Company: DARE
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001401914-25-000050
Chunk: 96

Company: Dare Bioscience, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 2
Chunk 96
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 include contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health, and menopause. 

Our business is subject to a number of risks common to biopharmaceutical companies and the process of developing, obtaining regulatory approvals for, and commercializing 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.  See our discussion of many of these risks under the section entitled “Risk Factors” in Item 1A of Part I of our 2024 10-K and Part II of this report.

Section 503B Compounding

As discussed above, we are working to bring to market select proprietary formulations via Section 503B-registered outsourcing facilities. In assessing which of our proprietary formulations are candidates for Section 503B compounding, in addition to the drug substance(s) being on the FDA’s interim Category 1 list of bulk drug substances, we take into account whether we believe the formulation is ready for cGMP manufacturing at scale to meet potential demand and that the data from nonclinical and clinical studies of the formulation to date will be compelling to healthcare providers. We do not believe bringing those proprietary formulations to market via Section 503B compounding will negatively impact the regulatory process or commercial opportunity for an FDA-approved product utilizing the same proprietary formulation.

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To execute our Section 503B compounding strategy, among other things, we have entered into and will need to maintain arrangements with one or more 503B-registered outsourcing facilities and other third parties with marketing, sales or distribution capabilities in the Section 503B market, and we intend to expand our collaborations, including by establishing relationships with telehealth platforms. We intend to focus our resources on provider-to-provider education about disease state and our proprietary formulations, leveraging online resources, including web-based ordering platforms and collaborations with telehealth platforms and other third parties. We do not plan to establish marketing, sales or distribution capabilities in order to bring our proprietary formulations to market under Section 503B.

When we use the term “Section 503B compounding” or “Section 503B,” we refer to the production and supply of compounded drugs by Section 503B-registered outsourcing facilities without patient-specific prescriptions in accordance with Section 503B of the FDCA.

DARE to PLAY™ Sildenafil Cream

Our proprietary topical cream formulation of sildenafil will be our first product to market under Section 503B. The compounded drug will be branded as DARE to PLAY