Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 37

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 37
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 surgical removal by a healthcare provider, which would improve convenience and could eliminate one of the barriers to use associated with existing implanted contraceptives. Casea S is being tested in a single-center, two-part Phase 1 clinical study to evaluate the PK of etonogestrel, removability, safety, and tolerability of Casea S pellets inserted subdermally in healthy women of reproductive age (ClinicalTrials.gov ID: NCT05174884). The ongoing Phase 1 study is being conducted by FHI 360, a nonprofit organization, with support from the Foundation. There are no development costs to us at this time. Casea S was recently acquired by Theramex. In February 2025, we entered into a co-development and licensing agreement with Theramex for the development of Casea S in the U.S. If we determine that the results from the Phase 1 study are positive and elect to proceed with development, we would be responsible for conducting a Phase 2 study in the U.S., In accordance with our agreement, the costs of such Phase 2 study would be shared by us and Theramex on terms to be agreed upon, taking into account the size of the opportunity for Casea S in our respective markets. See "Strategic Agreements for Pipeline Development" below for discussion of the terms of that agreement. 503B Compounding Sildenafil citrate is currently listed as a nominated bulk drug substance that may be used in compounding by 503B-registered outsourcing facilities, and we are taking action to make our proprietary Sildenafil Cream formulation available via prescription under Section 503B of the FDCA. Under Section 503B of the FDCA, outsourcing facilities, which must be registered with the FDA and are subject to current Good Manufacturing Practice, or cGMP, requirements and FDA inspections, may provide compounded drugs without an individual patient prescription. See "Government Regulation—U.S. Government Regulation—Regulation of Compounded Drugs” below for additional 17

information regarding compounding under Section 503B of the FDCA. We are targeting to make our proprietary Sildenafil Cream formulation available in the fourth quarter of 2025. For additional information, see ITEM 7. “MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS– Recent Events–Sildenafil Cream as a Compounded Drug,” below. Our Pipeline: Pre-Clinical Stage Programs Our pre-clinical stage programs include: • DARE-LARC