Dare Bioscience, Inc. Q3 FY2024 earnings call

• Daré has over $20 million in non-dilutive funding in the last 30 days.
• Focused on women's health pharmaceutical product development across contraception, sexual health, etc.
• XACIATO commercialization with Organon: steady month-over-month prescription increases, progress in go-to-market fulfillment and coverage.
• Sildenafil Cream: constructive interactions with FDA on Phase III development endpoints.
• Ovaprene: Phase III enrollment ongoing, grant from Gates Foundation to add sites and accelerate timeline.
• DARE-HPV: $10 million ARPA-H award for Phase II study.
• DARE-VVA1: preparation for Phase II clinical trial.
• DARE-PTB1: $2 million NICHD grant for Phase I study.
• Gates Foundation grant: supports Ovaprene and non-hormonal contraceptive development.

In the third quarter of 2024, general and administrative expenses were approximately $2 million, a 24% decrease compared to Q3 2023, primarily due to reduced professional services and commercial readiness expenses. R&D expenses were approximately $2.7 million, a 60% decrease compared to Q3 2023. The comprehensive loss for the third quarter was approximately $4.7 million. The company ended the third quarter with approximately $11.2 million in cash and cash equivalents and had approximately 8.7 million shares of common stock outstanding as of November 13.

• Full year 2024 R&D expenses expected to be less than 2023 R&D expenses.
• Anticipated meaningful milestones in 2025 with recent non-dilutive funding.
• Expectation to accelerate Ovaprene study with added sites from Gates Foundation grant.

Q: Congrats on Ovaprene enrollment, any interim look by end 2Q'25? What to look for?

A: Discussed interim look involves DSM monitoring safety, data consideration with Bayer as contraceptive rates improve over time. More updates to come as closer to time point.

Q: Sildefanil operational progress and time frame once FDA aligned and with funding?

A: Discussed focus on Phase III endpoints with FDA, operational progress includes protocol alignment, study start-up taking weeks including contracting sites, IRB, etc. Once FDA aligned and funding, study start-up possible next year with traditional study start-up activities.

Q: How soon to initiate Sildefanil trial if funded next month?

A: Study start-up takes weeks including contracting sites, IRB, etc., so could start next year once final protocol aligned with FDA.

Q: Ovaprene new sites, how soon they can enroll and proportion of enrollment?

A: New sites are experienced, expect quick onboarding. They can contribute meaningfully to enrollment, also help with diversity in study participants.

Q: Sildefanil funding needs, amount per study?

A: Estimates ~$15 million in direct external costs per Sildefanil study, total ~$30 million for two studies, but not all needed upfront as study period is short.