Dare Bioscience, Inc. Q3 FY2025 earnings call

• Dual path strategy: Commercializing proprietary formulations through 503B compounding while pursuing FDA approval and advancing select solutions as branded consumer health products.
• DARE to PLAY Sildenafil Cream: On track to be available via 503B outsourcing facility before end of 2025, with launch in select states in December and all 50 states in early 2026.
• DARE to RESTORE: Proprietary vaginal probiotic products targeting vaginal microbiome, targeting Q1 2026 launch in US.
• DARE to RECLAIM: Estradiol and progesterone intravaginal ring for perimenopause and menopause, targeting early 2027 availability, pursuing both FDA approval and 503B compounding.
• Clinical pipelines: Ovaprene in pivotal Phase III study for contraception, DARE-HPV for persistent high-risk HPV infection, DARE-LARC1 preclinical long-acting contraceptive, and Daré NHC nonhormonal contraceptive program, all advanced with grant funding.

During the third quarter, Daré received approximately $18.7 million in net proceeds from sales of common stock and $7.3 million in grant payments. G&A expenses were $2.5 million compared to $2 million in Q3 2024. R&D expenses were $1.2 million compared to $2.7 million in Q3 2024, a 56% decrease. The company ended the quarter with approximately $23 million in cash and cash equivalents and working capital of approximately $3.8 million.

• DARE to PLAY Sildenafil Cream: On track for launch via 503B outsourcing facility before end of 2025, with select states in December and all 50 states in early 2026.
• DARE to RESTORE: Targeting Q1 2026 availability in US.
• DARE to RECLAIM: Targeting early 2027 availability.
• Ovaprene: Anticipated enrollment completion in 2026.

• Actual results or events could differ materially from forward-looking statements due to known and unknown risks and uncertainties, as outlined in the company's SEC filings.
• Uncertainties related to FDA approval processes for various products.

Q: Comment on FDA's recent reversal and guidance on hormone replacement therapy and menopause, and feedback on DARE to RECLAIM.

A: Sabrina was thrilled by FDA's change, DARE to RECLAIM is a vaginal ring with estradiol and progesterone, pursuing both FDA approval and 503B compounding for faster access.

Q: How prioritizing R&D programs with cash runway?

A: Prioritizing DARE to PLAY Sildenafil Cream, DARE to RECLAIM, DARE to RESTORE, grant-funded programs like Ovaprene, DARE-HPV, DARE-LARC1, and programs with clear market path.

Q: ATM and additional capacity?

A: Limited by baby shelf restrictions, so not able to use ATM significantly at present.