Dare Bioscience, Inc. Q1 FY2025 earnings call

• Daré is using a dual path strategy: commercializing proprietary formulations via 503B compounding while seeking FDA approval and launching certain solutions as branded consumer health products without a prescription. • Upcoming products include Sildenafil Cream, 2 vaginal probiotics in 2025, and a monthly hormone therapy in 2026, with the hormone therapy creating a $4.5 billion compounding market opportunity. • Ovaprene's pivotal Phase 3 contraceptive efficacy study is ongoing, with a Safety Data Monitoring Board meeting scheduled for July 2025. • Sildenafil Cream is in interaction with the FDA regarding Phase 3 study design, targeting submission of additional info by end of Q2 2025. • DARE-HPV is an investigational treatment for HPV-related cervical diseases, with progress towards a Phase 2 clinical study supported by a $10 million award. • Strategic partnerships and collaborations are being sought to facilitate access to Daré's products across multiple channels.

No detailed financial performance for specific product segments was provided in the transcript. General and administrative expenses were approximately $2.3 million, a 14% decrease from Q1 2024. R&D expenses were approximately $2.3 million, a 31% decrease from Q1 2024. Comprehensive loss for the quarter was approximately $4.4 million.

• Expect to start recording revenue in the fourth quarter of 2025. • Target submission of additional information requested by the FDA along with the protocol and statistical analysis plan for Sildenafil's Phase 3 study by the end of Q2 2025. • Ovaprene's Safety Data Monitoring Board meeting is scheduled for July 2025, with updates to follow. • Plans to continue providing updates on therapeutic development programs and commercialization progress.

• Actual results could differ materially from forward-looking statements due to known and unknown risks and uncertainties as outlined in the company's SEC filings. • No specific operational failures were discussed in detail in the transcript.

Q: Would there be unique partnerships for each product or multiple partnerships for an individual product?

A: Both. Multiple partnerships for an individual product to ensure wide access, and potential for multiple Daré products on individual platforms.

Q: What additional information has the FDA requested regarding Sildenafil Phase 3?

A: Additional input and information requests from the FDA regarding patient reported outcomes psychometrics, with targeting submission of additional info along with protocol and statistical analysis plan for Phase 3 by end of Q2 2025.

Q: Can you provide additional information on the potential outcomes of the interim assessment for Ovaprene?

A: It's a safety meeting; the board is looking at safety and integrity, not statistical assessment of primary endpoint, so no opportunity to increase sample size.

Q: Are you pursuing a dual path for all four products mentioned?

A: Sildenafil and hormone therapy are dual path; vaginal probiotics are consumer health brands, not pursuing dual path.

Q: Does the grant received for Ovaprene cover cost to add additional sites?

A: The grant is designed to cover cost of adding additional subjects, with flexibility to add more sites.

Q: Will there be additional costs for additional products besides Sildenafil?

A: Similar ballpark costs for hormone therapy, related to supporting 503B manufacturers with GMP production activities, but specific to each product.