Risk factors

Dare Bioscience (DARE) risk factors

Item 1A of every Dare Bioscience, Inc. 10-K on file, and what changed from one year to the next.

  • FY2025 10-K risk factors

    78 risks, 15 new, 12 dropped, 18 reworded since the prior year. Terminated the Bayer license agreement for Ovaprene, requiring a new commercial partner. Launched the DARE to PLAY 503B compounded drug strategy using outsourcing facilities and telehealth platforms. Faced FDA regulatory scrutiny regarding radical transparency and public release of complete response letters.

    Filed Mar 26, 2026
  • FY2024 10-K risk factors

    75 risks. DaRE Bioscience faces heavy reliance on commercial partners like Organon and Bayer for revenue and product success. The company requires substantial additional capital to fund operations and develop its clinical pipeline. Extensive regulatory requirements and intense competition in women's health threaten long-term commercial viability.

    Filed Mar 31, 2025