Daré Bioscience (DARE) investor relations material

Executive summary

• Accelerated dual-path strategy: commercializing proprietary formulations via 503B compounding and pursuing FDA approval, with a focus on earlier market access and long-term value creation in women's health, including contraception, sexual health, and menopause.

• DARE to PLAY Sildenafil Cream on track for Q4 2025 launch via 503B compounding, with near-term revenue expected to begin in Q4 2025.

• Portfolio targets unmet needs in women's health, with multiple grant-funded programs advancing, including DARE-HPV, DARE-LARC1, and preterm birth initiatives.

• No internal sales or marketing infrastructure; commercialization relies on third-party partnerships and collaborations.

• XACIATO, the first FDA-approved product, is marketed by Organon; rights to future royalties and milestones sold to XOMA in April 2024.

Financial highlights

• Ended Q2 2025 with $5.0 million in cash and cash equivalents and a working capital deficit of $12.6 million.

• Post-quarter, raised $17.6 million from common stock sales and received a $6.0 million grant, significantly strengthening the balance sheet.

• Net loss for Q2 2025 was $4.0 million, compared to net income of $12.9 million in Q2 2024, mainly due to the absence of one-time royalty sale income.

• Operating expenses decreased 48% year-over-year to $3.8 million, with R&D expenses down 71% to $1.4 million, driven by increased grant offsets and lower program costs.

• Revenue for Q2 2025 was negative $21,172 due to an adjustment for lower actual royalty revenue than previously estimated.

Outlook and guidance

• DARE to PLAY Sildenafil Cream expected to launch commercially in Q4 2025 via 503B compounding, with product revenue anticipated to begin the same quarter.

• DARE HRT1 intravaginal ring targeting late 2026 availability through 503B outsourcing, with parallel FDA approval efforts.

• Two non-prescription vaginal probiotics planned for launch following DARE to PLAY, expanding consumer health offerings.

• Additional capital required to advance pipeline programs not supported by grants; recent equity raise and grant mitigate near-term liquidity risk, but substantial doubt remains about ability to continue as a going concern.

• Ongoing focus on Ovaprene Phase 3 study, Section 503B compounding, and grant-supported programs like DARE-LARC1 and DARE-HPV.