Dare Bioscience (NASDAQ: DARE) is a clinical-stage biopharmaceutical company focused exclusively on women's health that develops and seeks regulatory approval for product candidates across contraception, sexual health, fertility, and hormone therapy. The company has not generated meaningful product revenue; its primary cash inflows have come from licensing arrangements and the sale of royalty and milestone rights, including a transaction with XOMA in which Dare received $22.0 million (net of approximately $1.6 million in transaction costs) in exchange for future royalty and milestone payments tied to XACIATO. XACIATO is licensed to Organon for commercialization. As of December 31, 2025, Dare carried an accumulated deficit of approximately $188.7 million, reported a net loss of approximately $13.4 million, and negative operating cash flows of approximately $9.9 million for the year ended December 31, 2025. The company disclosed substantial doubt about its ability to continue as a going concern within 12 months of the March 26, 2026 filing date.
- Revenue model
- Revenue has consisted of license fees and other revenue, with no material product sales reported in FY2025 or FY2024 per the consolidated statements of operations filed March 26, 2026. The company monetized future royalties on XACIATO through a royalty purchase agreement with XOMA. Additional potential revenue pathways include Section 503B compounding arrangements for proprietary formulations such as sildenafil cream (DARE to PLAY) and future milestone payments contingent on clinical and regulatory outcomes.
- Products and services
- Pipeline and commercial-stage assets include XACIATO (licensed to Organon), Ovaprene (contraceptive), sildenafil cream sold as a compounded drug under the brand DARE to PLAY through Bravado Pharmaceuticals and Medvantx, DARE-HRT1 and DARE to RECLAIM (intravaginal rings for hormone therapy), DARE-FRT1 (luteal phase support in IVF), DARE-PTB1 (preterm birth prevention), and Casea S (investigational biodegradable contraceptive implant releasing etonogestrel for 18 to 24 months). DARE-FRT1 and DARE-PTB1 are being developed under a license with Catalent JNP, Inc. and target the FDA 505(b)(2) approval pathway.
- Customers and end markets
- End markets are women's health: contraception, sexual dysfunction, assisted reproduction, preterm birth prevention, and hormone therapy. Commercial partners and channel participants include Organon (XACIATO licensee), Bravado Pharmaceuticals (manufacturing and prescription fulfillment for DARE to PLAY), and Medvantx (logistics, telehealth, and dispensing pharmacy for DARE to PLAY). The company discloses no direct patient or institutional customer concentration data in the excerpts reviewed.
- Value-chain role
- Dare acts as a drug developer and licensor, relying on third-party manufacturers, outsourcing facilities, dispensing pharmacies, and commercial partners for manufacturing and distribution. It does not operate its own manufacturing or commercial sales infrastructure. Regulatory strategy includes the FDA 505(b)(2) pathway and Section 503B compounding frameworks.
- Geographic exposure
- The company references Australian R&D tax incentives, suggesting some development activity in Australia, and notes GDPR compliance obligations indicating EU clinical trial activity. Primary regulatory focus is the U.S. FDA. No revenue breakdown by geography is provided in the excerpts.
Source: SEC 10-K, filed 2026-03-26
Industry:
Pharmaceutical Preparations
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