 2026 from Flora Sync LF5 and DARE to PLAY dispensing targeted for summer 2026.

• Pipeline includes first-in-category assets, many supported by non-dilutive grant funding, and XACIATO commercialized via Organon with royalty rights sold to XOMA.

• Ovaprene Phase 3 and DARE-HPV Phase 2 are key clinical programs advancing with positive interim data and federal grant support.

Financial highlights

• Q1 2026 revenue was $152,455, up 500% year-over-year, mainly from R&D services agreements with the Gates Foundation.

• Net loss for Q1 2026 was $2.99 million, improved from $4.38 million in Q1 2025; SG&A expenses were $2.2 million, and R&D expenses were $0.7 million, both down year-over-year.

• Cash and cash equivalents as of March 31, 2026, were $18.5 million, with $0.5 million in working capital.

• Deferred grant funding liability was $18.2 million, reflecting significant non-dilutive funding.

• Received $13.6 million from Gates Foundation, $9 million from ARPA-H, and $1.3 million from NIH as of May 2026.

Outlook and guidance

• First product revenue expected in June 2026 from Flora Sync LF5 and in Q3 2026 from DARE to PLAY; DARE to RECLAIM revenue targeted for 2027.

• Ovaprene Phase 3 enrollment to complete in 2026, with primary endpoint analysis in 2027.

• DARE-HPV Phase 2 to begin in May 2026, supported by ARPA-H funding.

• Cash runway expected to fund operations into Q4 2026, but substantial doubt exists about ongoing viability without new capital.