Dare Bioscience, Inc. reported a net loss of $4.1 million for the fiscal year ended December 31, 2024, a significant improvement from the $30.2 million net loss in 2023. Revenue for 2024 totaled $9,784, a substantial decrease from $2.8 million in 2023. This decrease is primarily attributed to a decline in license fee and milestone revenue, offset partially by an increase in royalty revenue. Operating expenses decreased by 30% to $23.5 million, driven by reductions in general and administrative and research and development expenses. The significant increase in other income, totaling $20.4 million, resulted from the sale of royalty and milestone rights to XOMA.
A key development during the year was the sale of Dare Bioscience's rights to future royalty and milestone payments from Organon for XACIATO (clindamycin phosphate) vaginal gel 2%, to XOMA for $22 million. This transaction, along with a portion of potential future payments from Bayer for Ovaprene and a portion of future net sales of Sildenafil Cream, was structured as a traditional and synthetic royalty purchase agreement. The company also entered into a co-development and licensing agreement with Theramex for Casea S, a biodegradable contraceptive implant. Dare Bioscience received a royalty-free, exclusive license to U.S. patents for Casea S.
The company's research and development expenses decreased by 34% to $14.2 million in 2024 compared to 2023. This decrease was primarily due to the completion of the Phase 2b RESPOND clinical study for Sildenafil Cream, partially offset by increased costs associated with the ongoing Phase 3 clinical trial for Ovaprene. Dare Bioscience also received several grant awards during the year, including $2.5 million for DARE-LARC1, $1 million from NIAID for DARE-HPV, and $5.4 million from the Gates Foundation to support the Ovaprene Phase 3 study and the identification of a new non-hormonal contraceptive. As of March 28, 2025, the company employed 23 people.
Dare Bioscience's most advanced product candidates include Ovaprene (currently in a pivotal Phase 3 clinical study), Sildenafil Cream (preparing for Phase 3), and DARE-HRT1 (preparing for an IND submission). The company is also pursuing a dual-path strategy for Sildenafil Cream, aiming for both FDA approval and market entry via 503B compounding by the fourth quarter of 2025. The company's financial statements reflect substantial doubt about its ability to continue as a going concern due to its history of losses and dependence on securing additional capital.
In February 2025, Dare Bioscience received notification from Nasdaq that it did not meet the minimum market value of listed securities requirement. The company requested a hearing before the Nasdaq Hearing Panel, which was held on March 25, 2025. The outcome of this hearing remains pending, and the company acknowledges the risk of delisting from Nasdaq. The company's outlook is contingent upon securing additional capital to fund its operations and advance its product pipeline.
About Dare Bioscience, Inc.
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