Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 5

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 7
Chunk 5
---
 expenses will be supported by non-dilutive funding, with respect to DARE-LARC1, through at least 2026, and with respect to DARE-HPV, through October 2026. See Note 15, "Grant Awards" to the accompanying consolidated financial statements for additional information.

As discussed below, we will need to raise substantial additional capital to continue to fund our operations and execute our current business strategy. Our business is subject to a number of risks common to biopharmaceutical companies (see ITEM 1A. RISK FACTORS in Part I of this report) and the process of developing and obtaining regulatory approvals for prescription drug and drug/device products in the United States and in foreign jurisdictions is inherently uncertain and requires the expenditure of substantial financial resources without any guarantee of success. The commercialization of a product and compliance with applicable laws and regulations requires the expenditure of further substantial financial resources without any guarantee of commercial success. The amount of post-approval financial resources required for commercialization and the potential revenue we may receive from sales of any product will vary significantly depending on many factors, including whether, and the extent to which, we establish our own sales and marketing capabilities and/or enter into and maintain commercial collaborations with third parties with established commercialization infrastructure. 

Recent Events

Bringing Sildenafil Cream to Market under Section 503B

We are taking action to bring our proprietary Sildenafil Cream formulation to market under Section 503B of the FDCA, and we expect to begin recording revenue from sales therefrom, in the fourth quarter of 2025. See ITEM 1. “BUSINESS–503B Compounding” in Part I of this report for additional information. 

Bringing our proprietary Sildenafil Cream formulation to market under Section 503B is part of our dual-path approach to bring some of our proprietary formulations to market as soon as practicable because we believe women should not have to wait for a needed solution while we continue to pursue FDA approval of our product candidates. In parallel, we will continue to pursue FDA approval of Sildenafil Cream as a treatment for FSAD. Bringing our proprietary Sildenafil Cream formulation to market via 503B compounding will not impact the regulatory process or commercial opportunity for an FDA-approved Sildenafil Cream product. Rather, if successful, 503B compounding will be a source of revenue from existing assets that is non-dilutive to our stockholders.

To bring our proprietary Sildenafil Cream formulation to market under Section 503B, among other things, we will need to