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Dare Bioscience Inc. (DARE+0.34%) has filed its Form 10-K filing for the fiscal year ended December 31, 2024.
The filing outlines the company's financial condition, including an accumulated deficit of approximately $175.3 million and cash and cash equivalents of $15.7 million as of December 31, 2024. Dare Bioscience reports a working capital deficit of approximately $3.2 million and indicates a need for substantial additional capital to continue operations.
The report details the company's ongoing development programs in women's health, including its lead candidates Ovaprene, a hormone-free contraceptive, and Sildenafil Cream, intended for female sexual arousal disorder. Both candidates are in various stages of clinical development.
Dare Bioscience highlights its reliance on third-party collaborations for product development and commercialization. The company has exclusive license agreements with Organon for XACIATO, a treatment for bacterial vaginosis, and Bayer for Ovaprene, contingent on Bayer's election to make the license effective.
The filing discusses the company's strategic focus on utilizing the FDA's 505(b)(2) pathway for regulatory approval of its clinical-stage product candidates, except for Ovaprene, which is considered a combination product.
Dare Bioscience addresses the risks related to its financial position, including the need to raise additional capital and the potential impact of macroeconomic factors on its ability to secure funding.
The company outlines the competitive landscape in women's health, noting the presence of established pharmaceutical companies and the availability of generic and compounded drugs, which may affect the commercial success of its products.
Dare Bioscience also notes the regulatory challenges and uncertainties inherent in the development and approval process for its product candidates, emphasizing the importance of successful clinical trials and regulatory submissions.
The filing includes a summary of the company's strategic agreements for product development and commercialization, highlighting its reliance on third-party manufacturers and suppliers for clinical and commercial supply of its product candidates.
Dare Bioscience acknowledges the potential impact of legislative and regulatory changes on its business, particularly those related to health care costs and drug pricing, which could affect the reimbursement and market acceptance of its products.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Dare Bioscience Inc. annual 10-K report dated March 31, 2025. To report an error, please email earnings@qz.com.