Company: DARE
Filing Date: 2025-08-14
Form Type: 10-Q
Source: 0001401914-25-000044
Chunk: 91

Company: Dare Bioscience, Inc.
Filing Date: 2025-08-14
Form: 10-Q
Item: Part I, Item 2
Chunk 91
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 are a biopharmaceutical company solely focused on closing the gap in women's health between promising science and real-world solutions. Our mission is to accelerate innovation in women’s health by advancing evidence-based solutions that address decades of unmet needs. We believe innovation in women's health does not always have to start from scratch it can also come from rethinking how and when innovation reaches women. 

With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting. However, access to real, evidence-based solutions continues to lag. We regularly hear from healthcare providers, researchers, and women themselves about the urgent need for expanded access to evidenced-based and convenient options. Our goal is to fulfill that need by bringing innovative products to market as soon as practicable whether as FDA-approved therapies or through alternative regulatory pathways that enable earlier availability, such as Section 503B compounding.

In March 2025, we announced an expansion of our business model to include a dual-path approach to bringing new products to market. For select proprietary formulations, we are pursuing both traditional FDA approval and earlier market access via outsourcing facilities registered under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA), which may compound and distribute certain drugs without patient-specific prescriptions. We believe this strategy allows us to respond to clinician and patient demand for timely access while continuing to generate the data necessary to seek FDA approval and support long-term value creation.

We do not have sales, marketing or distribution infrastructure, and currently, we do not intend to build our own sales force or marketing and distribution infrastructure. However, reflecting the shift in our business model, we will be allocating resources to support commercial execution activities, including third-party manufacturing, market preparation, and strategic partnerships. In addition to prescription-based offerings — both FDA-approved products and compounded drugs— we intend to bring to market select consumer health products that do not require a physician’s prescription, where appropriate based on product profile and market opportunity.

Our diverse portfolio of proprietary programs, assembled through acquisitions, exclusive in-licenses, and collaborations, targets product categories we believe represent meaningful opportunities to improve women's health and quality of life. These include contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health, and menopause. 

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Our business is subject to a number of risks common to biopharmaceutical companies (see ITEM 1A. RISK FACTORS in Part I of our 2024 10-K) and the process of developing, obtaining regulatory approvals for, and commercial