Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 228

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 228
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 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 successfully identify and enter into satisfactory arrangements with one or more 503B-registered outsourcing facilities, and we intend to focus our resources on provider-to-provider education about disease state and our proprietary Sildenafil Cream formulation, leveraging online resources, including web-based ordering platforms and collaborations with telehealth platforms and providers. We anticipate needing to invest no more than $1.0 million to support a 503B-registered outsourcing facility with technology-transfer activities specific to our Sildenafil Cream formulation, activate an awareness campaign, and facilitate access to our proprietary Sildenafil Cream formulation as an option for providers and women. We are targeting the second quarter of 2025 to provide an update on the strategic partnerships to achieve these objectives. Noncompliance with Nasdaq’s Minimum Market Value of Listed Securities Requirement On August 12, 2024, we received a letter from The Nasdaq Stock Market LLC, or Nasdaq, notifying us that we do not meet the requirement in Nasdaq Listing Rule 5550(b)(2) for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(2) requires a company listed on Nasdaq to maintain a minimum market value of listed securities