Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 93

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 93
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 Practice, or cGMP, requirements and FDA inspections, may provide compounded drugs without an individual patient prescription. See "Government Regulation—U.S. Government Regulation—Regulation of Compounded Drugs” below for additional 

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information regarding compounding under Section 503B of the FDCA. We are targeting to make our proprietary Sildenafil Cream formulation available in the fourth quarter of 2025. For additional information, see ITEM 7. “MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS–Recent Events–Sildenafil Cream as a Compounded Drug,” below. 

Our Pipeline: Pre-Clinical Stage Programs

Our pre-clinical stage programs include: 

•DARE-LARC1, a contraceptive implant delivering levonorgestrel with a woman-centered design that has the potential to be a long-acting, yet convenient and user-controlled contraceptive option; 

•DARE-RH1, a novel approach to non-hormonal contraception for both men and women by targeting the CatSper ion channel; and

•DARE-PTB2, a novel approach for the prevention and treatment of idiopathic preterm birth through inhibition of a stress response protein.

DARE-LARC1, our potential user-controlled, long-acting reversible contraceptive, is designed to store and precisely deliver hundreds of therapeutic doses of the contraceptive levonorgestrel over a period of years and to be controlled by the user, without further intervention by a healthcare provider. DARE-LARC1’s woman-centered design seeks to offer the benefits of traditional long-acting reversible contraceptives with the added flexibility and convenience for the user to pause and resume release of levonorgestrel, depending on her desire for fertility or contraceptive protection. Under a grant agreement we entered into in June 2021, as amended, we may receive up to approximately $49.0 million, payable over approximately five years, to advance development of the technology through nonclinical proof of principle studies to enable an IND submission. As of the date of this report, we have received payments totaling approximately $31.8 million under the grant agreement. Additional payments are contingent upon the DARE-LARC1 program's achievement of development and reporting milestones specified in the grant agreement.

The DARE-LBT program has been supported by a private foundation grant of approximately $585,000 under a grant agreement that we entered into in November 2022. The grant funds supported activities related to development of a vaginal thermosetting gel formulation